Sentinel BreastScan II System

K162767 · First Sense Medical, LLC · LHQ · Jan 9, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162767
• Device Name: Sentinel BreastScan II System
• Applicant: First Sense Medical, LLC
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Jan 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The Sentinel BreastScan II 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

Portable telethermographic system; captures thermal infrared energy (heat) emitted from human body. Input: thermal images of breasts captured via FLIR A315 camera. Process: patient sits in chair with IR-reflecting mirrors; system blows cool air on breasts during test cycle; motorized vertical alignment adjusts camera/cooling unit to patient. Output: thermal data stored in cloud for review by healthcare professional or third-party lab. Used in hospitals, acute care, outpatient surgery, or practitioner facilities by trained personnel. No breast compression; no radiation; no patient contact. Benefits: non-invasive adjunctive screening for breast cancer and perfusion-related diseases.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed system performance, thermal camera accuracy, and software functionality met all requirements. Compliance with ANSI/AAMI ES60601-1 and IEC 60601-1-2 standards demonstrated.

Technological Characteristics

Telethermographic system; FLIR A315 thermal camera (45º lens); motorized vertical alignment; air cooling unit; IR-reflecting mirrors; Wi-Fi connectivity; cloud-based data storage. Operates via non-contact infrared sensing. Complies with ANSI/AAMI ES60601-1 and IEC 60601-1-2.

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

• Infrared Sciences Corp., BreastScan IR (K032350)

Submission Summary (Full Text)

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

January 9, 2017

First Sense Medical, LLC % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004

Re: K162767

Trade/Device Name: Sentinel BreastScan II System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: December 14, 2016 Received: December 14, 2016

Dear Dr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
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**Indications for Use**

| 510(k) Number ( <i>if known</i> ) | K162767 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sentinel BreastScan II System |
| Indications for Use (Describe) | The Sentinel BreastScan II 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. |

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
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#### 510(k) SUMMARY

First Sense Medical, LLC's Sentinel BreastScan II System

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341

Phone: [phone] Facsimile: 248-876-9278

> Contact Person: Alan Klevens, CEO

Date Prepared: September 30, 2016

#### Name of Device and Name/Address of Sponsor

Sentinel BreastScan II System

First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341

#### Common or Usual Name

Telethermographic System (Adjunctive Use)

#### Classification Name

Telethermographic System (Adjunctive Use) Product Code: LHQ 21 C.F.R. 884.2980

#### Predicate Devices

Infrared Sciences Corp., BreastScan IR (K032350)

#### Purpose of the Special 510(k) Notice

The Sentinel BreastScan II System is a modification to the Infrared Sciences Corp. BreastScan IR system.

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### Device Description

The Sentinel BreastScan II System consists of a portable device that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact with the device and the test emits no radiation to the patient. The device consists of a thermal camera, a metal enclosure to secure and protect components, a motor and electronics to raise and lower the tester to adjust the camera for various sized patients, a chair with attached armrests, adjustable special heat reflecting mirrors, a computer with a touchscreen monitor, data storage, software, and Wi-Fi communication. The tester includes an air cooling unit that blows cool air during part of the test cycle.

## Intended Use / Indications for use

The Sentinel BreastScan II 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 of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

### Summary of Technological Characteristics

Telethermography is the technological principle for both the subject and predicate devices. Using an advanced non-contact infrared thermal camera, the Sentinel BreastScan II system records thermal data (emission of body temperature) from a patient's breasts. During the procedure, the patient sits facing a thermal camera, cool air is blown on the patient's breasts for part of the test and additional thermal data is recorded. The data is verified for errors, securely stored and made available to the healthcare professional or a third party reference lab for later processing and evaluation. The test procedure does not involve any compression or touching of the breasts and the patient has no contact with the tester.

At a high level, the subject and predicate devices are based on the following same technological elements:

- . Advanced digital Thermal Camera (FDA cleared).
- · The Sentinel BreastScan II uses a FLIR A315 camera with a 45º lens at 2.5 ft. from the patient. The BreastScan IR uses a FLIR S40 camera with a 25º lens at 5 ft. from the patient. The FOV is the same for both cameras at patient chest.
- Test Sequence is the same for capturing thermal data and cooling patient. .
- . Tester housing contains computer, monitor(s), thermal camera, software and air cooling system equipment.
- . Patient Chair with attached special (IR reflecting) mirrors to capture side images of breasts and custom armrests for proper patient positioning.
- Air Cooling System blows cool air onto patient breasts during test. .

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The following technological differences exist between the subject and predicate devices:

- The Sentinel BreastScan II System Tester housing is custom designed and includes . motorized vertical travel for alignment of thermal camera and air cooling system with the patient. The BreastScan IR System Tester housing is a standard commercial cart containing the tester components at a fixed camera height. The vertical alignment of the patient is achieved by an adjustable chair.
- The Sentinel BreastScan II chair is a fixed height chair with vertically adjustable . mirrors and armrests. The BreastScan IR chair is vertically adjustable with fixed mirrors and armrests.
- . The Sentinel BreastScan II stores data securely in the cloud. The BreastScan IR stores data locally on the computer.

# Performance Data

The Sentinel BreastScan II System was tested to and complies with the following standards:

- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 . or IEC 60601-1 ed. 3.1 2012-08.
- [IEC] [60601-1-2:2007] Medical Electrical Equipment Part 1-2 Requirements for Basic . Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests} [2007}

The performance testing conducted for the thermal camera, system performance monitoring, software and the device functionality as a whole demonstrates that the device meets all Sentinel BreastScan II requirements and specifications as provided in the verification and validation testing results reports. In all instances, the Sentinel BreastScan II functioned and the results observed and reported were as expected.

## Conclusions

The Sentinel BreastScan II System has the same intended use and indications, principles of operation, and technological characteristics as the Infrared Sciences Corp. BreastScan IR. The minor differences in the Sentinel BreastScan II System's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Sentinel BreastScan II System is as safe and effective as the Infrared Sciences Corp., BreastScan IR. Thus, the Sentinel BreastScan II System is substantially equivalent to its predicate devices.