MODIFICATION TO GAMMA GUIDANCE SYSTEM by RADIATION MONITORING DEVICES, INC.

For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.

Device Description

The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.

AI/ML Overview

The provided text is a 510(k) summary for the "Modified GAMMA GUIDANCE SYSTEM." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or a study proving the device meets those criteria.

Generally, a 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria in the same way a PMA (Premarket Approval) would. The FDA letter confirms the substantial equivalence finding based on the information provided in the 510(k) submission, which would have included performance data, but that data is not detailed in the summary.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be stated based on the given document:

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

Not provided in the text. The document states the device is substantially equivalent to a predicate device (GAMMA GUIDANCE SYSTEM, K961321), implying its performance is comparable. However, specific acceptance criteria or quantitative performance metrics for the "Modified GAMMA GUIDANCE SYSTEM" are not listed.

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

Not provided in the text.

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 provided in the text.

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

Not provided in the text.

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 guidance system, a medical instrument for detecting and quantifying radiation, not an AI-assisted diagnostic imaging system that would involve human "readers" or an "AI vs. without AI assistance" comparison in the typical MRMC study context.

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

Not applicable. This is a hardware device (probe, counting unit, cable), not an algorithm.

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

Not provided in the text. (This would typically relate to the "predicate device" information, which is also not detailed enough here.)

8. The sample size for the training set:

Not applicable/Not provided. This device is a physical instrument, not a machine learning model that undergoes "training."

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

Not applicable/Not provided. This device is a physical instrument, not a machine learning model that relies on establishing ground truth for a "training set."

Summary

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2 1999 JUL -

K983768

510(k) Summary of Safety and Effectiveness IX.

Radiation Monitoring Devices, Inc. SUBMITTER: 44 Hunt Street Watertown, MA 02172

CONTACT PERSON: Paul Stoppel

DATE PREPARED: October 23, 1998

Nuclear Uptake Probe CLASSIFICATION NAME:

Probe COMMON NAME:

Not yet determined PROPRIETARY NAME:

GAMMA GUIDANCE SYSTEM (K961321) PREDICATE DEVICES:

DEVICE DESCRIPTION: The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.

The Modified GAMMA GUIDANCE SYSTEM is INTENDED USE: intended for the detection and quantization of gamma radiation from gamma-emitting isotopes in the body or tissues. Their use is indicated for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region.
The Modified GAMMA GUIDANCE SYSTEM is STERILIZATION: sterilized by exposure to an ethylene oxide sterilizer.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999

Paul Stoppel Product Engineer Radiation Monitoring Devices, Inc. 44 Hunt Street Watertown, MA 02172

Re:

K983768 GAMMA Guidance System (GGS) Dated: May 27, 1999 Received: June 1, 1999 Regulatory Class: I 21 CFR 892.1320/Procode: 90 IZD

Dear Mr. Stoppel:

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 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). 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 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 Requlations, 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 (QS) 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The overall design is simple and conveys a sense of unity and progress.

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Modified Gamma Guidance System K983768: Additional Information

IV. Indications For Use:

510(k) Number (if known): K983768

Name: Modified GAMMA GUIDANCE SYSTEM

Indications For Use:

For the detection and quantification of gamma radiation from gamma-emitting isotopes in Use for non-imaging procedures to measure the amount of the body or tissues. radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use:
(Per 21 CFR §801.109) OR Over-The-Counter Use:

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983768

Regulation Number and Section

§ 892.1320 Nuclear uptake probe.

(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.