NUMASTATION

K974444 · Numa, Inc. · KPS · Feb 13, 1998 · Radiology

Device Facts

• Record ID: K974444
• Device Name: NUMASTATION
• Applicant: Numa, Inc.
• Product Code: KPS · Radiology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

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 Story

NumaStation is a stand-alone computer interface connecting to third-party gamma cameras; functions as a conduit for nuclear medicine data. Input includes raw data from gamma cameras, including time-critical signals like time marks and ECG gate pulses. Device utilizes a microprocessor-based system separate from the host PC to ensure acquisition integrity independent of the PC operating system. Output consists of acquired data transferred to third-party workstations for processing. Operated by nuclear medicine technologists in clinical settings via a window-based GUI. Benefits include reliable data acquisition and integration with existing imaging workflows.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including EMC testing per EN60601-1-2 and NEMA testing per NU 1-1994.

Technological Characteristics

Microprocessor-based data acquisition system; stand-alone hardware interface; window-based GUI; connectivity to third-party gamma cameras and processing workstations. Complies with EN60601-1-2 (EMC) and NEMA NU 1-1994 standards.

Indications for Use

Indicated for use as a nuclear medicine data acquisition system for planar, whole-body, and SPECT imaging applications.

Regulatory Classification

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.

Predicate Devices

• Gamma 600t (K923736)

Submission Summary (Full Text)

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FEB 13 1998

9

K974444

# Summary of Safety and Effectiveness

for the

# NumaStation

Numa, Incorporated

NumaStation 510(k)

CONFIDENTIAL

November 17, 1997

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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.

NumaStation 510(k)
CONFIDENTIAL
November 17, 1997

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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.

NumaStation 510(k)
CONFIDENTIAL
November 17, 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 13 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 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 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 (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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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

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FROM : Numa, Inc. PHONE NO. : 6038830839 Dec. 10 1997 01:10PM P2

510(k: Number (if known): K974444

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974444

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use ☑ (1'er 2. CFR §01.109)