AlfaSight 9000 Thermographic System

K150457 · Alfa Thermodiagnostics, Inc. · LHQ · Apr 10, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150457
• Device Name: AlfaSight 9000 Thermographic System
• Applicant: Alfa Thermodiagnostics, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions. The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.

Device Story

AlfaSight 9000 is a non-invasive, handheld, battery-operated thermographic system for clinical use by licensed practitioners. It measures skin surface temperatures to assist in diagnosing various conditions. The system includes a handheld probe, an off-the-shelf computer, and disposable polyethylene sheaths. During operation, the sheathed probe contacts the skin; capacitive pins trigger temperature measurement via infrared technology. Data is transmitted wirelessly via Bluetooth to the computer, which displays graphical thermographic charts. The software guides the user through a fixed sequence of body measurement points. The output provides healthcare providers with relative temperature data to be used as an adjunct to other clinical diagnostic procedures (e.g., X-ray, CT, mammography). It does not replace standard diagnostic tests but aids clinical decision-making by quantifying thermal patterns.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included Corvalent Design Verification, temperature probe with sheath performance testing, biocompatibility (ISO 10993-1), and electrical safety/EMC (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Handheld probe with infrared sensor; disposable polyethylene sheaths (ISO 10993-1). Bluetooth wireless connectivity to off-the-shelf PC. Polymer Lithium-Ion battery. Measurement range 25-40°C; accuracy +/-0.2°C. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for adult patients (non-pediatric) as an adjunct diagnostic tool for breast abnormalities, peripheral vascular disease, musculoskeletal disorders, extracranial cerebral/facial vascular disease, thyroid abnormalities, and various neoplastic/inflammatory conditions. Not for use as a sole diagnostic screening procedure.

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

• Eidam's CRT 2000 (K971956)

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

April 10, 2015

Alfa Thermodiagnostics, Inc. % Mr. John Smith Regulatory Counsel 555 13th Street, N.W. WASHINGTON DC 20004

Re: K150457

Trade/Device Name: AlfaSight 9000 Thermographic System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHO Dated: February 20, 2015 Received: February 20, 2015

Dear Mr. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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

510(k) Number (if known) K150457

Device Name AlfaSight 9000 Thermographic System

#### Indications for Use (Describe)

The AlfaSight 9000 is intended for the adjunct diagnosis of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.

The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.

Type of Use (Select one or both, as applicable)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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#### 510(k) SUMMARY

| DATE | February 20, 2015 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Alfa Thermodiagnostics, Inc. |
| | 9057 Soquel Drive, Suite B-AA |
| | Aptos, CA 95003 |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| CONTACT PERSON | Daniel Beilin, O.M.D., Alfa Thermodiagnostics, Inc |
| | 9057 Soquel Drive, B-AA |
| | Aptos, CA. 95003 |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| DEVICE NAME | AlfaSight 9000 Thermographic System |
| Classification: | Class I |
| Common Name | Telethermographic system |
| Classification | 21 C.F.R. § 884.2980 (adjunctive use) |
| Product Code | LHQ |
| Review Panel | Obstetrics/Gynecology |
| PREDICATE DEVICE | Eidam's CRT 2000 (K971956) |
| INTENDED USE | The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of<br>the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders;<br>4) extracranial cerebral and facial vascular disease; 5) abnormalities of the<br>thyroid gland; and 6) various neoplastic and inflammatory conditions. |
| | The AlfaSight 9000 is not intended to serve as a sole diagnostic screening<br>procedure. |

#### DEVICE DESCRIPTION

The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.

The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the

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temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.

# SUBSTANTIAL EQUIVALENCE

A comparison of the AlfaSight 9000 System's indications for use, technological characteristics, and principles of operation with the predicate device indicates that the AlfaSight 9000 system is substantially equivalent to the FDA-cleared CRT 2000 thermographic device (K971956).

The AlfaSight 9000, like the predicate device CRT-2000, is intended as an adjunct to other clinical diagnostic procedures. The indications for use are identical to the indications for the predicate CRT-2000 device.

The AlfaSight 9000 system differs from its predicate, the CRT-2000, in that it measures the skin temperature (through a biocompatible sheath) using infrared technology rather than the thermocouple measurements employed by the CRT-2000 device. The use of infrared measurements does not affect the safety or effectiveness of the AlfaSight 9000 system for its intended use, as demonstrated by the completed bench testing, including Corvalent Design Verification Testing and Temperature Probe with Sheath Performance Testing.

The points measured for the AlfaSight 9000 systems are identical to the points measured by the CRT 2000 predicate device.

| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications for use | Adjunct diagnosis of:<br>1) abnormalities of the female breast;<br>2) peripheral vascular disease;<br>3) musculoskeletal disorders;<br>4) extracranial cerebral and facial vascular disease;<br>5) abnormalities of the thyroid gland; and<br>6) various neoplastic and inflammatory conditions.<br><br>The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure. | Adjunct diagnosis of:<br>1) abnormalities of the female breast;<br>2) peripheral vascular disease;<br>3) musculoskeletal disorders;<br>4) extracranial cerebral and facial vascular disease;<br>5) abnormalities of the thyroid gland; and<br>6) various neoplastic and inflammatory conditions.<br><br>The CRT 2000 is not intended to serve as a sole diagnostic screening procedure. |
| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
| Functionality | Captures skin surface<br>temperatures, provides that<br>data in a thermographic chart<br>for use by the healthcare<br>practitioner as an adjunct to<br>other clinical procedures. | Captures skin surface<br>temperatures, provides that<br>data in a thermographic chart<br>for use by the healthcare<br>practitioner as an adjunct to<br>other clinical procedures. |
| Where used | Doctor's Office, Clinic or<br>Hospital | Doctor's Office, Clinic or<br>Hospital |
| Anatomical Sites | Same | Same |
| Target Population/ demographic | Adult use, non pediatric | Adult use, non pediatric |
| Device Regulatory Classification | 21 CFR 884.2980 | 21 CFR 884.2980 |
| Product Code | LHQ | LHQ |
| Device Class | Class I | Class I |
| Biocompatibility | (Sheath) ISO 10993-1 | Data Not Available |
| EMC and Safety | IEC 60601-1; IEC 60601-1-2 | Data Not Available |
| 510(k) number | To be determined | K971956 |
| PC Supply voltage | AC 85 -264V | AC 110 - 240 V |
| PC Power Input | 60 Watts | 180 Watt |
| PC Frequency | Hz 47-63 Hz | Hz 50/60 |
| PC Storage Temperature Range | -40°C to +85°C | 0°C - 50°C |
| PC Screen Display | Graphic LCD Display | Graphic LCD Display |
| Probe Battery | Polymer Lithium-Ion | None |
| Probe Rechargeable | Yes | N/A |
| Probe Status Indicator | Yes | Yes |
| Probe Error Margin | +/-0.2 degrees C | +/-0.2 degrees C |
| Probe Temp. Collection method | Infrared thermocouple | bi-metal thermocouple |
| Probe Skin Contact | Sheathed probe tips contact<br>the skin to start the<br>temperature measurement.<br>The IR sensor does not touch<br>the skin. | Thermocouple sensor and edge<br>surface of probe tip contact<br>the skin to take the<br>measurement. The sensor<br>touches the skin. |
| Disposable Sheath Material | Polyethylene | N/A |
| Probe Optimum Range | 25-40°C | 27-35°C |
| Probe Communication | Blue Tooth Wireless<br>Communication of<br>measurement data from Probe<br>to PC | Wired Communications |
| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
| Software Main functions | Receives temperature signal<br>and generates multiple point<br>temperature measurement<br>graphics for healthcare<br>practitioners on measurement<br>locations and temperature<br>measurement readings. | Receives temperature signal<br>and generates multiple point<br>temperature measurement<br>graphics for healthcare<br>practitioners on measurement<br>locations and temperature<br>measurement readings. |
| Correct Orientation and location | Measurement points are<br>highlighted on the figure on<br>the display screen for<br>measurement location and<br>sequence of measurements. | Measurement points are<br>highlighted on the figure on<br>the display screen for<br>measurement location and<br>sequence of measurements. |

The following table provides more detailed information regarding the basis for the determination of substantial equivalence:

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## PERFORMANCE TESTING

The AlfaSight 9000 System has been determined through engineering to be substantially equivalent to the predicate device. Testing demonstrates that the AlfaSight 9000 conforms to ISO 10993-1, IEC 60601-1, and IEC 60601-1-2.

The following non-clinical bench performance testing has been completed for the subject device:

- Biocompatibility
- Software Risk Analysis
- Software Requirements Specification ●
- Software Validation Protocol
- Software Verification Summary and Test Case Report
- Software Test Results Report and Revision History in
- Software Design Specification
- Software Development Environment Description Document
- Electromagnetic Compatibility and Electrical Safety

## CONCLUSION

In sum, the results of non-clinical testing demonstrate that the AlfaSight 9000 System is as safe, as effective and performs as well as the predicate device. In sum, the AlfaSight 9000 is substantially equivalent to the CRT 2000 predicate device.