TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB

• K Number: K020783
• Device Name: TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
• Manufacturer: TELESIS TECHNOLOGIES INC.
• Date Cleared: 2002-06-07 ( 88 days)
• Product Code: LHQ
• Regulation Number: 884.2980

Intended Use

The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary does not contain any explicit mentions of AI, ML, DNN, or descriptions of training/test sets, which are typical indicators of AI/ML technology in medical devices.

Therapeutic

No
The device is intended for "adjunctive diagnostic screening," indicating it is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states, "The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses," which directly indicates it is a diagnostic device.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. While it mentions "Digital Infrared Thermal Image" as the input, it doesn't specify if the device is the software processing these images or if it includes the hardware for acquiring them.

IVD (In Vitro Diagnostic)

Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "adjunctive diagnostic screening for detection of breast cancer or other uses." While this is a diagnostic purpose, it's focused on the body (breast) and uses an imaging modality (Digital Infrared Thermal Image).
• Input Modality: The input is a "Digital Infrared Thermal Image." This is an imaging technique applied to the patient's body, not a sample taken from the patient (like blood, urine, tissue, etc.) that is then tested in vitro.
• Anatomical Site: The anatomical site is "breast." This reinforces that the device interacts with the patient's body directly.
• Lack of IVD Characteristics: The description lacks any mention of:
  • Analyzing biological samples (blood, urine, tissue, etc.).
  • Reagents or assays used to detect specific substances in samples.
  • Testing performed outside of the living body.

In summary, this device appears to be an imaging device used for diagnostic purposes on the human body, which falls outside the typical definition of an In Vitro Diagnostic device. IVDs are designed to examine specimens taken from the body to provide information about a person's health.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

Product codes

90 LHQ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2002

Mr. Ke-Min Jen Official Correspondent Telesis Technologies, Inc. 14F-3 & -4, No. 81, Sec. 1 Hsin-Tai-Wu Rd., His-Chih City, Taipei Hsien 221, TAIWAN, ROC

Re: K020783

Trade/Device Name: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: February 25, 2002 Received: March 11, 2002

Dear Mr. Jen:

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 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 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 this 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" (21 CFR Part 807.97). 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

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Telesis Technologies Incorporated

14F-3 & -4, No. 81, Sec. 1, Hsin-Tai-Wu Rd., His-Chih City, Taipei Hsien, 221, Taiwan, ROC TEL: [phone] FAX: [phone] E-MAIL: peter [e-mail]

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510 (K) NUMBER ( IF KNOW ):_ DEVICE NAME: TELESIS Digital Infrared Thermal Image System : Spectrum 9000MB INDICATIONS FOR USE:

The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use	✓	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K020783

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