COMPACT DIGITAL CARDIAC CAMERA (CDCC)

K033199 · Is2 Medical Systems, Inc. · KPS · Nov 12, 2003 · Radiology

Device Facts

• Record ID: K033199
• Device Name: COMPACT DIGITAL CARDIAC CAMERA (CDCC)
• Applicant: Is2 Medical Systems, Inc.
• Product Code: KPS · Radiology
• Decision Date: Nov 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment supports, radionuclide anatomical markers, component parts and accessories.

Device Story

Compact Digital Cardiac Camera (CDCC) is a nuclear imaging system featuring two rectangular detector heads. Device detects gamma ray emitting radionuclides within body; stores data for analysis. System optimized for minimal room space; utilizes automatic clinical motions. Operated by clinical staff in medical imaging environments. Output consists of planar and SPECT images used by healthcare providers to visualize radionuclide distribution, aiding in clinical diagnosis and decision-making. Benefits include compact footprint for space-constrained facilities while maintaining diagnostic imaging capabilities equivalent to predicate systems.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established via comparison to predicate device and certification to electrical safety standards.

Technological Characteristics

Nuclear imaging system with two rectangular detector heads. Energy range: 50-250 keV. Supports planar and SPECT imaging. Optimized for minimal room space. Software and hardware identical to predicate Bi90 Digital Cardiac Camera. Electrical safety certified by third-party organization.

Indications for Use

Indicated for detection and imaging of radionuclide distribution in the body or organs via planar imaging and tomographic imaging (SPECT) for non-positron emitters in the 50-250 keV energy range. Prescription use only.

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

• Bi90 Digital Cardiac Camera (K003882)

Submission Summary (Full Text)

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## 501(k) SUMMARY

K033199

#### NOV 1 2 2003 SUBMITTERS IDENTIFICATION IS2 Medical Systems Inc. Applicant's Name and Street Address: 20 Gurdwara Rd., Units 3-10 Ottawa, Ontario, Cunada K2E 883 Victor Woodburn, Manager Quality and Regulatory Contact Person: T- [phone]. F [phone] Telephone and Fax Number of Contact Person: Same as Applicant's Address noted above Address of Manufacturing Site: September 30, 20113 Date of Submission: DEVICE NAME Gamma Camera Device Name (Common): Compact Digital Cardiac Camera, (CDCCC) Proprietary Name: Emission Computed Tomography System Classification Name: 90-KPS Product Code: 21CFR 892.1200 CFR: l l Device Class: Bi90 Digital Cardiac Camera Predicate Device K003882 510(k) No .: (Predicate)

#### INTRODUCTION

This 510fk) Premarket Notification has been prepared to demonstrate that the Compuct Digital Cardiac Camera, manufactured by 152 Medical Systems Inc., is substantially equivalent to the Bi90 Digital Cardiac Camera which has previously been through the 510(k) premarket notification process. The COMPACT DIGITAL CARDIAC CAMERA nuclear imaging system has two rectangular fields of view detector heads.

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### 501(k) SUMMARY

#### INTENDED USE

The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting rudionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment supports, rudionwelide anatomicul markers, component parts and accessories

#### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the COMPACT DIGITAL CARDIAC CAMERA is the sume range of studies to that of the Bi90 Digital Cardiae Camera. The detector heads are identical in hardware and software. The ganny of the COMPACT DIGITAL CARDIAC CAMERA is optimized for minimal room space und has the same range of automatic clinical motions of the Bi90 Digital Curdiac Camera.

The COMPACT DIGITAL CARDIAC CAMERA has been deemed safe and effective and is certified to the same electrical sufery standards as the predicule device by a third party organization prior to use on patients. A mutrix was constructed comparing the features and intended use of the CQMPACT DIGITAL CARDIAC CAMERA with the predicate device. We conclude that the COMPACT DIGITAL CARDIAC CAMERA is substantially equivalent to the predicate device and that no new sufety or effectiveness concerns are raised

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 2 2003

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

Re: K033199 Trade/Device Name: Compact Digital Cardiac Camera (CDCC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 30, 2003 Received: October 2, 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 (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 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 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 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

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

Enclosure

Page 2

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# Indications for Use Statement

510(k) Number (K033199)

### Device Name COMPACT DIGITAL CARDIAC CAMERA

Indications for Use: The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gammu ray emitting radionuctides in the body und store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, rudionuclide unatomical markers, component parts and accessories.

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

| (a) Planar Imaging | YES | NO | Energy Range (keV) | |
|---------------------------------------------------------------------------------|-----|-----|--------------------|--|
| | ✓ | ✓ | 50-250 keV | |
| (b) Whole Body Imaging | | ✓ | | |
| (c) Tomographic Imaging (SPECT) for non Positron emitter | YES | NO | | |
| | ✓ | | 50-250 keV | |
| (d) Positron imaging by coincidence | | YES | NO | |
| | | ✓ | | |
| (e) Positron imaging without coincidence | | YES | NO | |
| | | ✓ | | |
| (f) Other indication(s) in the device label, but not included in the above list | | | None | |

PLEASE DO NOT WRITE BELOW TIMS I.INE - CONTINUE ON ANOTHER PAGE IF NEWDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc Brogdon
(Division Sign-C4
Division of Repr

Division of and Radiological 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use