TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P

K033967 · Flir Systems · LHQ · Mar 9, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033967
• Device Name: TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
• Applicant: Flir Systems
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Indications for Use

The Flir device is intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes

Device Story

Telethermographic camera system (Series A, E, S, P) captures passive infrared emissions via focal plane array sensors; non-contacting operation. Software processes captured energy to produce digital thermal values; output displayed on monitor or LCD. Used in hospitals, sub-acute institutions, and public areas (e.g., airports) by operators to visualize and document skin surface temperature patterns. Output serves as an adjunct to other clinical diagnostic procedures; assists clinicians in identifying temperature variations; potential benefit includes non-invasive screening and documentation of thermal changes.

Clinical Evidence

No clinical data provided; bench testing only. Device performance characterized by temperature range (-40°C to +250°C) and accuracy (±2°C or ±2% of reading).

Technological Characteristics

Non-contacting infrared camera; focal plane array detector; CPU-based data processing; temperature range -40°C to +250°C; accuracy ±2°C or ±2% of reading; display via monitor/LCD; complies with EMC/EMI standards.

Indications for Use

Indicated for use as an adjunct to clinical diagnostic procedures for the diagnosis, quantification, and screening of skin surface temperature changes. No specific patient population or contraindications defined.

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

• Inframetrics, Inc. Infracam-Med (K982327)
• Dorex, Inc. Spectrum 9000mb (K023434)

Submission Summary (Full Text)

{0}------------------------------------------------

Premarket Notification 510(k)

______________________________________________________________________________________________________________________________________________________________________________

# KO33967

# Telethermographic Camera ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

#### 510(k) Summary of Safety and Effectivencss 6.1

_--- ---- --------------------------------------------------------------------------------------------------------------------------------------------------------------------

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 December 19, 2003

| Flir Systems, Inc.<br>16 Esquire Road<br>North Billerica, MA 01862 | Tel [phone]<br>Fax [phone] |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tom Scanlon |
| Proprietary or Trade Name: | Series A, E, S, and P - IR cameras |
| Common/Usual Name: | Telethermographic system |
| Classification Name: | Telethermographic system (adjunctive use) |
| Predicate Devices: | Technology<br>Inframetrics, Inc.<br>Infracam-Med - K982327-<br>Indications of Use<br>Dorex, Inc.<br>Spectrum 9000mb - K023434 |
| Device Description: | Flir manufactures a number of IR camera's, they all include the<br>same basis temperature measurement and sensing technology.<br>They are non-contacting and employ passive infrared emissions<br>for sensing temperature variations. |
| | The captured energy is processed by software to produce digital<br>output values of the thermal energy captured by the camera's<br>thermal sensors. |
| Intended Use: | The Flir device is intended for use as an adjunct to other clinical<br>diagnostic procedures in the diagnosis, quantifying, and screening<br>of differences in skin surface temperature changes. It can visualize,<br>document temperature patterns and changes |
| Environment of Use: | Hospital, Sub-acute Institutions, public areas, i.e., airports |

{1}------------------------------------------------

## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 December 19, 2003

| General Technical Characteristics | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Proposed devices – Series – A, E, S, P |
| Indications for use | The Flir device is intended for use as an adjunct to<br>other clinical diagnostic procedures in the<br>diagnosis, quantifying, and screening of differences<br>in skin surface temperature changes. It can<br>visualize, document temperature patterns and<br>changes |
| Prescription | No |
| Intended population | Not applicable |
| Intended Environment of Use | Hospital, Sub-acute Institutions, public areas, i.e.<br>airports |
| Design | |
| Method of data collection | Non-contacting detection of passive infrared<br>emissions |
| Data processing | CPU |
| Detector type | Focal Plane Array |
| Display | Monitor or LCD |
| Temperature ranges | $-40 °C$ to $+250 °C$ |
| Accuracy | $±2 °C$ or $± 2%$ of reading |
| Materials | |
| Not applicable | Device is non-contacting |
| Performance Standards | |
| Under Section 514 | None |
| Complies with various ISO standards | EMC, EMI |

## Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed device is safe, effective, and substantially equivalent when compared to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Flir Systems, Inc. % Mr. Paul Dryden President ProMedic, Inc. 6329 W. Waterview Ct. MCCORDSVILLE IN 46055-9501 Re: K033967

MAR - 9 2004

Trade/Device Name: Telethermographic camera Series A. E. P. and S Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: December 19, 2003 Received: December 22, 2003

Dear Mr. Dryden:

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 docs 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.

{3}------------------------------------------------

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

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

Enclosure

{4}------------------------------------------------

#### Indications for Use 6.3

## Page 1 of 1

| 510(k) Number: | K033967 (To be assigned) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Telethermographic camera<br>Series A, E, P, and S |
| Intended Use: | The Flir devices are intended for use as an adjunct to other<br>clinical diagnostic procedures in the diagnosis, quantifying,<br>and screening of differences in skin surface temperature<br>changes. It can visualize, document temperature patterns<br>and changes.<br>Environment of use: hospital, sub-acute, public areas, i.e.,<br>airports |

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109) ✓

or

Over-the-counter use

Narayc Bogdan

(Division Sign-Off Division of Reproductive, Al dominal, and Radiological Devices 103-596 510(k) Number .

Page 16