(13 days)
The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
The OnePass Nuclear Medicine Imaging System acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available for processing and analysis.
The device consists of a vertical support, a single small FOV detector mounted on an articulating arm, a 15 in. color LCD acquisition display, and an acquisition and processing computer workstation. The OnePass system's small field-of-view (FOV) detector and small system footprint are designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The provided text is a 510(k) premarket notification for a medical device and does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document states that the OnePass Nuclear Medicine Imaging System is a modification of a previously cleared device (K0233373) and that this modification provides a "slightly larger UFOV to aid the operator" and a "new software application to automatically archive system-specific data files." The submission asserts substantial equivalence based on comparable type, similar performance characteristics, same technological characteristics, identical key safety and effectiveness features, same basic design, and same intended use as the predicate device.
The FDA's letter (K051402) acknowledges the substantial equivalence to a legally marketed predicate device, allowing the device to proceed to market. However, it does not describe specific acceptance criteria or an analytical or clinical study with the details requested in your prompt.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth for this device from the provided text. This type of information is typically found in detailed performance and clinical validation studies, which are not included in this summary of safety and effectiveness.
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JUN 1 3 2005
OnePass Nuclear Medicine Imaging System Attachment A - Summary of Safety and Effectiveness Special 510(k) Premarket Notification
Attachment A Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
Date Prepared 25-May-2005
Establishment Name and Registration Number
| Manufacturer Name and Address: | GVI Medical Devices1470 Enterprise ParkwayTwinsburg, Ohio 44087 |
|---|---|
| Contact: | Kevin Murrock |
| Telephone: | 330-963-4083, x113 |
| Fax: | 330-963-4084 |
| E-mail: | kevin.murrock@gvitp.com |
| Registration Number: | 3003917438 |
| Device Name and Classification | |
| 21 CFR Number: | 892.1100 |
| CDRH Product Code: | 90 IYX |
| Regulatory Device Class: | I |
| Classification Panel: | Radiology |
| Proprietary Name: | OnePass Nuclear Medicine Imaging System |
| Common Name: | Gamma Camera System |
| Classification Name: | Camera, Scintillation (Gamma) |
Reason for 510(k) Submission
Modification
Predicate Device
OnePass Nuclear Medicine Imaging System, 510(k) Number: K023373
Device Description
The OnePass Nuclear Medicine Imaging System acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available for processing and analysis.
The device consists of a vertical support, a single small FOV detector mounted on an articulating arm, a 15 in. color LCD acquisition display, and an acquisition and processing computer workstation. The OnePass system's small field-of-view (FOV) detector and small system footprint are designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
Intended Use
The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
GVI Medical Devices
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OnePass Nuclear Medicine Imaging System Attachment A - Summary of Safety and Effectiveness
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
Substantial Equivalence
The modified OnePass is of a comparable type and substantially equivalent to the OnePass System (510(k) Number K023373). Both devices are used to perform First-Pass Radionuclide Angiography (FPRNA) studies and contain similar performance characteristics. This modification provides a slightly larger UFOV to aid the operator in ensuring the myocardium remains positioned within the detector UFOV throughout an entire stress acquisition. This modification also includes a new software application to automatically archive system-specific data files (e.g. calibration, user settings) to a remote Webbased storage system. This application does not archive patient data, only system data files. It has the same technological characteristics, is identical in key safety and effectiveness features, uses the same basic design, and has the same intended use as the predicate device.
Conclusion
The modified OnePass system does not result in any new potential safety risks and performs as well as the OnePass Nuclear Medicine Imaging System.
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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin M. Murrock Manager, Quality and Regulatory GVI Technology Partners GVI Medical Devices 1470 Enterprise Parkway TWINSBURG OH 44087
Re: K051402
Trade/Device Name: OnePass Nuclear Medicine Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: I Product Code: IYX Dated: May 26, 2005 Received: May 31, 2005
Dear Mr. Murrock:
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 street 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 practices of alirag, 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 aos not nown the 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 Parts) with and (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.
JUN 1 3 2005
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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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Attachment D Indications for Use Statement
510(k) Number (if known): K051402
Device Name: OnePass Nuclear Medicine Imaging System
Indications for Use: The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801-109)
David A. Ingram
(Division Sinn-Off Division of Reproductive, Abdo and Radiological Devices 510(k) Number
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).