510K Brightspeed Series

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OCT 08 2008

(0) GE Healthcare
3000 N. Grandview Blvd, W-1 140
Waukesha, WI 53188

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS


This 510(k) summary of Safety and Effectiveness information is submitted in
accordance with the requirement of 21 CFR Part 807.87(h).

Submitter:
Name: GE Medical Systems, LLC (GE Healthcare)
Address: 3000 N. Grandview Blvd., W-1140
Waukesha, WI 53188
Contact: Steve Kachelmeyer
Premarket Regulatory Affairs Program Manager
Tel: 262-548-2432, Fax: 262-997-1080
e-mail: Steven.Kachelmeyer~med.ge.com
Date Prepared: August 11, 2008

PRODUCT IDENTIFICATION

Name: GE BrightSpeed Series CT


(Also known as BrightSpeed Delight Series CT
Scanner System)
Classification Name: Computed Tomography X-ray System
21 CFR892.1750, 90-JAK
Manufacturer: GE Yokogawa Medical Systems
7-127 asahigaoka 4-chome
Hino-shi, Tokyo, Japan 191-8503

GE Hangwei Medical Systems Co. Ltd.


No 1 Young Change North Rd
Beijing Economic and Tech Development Zone
Beijing, China 100176

Future Production may also be accomplished at one of our


other registered CT Manufacturing facilities.
Distributor: GE Medical Systems LLC. (GE Healthcare)
3000 N. Grandview Blvd.
Waukesha, WI 53188

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Marketed Devices: The GE BrightSpeed Delight series CT Scanner System (aka
GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed
Edge Select, and BrightSpeed Excel Select) is of
comparable type and substantially equivalent to GE's
currently marketed Computed Tomography X-ray Systems
that comply with the same or equivalent standards and have
similar intended uses, such as the previous StarSpeed CT
Scanners.

Predicate Device(s):

GE StarSpeed Series CT Scanner System (K052855)

DEVICE DESCRIPTION

The GE BrightSpeed Delight Series CT Scanner System (aka GE BrightSpeed Elite,


BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is
composed of a gantry, patient table, operator console, computer, and PDU and includes
image acquisition hardware, image acquisition and reconstruction software, associated
accessories and connections/interfaces to accessories. The GE BrightSpeed Delight
Series CT Scanner System is an evolutionary modification to StarSpeed Series CT
system (K052855). It is developed from the hardware platform of StarSpeed system by
adding new application features that involve changes in hardware, software, firmware,
recon, and scan mode.
The GE BrightSpeed Delight Series CT Scanner System is designed to be a head and
whole body CT scanner incorporating the same basic fundamental operating principles
and similar Indications for Use. Materials and construction are equivalent to our existing
marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated
collateral and particular standards, and 21CFR Subchapter J.

Indications for Use:


The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to
produce cross-sectional images of the body by computer reconstruction of x-ray
transmission data taken at different angles and planes, patient for all ages, including
Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained
either with or without contrast. This device may include signal analysis and display
equipment, patient, and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of
trans-axial and reformatted planes. Further the images can be post processed to
produce additional imaging planes or analysis results.

The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole
body, cardiac and vascular X-ray Computed Tomography applications.

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The device output is a valuable medical tool for the diagnosis of disease, trauma, or
abnormality and for planning, guiding, and monitoring therapy.

Comparison with Predicate:


The GE BrightSpeed Delight Series CT Scanner System is developed from the
hardware platform of our StarSpeed system (K052855). The GE BrightSpeed Delight
Series CT involves changes from the StarSpeed CT system to add new application
features that involve changes in hardware, application software, firmware, recon, and
scan mode. The GE BrightSpeed Delight Series CT Scanner System uses virtually the
same materials and identical operating principle as our existing marketed product,
StarSpeed CT system as well as having similar indications for use. We believe the GE
BrightSpeed Delight Series CT Scanner System is of comparable type and substantially
equivalent to our currently marketed system listed above and complies with the same or
equivalent standards and have the same intended uses.
The GE BrightSpeed Delight Series CT Scanner System will be certified to comply with
the X-ray requirements of 21CFR1020.30 andl020.33, as well as the safety
requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular
standards.

Adverse Effects on Health:


Potential electrical, mechanical and radiation hazards are identified in a risk
management including hazard analysis and controlled by:
* System verification and validation to ensure performance to specifications,
Federal Regulations, and user requirements.
• Adherence and certification to industry and international standards. (UL/CSA and
IEC).
* Compliance to applicable CDRH 21CFR subchapter J requirements.
The device is designed and manufactured under the Quality System Regulations of
21CFR820.

Conclusions:
The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification
to the StarSpeed Series CT system (K052855). It does not result in any new potential
safety risks and performs as well as or better than devices currently on the market. The
GE BrightSpeed Delight Series CT system will be certified to comply with the X-ray
requirements of 21CFR 1020.30 and 1020.33, as well as the safety requirements of UL
60601-1, and IEC 60601-1 and associated collateral and particular standards. GE
considers the GE BrightSpeed Delight Series CT Scanner System to be equivalent to
other marketed devices with similar indications for use and meeting similar standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration


9200 Corporate Boulevard
Rockville MD 20850
OCT 08 2008

GE Medical Systems, LLC


% Mr. James W. Monroe
Official Correspondent
Intertek Testing Services
2307 E. Aurora Rd., Unit B7
TWINSBURG OH 44087

Re: K082816
Trade/Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed
Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and
BrightSpeed Excel Select)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: II
Product Code: JAK
Dated: September 24, 2008
Received: September 25, 2008

Dear Mr. Monroe:


We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to such additional controls. Existing major regulations affecting your device
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA
may publish further announcements concerning your device in the Federal Register.
Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act or
any Federal statutes and regulations administered by other Federal agencies. You must comply with
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);
labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device to
proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at one of the following numbers, based on the regulation number
at the top of this letter:

21 CFR 876.xxx (Gastroenterology/Renal/Urology 240-276-0115


21 CFR 884.xxx (Obstetrics/Gynecology) 240-276-0115
21 CFR 894.xxx (Radiology) 240-276-0120
Other 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's
Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-
3474. For questions regarding the reporting of device adverse events (Medical Device Reporting
(MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(240) 276-3150 or at its Internet address http://www.fda.gov/edrh/industrv/support/index.html.

Sincerely yours,

Joyce M. Whang, Ph.D.


Acting Director, Division of Reproductive,
Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure
Indications for Use

510(k) Number (if known):

Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite,
BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)

Indications for Use:

The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-
sectional images of the body by computer reconstruction of x-ray transmission data taken at different
angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions.
These images may be obtained either with or without contrast. This device may include signal analysis
and display equipment, patient, and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and
reformatted planes. Further the images can be post processed to produce additional imaging planes or
analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and
vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for
planning, guiding, and monitoring therapy.

Prescription Use X Over-The-Counter Use


(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Dvision Sign-Oft)
Division of Reproductive, Abdominal,
and Radiological Deviches
510(k) Number_ _iau 4"/2
4-2

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