(19 days)
The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
The Discovery ST PET/CT Imaging System an with alternate detector option integrates a GE Positron Emission Tomography system and a GE LightSpeed CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.
The provided submission does not include any acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical performance study. This is a 510(k) submission for a Special 510(k) for the Discovery ST PET/CT Imaging System with an alternate detector option.
Here's why the requested information is absent:
- Type of Submission: A Special 510(k) is used when a device modification does not affect the device's fundamental scientific technology or its intended use, and the modification does not raise new questions of safety and effectiveness.
- "Clinical Tests: None required.": The document explicitly states "Clinical Tests: None required." This indicates that no new human clinical studies were performed to demonstrate performance against specific acceptance criteria because the device modification was considered minor and substantially equivalent to a predicate device already on the market (K010641).
- Focus on Substantial Equivalence: The entire submission focuses on demonstrating substantial equivalence to the predicate device (GE Discovery ST PET/CT System, K010641) both in terms of technological characteristics and safety/effectiveness features. The rationale is that if it's substantially equivalent to a device already cleared, it doesn't need new clinical data.
- Safety and Performance Evaluation: The evaluation appears to have focused on electrical and radiation safety, conformity with applicable medical device safety standards, and compliance with quality systems (21 CFR 820, ISO 9001, ISO 13485).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because such information is not present in the provided text. The document clearly states that clinical tests were not required, and the basis for clearance was substantial equivalence, not performance against new quantitative acceptance criteria established via a clinical study.
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SEP = 8 2004
Special 510(k) Premarket Notification Discovery ST with alternate detector option August 18, 2004
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
| Submitter: | GE Medical SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact Person. | D. DuerstelerSafety and Regulatory EngineeringTelephone: 262-312-7029; Fax: 262-312-7144 |
| Date Prepared: | August 18, 2004 |
| Device Name: | Discovery ST PET/CT Imaging System an with alternate detector option.Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | GE Medical Systems GE Discovery ST Positron Emission Tomography System, 510(k)Number K010641, currently in commercial distribution. |
Device Description: The Discovery ST PET/CT Imaging System an with alternate detector option integrates a GE Positron Emission Tomography system and a GE LightSpeed CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.
Indications for Use: The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Comparison with Predicate Device: The Discovery ST with alternate detector option is of a comparable type and substantially equivalent to the currently marketed GE Discovery ST PET/CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses as the predicate device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Discovery ST System. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the Discovery ST with alternate detector option PET/CT Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure, with three overlapping profiles suggesting a family or community. The profiles are rendered in a simple, flowing line. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion to follow the contour of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
SEP = 8 2004
Mr. D. Duersteler Safety and Regulatory Engineering General Electric Company GE Medical Systems W-1250 P.O. Box 414 MILWAUKEE WI 53201Re: K042257
Trade/Device Name: Discovery ST PET/CT Imaging System with Alternate Detector Option Regulation Number: 21 CFR 882.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS and JAK Dated: August 18, 2004 Received: August 20, 2004
Dear Mr. Duersteler:
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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ought maining of substantial equivalence of your device to a legally premarket notheation: "The PDF intrally stimally 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 If you desire spoolite da roof the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 queenoms on me f-4639. Also, please note the regulation entitled, "Misbranding Other of Somphalles as (s notification" (21CFR Part 807.97) you may obtain. Other general by receited to premarked nonitodnen. (er the Act may be obtained from the Division of Small miorination on 30ar respensional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brighton
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification Discovery ST with alternate detector option August 18, 2004
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
KD42257
Device Name: Discovery ST PET/CT Imaging System with alternate detector option
Indications for Use
The GE Discovery ST System with the alternate detector option is intended for head and whole body The GE Discovery ST Oystem with the altomate ooky (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery ST with alternate detector option is to be used by trained health care professionals The Discovery of With anomate dologicals in the body for the assessment of metabolic for lineging the distinution of fudiophamaceaes in the evaluation, diagnosis, staging, (Invectural) and follow up of lesions, This sam assist function such as (but not limited to) cancer, restaging, and follow up on looked and this device can also assist in radiotherapy planning.
The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
✓
OR Over-The-Counter Use
Daniel R. Lyman
(Division Division of 510(k) Num
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.