(78 days)
Not Found
No
The summary describes basic software processing of thermal data to produce digital output values, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for diagnosis, quantifying, and screening of differences in skin surface temperature changes. It is not intended for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Flir devices are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes." The use of terms like "diagnosis," "quantifying," and "screening" clearly indicates a diagnostic purpose.
No
The device description explicitly states it includes IR cameras and thermal sensors, which are hardware components. The software processes data from this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Flir device described measures skin surface temperature changes using passive infrared emissions. It does not analyze samples taken from the body.
- Intended Use: The intended use is to visualize and document skin surface temperature patterns and changes as an adjunct to other clinical diagnostic procedures. This is a non-invasive measurement of a physical characteristic, not an analysis of a biological sample.
Therefore, the Flir device, as described, falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
90 LHQ
Device Description
Flir manufactures a number of IR camera's, they all include the same basis temperature measurement and sensing technology. They are non-contacting and employ passive infrared emissions for sensing temperature variations. The captured energy is processed by software to produce digital output values of the thermal energy captured by the camera's thermal sensors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Passive infrared emissions
Anatomical Site
Not Found
Indicated Patient Age Range
Not applicable
Intended User / Care Setting
Hospital, Sub-acute Institutions, public areas, i.e., airports
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)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.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
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.
16 Esquire Road
North Billerica, MA 01862 | Tel (978) 901-8227
Fax (978) 901-8532 |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Inframetrics, Inc.
Infracam-Med - K982327-
Indications of Use
Dorex, Inc.
Spectrum 9000mb - K023434 |
| Device Description: | Flir manufactures a number of IR camera's, they all include the
same basis temperature measurement and sensing technology.
They are non-contacting and employ passive infrared emissions
for sensing temperature variations. |
| | The captured energy is processed by software to produce digital
output values of the thermal energy captured by the camera's
thermal sensors. |
| Intended 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 |
| 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 |
| 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 | |
| Prescription | No |
| Intended population | Not applicable |
| Intended Environment of Use | Hospital, Sub-acute Institutions, public areas, i.e. |
| airports | |
| Design | |
| Method of data collection | Non-contacting detection of passive infrared |
| 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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 |
| Series A, E, P, and S | |
| Intended Use: | The Flir devices are 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. | |
| Environment of use: hospital, sub-acute, public areas, i.e., | |
| 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 .
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