The MedX 1000 Series is an infrared lamp, as per 21 CFR 890.5500. It emits energy to provide topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions.

Device Description

MedX 1000 Series equipment consists of a console - (MBM 1050) and two different light emitting diodes (LED) accessories - (MCT 150 and MCT 600). The console unit supports the LED semiconductors and assembly, electronics, control panel and labels. The features of the accessories include energy emitted in the near infrared spectrum to provide therapeutic heating.

AI/ML Overview

Here's an analysis of the provided text regarding the MedX 1000 Series device, focusing on acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the MedX 1000 Series is a therapeutic heating device intended for temporary relief of various musculoskeletal conditions. Its acceptance criteria appear to be rooted in demonstrating substantial equivalence to a predicate device, the LightForce Therapy Acubeam, rather than specific, quantified performance metrics for clinical efficacy.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Safety:	Demonstrated safety in mechanical, electrical, thermal, environmental, and electromagnetic compatibility.	"The device has been found to be safe in all areas for the intended use."
Intended Use:	Same intended use as the predicate device.	"The MedX Health Inc., MedX 1000 Series is substantially equivalent to the LightForce Therapy Acubeam product in that it has the same intended use as the Light Force Therapy product..."Intended use: "temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis."
Technological Equivalence:	Technical characteristics (even if different) do not materially impact safety or effectiveness compared to the predicate.	"slightly different technical characteristics,... a differences in power source with the Light Force Therapy products are battery-operated devices operated where as the MedX 1000 series operates on grounded current, and provides continuous frequency. These differences in technical characteristics do not materially impact the safety or effectiveness of the device."

Study Proving Device Meets Acceptance Criteria:

The "study" or justification for meeting acceptance criteria is primarily a substantial equivalence claim based on a comparison to the predicate device, the LightForce Therapy Acubeam (K001179).

Detailed Information about the "Study":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. There is no mention of a clinical trial test set for the MedX 1000 Series itself to establish efficacy through patient outcomes. The evaluation focuses on technical characteristics and safety testing of the device hardware.
- Data Provenance: Not applicable for clinical efficacy data. The safety testing (mechanical, electrical, thermal, electromagnetic compatibility) would have been performed by MedX Health Corp. (Canada).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable. "Ground truth" in the sense of clinical diagnoses or outcomes established by experts for a test set is not present in this submission. The "ground truth" for the substantial equivalence claim would implicitly rely on the prior approval and established safety/efficacy of the predicate device, as determined by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication for clinical outcomes is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is an infrared lamp, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and intended use of the legally marketed predicate device (LightForce Therapy Acubeam). The MedX 1000 Series aims to demonstrate it is substantially equivalent to this predicate. The relevant "ground truth" for its own performance is its compliance with safety standards and its ability to emit energy in the near-infrared spectrum for topical heating.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.

Summary

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KOZODI 7

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 12 2002

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

Applicant:	MedXMedX Health Corp.3535 Laird Road, Unit 2Mississauga, ONCanadaL5L 5Y7Phone: 1 905 826-0766Fax: 1 905-826-0086
Contact Person:	Anita Saltmarche
Prepared on:	July 10th, 2002
Model No./Name:	MedX 1000 Series
Classification:	Lamp, Infrared - 89 ILYPhysical Medicine Device, 21 CFR 890.5500 (Class II)
Predicate Device:	LightForce Therapy, Acubeam K001179

Device Description

Statement of Intended Use for MedX 1000 Series:

The MedX 1000 Series is an infrared lamp. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

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Technological Characteristics Summary

Testing for the MedX 1000 Series has been carried out in the areas of mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, temperature control and irradiation distribution patterns. The device has been found to be safe in all areas for the intended use.

The MedX Health Inc., MedX 1000 Series is substantially equivalent to the LightForce Therapy Acubeam product in that it has the same intended use as the Light Force Therapy product, but slightly different technical characteristics,. This is a differences in power source with the Light Force Therapy products are battery-operated devices operated where as the MedX 1000 series operates on grounded current, and provides continuous frequency. These differences in technical characteristics do not materially impact the safety or effectiveness of the device. Hence the MedX 1000 Series is substantially equivalent to the LightForce Therapy Acubeam.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 2002

Anita Saltmarche. Vice President Clinical and Scientific Affairs MedX Health Corporation 3535 Laird Road, Unit 2 Mississauga, Ontario Canada L5L 5Y7

Re: K020017

Trade/Device Name: MedX 1000 Series Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: April 30, 2002 Received: May 1, 2002

Dear Ms. Saltmarche:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Anita Saltmarche

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stept Rhodes
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

Indication for Use

Stupt Rurle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020017

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.