To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the 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

Device Description

The NuCamma Rx nuclear imaging system has a rectangular field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.

AI/ML Overview

This document is a 510(k) Premarket Notification for the NuCamma Rx gamma camera system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through novel testing.

Therefore, many of the requested elements (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and training set details) are not typically found in a 510(k) submission that relies on equivalence to a predicate device. The information provided mainly covers the device's intended use and a qualitative comparison to the predicate.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

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

The document does not provide a table of acceptance criteria with quantitative performance metrics for the NuCamma Rx itself. Instead, it claims substantial equivalence to a predicate device based on its intended use and general safety/effectiveness. The key "performance" aspect is its ability to perform certain imaging techniques within a specified energy range.

Acceptance Criteria (Inferred from "Intended Use" and "Determination of Substantial Equivalence")	Reported Device Performance (as stated or inferred)
Intended Use: To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store data for analysis.	NuCamma Rx: Detects the location and distribution of radionuclides in the body; stores data for transmission/retrieval by existing commercially available data analysis software. (Does not include internal data analysis capability, distinguishing it from the predicate in this specific functional aspect, but not in its fundamental detection capability).
Imaging Techniques: Must perform Planar Imaging, Whole Body Imaging, and Tomographic imaging (SPECT) for non-Positron emitters.	NuCamma Rx: Performs Planar Imaging (✓), Whole Body Imaging (✓), and Tomographic imaging (SPECT) for non-Positron emitters (✓). Does not perform Positron imaging by coincidence or without coincidence (✗).
Energy Range: Must operate within a specified energy range for imaging.	NuCamma Rx: Operates within an energy range of 50 - 400 keV for Planar, Whole Body, and SPECT imaging.
Safety and Effectiveness: Must be safe and effective, and meet electrical safety standards.	NuCamma Rx: Deemed safe and effective, and certified to the same electrical safety standards as the predicate device by a third-party organization.
Substantial Equivalence: Must be substantially equivalent to the ISOCAM I gamma camera.	NuCamma Rx: A matrix comparing features and intended use demonstrated substantial equivalence to the predicate device, raising no new safety or effectiveness concerns.

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

Not applicable. The submission for NuCamma Rx relies on demonstrating substantial equivalence to a predicate device (ISOCAM I gamma camera) rather than conducting a new clinical performance study with a test set of patient data. Therefore, there is no mention of a specific sample size, data provenance, or whether the study was retrospective or prospective.

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. As stated above, no new clinical performance study on a test set was performed for this 510(k) submission.

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

Not applicable. No test set was used for a new clinical performance study.

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 system, not an AI-assisted diagnostic tool. There is no mention of AI or MRMC studies in the document.

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 standalone performance testing in the context of an algorithm.

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

Not applicable. No new clinical performance study with defined ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to a predicate device already on the market.

8. The sample size for the training set

Not applicable. No algorithm training was performed or described for this device.

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

Not applicable. No algorithm training was performed or described for this device.

Summary of the document's approach:

The core of this 510(k) submission is to demonstrate that the NuCamma Rx is "substantially equivalent" to a previously cleared predicate device (ISOCAM I gamma camera). This approach means the manufacturer doesn't need to perform extensive new clinical studies to prove safety and effectiveness from scratch. Instead, they compared the NuCamma Rx's intended use, technological characteristics, and safety certifications to the predicate device.

The "study that proves the device meets the acceptance criteria" in this context is the qualitative comparison (a "matrix was constructed comparing the features and intended use") and the certification to electrical safety standards, all aimed at establishing substantial equivalence to the predicate device. The FDA's letter confirms that, based on this comparison, the device is deemed substantially equivalent.

Summary

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

iS² Research Inc

K982045

510(K) SUMMARY

Image /page/0/Picture/3 description: The image shows a logo with a square in the center containing the roman numeral "I". The square is surrounded by a circle that is not fully closed, with gaps at the top left and bottom right. The logo is black and white and appears to be a simple, minimalist design.

2 1998 SEP

SUBMITTER IDENTIFICATION

Applicant's Name and Street Address:

IS2 Research Inc. 20 Gurdwara Road, Units 3 - 6, Nepean, Ontario, Canada K2E 8B3

Contact Person: Peter Schultz, Manager Quality and Regulatory

Telephone and Fax Numbers of Contact Person: T - (613) 228-8755, F - (613) 228-8228

same as Applicant's address above Address of Manufacturing Site:

Date of Submission: June, 1998

DEVICE NAME

Device Name (common): Gamma Camera NuCamma Rx Proprietary Name: Emission Computed Tomography System Classification Name:

INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the NuCamma Rx , manufactured by IS? Research Inc., is substantially equivalent to the ISOCAM I gamma camera which has previously underwent the 510(k) premarket notification process. The NuCamma Rx nuclear imaging system has a rectangular field of view.

INTENDED USE

The intended use of NuCamma Rx is to detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the 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.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the two devices is identical except that the NuCamma Rx system only detects the location and distribution of the radionuclides in the body. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.

The NuCamma Rx 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 companing the features and intended use of the NuCamma Rx with the predicate device. We conclude that the NuCamma Rx is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

Me d i c a l D i a g n o s t i c l m a g i n g

20 Gurdwara Road, #3-6, Nepean ON K2E 8B3 Canada (613) 228-8755 Fax: (613) 228-8228

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/3 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element resembling three abstract, curved shapes stacked on top of each other. To the left of the graphic, there is text arranged vertically, reading 'DEPARTMENT OF HEALTH &'. The text is oriented so that it is readable when the image is viewed with the graphic on the right side.

SEP 2 1998

Peter Schultz Manager, Quality Assurance and Regulatory Affairs IS2 Research, Inc. Medical Diagnostic Imaging 20 Gurdwara Road, #3-6 Nepean, Ontario K2E 8B3 CANADA

K982045 Re:

NuCamma Rx Dated: June 5, 1998 Received: June 10, 1998 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Schultz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.n.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):	K982045
Device Name:	GAMMA CAMERA (NUCAMMA Rx)

Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):

		YES	NO	Energy Range (keV)
A.	Planar Imaging	✓	-	50 - 400
B.	Whole Body Imaging	✓	-	50 - 400
C.	Tomographic imaging (SPECT) for non Positron emitter	✓	-	50 - 400
D.	Positron imaging by coincidence	-	✓
E.	Positron imaging without coincidence	-	✓
F.	Other indication(s) in the device label, but not included in above list

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

510(k) Number.

Over-the-Counter Use __

(Optional Format 1-2-96)

Tamil C. Segarra

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi-

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.