BCC GAMMA CAMERA

K013667 · Is2 Research, Inc. · KPS · Jan 28, 2002 · Radiology

Device Facts

• Record ID: K013667
• Device Name: BCC GAMMA CAMERA
• Applicant: Is2 Research, Inc.
• Product Code: KPS · Radiology
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The intended use of BCC is to detect the location and distribution of gamma ray 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

The Breast Cancer Camera (BCC) is a planar scintillation camera designed for nuclear imaging. It utilizes two rectangular detector heads to capture gamma-ray emissions from radionuclides administered to a patient. The device stores this data for subsequent analysis and display. The system is optimized for clinical breast imaging. It is operated by clinical staff in a medical setting. The device provides visual output of radionuclide distribution, which assists healthcare providers in identifying the location of tracers within the breast and surrounding tissues, thereby supporting clinical diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on hardware and software identity to the predicate device and adherence to established electrical safety standards.

Technological Characteristics

Planar scintillation (gamma) camera; two rectangular detector heads; gantry optimized for breast imaging; electrical safety certified to standards identical to predicate; software-based data storage and analysis.

Indications for Use

Indicated for imaging and detecting the distribution of gamma-ray emitting radionuclides administered into the patient's body, specifically for the breast and surrounding area.

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

• NuCamma Bi90

Submission Summary (Full Text)

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JAN 2 8 2002

K013667

# 510(K) SUMMARY

#### SUBMITTER IDENTIFICATION

Applicant's Name and Street Address: IS2 Research Inc. 20 Gurdwara Road, Units 3 - 6, Nepean, Ontario, Canada K2E 8B3

Contact Person: Victor Woodburn, 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:

October 2001 Date of Submission:

#### DEVICE NAME

Device Name (common): Gamma Camera Proprietary Name: BCC Planar Scintillation Camera Imaging Classification Name:

### INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the BCC, manufactured by IS2 Research Inc., is substantially equivalent to the NuCamma Bi90 camera, which has previously, underwent the 510(k) premarket notification process. The BCC nuclear imaging system has two rectangular fields of view detector heads.

#### INTENDED USE

The intended use of BCC is to detect the location and distribution of gamma ray 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 BCC is a reduced range of studies of NuCamma Bi90 can perform the identical studies to the BCC. The detector heads are identical in hardware and software. The ganty of the BCC is optimized for clinical study of the breast and does not have the range of automatic motions of the NuCamma Bi90

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

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is a stylized eagle with three horizontal lines above it, representing the three branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Mr. Victor Woodburn Manager, Quality and Regulatory IS4 Research Inc. 20 Gurdwara Road, Bays 3-6 Nepean, Ontario, Canada K2E 8B3

Re: K013667

Trade/Device Name: Breast Cancer Camera (BCC) Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 KPS Dated: October 31, 2001 Received: November 6, 2001

Dear Mr. Woodburn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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), please contact the Office of Compliance at one 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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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Page **_ of _**

510(k) Number (if known):_KQ13 667

CANERA Device Name: BREAST CANCER

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymann

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Device 510(k) Number

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)