The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting 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.

Device Description

The Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Mobile Single Rectangular Camera (MSR). The detector head is identical in hardware and software. The gantry of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) are optimised for being attached to a mobile platform which is transported from location to location in a truck and have the same range of automatic clinical motions of Mobile Single Rectangular Cumera (MSR).

AI/ML Overview

This 510(k) summary (K033956) is for the Mobile Single Circular Camera (MSC) and Mobile Digital Cardiac Camera (MDCC). This submission is a declaration of substantial equivalence to a predicate device, the Mobile Single Rectangular Camera (MSR) (K032779). As such, it does not involve new clinical studies with acceptance criteria and device performance evaluation in the typical sense of a novel device. Instead, the focus is on demonstrating that the new devices are essentially the same as the predicate in terms of safety and effectiveness, despite some mechanical differences.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a device with the same hardware and software as a predicate, there are no specific performance acceptance criteria or reported performance values from a new study presented in this 510(k) summary. The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, which would have already met its own performance specifications.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Same intended use as predicate	The intended use is the same as the predicate (Mobile Single Rectangular Camera).
Same hardware and software for detector head as predicate	The detector head is "identical in hardware and software" to the predicate device.
Same range of automatic clinical motions as predicate	The gantry has the "same range of automatic clinical motions" as the predicate device.
Deemed safe and effective to predicate's standards	Device "has been deemed safe and effective and is certified to the same safety standards as the predicate device by a third party organization prior to use on patients."
No new safety or effectiveness concerns	Conclusion states "no new safety or effectiveness concerns are raised."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No new test set or clinical data is mentioned or used for this 510(k) submission as it relies on substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set requiring expert ground truth establishment was conducted for this substantial equivalence claim.

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

Not applicable. No new test set requiring adjudication was conducted for this substantial equivalence claim.

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

Not applicable. This device is a gamma camera, not an AI-powered diagnostic tool, and the submission does not mention any MRMC studies or AI assistance.

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

Not applicable. This device is a gamma camera, not an algorithm, and the submission does not describe any standalone performance studies of an algorithm.

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

Not applicable. No new ground truth was established as the submission relies on the substantial equivalence to a predicate device. The predicate device's performance would have been established against appropriate ground truths for medical imaging devices (e.g., phantom studies, clinical correlation, etc. as per the standards applicable at the time of its clearance).

8. The sample size for the training set

Not applicable. The submission does not describe any machine learning or AI components requiring a training set. The device is a medical imaging hardware system with associated software for signal analysis and display.

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

Not applicable. No training set for machine learning was involved.

Summary

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K033956

501(k) SUMMARY

'JAN 2 0 2004

Labelling:

SUBMITTERS IDENTIFICATION

Applicant's Name and Street Address:	IS2 Medical Systems Inc.20 Gurdwara Rd., Units 3-10Ottawa, Ontario, CanadaK2E 8B3
Manufacturing Site:	IS2 Medical Systems Inc.20 Gurdwara Rd., Units 3-10Ottawa, Ontario, CanadaK2E 8B3
FDA Registration #	9615403
Contact Person:	Victor Woodburn, Manager Quality and Regulatory
Contact Person E-mail address:	vwoodburn@is2medical.com
Telephone and Fax Number of Contact Person:	T-(613) 228-8755, F-(613) 228-8228
Date of Submission:	December 3, 2003
	DEVICE NAME
Device Name (Common):	Gamma Camera
Proprietary Name:	Mobile Single Circular Camera (MSC)& Mobile Digital Cardiac Camera (MDCC)
Classification Name:	Emission Computed Tomography System
Product Code:	90-KPS
CFR:	21CFR 892.1200
Device Class:	II
Predicate Device:	Mobile Single Rectangular Camera
(Predicate) 510(k) No.:	K032779

Labels and Instructions for Use can be found in Attachment # 1 no changes to the labels or Instructions for Use have occurred except for adding information labels and instructions specific to the application of mounting and using the Camera systems in a Mobile Environment.

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INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the, Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Mobile Single Rectangular Camera (MSR) which has previously been through the 510(k) equivalent in the Movie Barge nessant of the systems include the mounting of the gantry to the mobile platform incorporating the use of "Dome Mounting" pads to facilitate high load isolation.

INTENDED USE

The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for andysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories. The Indications for Use found in Attachment 2.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is the same range of studies to that of the Mobile Single Rectangular Camera (MSR). The detector head is identical in hardware and software. The gantry of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) are optimised for being attached to a mobile platform which is transported from location to location in a truck and have the same range of automatic clinical motions of Mobile Single Rectangular Cumera (MSR).

The Mobile Single Circular Camera (MSC) and the Mobile Digital Camera (MDCC)) has been deemed safe and effective and is certified to the same 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 Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) with the predicate device. We conclude that the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

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Image /page/2/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 three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2004

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

Re: K033956

Trade/Device Name: Mobile Single Circular Camera (MSC & Mobile Digital Cardiac Camera (MDCC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: December 18, 2003

Received: December 22, 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 (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.

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Page 2

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 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

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510(k) Number (K033956)

Device Name: Mobile Single Circular (MSC) and the Mobile Digital Cardiac Camera (MDCC)

Indications for Use: The intended use of the Mobile Single Circular (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device gamma ray entiting factoriable in ades accessories such as signal analysis and display restics on a moone pratent and equipment supports, radionuclide anatomical markers, component parts and accessories.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Reproduction, Abdomin
	a ogical Devices K03386
	510(k) Number

Prescription Use (Per 21 CFR 801.109)	YES
---------------------------------------	-----

Over-The-Counter Use	NO
	(Optional Format 1-2-96)

RECEIVED DATE : 01/07 14:40'04 FROM : 3014804224

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.