The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

To detect or image the distribution of radionuclides in the body or organ using the following technique(s);
(a) Planar Imaging
(b) Whole Body Imaging
(c) Tomographic Imaging (SPECT) for non Positron emitter
(d) Positron imaging by coincidence
(e) Positron imaging without coincidence
(f) Other indication(s) in the device label, but not included in the above list None

Device Description

The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads. The intended use of the Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).

AI/ML Overview

This 510(k) submission (K032779) is for a medical device (Mobile Rectangular Single Head Camera - MSR) that is substantially equivalent to a predicate device (Rectangular Single Head Camera - SR). Therefore, it relies on comparison to the predicate device rather than a new study to meet acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (from K032779)
Intended Use: Detect location and distribution of gamma ray emitting radionuclides for analysis.	Intended Use: "detect the location and distribution of gamma ray enitting radionuclides in the body and store data for analysis." (Identical to predicate)
Detector Head Hardware/Software: Match the predicate device.	Performance: "The detector head is identical in hardware and software."
Gantry Functionality: Optimized for mobile platform with same range of automatic clinical motions as the predicate.	Performance: "The gantry... is optimized for being attached to a mobile platform... and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR)."
Safety and Effectiveness: Meet established electrical safety standards.	Performance: "has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients."
No New Safety or Effectiveness Concerns.	Performance: "We conclude that the Mobile Rectangular Single Head Cameru (MSR) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised."

2. Sample size used for the test set and the data provenance:

The document does not describe a specific clinical test set or data provenance for this 510(k) submission.
The argument for substantial equivalence is based on the device's technical specifications and intended use being identical or very similar to the predicate device, which would have undergone its own testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no new clinical test set was described, there's no mention of experts establishing ground truth for a new study. The safety and effectiveness are established through comparison to a certified predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No new clinical test set was conducted or detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done or described. This device is a gamma camera, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical imaging system, not an algorithm, so a standalone algorithm performance test is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No new clinical study requiring ground truth establishment is described in this submission. The ground truth for the predicate device's original clearance would have been established at that time (likely through various validation methods relevant to gamma cameras).

8. The sample size for the training set:

Not applicable. This submission concerns a physical medical imaging device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" to prove the device meets acceptance criteria in this 510(k) submission is a comparison to a legally marketed predicate device (Rectangular Single Head Camera (SR), K982045).

The manufacturer, IS2 Medical Systems Inc., demonstrated that their new device, the Mobile Rectangular Single Head Camera (MSR), is substantially equivalent to the predicate by showing:

Identical Intended Use: Both devices are used to detect the location and distribution of gamma ray-emitting radionuclides for analysis.
Identical Detector Head: The hardware and software of the detector head are the same.
Similar Gantry Functionality: Though optimized for mobility, the gantry provides the same range of automatic clinical motions as the predicate.
Compliance with Safety Standards: The device is certified to the same electrical safety standards as the predicate device by a third-party organization.
No New Concerns: The manufacturer concluded that these similarities mean no new safety or effectiveness concerns are raised compared to the predicate.

This approach, demonstrating substantial equivalence to a predicate, is a common pathway for medical device clearance through the 510(k) process when a new device does not raise new questions of safety or effectiveness.

Summary

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501(k) SUMMARY

K032779

DEC 17 2003

SUBMITTERS IDENTIFICATION

Applicant's Name and Street Address:	IS2 Medical Systems Inc.20 Gurdwara Rd., Units 3-10Ottawa, Ontario, CanadaK2E 8B3
Contact Person:	Victor Woodburn, Manager Quality and Regulatory
Telephone and Fax Number of Contact Person:	T- (613) 228-8755, F - (613) 228-8228
Address of Manufacturing Site:	Same as Applicant's Address noted above
Date of Submission:	September 30, 2003
	DEVICE NAME
Device Name (Common):	Gamma Camera
Proprietary Name:	Mobile Rectangular Single Head Camera (MSR))
Classification Name:	Emission Computed Tomography System
Product Code:	90-KPS
CFR:	21CFR 892.1200
Device Class:	II
Predicate Device:	Rectangular Single Head Camera (SR)
510(k) No.:(Predicate)	K982045

INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the Mobile Rectangular Single Head Camera (MSR), manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Read Camera (SR) which has previously been through the 510(k) premarket notification process. The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads.

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501(k) SUMMARY

INTENDED USE

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).

The Mobile Rectangular Single Head Camera (MSR) has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients. A matrix was constructed comparing the features and intended use of the Mobile Rectangular Single Head Camera (MSR) with the predicate device. We conclude that the Mobile Rectangular Single Head Cameru (MSR) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2003

Mr. Victor Woodburn Manager, Quality and Regulatory IS2 Medical Systems, Inc. 20 Gurdwara Road, Units 3-10 Ottawa, Ontario, K2E 8B3 CANADA

Re: K032779 Trade/Device Name: Mobile Rectangular Single Head Camera (MSR) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 5, 2003 Received: September 18, 2003

Dear Mr. Woodburn:

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 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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

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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

to proceed to the market.

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510(k) Number (K032779)

Device Name Mobile Rectangular Single Head Camera (MSR)

Indications for Use: The intended use of the Mobile Rectangular Single Head Camera is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

To detect or image the distribution of radionuclides in the body or organ using the following technique(s);

YES NO Energy Range (keV) 50 – 400 keV (a) Planar Imaging (b) Whole Body Imaging 50 – 400 keV (c) Tomographic Imaging (SPECT) for non Positron 50 - 400 keV emitter (d) Positron imaging by coincidence (e) Positron imaging without coincidence (f) Other indication(s) in the device label, but not None included in the above list
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K 032779

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
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.(b)
Classification. Class II.