(97 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on hardware components and their function.
Yes
The "Device Description" explicitly states, "The MLT - 1000 IR Laser System is an innovative, safe, easy to use, hand-held, non-invasive therapeutic device..."
No
The device description indicates its purpose is 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." This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system consists of a Control Unit and a treatment probe hand piece, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a direct treatment applied to the patient.
- Device Description: The description confirms it's a hand-held, non-invasive therapeutic device that delivers infrared energy.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health condition, or disease.
IVD devices are used to perform tests in vitro (outside the body) on biological samples to diagnose, monitor, or screen for medical conditions. This device operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974468, K001179, K023621, K032787
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
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.
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).
1
V. Description of the Device
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.
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.
2
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:
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.
(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
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