(74 days)
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.
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.
The provided document is a 510(k) summary for the MedX 1100 Console and its accessories, categorizing them as an infrared lamp system. It largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not available in this document. The submission explicitly states: "No research was conducted for this specific 510(k) submittal."
Based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from device classification and predicate) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: Meets international and US medical electrical equipment standards for safety. | Meets the requirements of international and US medical electrical equipment standards for safety. |
| Functional Requirements: Meets design and performance functional requirements. | Meets design and performance functional requirements. |
| Effectiveness (Indications for Use): Provides topical heating for temporary increase in local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; muscle spasms; minor pain and stiffness associated with arthritis. | The devices are indicated for these uses. (Note: This is an assertion of indication, not a proven performance metric within this document, as no research was conducted). |
| Technological Characteristics: Substantial equivalence to predicate device K020017. | Technological characteristics are based on the predicate device – K020017. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document explicitly states "No research was conducted for this specific 510(k) submittal." This means there was no new test set with associated data provenance or sample size for this device's performance. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device.
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 / Not provided. Since no new study or test set was conducted, there were no experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set, no adjudication method.
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
- No. This document is for an infrared lamp system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an infrared lamp system, not an algorithm. Standalone performance as typically described for AI/software devices is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided directly for this submission. The "ground truth" for this 510(k) relies on the prior regulatory clearance and established safety and effectiveness of the predicate device (K020017). The current device is deemed safe and effective because it shares "technological characteristics" and "indications for use" with the predicate, which presumably had its own ground truth established during its clearance process.
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As no training set exists for this device.
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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 & Duolight100 & 500 AccessoriesMedX LCS 100 Portable Laser |
|---|---|
| Classification: | Lamp Infrared, Heating Category ILYPhysical Medicine Device, 21 CFR 890.5500 (Class II) |
| Predicate Devices: | K020017MedX 1000 Series Console & LED Accessories - MedXMCT 600 and MedX MCT 150 |
| Contact Person: | Phil PassyPresident and CEOMedX 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.
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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.
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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.
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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), 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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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/
§ 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.