AXON IR Heat Lamp

K171087 · Crystal Medtech, LLC · ILY · Jul 7, 2017 · Physical Medicine

Device Facts

• Record ID: K171087
• Device Name: AXON IR Heat Lamp
• Applicant: Crystal Medtech, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Non-invasive therapeutic heat lamp; emits infrared laser light at 810 and 915 nm via GaAs diode sources; fiberoptic cables deliver energy to handpiece probe; non-therapeutic green laser guide light (3 mW) assists targeting. System comprises control console (PVC, membrane interface, LCD) and treatment probe. Used in clinical settings; operated by healthcare professionals. Device elevates tissue temperature (40-45°C) to provide temporary pain relief, muscle relaxation, and increased local circulation. Benefits include non-pharmacological management of minor musculoskeletal discomfort.

Clinical Evidence

Bench testing only. Study evaluated temperature elevation on 3 human subjects across multiple anatomical locations (knee, ankle, shoulder, neck, back). Results demonstrated the device achieved therapeutic temperature (40-45°C) within 2 minutes and maintained this range over a 10-minute treatment duration. No clinical trials were conducted.

Technological Characteristics

Materials: Medical grade PVC, quartz optical fibers, glass protective lens. Energy: GaAs diode laser (810/915 nm), 1-20 W output. Form factor: Control console with handpiece probe. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 62304, ISO 14971.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and/or temporary muscle relaxation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016)
• NEXUS Series IR Heat Lamp System (K101893)
• K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604)

Submission Summary (Full Text)

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

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

# Indications for Use

510(k) Number (if known) K171087

Device Name AXON IR Heat Lamp

Indications for Use (Describe)

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.

| 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) |

## 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 [e-mail]

"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}------------------------------------------------

## 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 Standards<br>21CFR 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

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.

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

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.

### lll. Indications For Use

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.

### 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),
- 2. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp System (K101893),
- 3. 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:

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

| IEC 60601-1:2006 – Ed. 3 | Medical Electrical Equipment, Part 1:<br>General Requirements for Basic Safety<br>and Essential Performance |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60825-1:2014 - Ed. 2 | Safety of Laser Products - Part 1:<br>Classification of laser devices and<br>requirements |
| IEC 60601-1-2:2007 - Ed. 3 | Medical Electrical Equipment - Part 1-2:<br>Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-1-6:2013 - Ed. 3.1 | Medical Electrical Equipment - Part 1-6:<br>Collateral Standard: Usability |
| IEC 60601-2-22:2012 - Ed. 3.1 | Medical Electrical Equipment - Part 2-22:<br>Particular requirements for basic and<br>essential performance of surgical,<br>cosmetic, therapeutic and diagnostic laser<br>equipment |
| IEC 63204:2006 | Software for Medical Devices: Software<br>life 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.

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

| 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

{7}------------------------------------------------

## 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.

{8}------------------------------------------------

| Device: | AXON | Spacer: 6 cm Diam: 6 cm | | Spot: 28 cm² | |
|-----------|---------------------------------------|-------------------------|---------------------|---------------------------------|-----------|
| Settings: | AP 810 & 915 nm combined = 4.0 W | | | | |
| | t = 600 s<br>Warming 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

{9}------------------------------------------------

| 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

{10}------------------------------------------------

| 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