CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM

K072191 · Gvi Technology Partners · KPS · Oct 25, 2007 · Radiology

Device Facts

• Record ID: K072191
• Device Name: CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
• Applicant: Gvi Technology Partners
• Product Code: KPS · Radiology
• Decision Date: Oct 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images. Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Device Story

ClearVision Nuclear Medicine Imaging System acquires gated/non-gated SPECT cardiac data; utilizes single or dual small field-of-view detectors with Anger technology (33 photomultiplier tubes) and NaI(Tl) crystals; incorporates proprietary inverse fan-beam collimators. System features motorized patient chair (360-degree rotation) and horizontal detector tower movement for precise myocardial centering; laser alignment guides included. Operated by clinical staff in space-constrained facilities. Data processed via Segami Mirage Release 5.6 software to generate qualitative/quantitative cardiac images. Physician reviews output to assess myocardial radioisotope distribution, aiding clinical diagnosis of cardiac conditions.

Clinical Evidence

Bench testing only. Performance metrics compared to predicate include NEMA reconstructed spatial resolution (9.8 mm central), system sensitivity (147 cpm/uci), and energy resolution (≤ 9.0%). No clinical data provided.

Technological Characteristics

Detector: Anger technology with 33 photomultiplier tubes; Crystal: NaI(Tl); Collimator: Inverse fan-beam; Energy Range: 90–160 keV; Patient Weight Limit: ≤ 500 lbs; Footprint: 8' x 8'; Connectivity: Standalone; Software: Segami Mirage Release 5.6.

Indications for Use

Indicated for diagnostic imaging of the myocardium using gated and non-gated SPECT in patients requiring assessment of radioisotope distribution. No specific age or gender contraindications stated.

Regulatory Classification

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.

Predicate Devices

• Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems (K070542)

Reference Devices

• GVI Medical Devices OnePass Nuclear Imaging System (K023373)

Submission Summary (Full Text)

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#### B Administrative Information

K072191

OCT 2 5 2007

#### B.1 510(k) Summary of Safety and Effectiveness

Image /page/0/Picture/6 description: The image shows the logo of GVI Medical Devices, along with their address. The logo features an atom-like graphic with the letters "gvi" in a stylized font. Below the logo, the words "MEDICAL DEVICES" are printed in smaller letters. The address is "1470 Enterprise Parkway Twinsburg, OH 44087".

p. **330.963.4083**
f. 330.963.4084
www.avimd.com

The following information is in accordance with 21 CFR 807.92.

- B.1.1 Submitted By:
Name and Address:

| Contact Person: | |
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| Telephone: | |
| Fax: | |
| E-mail: | |
| Date Prepared: | |

B.1.2 Device Identification

Trade / Proprietary Name: Common Name: Classification Name: 21 CFR Number: CDRH Product Code: Regulatory Device Class: Classification Panel:

GVI Medical Devices 1470 Enterprise Parkway Twinsburg, Ohio 44087 Kevin Murrock 330-963-4083, x113 330-963-4084 mailto:[e-mail] 3-August-2007

ClearVision Nuclear Imaging System SPECT System System, Emission Computed Tomography 892.1200 90 KPS ll Radiology

B.1.3 Predicate Device Manufacturer: Digirad Corporation Trade Name: Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems 510(k) Number: K070542 CDRH Product Code: 90 KPS

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### B.1.4 Device Description

The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.

The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.

Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):

- . Each tower can be moved horizontally along rails mounted to the floor plate.
- . The patient chair seat pan can be moved side-to-side.
- Vertical and a horizontal beam lasers are mounted to side of detector.

The ClearVision 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.

#### B.1.5 Intended Use

The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

## B.1.6 Substantial Equivalence Comparison

The ClearVision is of a comparable type and substantially equivalent to the Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems (510(k) Number K070542), as both devices are used to acquire gated and non-gated SPECT studies using similar physical characteristics (refer to feature comparison summary table in Section B.1.7). In addition, the detector layout and electronics are identical in both physical and performance characteristics to the detector used on the GVI Medical Devices OnePass Nuclear Imaging System (510(k) K023373).

The primary difference between the ClearVision and the Cardius 1 and 2 XPO Systems is in detector technology and collimation. ClearVision uses traditional Anger technology detectors along with proprietary inverse fan-beam collimators, while the Cardius XPO systems use solidstate detectors and parallel-hole collimators. Refer to Attachment B for detailed description of the inverse fan-beam collimator.

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| Feature | ClearVision | Cardius 1 and 2 XPO |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Acquisition Types | SPECT and Gated SPECT | Same |
| Other Acquisition Types | None | Planar and Planar Gated |
| Number of Detectors | One or Two | One or Two |
| Detector Technology | Anger (33 photomultiplier tubes) | Solid-state |
| Crystal Material | Nal(TI) | Csi(TI) |
| Small Detector UFOV | Yes<br>8.5" x 8.5" UFOV | Yes<br>6.2" x 8.3" UFOV |
| Collimator | Inverse Fan-Beam | Parallel-Hole (LEHR) |
| NEMA Reconstructed Spatial<br>Resolution with Scatter | 9.8 mm (central)<br>7.6 mm (tangential)<br>8.4 mm (radial) | 11.00 mm |
| NEMA System Sensitivity | 147 cpm / uci | 160 cpm / uci |
| NEMA Energy Resolution | ≤ 9.0 % | < 10.5 % |
| Energy Range | 90 – 160 keV | 50 - 170 keV |
| Patient Position | Upright Chair | Upright Chair |
| Patient Weight Limit | ≤ 500 lbs. | Same |
| Motor Driven Motions | 1) Detector Tower Horizontal<br>2) SPECT Chair Rotation<br>3) SPECT Chair Vertical | 1) SPECT Chair Vertical<br>2) SPECT Chair Rotation<br>3) SPECT Chair Horizontal |
| System Mount | Secured directly to floor. | N/A |
| Small Room Size | Yes<br>8' x 8' | Yes<br>7.5' x 8.0" |
| Processing Functions | SPECT and Gated SPECT processing and<br>display, including SPECT reconstruction and<br>cardiac reorientation. | SPECT, Gated SPECT, Planar, and Gated Planar<br>processing and display, including SPECT<br>reconstruction and cardiac reorientation. |
| SPECT Processing Software | Segami Mirage Release 5.6 | Same |

### B.1.7 Feature Comparison Summary

### B.1.8 Conclusion

The ClearVision does not pose any new potential safety risks and performs as well as the predicate Digirad Cardius 1 and 2 XPO Systems. Therefore, it is the opinion of GVI Medical Devices that the ClearVision is substantially equivalent in terms of safety and effectiveness to the legally marketed Digirad Cardius 1 and 2 XPO Systems for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an abstract symbol that resembles a stylized human figure with three wavy lines representing the body and head.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 25 2007

Mr. Kevin M. Murrock Manager, Quality & Regulatory GVI Medical Devices 1470 Enterprise Parkway TWINSBURG OH 44087

Re: K072191

Trade/Device Name: ClearVision Nuclear Medicine Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 3, 2007 Received: August 6, 2007

#### 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 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. Iisting 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.

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

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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#### B.2 Indication for Use

Page 1 of 1

510(k) Number (if known): K072191

Device Name: ClearVision Nuclear Medicine Imaging System

Indication for Use: The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Prescription Use
(21 CFR Part 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halal Remmer

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number