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.

Device Description

The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET Scanner (Solo II) is a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot, i.e. limited field, imaging. The Solo II is a partial-ring PET scanner, equipped with lutetium-containing gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The Solo II is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. Properly configured, the Solo II can display images obtained from other digital imaging modalities for correlative purposes.

AI/ML Overview

The PEMFlex Solo II High Resolution PET Scanner's acceptance criteria and study details are summarized as follows:

1. Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with applicable Standards and predetermined specifications.	Complies with its predetermined specification and applicable Standards.
Electrical Safety	Compliance with applicable Standards and predetermined specifications.	Complies with its predetermined specification and applicable Standards.
Electromagnetic Compatibility (EMC)	Compliance with applicable Standards and predetermined specifications.	Complies with its predetermined specification and applicable Standards.
Performance Testing	Compliance with applicable Standards and predetermined specifications.	Complies with its predetermined specification and applicable Standards.
Software Testing	Compliance with predetermined specifications.	Complies with its predetermined specification.
Clinical Images	Demonstration of high-resolution image capability and compliance with predetermined specifications.	Three clinical case images demonstrated high resolution capability and compliance with specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Three clinical case images were provided for demonstration purposes.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "clinical case images."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The clinical images were presented to "demonstrate the high resolution image capability."

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission focuses on device performance and substantial equivalence to a predicate device, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance evaluation was conducted for various aspects of the device, including Biocompatibility, Electrical Safety, EMC, Performance Testing, and Software Testing. The clinical images were also presented as a standalone demonstration of the device's imaging capability.

7. Type of Ground Truth Used

Based on the nature of the tests:

For Biocompatibility, Electrical Safety, and EMC, the ground truth was based on adherence to applicable Standards and predetermined specifications.
For Performance Testing, the ground truth was likely based on technical specifications and performance metrics defined by applicable standards.
For Software Testing, the ground truth was based on predetermined specifications for the software's design and functionality.
For Clinical Images, the ground truth for "high resolution image capability" likely refers to the visual quality and diagnostic utility of the images as assessed against expected performance standards for PET scanners, though specific expert review details are not provided.

8. Sample Size for the Training Set

The document does not mention the use of a "training set" in the context of machine learning or AI. This device is a PET scanner, and its performance evaluation focused on hardware and software functionality without indication of an AI component requiring a training set.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this device's evaluation, there is no information on how its ground truth would have been established.

Summary

{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.6865 Flanders Drive, Suite BSan Diego, CA 92121 USA
Submitter Contact:	Ms. Heather JalisiDirector, Quality and Regulatory Affairs858 332 9042hjalisi@naviscan.com
Manufacturing Site:	Naviscan, Inc.6865 Flanders Drive, Suite BSan 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
ClassificationRegulation:	21 CFR §892.1200
Product Code:	KPS
SubstantiallyEquivalent Devices:	New Naviscan Model	Predicate510(k) Number	PredicateManufacturer / Model
	PEMFlex Solo II HighResolution PET Scanner	K032063	Naviscan, Inc. PEM2400 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

Device Description:	The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PETScanner (Solo II) is a high spatial resolution, small field-of-view PETimaging system specifically developed for close-range, spot, i.e. limitedfield, imaging. The Solo II is a partial-ring PET scanner, equipped withlutetium-containing gamma-ray detectors, which collects gamma raysemitted by injected positron-emitting radiopharmaceuticals, andgenerates images corresponding to concentration of theseradiopharmaceuticals in the body. The Solo II is designed to collectgamma rays from a patient's body part with high efficiency. In order toachieve this high efficiency, the detectors should be positioned as closeas possible to the body part under examination. Properly configured, theSolo II can display images obtained from other digital imagingmodalities for correlative purposes.
Intended Use:	The Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner isintended for medical purposes to image and measure the distribution ofinjected positron emitting radiopharmaceuticals in human beings for thepurpose of determining various metabolic and physiologic functionswithin the human body.
TechnologyComparison:	The Solo II employs the same technological characteristics as thepredicate devices to collect and generate radiological images. Thisconsists of lutetium-containing gamma-ray detectors that collectgamma rays emitted by injected positron-emittingradiopharmaceuticals, and generates images corresponding toconcentration of these radiopharmaceuticals in the body.
Summary of Performance Testing:
Biocompatibility	The patient contact material in the Solo II was tested forbiocompatibility in accordance with applicable Standards.
	Test results indicated that the patient contact material in the Solo IIcomplies with its predetermined specification and with the applicableStandards.
Electrical Safety	The Solo II was tested for patient safety in accordance with applicableStandards.
	Test results indicated that the Solo II complies with its predeterminedspecification and with the applicable Standards.
ElectromagneticCompatibilityTesting	The Solo II was tested for EMC in accordance with applicableStandards.
Test results indicated that the Solo II complies with its predeterminedspecification and with the applicable Standards.
Performance Testing	The Solo II was tested for performance in accordance with applicableStandards.
Test results indicated that the Solo II complies with its predeterminedspecification and with the applicable Standards.
Software Testing	Software for the Solo II was designed and developed according to arobust software development process, and was rigorously verified andvalidated.
Test results indicated that the Solo II complies with its predeterminedspecification.
Clinical Images	Three (3) clinical case images are provided from the Solo II todemonstrate the high resolution image capability of the Solo II.
Image results indicated that the Solo II complies with its predeterminedspecification.
Conclusion	Based upon a comparison of devices and performance testing results,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)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

N/A