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): Planar Imaging, Whole Body Imaging, Tomographic imaging (SPECT) for non Positron emitter.

Device Description

The NuCamma R* nuclear imaging system has a round 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

The provided text does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets such criteria. It primarily focuses on the 510(k) submission for the NuCamma R* Gamma Camera, demonstrating its substantial equivalence to a predicate device (ISOCAM I).

Here's an analysis of the information that is present, and an explanation of why many of your requested items cannot be fulfilled from the provided text:

Lack of Specific Acceptance Criteria and Performance Study:

The document is a 510(k) submission summary, which primarily aims to establish substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria. This means:

No specific quantified acceptance criteria are listed. The approval hinges on demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness concerns compared to the predicate device.
No detailed performance study results are provided. The document mentions a "matrix was constructed comparing the features and intended use of the NuCamma R* with the predicate device," but it doesn't elaborate on the methodology or specific outcomes of this comparison in a way that aligns with a typical performance study against acceptance criteria.

Therefore, the following points cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for the training set
How the ground truth for the training set was established

Information that can be extracted or inferred:

While a detailed performance study isn't available, the document does touch upon the basis for the FDA's decision, which suggests some implicit "acceptance criteria" are being met through substantial equivalence.

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

As explained, no explicit table is provided. The acceptance, in this context, is primarily based on substantial equivalence to the predicate device (ISOCAM I).

Acceptance Criteria (Implicitly met via Substantial Equivalence)	Reported Device Performance / Characteristics
Intended Use: Detect location and distribution of gamma ray and positron emitting radionuclides in the body.	*NuCamma R Intended Use:** To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. The system only detects and stores data, analysis is done by external software.
Technological Characteristics: Similar to predicate.	*NuCamma R Technological Characteristics:** Nuclear imaging system with a round field of view. "A matrix was constructed comparing the features and intended use of the NuCamma R* with the predicate device."
Safety and Effectiveness: No new safety or effectiveness concerns compared to predicate.	*NuCamma R Safety and Effectiveness:** "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." "We conclude that the NuCamma R* is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised."
Electrical Safety Standards: Compliance with relevant standards.	Certified to the "same electrical safety standards as the predicate device by a third party organization."

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

Not applicable/Not provided. The document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation appears to be a technical comparison and safety assessment against a predicate device.

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

Not applicable/Not provided. No "ground truth" establishment by experts for a test set is described.

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

Not applicable/Not provided. No test set or adjudication process is 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. This is not an AI device, and no MRMC study or AI assistance is mentioned.

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

Not applicable/Not provided. This is a gamma camera, not an algorithm, so "standalone performance" in this context is not what is being assessed as an algorithm.

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

Not applicable/Not provided. No explicit ground truth is mentioned regarding clinical performance data. The basis for approval is substantial equivalence to the predicate device, relying on its established safety and effectiveness.

8. The sample size for the training set:

Not applicable/Not provided. As there is no mention of an algorithm or AI component, there would be no "training set."

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

Not applicable/Not provided. As above, no training set information is available.

Summary

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

IS2 Research Inc

K982044

2 1998

510(K) SUMMARY

Image /page/0/Picture/4 description: The image shows a stylized logo. The logo consists of a square in the center with the Roman numeral "I" inside. The square is surrounded by a circular shape that is open at the top and bottom, giving the impression of a crescent moon or a partial ring.

SUBMITTER IDENTIFICATION

Applicant's Name and Street Address:

SEP

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

Contact Person: Peter Schultz, Manager Quality and Regulatory

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

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

Date of Submission: June, 1998

DEVICE NAME

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

INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the NuCamma R*, manufactured by IS2 Research Inc., is substantially equivalent to the ISOCAM I gamma camera which has previously underwent the 510(k) premarket notification process. The NuCamma R* nuclear imaging system has a round field of view.

INTENDED USE

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

Medical Diagnostic l maging

{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, specifically the emblem of the U.S. Department of Health & Human Services (HHS). The emblem features a stylized depiction of an eagle or bird-like figure, rendered in black. The text "DEPARTMENT OF H" is partially visible, oriented vertically along the left side of the emblem.

2 1998 SEP

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

Re:

K982044 NuCamma R+ 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration.

If your device is classified (see above) into either class III (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 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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

510(k) Premarket Notification

LART PRODUCTION

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ (NU CAMMA R') CAMERA GAMMA Device Name:

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)

Over-the-Counter Use

(Optional Format 1-2-96)

la Segon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,

and Radiological D

ve, Abdominal, ENT,

510(k) Number K982044

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.