MODIFICATION TO: NUCAMMA RX

K032779 · Is2 Research, Inc. · KPS · Dec 17, 2003 · Radiology

Device Facts

• Record ID: K032779
• Device Name: MODIFICATION TO: NUCAMMA RX
• Applicant: Is2 Research, Inc.
• Product Code: KPS · Radiology
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store 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

Mobile nuclear imaging system; utilizes single rectangular field-of-view detector head to detect gamma ray emitting radionuclides; inputs include radioactive emissions from patient; transforms inputs into planar, whole body, or SPECT images; mounted on mobile platform for transport via truck; operated by clinical staff; output displayed on integrated signal analysis/display equipment; assists clinicians in visualizing radionuclide distribution for diagnostic decision-making; benefits include mobile access to nuclear imaging capabilities.

Clinical Evidence

Bench testing only; device certified to electrical safety standards by a third party; substantial equivalence established via feature comparison matrix.

Technological Characteristics

Single rectangular field-of-view detector head; energy range 50–400 keV; supports planar, whole body, and SPECT imaging; mobile gantry platform; electrical safety certified.

Indications for Use

Indicated for patients requiring planar, whole body, or tomographic (SPECT) imaging to detect or image the distribution of gamma ray emitting radionuclides (50–400 keV) in the body or organs.

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

• Rectangular Single Head Camera (SR) (K982045)

Submission Summary (Full Text)

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## 501(k) SUMMARY

K032779

# DEC 17 2003

### SUBMITTERS IDENTIFICATION

| Applicant's Name and Street Address: | IS2 Medical Systems Inc.<br>20 Gurdwara Rd., Units 3-10<br>Ottawa, Ontario, Canada<br>K2E 8B3 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Victor Woodburn, Manager Quality and Regulatory |
| Telephone and Fax Number of Contact Person: | T- [phone], F - [phone] |
| Address of Manufacturing Site: | Same as Applicant's Address noted above |
| Date of Submission: | September 30, 2003 |
| | DEVICE NAME |
| Device Name (Common): | Gamma Camera |
| Proprietary Name: | Mobile Rectangular Single Head Camera (MSR)) |
| Classification Name: | Emission Computed Tomography System |
| Product Code: | 90-KPS |
| CFR: | 21CFR 892.1200 |
| Device Class: | II |
| Predicate Device: | Rectangular Single Head Camera (SR) |
| 510(k) No.:<br>(Predicate) | K982045 |

### INTRODUCTION

This 510(k) Premarket Notification has been prepared to demonstrate that the Mobile Rectangular Single Head Camera (MSR), manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Read Camera (SR) which has previously been through the 510(k) premarket notification process. The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads.

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### 501(k) SUMMARY

#### INTENDED USE

The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store 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 Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).

The Mobile Rectangular Single Head Camera (MSR) 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 Mobile Rectangular Single Head Camera (MSR) with the predicate device. We conclude that the Mobile Rectangular Single Head Cameru (MSR) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 17 2003

Mr. Victor Woodburn Manager, Quality and Regulatory IS2 Medical Systems, Inc. 20 Gurdwara Road, Units 3-10 Ottawa, Ontario, K2E 8B3 CANADA

Re: K032779 Trade/Device Name: Mobile Rectangular Single Head Camera (MSR) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 5, 2003 Received: September 18, 2003

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 such 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 (OS) 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 Section 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

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 the 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" (21CFR Part 807.97) you may obtain. 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

Page 2

to proceed to the market.

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## 510(k) Number (K032779)

Device Name Mobile Rectangular Single Head Camera (MSR)

Indications for Use: The intended use of the Mobile Rectangular Single Head Camera is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

To detect or image the distribution of radionuclides in the body or organ using the following technique(s);

- YES NO Energy Range (keV) 50 – 400 keV (a) Planar Imaging (b) Whole Body Imaging 50 – 400 keV (c) Tomographic Imaging (SPECT) for non Positron 50 - 400 keV emitter (d) Positron imaging by coincidence (e) Positron imaging without coincidence (f) Other indication(s) in the device label, but not None included in the above list
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K 032779

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use