The NoTouch BreastScan system is intended to be used as an adjunctive screening device for the detection of breast cancer by measuring various temperature parameters from the surface of the breast.

The NoTouch BreastScan™ 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 an environment where patient care is provided by qualified healthcare personnel. The patient include adult. The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.

Device Description

The NoTouch BreastScan consists of a group of hardware components. The hardware components consist of:

Two digital infrared cameras
. A computer system, with printer
. An air conditioner unit
. A specially designed mobile cart.

Software Components include:

. NoTouch BreastScan Software
. PDF Viewer
. Drivers for Infrared imagers
. ThermaCam Researcher Software

AI/ML Overview

The provided text is a 510(k) summary for the NoTouch BreastScan device. While it states that "Testing of NoTouch BreastScan was performed as per the requirements" and "Complete validation and verification was performed on all software and hardware subsystems," it does not contain the detailed acceptance criteria or the specific study results proving the device meets these criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (BREASTSCAN IR) and outlining the general intended use and technological characteristics. There is no information regarding 1. acceptance criteria, 2. sample size for test set and data provenance, 3. number and qualifications of experts for ground truth, 4. adjudication method, 5. comparative effectiveness study (MRMC), 6. standalone performance, 7. type of ground truth used, 8. sample size for training set, or 9. how ground truth for the training set was established.

Therefore, I cannot fulfill your request with the provided input because the necessary information about acceptance criteria and the detailed study results are absent.

Summary

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K113259

510(K) SUMMARY V.

FEB 1 0 2012

510(k) SUMMARY

UE LifeSciences Inc.'s NoTouch BreastScan

UE LifeSciences, Inc. 4435 Lobella Court Chester Springs PA 19425

Tel: 631-980-8340

Contact Person: Mihir Shah Tel: 267-342-3303 Email: MShah@notouchbreastscan.com

Date Prepared: January 17, 2012

Common or Usual Name: NoTouch BreastScan

Classification Name: Class 1 per 21 CFR 884.2980 Telethermographic system.

Predicate Devices

BREASTSCAN IR

Intended Use / Indications for Use

The NoTouch BreastScan system is intended to be used as an adjunctive screening device for the detection of breast cancer by measuring various temperature parameters from the surface of the breast.

Technological Characteristics

The NoTouch BreastScan consists of a group of hardware components. The hardware components consist of:

Two digital infrared cameras
. A computer system, with printer
. An air conditioner unit
. A specially designed mobile cart.

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Software Components include:

. NoTouch BreastScan Software
. PDF Viewer
. Drivers for Infrared imagers
. ThermaCam Researcher Software

Performance Data

Testing of NoTouch BreastScan was performed as per the requirements. In all instances, the NoTouch BreastScan functioned as intended and the software and hardware performed as expected. Complete validation and verification was performed on all software and hardware subsystems.

Substantial Equivalence

The NoTouch BreastScan is as safe and effective as BreastScan IR. The NoTouch BreastScan has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the NoTouch BreastScan and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the NoTouch BreastScan is as safe and effective as BreastScan IR. Thus, the NoTouch BreastScan is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Mihir Shah CEO UE LifeSciences, Inc. 4435 Lobella Court CHESTER SPRINGS PA 19425

FEB 1 0 2012

Re: K113259

Trade/Device Name: NoTouch BreastScan™ System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: January 17, 2012 Received: January 23, 2012

Dear Mr. Shah:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT IV.

Indications for Use Statement

510(k) Number (if known): K113259

Device Name: NoTouch BreastScan™ System

Indications for Use:

The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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K113259

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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.