(117 days)
Not Found
No
The device description details preprogrammed, fixed protocols and hardware-based functions without mentioning any adaptive learning, data analysis for decision making, or features typically associated with AI/ML.
Yes
Explanation: The device is indicated for providing relief for minor chronic low back pain and reducing chronic heel pain, which are therapeutic uses.
No.
The device description and intended use clearly state that the Erchonia® FX-635 is a low-level laser system indicated for pain relief (adjunct to provide relief of minor chronic low back pain and reducing chronic heel pain arising from plantar fasciitis). It is a therapeutic device that delivers light energy, not a device that diagnoses conditions.
No
The device description clearly outlines multiple hardware components including laser diodes, a mobile base, a touch screen, a PCB, an adjustable arm, and a laser head assembly. While it contains software, it is integral to the operation of the physical device.
Based on the provided information, the Erchonia® FX-635 laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended uses are for providing relief of minor chronic low back pain and reducing chronic heel pain. These are therapeutic applications, not diagnostic tests performed on samples taken from the human body.
- Device Description: The device is a low-level laser system that applies light energy externally to the patient's body. It does not interact with biological samples (like blood, urine, tissue) for the purpose of diagnosis.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the therapeutic effect of the laser on pain levels and disability, not on the accuracy or reliability of a diagnostic test.
In summary, the Erchonia® FX-635 is a therapeutic device used for pain management, not a device used to perform tests on samples from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Erchonia® FX-635 laser is indicated for the following two indications:
a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin.
b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
Product codes (comma separated list FDA assigned to the subject device)
NHN
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/IIa device and a Class II/2 Laser. Erchonia® FX-635 (Model#: HPS) is indicated for use as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. Erchonia® FX-635 (Model#: HPS) is also indicated for use as an adjunct to reducing chronic heel pain arising from 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, 20 minutes for providing relief of minor chronic low back pain of musculoskeletal origin, or 10 minutes for reducing chronic heel pain arising from plantar fasciitis, prior clearance K132940. 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 low back pain or treatment for heel 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 kevs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back, heel
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
STUDY DESIGN: The study was a placebo-controlled, randomized, double-blind parallel group multi-center design.
SUBJECTS: Fifty-eight (58) subjects completed the study: 29 randomized to the active procedure group and 29 randomized to the placebo group. Subjects were males and females 18 years or older with episodic chronic low back pain of musculoskeletal origin lumbar sprain or strain etiology and rating 40 or greater on the 0 to 100 Visual Analog Pain Scale (VAS).
Average subject age was 45.57 years. Subject gender was evenly distributed amongst males (47%) and females (53%). The majority of subjects were Caucasian (69%); followed by Hispanic (14%), African American (8.5%) and Asian (8.5%).
Average subject duration of low back pain was 97.8 months (approx. 8 years). The majority of subjects (79%) had low back pain on both the right and left sides with an average pain rating at the time of study entry of 59.10 on the 0 to 100 Visual Analog Scale (VAS).
STUDY PROCEDURES: Subjects received eight 20-minute procedure administrations across the lower back region with the Erchonia® FX-635IM laser (active or sham) across a four-week period: two procedures per week, each procedure three to four days apart.
Subjects agreed to use only the study pain relief medication of over-the-counter (OTC) Tylenol to relieve any low back pain, as needed, throughout study participation and to record this usage in a daily diary. Subjects were instructed not to record a VAS pain rating any sooner than six hours after taking a dosage of the study pain relief rescue medication.
STUDY RESULTS: The study primary outcome measure was pre-determined as the difference in the proportion of subjects between test and control groups who achieved a 30% or greater decrease in self-reported VAS low back pain rating from baseline (pre-procedure) to study endpoint (2 months post-procedure evaluation).
It was pre-determined that the study would be considered a success if the difference in the proportion of individual subject successes between procedure groups was 35% or greater.
72.4% of subjects who received the active procedures with the Erchonia® FX-635™ attained a 30% or greater decrease in low back pain VAS rating from baseline to endpoint compared with 27.6% of subjects who received the 'fake' (placebo) procedures. A Fischer's Exact Test for two independent proportions found this 44.8% difference to be statistically significant at p
§ 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.
0
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.
May 21, 2018
Erchonia Corporation % Kevin Walls Principle Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K180197
Trade/Device Name: Erchonia® FX-635 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: February 17, 2018 Received: February 20, 2018
Dear Mr. Walls:
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
1
801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180197
Device Name Erchonia® FX-635
Indications for Use (Describe)
The Erchonia® FX-635 laser is indicated for the following two indications:
- a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin.
b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
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) |
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3
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
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127 Contact: Mr. Kevin Walls, RAC Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Date Prepared
1/21/2018
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 predicate device:
Erchonia® Allay (Model# HPS) K132940
The Erchonia® Allay is the same model as the Erchonia® FX-635 with a different tradename. Based on this, Erchonia® FX-635 is substantially equivalent to itself, being previously cleared as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
4
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. Erchonia® FX-635 (Model#: HPS) is indicated for use as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. Erchonia® FX-635 (Model#: HPS) is also indicated for use as an adjunct to reducing chronic heel pain arising from 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, 20 minutes for providing relief of minor chronic low back pain of musculoskeletal origin, or 10 minutes for reducing chronic heel pain arising from plantar fasciitis, prior clearance K132940. 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 low back pain or treatment for heel 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 kevs .
Intended Use
The Erchonia® FX-635 laser is indicated for the following two indications: a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
5
NOTE: The Erchonia® FX-635 is the same model as the Erchonia® Allay with a changed tradename. Based on this, the HPS model was previously cleared as an adjunct to reducing chronic heel pain arising from plantar fasciitis. Ref: K132940
Comparison of Technological Characteristics with the Predicate Device
The Erchonia® FX-635 is equivalent to the predicate device, Erchonia® Allay manufactured by Erchonia®. The principles of operation of the Erchonia® FX-635 are identical in every aspect to the previously cleared Erchonia® Allay (Model#: HPS).
| Device | Erchonia® FX-635 (Model#
HPS) | Erchonia® Allay (Model#
HPS) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Power (measured at
aperture) | 17.25mW ± 1.25mW | 17.25mW ± 1.25mW |
| Wavelength | 630nm to 640nm | 630nm to 640nm |
| Energy Source | Multi diode collected then line
dispersed (coherent) | Multi diode collected then line
dispersed (coherent) |
| Treatment time | 20 minutes for Low Back Pain
and 10 minutes for Heel Pain | 10 minutes |
| Total Joules Per
Minute | 1.53 J | 1.53 J |
| Power Supply | 1.5A/100VAC &
0.5A/240VAC, 50-60Hz
electrical outlet | 1.5A/100VAC &
0.5A/240VAC, 50/60Hz
electrical outlet |
| Energy Delivery | Floor model device with probe
head | Floor model device with probe
head |
| Target Size | Line pattern, electronically
scanned over area of treatment | Line pattern, electronically
scanned over area of treatment |
| Indication for Use | The Erchonia® FX-635 laser is
indicated for the following two
indications:
a. as an adjunct to provide
relief of minor chronic low
back pain of musculoskeletal
origin.
b. as an adjunct to reducing
chronic heel pain arising from
plantar fasciitis. | The Erchonia® Allay is
indicated as an adjunct to
reducing chronic heel pain
arising from plantar fasciitis |
| Principles of Operation | Mains power, converted to DC,
powering semi-conductor
diodes | Mains power, converted to DC,
powering semi-conductor
diodes |
| Mechanism of Action | Stimulates the mitochondria to
increase the production of ATP | Stimulates the mitochondria to
increase the production of ATP |
6
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, 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 Trial Summary
BACKGROUND: The purpose of this clinical study was to determine the effectiveness of the Erchonia® FX-635™, manufactured by Erchonia Corporation (the Company), in providing temporary acute relief of minor episodic chronic low back pain of musculoskeletal origin.
STUDY DESIGN: The study was a placebo-controlled, randomized, double-blind parallel group multi-center design.
SUBJECTS: Fifty-eight (58) subjects completed the study: 29 randomized to the active procedure group and 29 randomized to the placebo group. Subjects were males and females 18 years or older with episodic chronic low back pain of musculoskeletal origin lumbar sprain or strain etiology and rating 40 or greater on the 0 to 100 Visual Analog Pain Scale (VAS).
7
Average subject age was 45.57 years. Subject gender was evenly distributed amongst males (47%) and females (53%). The majority of subjects were Caucasian (69%); followed by Hispanic (14%), African American (8.5%) and Asian (8.5%).
Average subject duration of low back pain was 97.8 months (approx. 8 years). The majority of subjects (79%) had low back pain on both the right and left sides with an average pain rating at the time of study entry of 59.10 on the 0 to 100 Visual Analog Scale (VAS).
STUDY PROCEDURES: Subjects received eight 20-minute procedure administrations across the lower back region with the Erchonia® FX-635IM laser (active or sham) across a four-week period: two procedures per week, each procedure three to four days apart.
Subiects agreed to use only the study pain relief medication of over-the-counter (OTC) Tylenol to relieve any low back pain, as needed, throughout study participation and to record this usage in a daily diary. Subjects were instructed not to record a VAS pain rating any sooner than six hours after taking a dosage of the study pain relief rescue medication.
STUDY RESULTS
The study primary outcome measure was pre-determined as the difference in the proportion of subjects between test and control groups who achieved a 30% or greater decrease in self-reported VAS low back pain rating from baseline (pre-procedure) to study endpoint (2 months postprocedure evaluation).
It was pre-determined that the study would be considered a success if the difference in the proportion of individual subject successes between procedure groups was 35% or greater.
72.4% of subjects who received the active procedures with the Erchonia® FX-635™ attained a 30% or greater decrease in low back pain VAS rating from baseline to endpoint compared with 27.6% of subjects who received the 'fake' (placebo) procedures. A Fischer's Exact Test for two independent proportions found this 44.8% difference to be statistically significant at p