The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer, it is used in planar and whole-body and SPECT imaging.

Device Description

The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer. The acquisition hardware is a microprocessor-based system and is separate from the host personal computer. It uses simple, window-based GUIs.

AI/ML Overview

The provided text describes the "NumaStation" device and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria, device performance, results of a study, or details about ground truth establishment or sample sizes.

The document is a 510(k) submission summary for the NumaStation, a nuclear medicine data acquisition system. It focuses on demonstrating substantial equivalence to a predicate device (Gamma 600t) based on functional similarities and adherence to EMC and NEMA standards.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The text primarily addresses regulatory compliance through substantial equivalence, not performance metrics derived from a detailed study.

Summary

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FEB 1 3 1998

K974444

Summary of Safety and Effectiveness

for the

NumaStation Numa, Incorporated

NumaStation 510(k)

ﺳﺴﻪ

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9.0 Introduction

This document is intended to be in accordance with the Safe Medical Devices Act of 1990 providing a summary of the information used to determine safety and effectiveness of the NumaStation nuclear medicine data acquisition system.

9.1 Substantial Equivalence

The NumaStation has been shown to be safe and effective because of its substantial equivalence to a predicate device: the Gamma 600t (K923736) from Strichman Medical Equipment, Incorporated.

In both products the acquisition hardware is a microprocessor-based system and is . separate from the host personal computer. This design is used to insure that integrity of the time-critical aspects of the data acquisition (time marks and ECG gate pulses) is kept independent of the personal computer operating system.
. Both the NumaStation and the Gamma 600t use simple, window-based GUIs to provide the nuclear medicine technologist with a comfortable work environment that insures reliable use of the system.
. The intended use of the NumaStation is as a conduit for nuclear medicine data. After acquisition of the data on the NumaStation, it is transferred through a variety of possible connectivity options to a third party workstation for processing. The Gamma 600t has similar third party connectivity designed in as well.

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9.2 EMC Test Results

The following are the test results for the EMC testing per EN60601-1-2 and the NEMA testing per NU 1-1994.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem. The overall design is simple and conveys a sense of authority and service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Kurt N. Larson President Numa, Inc. 10 Northern Boulevard, Unit 12 Amherst, NH 03031

Re: K974444

NumaStation (Nuclear Medicine Data Acquisition Computer) Dated: November 18, 1997 Received: November 25, 1997 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Larson:

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 included in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 misbranting 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 yitro 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/cdrb/dsmamain.html", ... ........................................................................................

Sincerely yours.

William Yu, 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

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Page 1 of 1

510(k Number (if known):	K974444
Devic: Name:	NumaStation

Indications For Use:

(PI .EASE !)O NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elaine A. Bergman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.