ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM

K051402 · Gvi Technology Partners · IYX · Jun 13, 2005 · Radiology

Device Facts

• Record ID: K051402
• Device Name: ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
• Applicant: Gvi Technology Partners
• Product Code: IYX · Radiology
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1100
• Device Class: Class 1

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. 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.

Device Story

OnePass Nuclear Medicine Imaging System is a compact gamma camera for First-Pass Radionuclide Angiography (FPRNA). System components include a vertical support, articulating arm with small field-of-view (FOV) detector, 15-inch LCD display, and workstation. Device acquires and processes gated radionuclide images to assess ventricular function. Designed for facilities with limited floor space. Modification includes slightly larger UFOV to ensure myocardium remains within detector range during stress acquisition. Includes software for automatic archival of system-specific data (calibration, settings) to remote web-based storage; does not archive patient data. Operated by clinical staff in medical facilities. Output provides qualitative and quantitative cardiac function data to assist clinicians in diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gamma camera system with small FOV detector. Includes vertical support, articulating arm, 15-inch color LCD acquisition display, and computer workstation. Software includes system-specific data archival to remote web-based storage. Modification involves increased UFOV dimensions.

Indications for Use

Indicated for patients undergoing First-Pass Radionuclide Angiography (FPRNA) to assess left and right ventricular function at rest or during stress using radiopharmaceuticals.

Regulatory Classification

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.

Predicate Devices

• OnePass Nuclear Medicine Imaging System (K023373)

Submission Summary (Full Text)

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JUN 1 3 2005

K051402

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 Devices<br>1470 Enterprise Parkway<br>Twinsburg, Ohio 44087 |
|--------------------------------|-------------------------------------------------------------------------|
| Contact: | Kevin Murrock |
| Telephone: | 330-963-4083, x113 |
| Fax: | 330-963-4084 |
| E-mail: | [e-mail] |
| 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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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 [phone] or [phone] 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