The AXON IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Device Description

The AXON IR Heat Lamp System is intended for use as a therapeutic heat lamp. The System is a non-invasive device that emits light energy to the skinsurface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.

The AXON IR Heat Lamp System deliver invisible laser light beams at 810 and 915 nm wavelengths using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic green laser guide light with 3 mW of power. TThe System consists of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.

The control consoles are made of standard medical PVC material and are designed to be placed in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.

The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of qlass suitable for medical applications.

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for the AXON IR Heat Lamp System, an infrared lamp intended for therapeutic heating. The submission focuses on demonstrating substantial equivalence to predicate devices and provides non-clinical performance data related to its heating capabilities.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document describes a relatively simple medical device (an infrared heat lamp). Therefore, the "acceptance criteria" and "study" are focused on demonstrating its ability to produce therapeutic heat safely and effectively, rather than complex diagnostic or treatment algorithms that would typically involve AI, expert ground truth, or MRMC studies. The questions in the prompt are more suited for AI/ML device evaluations. This submission primarily relies on bench testing and basic human subject testing for thermal performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Therapeutic Heating:

Criteria	Reported Device Performance (AXON IR Heat Lamp System)
Ability to achieve therapeutic temperature range	Achieves 40-45 degrees Celsius.
Increase in topical heating of tissue level	At least 5 degrees Celsius increase reached within 1 minute.
Maintenance of therapeutic temperature	Maintained for the 10-minute testing time.
Average warm-up time to therapeutic temperature	Less than 2 minutes.
Compliance with international safety and performance standards	Complies with IEC 60601-1, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 63204, ISO 14971.

Study Proving Acceptance Criteria:

The study conducted was a non-clinical bench test with limited human subject data collection to evaluate the thermal performance of the AXON IR Heat Lamp System.

Study Title/Description: "Non-Clinical Performance Data" for the AXON IR Heat Lamp System on Page 7.
Objective: To demonstrate that the AXON IR Heat Lamp System can achieve and maintain a therapeutic temperature range accepted by the FDA (40-45 degrees Celsius) and produce at least a 5-degree Celsius increase in topical tissue temperature within one minute.

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

Sample Size for Test Set (Human Subjects): 3 subjects.
Data Provenance: The document does not explicitly state the country of origin for the human subject data. The device applicant is Crystal Medtech, LLC, located in Schofield, Wisconsin, USA, which suggests the study was likely conducted in the USA.
Retrospective or Prospective: The study appears to be prospective as it describes conducting temperature measurements on subjects after the device was built.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable in the context of this thermal performance study.
Qualifications of Experts: The "ground truth" (therapeutic temperature range of 40-45 degrees Celsius) is stated to be "as accepted by the FDA." This is a regulatory standard, not established by individual experts for this specific device test.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This study measures physical temperature outputs, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI tools where human readers are interpreting images. The AXON IR Heat Lamp is a therapeutic device, and its performance evaluation focused on physical parameters (temperature).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Standalone Performance: Yes, the described "bench testing" and "temperature versus time measurements" are essentially a standalone performance evaluation of the device's ability to generate heat and maintain temperature, without a human actively interpreting or modifying the output in a typical AI "human-in-the-loop" sense. The device is the algorithm in this context – it delivers heat as designed.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's performance is the regulatory standard for therapeutic heating temperature range (40-45 degrees Celsius), as "accepted by the FDA." It is based on established medical understanding of what constitutes therapeutic heat for the stated indications, rather than expert consensus on individual cases, pathology, or outcomes data from a specific study for this device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is an infrared heat lamp; it does not appear to employ machine learning or AI models that require a "training set" in the conventional sense. Its "training" would be the engineering design and iteration process.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no mention or indication of a machine learning "training set" for this device. The design and performance targets would be based on established medical and engineering principles for heat therapy devices.

Summary

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 7, 2017

Crystal Medtech, LLC Nelson Marquina Manager, Regulatory Affairs 4704 Bavberry Street Schofield, Wisconsin 54476

Re: K171087

Trade/Device Name: AXON IR Heat Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: April 8, 2017 Received: April 12, 2017

Dear Nelson Marquina:

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 Actinclude 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

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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.

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/ResourcesforYou/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,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171087

Device Name AXON IR Heat Lamp

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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008_510(k) Summary (as per 21 CFR 807.92)

GENERAL INFORMATION l.

Device Generic Name:

Trade Name:

AXON IR Heat Lamp System

Device Classification:	Class II, Performance Standards21CFR Part 890.5500 – Infrared Lamp
------------------------	------------------------------------------------------------------------

Product Code: ILY

Applicant Name and Address: Crystal MedTech, LLC 4704 Bayberry Street Schofield, WI 54476 USA Telephone: 715 / 843-0325

510(k) Number: Pending

II. Device Description

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lll. Indications For Use

IV. Predicate Devices

The AXON IR Heat Lamp System is substantially equivalent to other therapeutic heat lamps that are currently in commercial distribution. These predicate devices include, but are not limited to:

1. USA Laser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016),
1. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp System (K101893),
1. ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604).

v. Summary of the Technical Characteristics of the AXON System as Related to the Referenced Predicate Devices

The AXON IR Heat Lamp System and the predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

VI. Testing

Testing of the AXON System includes electromagnetic compatibility, software validation and verification, functional performance testing, and electrical safety testing. The System is manufactured to comply with the following international standards:

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IEC 60601-1:2006 – Ed. 3	Medical Electrical Equipment, Part 1:General Requirements for Basic Safetyand Essential Performance
IEC 60825-1:2014 - Ed. 2	Safety of Laser Products - Part 1:Classification of laser devices andrequirements
IEC 60601-1-2:2007 - Ed. 3	Medical Electrical Equipment - Part 1-2:Collateral Standard: Electromagneticdisturbances - Requirements and tests
IEC 60601-1-6:2013 - Ed. 3.1	Medical Electrical Equipment - Part 1-6:Collateral Standard: Usability
IEC 60601-2-22:2012 - Ed. 3.1	Medical Electrical Equipment - Part 2-22:Particular requirements for basic andessential performance of surgical,cosmetic, therapeutic and diagnostic laserequipment
IEC 63204:2006	Software for Medical Devices: Softwarelife cycle processes
ISO 14971:2012 – Ed. 2	Risk Management to Medical Devices

VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the AXON IR Heat Lamp System have the same intended uses, with similar functional and performance characteristics. The AXON IR Heat Lamp System is designed to comply with applicable performance standards promulgated by the U.S. Food and Drug Administration. - These Systems perform as intended and do not raise any new safety or efficacy issues.

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Characteristic	AXON IR Heat Lamp	LUMIX 3 Series IR Heat Lamp	NEXUS Series IR Heat Lamp	K-LASER CUBE 1, 2, 3, and 4 Heat Lamp
Manufacturer	Crystal MedTech, LLC	Fisioline S.r.l.	Wuhan Gigaa Laser Optronics Technology Co., Ltd.	ELTECH S.r.l.
510k Number	Pending	K132016	K101893	K120604
Power Supply	115/230 VAC, 6.3A power supply, single phase	115/230 VAC, 6.3A power supply, single phase	DC26V/4A. Use SINPRO MPU100-102 desktop power supply adapter	DC12V SINPRO MPU100-106 desktop power supply adapter
Heat Source	GaAs diode and red guide beam diode	GaAs diode and red guide beam diode	GaAIAs diode and red guide beam diode	GaAIAs diode and red guide beam diode
Wavelengths (nm)	810 and 915	650, 810 and 910	665, 810 and 980	660, 800, 905, and 970
Power Range of Max. Output	1 W to 20 W	4.2 W to 8.2 W	7 W to 60 W	10 W to 20 W
Laser Classification	4	4	4	4
CFR Regulation Product Code	21 CFR 890.5500 ILY	21 CFR 890.5500 ILY	21 CFR 890.5500 ILY	21 CFR 890.5500 ILY
Clearance Type	Prescription	Prescription	Prescription	Prescription
Treatment Mode	Pulsed / Continuous	Pulsed / Continuous	Pulsed / Continuous	Pulsed / Continuous
Treatment Times	Variable	Variable	Variable	Variable
Delivery System	Fiberoptic cable / handheld probe	Fiberoptic cable / handheld probe	Fiberoptic cable / handheld probe	Fiberoptic cable / handheld probe

Table 3. Technical Characteristics and Comparison Chart

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014_Non-Clinical Performance Data

AXON IR Heat Lamp System

The AXON IR Heat Lamp System can achieve therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing that was conducted. The therapeutic temperature range was maintained for the 10-minute testing time.

The average ambient temperature at the beginning of the testing was approximately 22 degrees centigrade. The temperatures versus time measurements were conducted on 3 subjects at 2 physical locations i.e., knee, ankle, shoulder, neck, upper and/or low back. On an average, the pre-exposed topical skin temperature ranged from 30 to 32 degrees centigrade.

The topical temperature during exposure following brief stabilization time ranged from 40 to 45 degrees centigrade. The average warm-up time for the devices was less than two minutes. The average time to achieve therapeutic temperature (40 - 45 degrees centigrade) was less than 2 minutes. These data demonstrate the System meets the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes. The results of these tests are summarized in Tables 4 to 6.

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Device:	AXON	Spacer: 6 cm Diam: 6 cm		Spot: 28 cm²
Settings:	AP 810 & 915 nm combined = 4.0 W
	t = 600 sWarming Time = 2 minutes
Subject:	Gender: male	Age: 62	Ethnicity: Hispanic	L1: back	L2: ankle

	Room Temperature: start = 22.2 °C			Room Temperature: end = 22.3 °C
	Location1:	Upper Back		Location2:	Ankle
	Time (min)	Temp (°C)		Time (min)	Temp (°C)
	initial	31.0		initial	29.0
	1	40.0		1	40.0
	2	41.0		2	41.0
	3	42.0		3	41.0
	4	42.0		4	41.0
	5	43.0		5	42.0
	6	43.0		6	42.0
	7	43.0		7	42.0
	8	44.0		8	42.0
	9	44.0		9	43.0
	10	45.0		10	43.0
	Mean (active):	42.7		Mean (active):	41.7
	St. Dev.:	1.49		St. Dev.:	0.95
Comments:

Table 4. Temperature versus Time for AXON IR Heat Lamp System: Subject 1

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Device:	AXON	Spacer: 6 cm Diam: 6 cm	Spot: 28 cm²
Settings:	AP 810 & 915 nm combined = 4.0 W
	t = 600 s Warming Time = 2 minutes
Subject:	Gender: female Age: 30	Ethnicity: Black L1: leg	L2: ankle
	Room Temperature: start = 23.1 °C
	Room Temperature: end = 22.9 °C
	Location1:	Leg	Location2: Ankle
	Time (min)	Temp (°C)	Time (min) Temp (°C)
	initial	30.0	initial 30.0
	1	41.0	1 40.0
	2	41.0	2 41.0
	3	41.0	3 41.0
	4	42.0	4 42.0
	5	42.0	5 42.0
	6	42.0	6 43.0
	7	43.0	7 42.0
	8	43.0	8 43.0
	9	44.0	9 42.0
	10	43.0	10 43.0
	Mean (active):	42.2	Mean (active): 41.9
	St. Dev.:	1.03	St. Dev.: 0.99
Comments:

Table 5. Temperature versus Time for AXON IR Heat Lamp System: Subject 2

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Device:	AXON	Spacer: 6 cm Diam: 6 cm	Spot: 28 cm²
Settings:	AP 810 & 915 nm combined = 4.0 W
	t = 600 s Warming Time = 2 minutes
Subject:	Gender: female Age: 37	Ethnicity: White L1: leg	L2: shoulder
	Room Temperature: start = 21.8 °C		Room Temperature: end = 22.2 °C
	Location1: Leg		Location2: Shoulder
	Time (min) Temp (°C)		Time (min) Temp (°C)
	initial 31.0		initial 30.0
	1 41.0		1 40.0
	2 42.0		2 41.0
	3 42.0		3 42.0
	4 42.0		4 43.0
	5 43.0		5 42.0
	6 44.0		6 42.0
	7 43.0		7 43.0
	8 43.0		8 44.0
	9 44.0		9 44.0
	10 45.0		10 45.0
	Mean (active): 42.9		Mean (active): 42.6
	St. Dev.: 1.20		St. Dev.: 1.51
	Comments:

Table 6. Temperature versus Time for AXON IR Heat Lamp System: Subject 3

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.