NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER

K090553 · Naviscan, Inc. · KPS · Mar 31, 2009 · Radiology

Device Facts

• Record ID: K090553
• Device Name: NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
• Applicant: Naviscan, Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Device Story

The PEMFlex Solo II is a high-resolution, partial-ring PET scanner for close-range, limited-field imaging. It utilizes lutetium-containing gamma-ray detectors to collect emissions from injected radiopharmaceuticals; transforms these inputs into images representing radiopharmaceutical concentration. Designed for high efficiency by positioning detectors close to the target body part. Used in clinical settings; operated by trained personnel. Output is displayed as radiological images, potentially integrated with other digital imaging modalities for correlative purposes. Assists clinicians in evaluating metabolic and physiologic functions. Benefits include high-resolution visualization of localized tracer distribution.

Clinical Evidence

Bench testing only. Performance evaluated via biocompatibility, electrical safety, EMC, and software verification/validation testing. Three clinical case images provided to demonstrate high-resolution imaging capability. No formal clinical trial data or statistical performance metrics (sensitivity/specificity) reported.

Technological Characteristics

Partial-ring PET scanner; lutetium-containing gamma-ray detectors; small field-of-view; high spatial resolution. Materials tested for biocompatibility per applicable standards. Electrical safety and EMC compliance per applicable standards. Software-based image reconstruction.

Indications for Use

Indicated for imaging and measuring distribution of injected positron-emitting radiopharmaceuticals in humans to determine metabolic and physiologic functions. No specific age or gender contraindications provided.

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

• Naviscan, Inc. PEM 2400 PET Scanner (K032063)

Submission Summary (Full Text)

{0}------------------------------------------------

K090553

MAR 3 1 2009

### 510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary

. .

,----

| Submission Date: | 27 February 2009 | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------|--|
| Submitter: | Naviscan, Inc.<br>6865 Flanders Drive, Suite B<br>San Diego, CA 92121 USA | | | |
| Submitter Contact: | Ms. Heather Jalisi<br>Director, Quality and Regulatory Affairs<br>858 332 9042<br>[e-mail] | | | |
| Manufacturing Site: | Naviscan, Inc.<br>6865 Flanders Drive, Suite B<br>San Diego, CA 92121 USA | | | |
| Trade Name: | Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner | | | |
| Common Name: | Positron Emission Tomography System | | | |
| Classification Name: | System, Tomography, Computed, Emission | | | |
| Classification<br>Regulation: | 21 CFR §892.1200 | | | |
| Product Code: | KPS | | | |
| Substantially<br>Equivalent Devices: | New Naviscan Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model | |
| | PEMFlex Solo II High<br>Resolution PET Scanner | K032063 | Naviscan, Inc. PEM<br>2400 PET Scanner | |

Page 1 of 3 000C32

{1}------------------------------------------------

# 510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary

ア

i

| Device Description: | The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET<br>Scanner (Solo II) is a high spatial resolution, small field-of-view PET<br>imaging system specifically developed for close-range, spot, i.e. limited<br>field, imaging. The Solo II is a partial-ring PET scanner, equipped with<br>lutetium-containing gamma-ray detectors, which collects gamma rays<br>emitted by injected positron-emitting radiopharmaceuticals, and<br>generates images corresponding to concentration of these<br>radiopharmaceuticals in the body. The Solo II is designed to collect<br>gamma rays from a patient's body part with high efficiency. In order to<br>achieve this high efficiency, the detectors should be positioned as close<br>as possible to the body part under examination. Properly configured, the<br>Solo II can display images obtained from other digital imaging<br>modalities for correlative purposes. | |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use: | The Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner is<br>intended for medical purposes to image and measure the distribution of<br>injected positron emitting radiopharmaceuticals in human beings for the<br>purpose of determining various metabolic and physiologic functions<br>within the human body. | |
| Technology<br>Comparison: | The Solo II employs the same technological characteristics as the<br>predicate devices to collect and generate radiological images. This<br>consists of lutetium-containing gamma-ray detectors that collect<br>gamma rays emitted by injected positron-emitting<br>radiopharmaceuticals, and generates images corresponding to<br>concentration of these radiopharmaceuticals in the body. | |
| Summary of Performance Testing: | | |
| Biocompatibility | The patient contact material in the Solo II was tested for<br>biocompatibility in accordance with applicable Standards. | |
| | Test results indicated that the patient contact material in the Solo II<br>complies with its predetermined specification and with the applicable<br>Standards. | |
| Electrical Safety | The Solo II was tested for patient safety in accordance with applicable<br>Standards. | |
| | Test results indicated that the Solo II complies with its predetermined<br>specification and with the applicable Standards. | |
| Electromagnetic<br>Compatibility<br>Testing | The Solo II was tested for EMC in accordance with applicable<br>Standards. | |
| Test results indicated that the Solo II complies with its predetermined<br>specification and with the applicable Standards. | | |
| Performance Testing | The Solo II was tested for performance in accordance with applicable<br>Standards. | |
| Test results indicated that the Solo II complies with its predetermined<br>specification and with the applicable Standards. | | |
| Software Testing | Software for the Solo II was designed and developed according to a<br>robust software development process, and was rigorously verified and<br>validated. | |
| Test results indicated that the Solo II complies with its predetermined<br>specification. | | |
| Clinical Images | Three (3) clinical case images are provided from the Solo II to<br>demonstrate the high resolution image capability of the Solo II. | |
| Image results indicated that the Solo II complies with its predetermined<br>specification. | | |
| Conclusion | Based upon a comparison of devices and performance testing results,<br>Solo II is substantially equivalent to the predicate device. | |

Page 2 of 3

{2}------------------------------------------------

# 510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary

ﺬ

Page 3 of 3 000C34

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR 3 1 2009

Ms. Heather Jalisi Director, Quality and Regulatory Affairs Naviscan, Inc. 6865 Flanders Drive, Suite B SAN DIEGO CA 92121

#### Re: K090553

Trade/Device Name: Naviscan PEMFlex Solo II High Resolution PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 27, 2009 Received: March 2, 2009.

#### Dear Ms. Jalisi:

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 devicecan 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.

{4}------------------------------------------------

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 os 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.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

090553 K

Device Name:

Indications for Use:

K 070553

Naviscan PEMFlex Solo II High Resolution PET Scanner

The Naviscan PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Over-The-Counter Use

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubluna
(Division Sign-Off)

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

Page 1 of 1 000025