The MLT - 1000 IR Laser 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 promoting relaxation of muscle.

Device Description

The MLT - 1000 IR Laser System is an innovative, safe, easy to use, hand-held, non-invasive therapeutic device that provides continuous heat therapy. The System consists of a Control Unit that houses the electronics and controls and a treatment probe hand piece that delivers the infrared energy.

AI/ML Overview

This document is a 510(k) premarket notification for the MLT - 1000 IR Laser System. It is focused on demonstrating substantial equivalence to predicate devices, not on a clinical study proving performance against acceptance criteria in the typical sense of a novel diagnostic or therapeutic device.

Therefore, many of the requested categories are not applicable or not provided in this type of submission. This 510(k) summary primarily focuses on functional performance and electrical safety testing to ensure the device is as safe and effective as existing, legally marketed devices.

Here's an analysis based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to a 510(k) substantial equivalence submission for an infrared lamp:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Summary in Document)
Functional Performance: "To generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain."	"The MLT-1000 has the same intended uses, with similar functional and performance characteristics [as predicate devices]." "The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration."
Electrical Safety: Compliance with applicable standards for medical devices.	"Testing... will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device." (Implies compliance was achieved and formed basis for conclusions, but specific results not detailed).
Intended Use Equivalence: Substantially equivalent to predicate devices for intended uses (temporary relief of minor muscle/joint pain/stiffness, minor arthritis pain, muscle spasm, increased local blood circulation, muscle relaxation).	"The MLT - 1000 IR Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution." "The MLT-1000 has the same intended uses, with similar functional and performance characteristics."

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 in the context of a clinical performance study as typically understood for new therapeutic or diagnostic devices. This submission relies on "functional performance testing and electrical safety testing" which are engineering and bench tests, not patient studies with a "test set" of patient data.
Data Provenance: Not applicable. The "testing" mentioned refers to engineering and safety testing of the device itself, not data collected from patients.

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)

Not applicable. This submission does not describe a clinical study requiring expert-established ground truth. The "ground truth" for this device, in the context of a 510(k), is its ability to perform its stated function (topical heating) safely and similarly to predicate devices. This is established through engineering and safety evaluations, not expert clinical consensus on patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication process 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

Not applicable. This device is an infrared lamp, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. There are no "human readers" interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device (infrared lamp) that delivers energy for topical heating. It does not involve an "algorithm" or standalone "algorithm only" performance studies. The device's performance is its physical output (heat) and its safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for the device's functional performance relates to its ability to produce infrared energy, elevate tissue temperature, and comply with safety standards. This is evaluated through engineering specifications, measurements of physical output (e.g., temperature, infrared spectrum), and compliance with electrical safety standards. The "ground truth" for its therapeutic claims (e.g., temporary pain relief) is based on the established mechanism of action of infrared heat therapy and the legally marketed predicate devices—not on novel outcomes data for this specific device in this submission.

8. The sample size for the training set

Not applicable. This is a hardware device and not based on machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is used.

Summary

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K033986

MAR 2 9 2004

APPENDIX B

510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

MLT - 1000 IR Laser System

Applicant: ا.

Medical Laser Therapeutics LP 1019 Dragon Street Dallas, Texas 75207 1 214 748 - 1088

Contact Person: James Nairne

December 22, 2003 Date Prepared:

Device Name ll.

MLT - 1000 IR Laser System Proprietary Name: Infrared Lamp Common / Usual Name: Infrared Lamp (21 CFR 890.5500) Classification Name: ILY Product Code:

lll. Intended Use of the Device

IV. Predicate Devices

The MLT-1000 IR Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the Bales Scientific. Inc. Photonic Stimulator (K974468), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), the Meditech International Inc BioFlex Professional Therapy System (K023621) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787).

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V. Description of the Device

Summary of the technical characteristics of the MLT - 1000 IR Laser VI. System to the referenced predicate devices

The MLT - 1000 IR Laser System and the aforementioned 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 ioint pain.

VII. Testing

Testing of the MLT - 1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the MLT-1000 has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 graphic of three abstract shapes that resemble human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2004

Medical Laser Therapeutics LP c/o Ms. M. Joyce Heinrich Texas Applied Biomedical Services 12101-A Cullen Boulevard Houston, Texas 77047

Re: K033986

Trade/Device Name: MLT -- 1000 IR Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: December 22, 2003 Received: December 30, 2003

Dear Ms. Heinrich:

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. M. Joyce Heinrich

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Miriam C. Provost

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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APPENDIX C

STATEMENT OF INDICATIONS FOR USE

ن جي

510(k) Number (if known):

Pending

KO 33986

Device Name:

MLT - 1000 IR Laser System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:(Per 21 CFR 801.109)	✓	OR	Over the Counter Use:(Optional Format 1-2-96)
(Division Sign-Off)	Miriam C. Provost
	(Division Sign-Off)
510(k) Number	Division of General, Restorative,and Neurological Devices

510(k) Premarket Notification MLT-1005 MUL(k) sheamber________________________________________________________________________________________________________________________ December 22, 2003

Page 16 of 18

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.