(74 days)
Not Found
No
The document describes an infrared lamp system for topical heating and pain relief, with no mention of AI or ML technologies in the intended use, device description, or other sections.
Yes
The device is described as providing "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," which indicates its intended use for treating medical conditions.
No
The device is described as an infrared lamp system providing topical heating for therapeutic purposes, such as pain relief and muscle relaxation. It is not mentioned to diagnose any conditions.
No
The device description explicitly mentions a "Console" and "Accessories" which are hardware components (infrared lamp system, laser diodes). The intended use also describes the emission of energy for topical heating, which is a physical process requiring hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is an infrared lamp system used for topical heating to provide temporary relief of various musculoskeletal issues. This involves applying energy to the body, not analyzing samples taken from the body.
- Device Description: The description reinforces that the accessories are therapeutic heating devices using infrared lasers for topical heating.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is entirely external and therapeutic.
N/A
Intended Use / Indications for Use
The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. 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.
The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The MedX 1100 Console powers three different accessories the MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories. All therapeutic heating accessories are indication for use within the heating category, ILY, as applied for in this submission. The low level laser accessories use 785 nm GaAlAs (galliumaluminum-arsenide) infrared lasers diodes indicated for use where heat is indicated for 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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing carried out for the MedX 1100 Console and infra red heating accessories and the MedX LCS 100 Portable Laser indicates that they meet design and performance functional requirements. The proposed device meets the requirements of international and US medical electrical equipment standards for safety, and key performance and safety requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT - 6 2003
KO3A231
5. DISCUSSION OF SAFETY AND EFFECTIVENESS
A. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
| Model No. /Names: | MedX 1100 Console and MedX LCT 100 & Duolight
100 & 500 Accessories
MedX LCS 100 Portable Laser |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Classification: | Lamp Infrared, Heating Category ILY
Physical Medicine Device, 21 CFR 890.5500 (Class II) |
| Predicate Devices: | K020017
MedX 1000 Series Console & LED Accessories - MedX
MCT 600 and MedX MCT 150 |
| Contact Person: | Phil Passy
President and CEO
MedX Health Inc.
905 826-0766 |
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description of the Device
The MedX 1100 Console powers three different accessories the MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories. All therapeutic heating accessories are indication for use within the heating category, ILY, as applied for in this submission. The low level laser accessories use 785 nm GaAlAs (galliumaluminum-arsenide) infrared lasers diodes indicated for use where heat is indicated for 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.
1
$$\left| \sqrt[3]{\pi \sec \xi \circ \lambda} \right|$$
Image /page/1/Picture/1 description: The image contains three stylized figures that resemble the number 2. The figures are drawn in black ink and have a cursive style. The figure in the middle is oriented vertically, while the other two are oriented horizontally.
Technological Characteristics Summary
The technological characteristics are based on the predicate device – K020017.
Discussion of Non-Clinical and Clinical Data
No research was conducted for this specific 510(k) submittal.
Conclusions Demonstrating Safety, Effectiveness and Performance
The testing carried out for the MedX 1100 Console and infra red heating accessories and the MedX LCS 100 Portable Laser indicates that they meet design and performance functional requirements. The proposed device meets the requirements of international and US medical electrical equipment standards for safety, and key performance and safety requirements.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three overlapping profiles of human faces forming the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2003
Ms. Anita Saltmarche Vice President Clinical and Scientific Affairs MedX Electronics, Inc. 3535 Laird Road, Unit 2 Mississauga, Ontario Canada L5L 5Y7
Re: K032231
Trade/Device Name: MedX 1100 Console & MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories MedX LCS 100 Portable Laser (785 nm) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 17, 2003 Received: July 31, 2003
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. Drue, 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. Iisting 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 mav 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.
3
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), 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
4
K032231 510 (k) Number: MedX 1100 Console & MedX LCT 100 (785 nm) and Device Names: Duolight 100 (785 nm) & 500 Accessories MedX LCS 100 Portable Laser (785 nm)
INDICATION FOR USE
Indication for Use
The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. 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.
The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-counter Use_ (Optional Format 1-2-96)
(Division Sign-off) Division of General Restorative Devices 510(k) Number: K032231
Miriam C. Provost
and Neurological Devic
510(k) Number K63223/