NUCAMMA R+

K982044 · Is2 Research, Inc. · KPS · Sep 2, 1998 · Radiology

Device Facts

• Record ID: K982044
• Device Name: NUCAMMA R+
• Applicant: Is2 Research, Inc.
• Product Code: KPS · Radiology
• Decision Date: Sep 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

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.

Device Story

NuCamma R* is a nuclear imaging system featuring a round field of view; designed to detect location and distribution of gamma ray and positron-emitting radionuclides in the body. Device captures raw data; stores it for transmission to or retrieval by external, commercially available data analysis software and computer equipment. System includes patient/equipment supports, radionuclide anatomical markers, and signal analysis/display accessories. Operated in clinical settings by trained personnel. Unlike predicate, device lacks internal data analysis capability; relies on external systems for processing. Benefits include diagnostic imaging of radionuclide distribution for clinical assessment.

Clinical Evidence

Bench testing only. Device certified to electrical safety standards by a third-party organization.

Technological Characteristics

Nuclear imaging system with round field of view; energy range 50-400 keV. Supports planar, whole body, and SPECT imaging. Connectivity provided for external data analysis systems. Electrical safety compliant with established standards.

Indications for Use

Indicated for planar imaging, whole body imaging, and tomographic imaging (SPECT) for non-positron emitters in the 50-400 keV energy range to detect or image the distribution of radionuclides in the body or organ.

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

• ISOCAM I gamma camera

Submission Summary (Full Text)

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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 - [phone], F - [phone] 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 [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/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

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# 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)

OR

### 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

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