(11 days)
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.
Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
- The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients.
- Treatment planning and interventional radiology procedures.
The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.
The provided text is a 510(k) summary for the "Gemini Raptor" device. It describes a hybrid diagnostic imaging system combining Positron Emission Tomography (PET) and X-ray Computed Tomography (CT).
However, the document does not include the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The "System Performance Test/ Summary of Studies" section only states that Philips adheres to recognized industry practices and complies with performance standards for ionizing radiation and electrical/mechanical safety (21 CFR 1020.30, 21 CFR 1020.33, IEC 60601-1 series, and NEMA-NU2 standard). It does not provide:
- A table of acceptance criteria and reported device performance.
- Details on sample size or data provenance for a test set.
- Information on expert qualifications or the number of experts used for ground truth.
- The adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore,Based on the provided 510(k) summary, the requested information regarding acceptance criteria and specific study details for proving the device meets these criteria is not available.
The document states:
- Performance Standards: The device adheres to recognized and established industry practices and complies with performance standards for ionizing radiation emitting products (21 CFR 1020.30 and 21 CFR 1020.33), electrical and mechanical safety (IEC 60601-1 series), and the NEMA-NU2 standard for device performance measurement.
This indicates the device was tested against these general regulatory and industry standards, but it does not provide any specific quantitative acceptance criteria or the results of a study designed to demonstrate compliance with such criteria in the format requested.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, or training set details based on the provided text.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| A. | Submitter/ Contact Person: | |
|---|---|---|
| Philips Medical Systems (Cleveland), Inc.595 Miner Rd.Cleveland, OH 44143 | Melinda NovatnyTel: (440) 483-4255Fax: (440) 483-7339 | |
| B. | Device Trade Name: Gemini Raptor |
| Device Trade Name: | Gemini Raptor |
|---|---|
| Common Name: | Positron Emission TomographyComputed Tomography X-Ray |
| Classification Name: | System, Emission Computed Tomography, (892.1200System, Computed Tomography X-Ray, (892.1750) |
| Device Class: | 21CFR 892.1200, Class II21 CFR 892.1750, Class II |
| Product Code: | 90 KPS and 90 JAK |
Classification Panel: Radiology
- C. Date prepared: September 15, 2005
- D. Predicate Device: Gemini GXL System (K051170)
E. Performance Standards:
- 21 CFR 1020.30 1020.33 Performance Standards for Ionizing Radiation . Emitting Products, Computed Tomography Equipment (Applicable Sections)
- NEMA NU-2 .
F. Intended Use:
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.
Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
Section X .- 1
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- o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
- o The detection, localization, and staging of turnors and diagnosing cancer patients.
- o Treatment planning and interventional radiology procedures.
The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
G. Device Description/ Comparison with Predicate Device:
The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.
H. System Performance Test/ Summary of Studies:
To minimize electrical, mechanical and radiation hazards, Philips Medical System adheres to recognized and established industry practice. Radiation safety is assured by compliance and certification to the performance standards for ionizing radiation emitting product, 21CFR 1020.30 and 21CFR 1020.33. The radiation safety product report will be filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the IEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU2 standard.
I. Comparison to Predicate Devices:
The basic differences in the system include the following:
- . Change from GSO to LYSO crystals
- . Modifications to Reconstruction
In conclusion, the device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance.
Section X -7
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
Philips Medical Systems (Cleveland), Inc. % Ms. Elizabeth Drew Project Engineer, Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K052640
Trade/Device Name: GEMINI Raptor Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: September 21, 2005 Received: September 26, 2005
Dear Ms. Drew:
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 (Premarket Approval), 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) 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
510(k) Number (if known): Not Known K052640
Device Name: Gemini Raptor
Indications for Use.
The device is a diagnostic imaging system for fixed or mobile installations that combines Position Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem producer croas-on sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient Pody (specific radiophamaceuticals are used for whole body, brain, heart and other organ imaging) Attention correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.
Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused") (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical cata at different angles. Trained professionals use the images in:
- The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to 0 cancer, cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients. O
- Treatment planning and interventional radiology procedures. O
The device includes software that provides a quantified analysis of regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of datast ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment as cornary artery images from CT coronary angiography onto the myocardium.
Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
David A. Lymm
Page 1 of 7
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052640
§ 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.