← Product Code [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN) · K190572

# Erchonia FX-635 (K190572)

_Erchonia Corporation · NHN · Jun 1, 2019 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K190572

## Device Facts

- **Applicant:** Erchonia Corporation
- **Product Code:** [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN.md)
- **Decision Date:** Jun 1, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5500
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## Indications for Use

The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

## Device Story

Erchonia FX-635 is a low-level laser system using three 630-650nm semiconductor diodes; emits pulsed red light to stimulate mitochondria and increase ATP production. Device features a mobile base with hospital-grade power, touch screen interface, and adjustable arm with a laser head assembly. Laser head uses internal mechanics to rotate three diodes in independent, random spiraling patterns. Operated by clinicians in clinical settings; positioned 3-4 inches from patient skin. Factory-set protocols for low back and heel pain; user cannot alter diode output or pulse parameters. Output is non-thermal; intended to provide temporary relief of nociceptive musculoskeletal pain. Benefits include non-invasive pain management without reported adverse events in clinical trials.

## Clinical Evidence

Supported by three pivotal studies (total N=213) evaluating neck/shoulder pain, heel pain, and low back pain. Studies were prospective, multi-center, randomized, double-blind, placebo-controlled. Primary endpoint: 30% improvement in VAS pain scores. Results showed statistically significant differences between active and placebo groups (p<0.0001 to p<0.005). No treatment-related adverse events reported.

## Technological Characteristics

Class II infrared lamp (21 CFR 890.5500). Three semiconductor diodes (630-650nm). Power: 17.25mW ± 1.25mW. Energy source: AC power (120V/220V). Form factor: Mobile floor unit with adjustable arm and rotating laser head assembly. Software: Minor level of concern. Standards: IEC 60601-1, IEC 60601-2, IEC 60825-1, 21 CFR 1040.10/11.

## Regulatory 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

- Erchonia® FX-635 ([K180197](/device/K180197.md))
- Erchonia® Allay ([K132940](/device/K132940.md))
- TUCO Erchonia® PL2000 ([K012580](/device/K012580.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 1, 2019

Erchonia Corporation % Steven Shanks President 650 Atlantis Road Melbourne, FL 32904

Re: K190572

Trade/Device Name: Erchonia® FX-635 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: March 5, 2019 Received: March 6, 2019

Dear Steven Shanks:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190572

Device Name Erchonia ® FX-635

Indications for Use (Describe)

The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### Owner Information

#### Name and Address of Sponsor / Manufacturer

Erchonia Corporation 650 Atlantis Rd. Melbourne, FL. 32904 Telephone: 321-473-1251 Fax: 321-473-1608

Establishment Registration Number 2032513

### Name and Address of Official Correspondent

Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 Contact: Mr. Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia.com

## Date Prepared

2/28/2019

## Device Information

Trade Name: Erchonia® FX-635 Model#: HPS Common Name: Infrared Lamp Classification Name: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy (21 CFR 890.5500) Classification: Class II Panel: Physical Medicine Product Code: NHN

### Predicate Device

The Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following primary predicate device: Erchonia® FX-635 (Model# HPS) K180197 Additionally the Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following secondary predicate device(s):

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Erchonia® Allay (Model# HPS) K132940 as well as the TUCO Erchonia® PL2000 (Model# PL2) K012580

The Erchonia® FX-635 is the same model as the Erchonia® FX-635 previously submitted under K180197.

## Device Description

The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser.

The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

- Hospital grade power cord ●
- Patient protective eyewear ●
- Power safety lockout keys ●

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# Intended Use

The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

## Comparison of Technological Characteristics with the Predicate Device

The Erchonia® FX-635 is equivalent to the primary predicate device, Erchonia® FX 635 manufactured by Erchonia® as well as the secondary predicate device(s) the Erchonia® Allay as well as the TUCO Erchonia® PL2000. The principles of operation of the Erchonia® FX-635 are identical in every aspect to the previously cleared Erchonia® FX 635.

| Device                             | Erchonia® FX-<br>635 (Model#<br>HPS)                                           | Erchonia® FX-<br>635 (Model#<br>HPS)                                 | Erchonia®<br>Allay (Model#<br>HPS)                                      | TUCO<br>Erchonia®<br>PL2000                                                  |
|------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) #                           | N/A                                                                            | K180197                                                              | K132940                                                                 | K012580                                                                      |
| Power<br>(measured at<br>aperture) | 17.25mW ±<br>1.25mW                                                            | 17.25mW ±<br>1.25mW                                                  | 17.25mW ±<br>1.25mW                                                     | <5mW                                                                         |
| Wavelength                         | 630nm to 640nm                                                                 | 630nm to 640nm                                                       | 630nm to<br>640nm                                                       | 630nm to<br>640nm                                                            |
| Energy Source                      | Multi diode<br>collected then<br>line dispersed<br>(coherent)                  | Multi diode<br>collected then line<br>dispersed<br>(coherent)        | Multi diode<br>collected then<br>line dispersed<br>(coherent)           | Single diode<br>collected then<br>line dispersed<br>(coherent)               |
| Treatment<br>time                  | Variable<br>depending on<br>area being treated<br>- refer to<br>Owner's Manual | 20 minutes for<br>Low Back Pain<br>and 10 minutes for<br>Heel Pain   | 10 minutes for<br>Heel Pain                                             | 0-9.9 minutes                                                                |
| Total Joules<br>Per Minute         | 1.53 J                                                                         | 1.53 J                                                               | 1.53 J                                                                  | .15 J                                                                        |
| Power Supply                       | 1.5A/100VAC &<br>0.5A/240VAC,<br>50-60Hz<br>electrical outlet                  | 1.5A/100VAC &<br>0.5A/240VAC,<br>50/60Hz electrical<br>outlet        | 1.5A/100VAC<br>&<br>0.5A/240VAC,<br>50/60Hz<br>electrical<br>outlet     | Rechargeable<br>batteries: (six)<br>nickel-metal<br>hydride 7.2V,<br>2500mAh |
| Energy<br>Delivery                 | Floor model<br>device with<br>probe head                                       | Floor model<br>device with probe<br>head                             | Floor model<br>device with<br>probe head                                | Handheld<br>treatment probe                                                  |
| Target Size                        | Line pattern,<br>electronically<br>scanned over<br>area of treatment           | Line pattern,<br>electronically<br>scanned over area<br>of treatment | Line pattern,<br>electronically<br>scanned over<br>area of<br>treatment | Line pattern,<br>manually<br>scanned over<br>area of<br>treatment            |

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| Indication for<br>Use      | The Erchonia®<br>FX-635 laser is<br>indicated for the<br>adjunctive use in<br>providing<br>temporary relief<br>of nociceptive<br>musculoskeletal<br>pain. | The Erchonia®<br>FX-635 laser is<br>indicated for the<br>following two<br>indications:<br>a. as an adjunct to<br>provide relief of<br>minor chronic low<br>back pain of<br>musculoskeletal<br>origin.<br>b. as an adjunct to<br>reducing chronic<br>heel pain arising<br>from plantar<br>fasciitis. | The<br>Erchonia®<br>Allay™ laser<br>is indicated as<br>an adjunct to<br>reducing<br>chronic heel<br>pain arising<br>from plantar<br>fasciitis. | The TUCO<br>Erchonia®<br>PL2000 is<br>indicated for<br>adjunctive use<br>in providing<br>temporary<br>relief of minor<br>chronic neck<br>and shoulder<br>pain of<br>musculoskeletal<br>origin. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of<br>Operation | Mains power,<br>converted to DC,<br>powering semi-<br>conductor diodes                                                                                    | Mains power,<br>converted to DC,<br>powering semi-<br>conductor diodes                                                                                                                                                                                                                              | Mains power,<br>converted to<br>DC, powering<br>semi-<br>conductor<br>diodes                                                                   | DC, powering<br>semi-conductor<br>diodes                                                                                                                                                       |
| Mechanism of<br>Action     | Stimulates the<br>mitochondria to<br>increase the<br>production of<br>ATP                                                                                 | Stimulates the<br>mitochondria to<br>increase the<br>production of ATP                                                                                                                                                                                                                              | Stimulates the<br>mitochondria<br>to increase the<br>production of<br>ATP                                                                      | Stimulates the<br>mitochondria to<br>increase the<br>production of<br>ATP                                                                                                                      |

## Performance Data

### Compliance with Voluntary Standards

The device complies with the IEC 60601-1, IEC 60601-2 and IEC 60825-1 standards.

### Performance Standards

The device complies with FDA's performance standards for light-emitting products (21 CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).

### Biocompatibility

Not applicable. The device does not come in contact with the patient's skin or any other bodily tissue.

## Sterilization and Shelf-Life

The device is not provided sterile. As an electromechanical device containing no biodegradable materials, such as chemical or biologic, and no mechanical componentry subject to degradation, 

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such as batteries, the aging rationale is based on only the acceptable transportation parameters of time and conditions. The transportation range was assessed by evaluating each component's acceptable temperature and humidity parameters, then identifying a high-low spread that was allinclusive. The range noted in the Erchonia® FX-635 (Model#: HPS) Owner's Manual was considered and determined acceptable as part of the IEC 60601-1 Safety Testing and is in compliance with the FDA guidance document "Shelf-Life of Medical Devices."

## Software Verification and Validation Testing

Software verification and validation testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern.

## Clinical Data

Clinical testing of the Erchonia FX-635™ Laser device included three pivotal studies evaluating reduction of chronic neck and shoulder pain, chronic low back pain and heel pain arising from plantar fasciitis. A total of 213 subjects were evaluated across all three studies. Each of these pivotal studies was used to support clearance of the respectively evaluated indications. Substantial equivalence is based in part on these three pivotal studies.

Pivotal Study 1: Study of the Effectiveness of the TUCO Erchonia PL2000 in Providing Temporary Relief of Minor Neck and/or Shoulder Pain of Chronic Origin

The pivotal study was a prospective, multi-center, randomized, double-blinded and placebo controlled multi-arm study of 100 subjects, of which 86 were available for primary endpoint analysis. Each of the 14 excluded subjects failed the study qualification evaluation.

The device was administered to the sagittal suture (top of head); left and right cervical, shoulder and torso areas: right and left shoulders during each of passive external rotation and passive adduction of the arm and shoulder: right and left cervical muscles and trapezius muscles during passive left lateral flexion of the cervical spine; and the right and left sternocleidomastoid and scalene muscles during passive range of motion, for a total of 13 minutes during a single treatment administration.

Subjects were adults with neck and shoulder pain of musculoskeletal origin (osteoarthritis, chronic muscle spasms and cervical and thoracic spine sprain strain) ongoing for at least 30 days. and a rating of 50 or greater on the 0-100 Visual Analog Pain scale (VAS). Average duration of neck and/or shoulder pain at study entry was about 6 years. Demographic data was not collected for subjects in this study.

All subjects were followed for a period of 48 hours at 3 sites, each in the United States only.

## Patient Accountability

| Stage      | Investigational Device<br>Arm Total | Control (Placebo) Arm<br>Total | Total |
|------------|-------------------------------------|--------------------------------|-------|
| Enrollment | 50                                  | 50                             | 100   |
| Treatment  | 43                                  | 43                             | 86    |

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| Primary Effectiveness Endpoint<br>Analysis | 43 | 43 | 86 |
|--------------------------------------------|----|----|----|
| Primary Safety<br>Endpoint Analysis        | 43 | 43 | 86 |

### Primary effectiveness endpoint

The primary efficacy endpoint was immediately following the single device treatment administration relative to baseline. The primary efficacy measure was the change in neck and shoulder pain rating as recorded on the 0-100 VAS.

Individual subject success was defined as a 30% or greater improvement (decrease) in the primary efficacy measure from baseline to endpoint. Study success was defined as a minimum 30% difference between treatment groups, comparing the proportion of individual successes.

Study results demonstrated that 65.1% of actively treated subjects attained individual success compared with 11.6% of control (placebo) subjects, resulting in a 53.5% difference between treatment groups, exceeding the 30% criteria by 23.5% (p<0.0001). Hence the study met its primary efficacy endpoint.

The magnitude of the mean change in neck and shoulder pain VAS rating at endpoint relative to baseline was -29.02 for actively-treated subjects and -4.91 for control (placebo) subjects, a 20.08 difference (p<0.0005).

## Primary safety endpoint:

The primary safety endpoint consisted of all treatment-related adverse events.

No treatment-related adverse event was reported or observed for any subject throughout study duration, and no other safety issues occurred; therefore, device safety is supported through these study results.

## Summary

Based on the clinical performance as documented in pivotal study 1, the Erchonia PL2000 was found to have a safety and effectiveness profile that supported clearance of K012580. indicated for "adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin."

Pivotal Study 2: A Double-Blind, Placebo-Controlled, Randomized Evaluation of the Effect of The Erchonia® Allay™ Laser on Chronic Heel Pain.

The pivotal study was a prospective, multi-center, randomized, double-blinded and placebo controlled multi-arm study of 69 subjects, of which all 69 were available for primary endpoint analysis. The device was administered across the top of the foot (dorsal aspect), the myofacial junction of the heel, and the plantar aspect of the heel, simultaneously, for ten minutes per treatment: two treatments per week, each three of four days apart, across a consecutive threeweek period, for a total of six treatments.

Subjects were adults with unilateral mechanical plantar heel pain of at least three months duration and a rating of 50 or greater on the Visual Analog Pain scale (VAS) with failure to respond to prescription non-steroidal anti-inflammatory drugs (NSAIDs) and two or more additional conservative treatment approaches. Subjects averaged 56.29 years, were

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predominantly Caucasian (90%), with a 2:3 ratio of females to males (39% versus 61%). Average duration of heel pain at study entry was 12.29 months.

All subjects were followed for a period of two weeks after treatment end, and 23 of the active treatment subjects were followed for 12 months, at 2 sites, both in the United States only.

## Patient Accountability

| Stage                                      | Investigational<br>Device Arm Total | Control (Placebo) Arm<br>Total | Total |
|--------------------------------------------|-------------------------------------|--------------------------------|-------|
| Enrollment                                 | 37                                  | 32                             | 69    |
| Treatment                                  | 37                                  | 32                             | 69    |
| Primary Effectiveness<br>Endpoint Analysis | 37                                  | 32                             | 69    |
| Primary Safety<br>Endpoint Analysis        | 37                                  | 32                             | 69    |

## Primary effectiveness endpoint

The primary efficacy endpoint was two weeks after treatment end relative to baseline. The primary efficacy measure was the change in 2-day average first steps of the day heel pain as recorded on the 0-100 VAS.

Individual subject success was defined as a 30% or greater improvement (decrease) in the primary efficacy measure from baseline to endpoint. Study success was defined as a minimum 35% difference between treatment groups, comparing the proportion of individual successes.

Study results demonstrated that 62% of actively treated subjects attained individual success compared with 12.5% of control (placebo) subjects, resulting in a 49.5% difference between treatment groups, exceeding the 30% criteria by 19.5% (p<0.00005). Hence the study met its primary efficacy endpoint.

The magnitude of the mean change in 2-dav average first steps of the day heel pain VAS rating at endpoint relative to baseline was -29.47 for actively-treated subjects and -5.38 for control (placebo) subjects, a 24.09 difference (p<0.0001).

For actively-treated subjects followed through to 12 months post-treatment, mean change in 2day average first steps of the day heel pain VAS rating relative to baseline decreased 62.94 points to 6.94 (p<0.0001).

## Primary safety endpoint:

The primary safety endpoint consisted of all treatment-related adverse events.

No treatment-related adverse event was reported or observed for any subject throughout study duration, and no other safety issues occurred; therefore, device safety is supported through these study results.

## Summary

Based on the clinical performance as documented in pivotal study 4, the Erchonia Allay™ was found to have a safety and effectiveness profile similar to the predicate device. The results of this 

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pivotal study supported clearance for K132940, indicated as "an adjunct to reducing chronic heel pain arising from plantar fasciitis."

Pivotal Study 3: A double-blind, placebo-controlled randomized evaluation of the effect of the Erchonia® FX-635™on low back pain

The pivotal study was a prospective, multi-center, randomized, double-blinded and placebo controlled multi-arm study of 58 subjects, of which all 58 were available for primary endpoint analysis. The device was administered across the lower back region for twenty minutes per treatment: two treatments per week, each three of four days apart, across a consecutive fourweek period, for a total of eight treatments.

Subjects were adults with episodic chronic low back pain of musculoskeletal origin of lumbar sprain or strain etiology and a low back pain rating of 40 or greater on the 0 to 100 VAS.

Subjects averaged 45.57 years, were predominantly Caucasian (69%) followed by Hispanic (14%), African American (8.5%) and Asian (8.5%), with equal distribution of males and females (47% versus 53%). Average duration of low back pain at study entry was just over 8 years.

Subjects were followed for a period of three months at 3 sites, each in the United States only.

## Patient Accountability

| Stage                                      | Investigational<br>Device Arm Total | Control (Placebo) Arm<br>Total | Total |
|--------------------------------------------|-------------------------------------|--------------------------------|-------|
| Enrollment                                 | 29                                  | 29                             | 58    |
| Treatment                                  | 29                                  | 29                             | 58    |
| Primary Effectiveness<br>Endpoint Analysis | 29                                  | 29                             | 58    |
| Primary Safety<br>Endpoint Analysis        | 29                                  | 29                             | 58    |

## Primary effectiveness endpoint

The primary efficacy endpoint was two months after treatment end relative to baseline. The primary efficacy measure was the change in low back pain rating as recorded on the 0-100 VAS. Individual subject success was defined as a 30% or greater improvement (decrease) in the primary efficacy measure from baseline to endpoint. Study success was defined as a minimum 35% difference between treatment groups, comparing the proportion of individual successes.

Study results demonstrated that 72.4% of actively treated subjects attained individual success compared with 27.6% of control (placebo) subjects, resulting in a 44.8% difference between treatment groups, exceeding the 30% criteria by 14.8% (p<0.005). Hence the study met its primary efficacy endpoint.

The magnitude of the mean change in low back pain VAS rating at endpoint relative to baseline was -34.24 for actively-treated subjects and -10.97 for control (placebo) subjects, a 23.37 difference (p<0.001).

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### Primary safety endpoint:

The primary safety endpoint consisted of all treatment-related adverse events.

No treatment-related adverse event was reported or observed for any subject throughout study duration, and no other safety issues occurred; therefore, device safety is supported through these study results.

### Summary

Based on the clinical performance as documented in pivotal study 3, the Erchonia FX-6535TM was found to have a safety and effectiveness profile similar to the predicate device. The results of this pivotal study supported clearance for K180197, indicated as an "adjunct to provide relief of minor chronic low back pain of musculoskeletal origin."

### Conclusion

Any technological differences between the subject device and predicate do not render the device not substantially equivalent, do not affect the safety or effectiveness, or raise questions regarding the safety and effectiveness due to the fact the total light energy delivered per treatment is equivalent to the predicate(s). The new and predicate device(s) have equivalent technology and provides the same wavelength. The predicate device(s) treatment protocols went through clinical trials to demonstrate that they are safe and effective in providing relief of nociceptive pain of musculoskeletal origin; specifically, chronic neck and shoulder pain (K012580) and low back pain (K180197) as well as chronic heel pain arising from plantar fasciitis (K132940).

The table below provides a comparison of study design and results for each of the respective clinical studies with their associated nociceptive musculoskeletal pain reduction clearance:

{12}------------------------------------------------

| 510(k) # | Device<br>Name | IFU                                                                                                                                  | Study<br>Design                                         | # Subjects                     | #<br>Sites | Treatment<br>Administration                                                                                                                      | Primary Outcome                                                                                                                                                                        | Blinding<br>Assess-<br>ment | Results                                                                                                                |
|----------|----------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------|
| K012580  | PL2000         | adjunctive use in<br>providing<br>temporary relief of<br>minor chronic<br>neck and shoulder<br>pain of<br>musculoskeletal<br>origin. | Double-blind,<br>randomized,<br>placebo-<br>controlled. | 86:<br>Test: 43<br>Placebo: 43 | 3          | Single treatment<br>to the sagittal<br>suture, shoulder,<br>cerebral,<br>cervical and<br>torso regions for<br>a combined total<br>of 13 minutes. | Change in 0-100 VAS<br>pain rating pre- to post-<br>treatment.<br>Individual Success<br>Criteria: 30%+ VAS<br>decrease<br>Study Success Criteria:<br>30% difference between<br>groups. | Yes.                        | Individual<br>Subject<br>Success:<br>Test: 65.1%.<br>Placebo: 11.6%.<br>Overall Study<br>Success: 53.5%<br>difference. |
| K132940  | Allay          | adjunct to<br>reducing chronic<br>heel pain arising<br>from plantar<br>fasciitis.                                                    | Double-blind,<br>randomized.<br>placebo-<br>controlled. | 69:<br>Test: 37<br>Placebo: 32 | 2          | 6 10-minute<br>treatments 2<br>times/week for 3<br>weeks to the<br>foot.                                                                         | Change in 0-100 VAS<br>pain rating pre- to post-<br>treatment.<br>Individual Success<br>Criteria: 30%+ VAS<br>decrease<br>Study Success Criteria:<br>30% difference between<br>groups. | Yes.                        | Individual<br>Subject<br>Success:<br>Test: 62%.<br>Placebo: 12.5%.<br>Overall Study<br>Success: 49.5%<br>difference.   |
| K180197  | FX-635         | adjunct to provide<br>relief of minor<br>chronic low back<br>pain of<br>musculoskeletal<br>origin.                                   | Double-blind,<br>randomized,<br>placebo-<br>controlled. | 58:<br>Test: 29<br>Placebo: 29 | 3          | 8 20-minute<br>treatments 2<br>times/week for 4<br>weeks across<br>the lower back<br>region                                                      | Change in 0-100 VAS<br>pain rating pre- to post-<br>treatment.<br>Individual Success<br>Criteria: 30%+ VAS<br>decrease<br>Study Success Criteria:<br>35% difference between<br>groups. | Yes.                        | Individual<br>Subject<br>Success:<br>Test: 72.4%.<br>Placebo: 27.6%.<br>Overall Study<br>Success: 44.8%<br>difference. |

Therefore, based on the collective clinical performance of the equivalent predicate devices, the physiological mechanism of action provided by the Erchonia Corporation 635mm diode laser has demonstrated safety and effectiveness to support the proposed indication of use "for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain."

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K190572](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K190572)

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