INFRARED SCIENCES BREASTSCAN IR SYSTEM

K032350 · Infrared Sciences Corp. · LHQ · Feb 20, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032350
• Device Name: INFRARED SCIENCES BREASTSCAN IR SYSTEM
• Applicant: Infrared Sciences Corp.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The Infrared Sciences BreastScan IR™ System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

Device Story

BreastScan IR System is a non-invasive, non-contact infrared imaging device used in clinical settings by qualified healthcare personnel. It captures passive infrared emissions from the breast using a focal plane array camera; no breast compression or physical contact occurs. The system processes thermal data via proprietary algorithms to generate non-subjective reports of static and dynamic thermal patterns. Results are presented to clinicians to assist in determining breast health as an adjunct to mammography, ultrasound, or clinical examination. The system includes an infrared camera, server, printer, and patient chair. By providing immediate visualization of heat patterns, the device aids in the adjunctive screening of breast cancer and perfusion-related diseases.

Clinical Evidence

No clinical data. Bench testing only, including compliance with IEC-60601-1 and IEC 60601-1-2, and software validation.

Technological Characteristics

Focal plane array infrared camera; 320x240 pixel resolution; 0.08°C thermal sensitivity; 14-bit digital output. System includes infrared camera, server, printer, and medical cart. Connectivity via standard monitor/printer interfaces. Complies with IEC-60601-1 and IEC 60601-1-2. Proprietary software algorithms for thermal pattern analysis.

Indications for Use

Indicated for adult patients as an adjunctive diagnostic screening tool for the detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs.

Regulatory Classification

Identification

A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• OmniCorder BioScan System (K990416)

Submission Summary (Full Text)

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FEB 2 0 2004

Page 1 of 3

Exhibit # 1

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is 032350

#### Submitter's Identification: 1.

Infrared Sciences Corp. 380 Townline Road Hauppauge, NY 11788

Contact: Mr. Anthony Trotta Principal Engineer

Date Summary Prepared: July 29, 2003

#### Name of the Device: 2.

Infrared Sciences BreastScan IR™ System

#### Predicate Device Information: 3.

K#990416, OmniCorder BioScan System, OmniCorder Technologies, Inc., Stony Brook. NY

#### Device Description: 4.

The BreastScan IR ™ System is a new, non-invasive procedure offered to women, of any age, to determine current breast health by measuring various temperature parameters in the breast. Designed exclusively by Infrared Sciences Corp., BreastScan IR ™ System has demonstrated its effectiveness as an adjunctive tool for the doctor to use along with mammography, ultrasound, or clinical examination. The entire procedure takes approximately 10 minutes with the results immediately available, to assist in the doctor's determination of breast health. The results are analyzed by proprietary algorithms and then presented in a non-subjective report. The procedure does not involve any compression of the breast, or touching of the breast in any way. The patient simply sits in a chair, facing an infrared camera for a few minutes.

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K032350

Page 2 of 3

# Components of the system include:

Infrared System Device

Color Inkjet Printer

TVNCR

Medical Cart

BreastScan IR Server

Air Cooling Device

Patient Chair

## Intended Use: . 5.

The Infrared Sciences BreastScan IR™ System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

## Comparison to Predicate Devices: 6.

# A Comparison Chart Outlining Similarities and Differences Follows:

| Feature | BreastScan IR™ System | BioScan System |
|---------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intended Use | Visualization/Documentation<br>of Temperature Patterns<br>and Changes – Adult Only | Visualization/Documentation<br>of Temperature Patterns<br>and Changes - Adult,<br>Pediatric and Neonatal |
| Method of Data Collection | Non-Contact Passive<br>Infrared Emissions | Non-Contact Passive<br>Infrared Emissions |
| Collection Instrument | Infrared Camera | Infrared Camera |
| Data Processing | CPU with Custom<br>Algorithms | CPU with Custom<br>Algorithms |
| Measurement Parameters | Allows for Static and | Allows for Static |

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K032350
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| | Dynamic Measurement of | Measurement of Thermal |
|---------------------|------------------------|------------------------|
| | Thermal Patterns | Patterns |
| Storage | Hard Disk | Hard Disk |
| Detector Type | Focal Plane Array | Focal Plane Array |
| Detector Resolution | 320 x 240 Pixels | 256 x 256 Pixels |
| Thermal Sensitivity | 0.08°C | 0.05°C |
| Camera Output | 14 Bit Digital | 14 Bit Digital |
| Display | Monitor, TV, Printer | Monitor, TV, Printer |
| User Interface | Keyboard, Mouse, On- | Keyboard, Mouse, On- |
| | System Controls | system Controls |

# Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

The device will comply with IEC-60601-1 and IEC 60601-1-2. Software validation was performed.

### Discussion of Clinical Tests Performed: 8.

Not applicable

### 9. Conclusions:

The subject device has the same intended use and similar characteristics as the predicate device. Moreover, documentation supplied in this submission demonstrates that any difference in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Infrared Sciences BreastScan IR™ System is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Infrared Sciences Corp. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants. Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

Re: K032350 Trade/Device Name: Infrared Sciences BreastScan IRTM System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: December 17, 2003 Received: December 18, 2003

Dear Ms. Goldstein-Falk:

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. Ilsting 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. Brigdon

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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Exhibit B

Page _ 1

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Infrared Sciences BreastScan IR™ System

Indications For Use:

The Infrared Sciences BreastScan IR™ System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

(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) | <div style="display:inline-block;">✓</div> |
|---------------------------------------|--------------------------------------------|
|---------------------------------------|--------------------------------------------|

OR

| Over-The Counter Use (Optional Format 1-2-96) | |
|-----------------------------------------------|--|
|-----------------------------------------------|--|

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K032350 |