NEUROSPECTQUAD GAMMA CAMERA

K013353 · Nuclear Cardiology Systems, Inc. · KPS · Mar 4, 2002 · Radiology

Device Facts

• Record ID: K013353
• Device Name: NEUROSPECTQUAD GAMMA CAMERA
• Applicant: Nuclear Cardiology Systems, Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The intended use of the NeuroSpect QUAD Gamma Camera is to detect the location and distribution of gamma ray emitting radionuclides in the brain and store the data for analysis. This device includes accessories such as signal analysis and display equipment previously approved, K010726, patient and equipment supports, component parts and accessories.

Device Story

NeuroSpect QUAD is a nuclear imaging system featuring four rectangular field-of-view detector heads. It detects gamma-ray emitting radionuclides within the brain; stores data for subsequent analysis. Device does not perform internal data analysis; data is stored for transmission to or retrieval by external, commercially available analysis software and equipment. Used in clinical settings; operated by trained personnel. Benefits include diagnostic imaging of radionuclide distribution for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only. Safety and effectiveness established through comparison to predicate device and third-party electrical safety certification.

Technological Characteristics

Four rectangular field-of-view detector heads; emission computed tomography system; standalone data storage; certified to electrical safety standards.

Indications for Use

Indicated for the detection and acquisition of planar and SPECT images of the distribution of gamma-emitting radionuclides administered in the brain.

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

• Picker Prism 3000

Reference Devices

• K010726

Submission Summary (Full Text)

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K013353
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SERVICES FOR NUCLEAR IMAGING

4 2002 MAR

# 510(K) SUMMARY

### SUBMITTER IDENTIFICATION

Applicant's Name and Street Address:

Nuclear Cardiology Systems, Inc. dba NC Systems, Inc. 5660 Airport Blvd., Suite 101 Boulder, Colorado 80301

Charles H. Rose Contact Person:

Telephone and Fax Numbers of Contact Person:

T-[phone] 800-548-4024 F-[phone]

Address of Manufacturing Site:

Alsotorokvesz 14 H-1022 Budapest, Hungary

Date of Submission: October 10, 2001

#### DEVICE NAME

Device Name (common): Proprietary Name: Classification Name:

Gamma Camera NeuroSpect QUAD Gamma Camera Emission Computed Tomography System

#### INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the NeuroSpect QUAD Gamma Camera, manufactured by NC Systems, Inc., is substantially equivalent to the Picker Prism 3000 which has previously underwent the 510(k) premarket notification process. The NeuroSpect QUAD nuclear imaging system had four (4) rectangular field of view detector heads.

#### INTENDED USE

The intended use of the NeuroSpect QUAD Gamma Camera is to detect the location and distribution of gamma ray emitting radionuclides in the brain and store the data for analysis. This device includes accessories such as signal analysis and display equipment previously approved, K010726, patient and equipment supports, component parts and accessories.

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## DETERMINE OF SUBSTANTIAL EQUIVALENCE

The intended use of the two devices is identical. 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 equipment.

The NeuroSpect QUAD 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 NeuroSpect QUAD with the predicate device. We conclude that the NeuroSpect QUAD is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

I certify that, in my capacity as the CEO of NC Systems, Inc., I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety identifiers, and trade secret and confidential commercial information, as defined in 21CFR20.61

Charles H. Rose, MA, MSPH, D(ABSNM)

Charles H. Rose, MA, MSPH, D(ABSNM) 30 November 2001

510(k) #K013353

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2002

Mr. Charles H. Rose CEO Nuclear Cardiology Systems, Inc. 5660 Airport Blvd., Suite 101 BOULDER CO 80301

Re: K013353

Trade/Device Name: NeuroSpect QUAD Gamma Camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: November 30, 2001 Received: December 4, 2001

Dear Mr. Rose:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rovious your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the bared in the 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 noutication. The I Dri Imaling of succion 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), please If you desire spoolite acries as a see of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding Office of Compilation at (2017 224105" (21 CFR Part 807.97). Other general information on by relefence to premarker nearlied on the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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013353 510(k) Number (if known):

NeuroSpect QUAD Gamma Camera Device Name:

Indications For Use:

NeuroSpect QUAD is intended to detect and obtain planar and NeuroSpect QUAD is intended to detect and obcain promotion
SPECT images of the distribution of a gamma emitting radionuclide is SPECT images of the distribution of a game and original of the bray.
in the brain and store the bedy administered in the body.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) ivumber `K013353`

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

(Options) Formal 1-2-96)