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.

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 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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in terms of accuracy, sensitivity, or specificity for its intended diagnostic uses. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Eidam's CRT 2000, K971956) based on technological characteristics and safety.

Here's a breakdown of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantifiable acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and then reporting the device's performance against those criteria.

The only direct performance metric mentioned for the probe is:

Acceptance Criteria	Reported Device Performance
Probe Error Margin: +/-0.2 degrees C	+/-0.2 degrees C
Probe Optimum Range: 25-40°C	25-40°C

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable as no clinical performance study demonstrating diagnostic accuracy was conducted. The "test set" in this context refers to non-clinical bench testing.
Data Provenance: Not applicable for diagnostic performance. Bench testing data is implicitly from internal lab settings.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable as no clinical study with ground truth established by experts was performed for diagnostic performance validation.

4. Adjudication Method for the Test Set:

Not applicable as no clinical study with adjudication of ground truth was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that the new device measures skin temperature using infrared technology rather than the thermocouple measurements employed by the predicate device, but it asserts that this difference "does not affect the safety or effectiveness" without providing a comparative clinical trial.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device, a "Thermographic System," measures and presents temperature data to a healthcare practitioner. It's not an AI algorithm in the contemporary sense that provides diagnostic outputs. Therefore, the concept of "standalone (algorithm only)" as typically applied to AI/ML devices is not directly applicable. The performance testing conducted was non-clinical bench testing of the hardware and software's ability to measure and process temperature data.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" implicitly refers to physical standards and measurements (e.g., precise temperature references) used to verify the probe's accuracy and internal consistency during bench testing. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used to validate the device's diagnostic claims.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML system that requires a "training set" in the context of machine learning model development. The software development focuses on requirements, validation, and verification, typical for traditional medical device software.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as above.

Summary of what the document does provide regarding "performance testing":

The "PERFORMANCE TESTING" section primarily describes non-clinical bench testing to demonstrate the device's technical specifications and safety profile, asserting that these differences from the predicate do not affect its safety or effectiveness for its intended use.

Testing Categories:
- Biocompatibility (conforms to ISO 10993-1)
- Software Risk Analysis
- Software Requirements Specification
- Software Validation Protocol
- Software Verification Summary and Test Case Report
- Software Test Results Report and Revision History
- Software Design Specification
- Software Development Environment Description Document
- Electromagnetic Compatibility and Electrical Safety (conforms to IEC 60601-1; IEC 60601-1-2)
- Corvalent Design Verification Testing
- Temperature Probe with Sheath Performance Testing (this likely verified the +/- 0.2 degrees C error margin)
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." This conclusion is based on the technical and safety performance, not on direct clinical diagnostic accuracy comparison.

Key Missing Information:
The document does not include any clinical studies (e.g., prospective, retrospective, expert-read) that quantify the diagnostic accuracy (sensitivity, specificity, AUC) of the AlfaSight 9000 Thermographic System for any of its stated indications for use (e.g., "adjunct diagnosis of the female breast," "peripheral vascular disease"). The FDA clearance is based on substantial equivalence to an existing predicate device (CRT 2000), assuming the new technology (infrared vs. thermocouple) does not alter the fundamental safety or effectiveness for the adjunct diagnostic purpose, as demonstrated by bench testing.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the outside. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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.

{1}------------------------------------------------

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K150457

Device Name AlfaSight 9000 Thermographic System

Indications for Use (Describe)

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

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

DATE	February 20, 2015
SUBMITTER	Alfa Thermodiagnostics, Inc.
	9057 Soquel Drive, Suite B-AA
	Aptos, CA 95003
	Tel: (831) 901-9248
	Fax: (831) 685-1128
	Email: drbeilin@alfathermo.com
CONTACT PERSON	Daniel Beilin, O.M.D., Alfa Thermodiagnostics, Inc
	9057 Soquel Drive, B-AA
	Aptos, CA. 95003
	Tel: (831) 901-9248
	Fax: (831) 685-1128
	Email: drbeilin@alfathermo.com
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 ofthe female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders;4) extracranial cerebral and facial vascular disease; 5) abnormalities of thethyroid gland; and 6) various neoplastic and inflammatory conditions.
	The AlfaSight 9000 is not intended to serve as a sole diagnostic screeningprocedure.

DEVICE DESCRIPTION

{4}------------------------------------------------

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: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; and6) various neoplastic and inflammatory conditions.The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.	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; and6) various neoplastic and inflammatory conditions.The CRT 2000 is not intended to serve as a sole diagnostic screening procedure.
Parameter	AlfaSight 9000	CRT 2000 (K971956)
Functionality	Captures skin surfacetemperatures, provides thatdata in a thermographic chartfor use by the healthcarepractitioner as an adjunct toother clinical procedures.	Captures skin surfacetemperatures, provides thatdata in a thermographic chartfor use by the healthcarepractitioner as an adjunct toother clinical procedures.
Where used	Doctor's Office, Clinic orHospital	Doctor's Office, Clinic orHospital
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 contactthe skin to start thetemperature measurement.The IR sensor does not touchthe skin.	Thermocouple sensor and edgesurface of probe tip contactthe skin to take themeasurement. The sensortouches the skin.
Disposable Sheath Material	Polyethylene	N/A
Probe Optimum Range	25-40°C	27-35°C
Probe Communication	Blue Tooth WirelessCommunication ofmeasurement data from Probeto PC	Wired Communications
Parameter	AlfaSight 9000	CRT 2000 (K971956)
Software Main functions	Receives temperature signaland generates multiple pointtemperature measurementgraphics for healthcarepractitioners on measurementlocations and temperaturemeasurement readings.	Receives temperature signaland generates multiple pointtemperature measurementgraphics for healthcarepractitioners on measurementlocations and temperaturemeasurement readings.
Correct Orientation and location	Measurement points arehighlighted on the figure onthe display screen formeasurement location andsequence of measurements.	Measurement points arehighlighted on the figure onthe display screen formeasurement location andsequence of measurements.

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

{5}------------------------------------------------

{6}------------------------------------------------

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.

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.