(15 days)
The MedX LPT 200 single diode tethered laser is a part of the infrared console system, as per 21 CFR 890.5500. The device is used when heat is indicated 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 LPS 200 single diode Portable Laser is a rechargeable infrared device, as per 21 CFR 890.5500. The device is used when heat is indicated 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 LPT 200 is a single diode. 200 mW tethered laser powered and controlled by the MedX 1100 Console. The MedX LPS 200 Portable Laser is a single diode, 200 mW laser that has embedded control and contains a rechargeable battery. The two devices have substantially equivalent output parameters. Both of these products use 808 nm near infrared laser diodes. Additionally these devices have been designed to produce therapeutic heating for the same indications of use as described in the ILY category. Therefore the requested indications of use for these two devices; when heat is indicated for the 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.
Both of the MedX Laser devices in this submission utilize a single semiconductor laser diode emitting approximately 200 mW (maximum + or - 10%) at the end of the fiber optic light guide. Both laser devices use 808 nm GaAlAs (galliumaluminum-arsenide) laser diodes.
The LPS 200 Portable Laser produces only continuous mode light at 808 nm. The tethered MedX laser is powered by the MedX 1100 console and is capable of continuous duty cycle or pulsing at 8, 146 and 1000 Hz at 80% duty cycle. The console and portable automatically turns itself off after the set treatment time has been delivered.
The MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser are medical devices intended for therapeutic heating.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional & Performance | * Substantially equivalent output parameters to predicate devices. |
- Utilize single semiconductor laser diode emitting ~200 mW (maximum +/- 10%) at 808 nm.
- LPS 200 Portable Laser: Continuous mode light at 808 nm.
- LPT 200 Tethered Laser (with MedX 1100 Console): Continuous duty cycle or pulsing at 8, 146, and 1000 Hz at 80% duty cycle.
- Automatic shut-off after set treatment time. | * Devices have "substantially equivalent output parameters" to predicate devices (MedX 1100 Console, LCS 100 Portable Laser, LCT 100 Tethered Laser - K032231).
- Both devices use 808 nm GaAlAs laser diodes emitting "approximately 200 mW (maximum + or - 10%)".
- LPS 200 produces "only continuous mode light at 808 nm".
- LPT 200 (with console) is "capable of continuous duty cycle or pulsing at 8, 146 and 1000 Hz at 80% duty cycle".
- Both devices "automatically turn itself off after the set treatment time has been delivered". |
| Safety | * Meet mechanical safety requirements. - Meet electrical safety requirements.
- Meet thermal safety requirements.
- Meet environmental conditions requirements.
- Meet electromagnetic compatibility (EMC) requirements.
- Meet temperature control requirements.
- Safe for intended use. | * Testing was carried out across "mechanical, electrical, firmware, thermal safety, environmental conditions and electromagnetic compatibility, temperature control and irradiation distribution patterns".
- Devices "have been found to be safe in all areas for the intended use".
- "Meets the requirements of international and US medical electrical equipment standards for safety". |
| Effectiveness | * Ability to warm surface temperature. - Provide relief of minor aches and pains associated with minor muscle and tissue injury.
- Temporary increase in local blood circulation.
- Temporary relief of minor muscle and joint aches, pains, and stiffness.
- Relaxation of muscles.
- Relief for muscle spasms.
- Relief for minor pain and stiffness associated with arthritis. | * "Clinical practice in Canada has demonstrated the ability... to warm the surface temperature and provide relief of minor aches and pains associated with minor muscle and tissue injury."
- Specific heat testing data is available in Appendix I (not provided here).
- "Clinical practice and academic research demonstrate the successful use of the infrared lamp when heat is indicated for temporary increase in local blood circulation, temporary relief of minor aches and pains associated with minor muscle and minor joint pain associated with arthritis." |
| Premarket Equivalence | * Substantial equivalence to predicate device K032231. | * "Technological characteristics are a combination of the predicate Device - K032231." - "Indications for use are identical to these predicate products."
- FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
Description of the Study Proving Device Meets Acceptance Criteria
The provided text describes a 510(k) submission for the MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy from scratch.
Here's a breakdown of the information requested:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No new clinical trials were conducted. The submission relies on existing "clinical practice in Canada" and "over 30 years of research and clinical experience" with therapeutic heating, in addition to specific non-clinical heat testing.
- Data Provenance: Clinical data provenance is described as "clinical practice in Canada" and general "over 30 years of research and clinical experience." The "heat testing data" in Appendix I is non-clinical. The specific origin of test sets for mechanical, electrical, thermal, environmental, and EMC testing is not detailed beyond being "carried out" on the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The submission refers to "clinical practice in Canada" and "academic research" which would implicitly involve healthcare professionals and researchers, but no specific number or detailed qualifications of experts are provided for a defined test set's ground truth.
4. Adjudication method for the test set:
- Not applicable. There is no mention of a specific adjudication method for a test set in the context of a new clinical study. The determination of substantial equivalence is made by the FDA based on the provided documentation.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "No new clinical trials were performed on the submitted products for this 510(k) submission."
6. Standalone (algorithm only without human-in-the-loop performance) study:
- Not applicable. This device is a laser therapy product, not an AI algorithm. Its performance is assessed directly through its physical output and functional capabilities, as well as its clinical indications supported by prior art.
7. Type of ground truth used:
- The "ground truth" for effectiveness relies on:
- Clinical Practice/Experience: "Clinical practice in Canada" and "over 30 years of research and clinical experience with therapeutic heating."
- Academic Research: Cited as demonstrating successful use of infrared lamps for similar indications.
- Non-Clinical Test Data: "Heat testing data" (Appendix I) demonstrating the ability of the device to warm the surface temperature.
- Substantial Equivalence: The primary "ground truth" for regulatory approval in a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
8. Sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's efficacy comes from historical clinical practice and research on therapeutic heating in general, and the predicate devices in particular.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI algorithm. The basis for the claims of safety and effectiveness are established through:
- Demonstration of identical indications for use to predicate products.
- Documentation of technological characteristics being a combination of the predicate device.
- Non-clinical testing (mechanical, electrical, firmware, thermal safety, environmental, EMC, temperature control, irradiation patterns) confirming functional and safety requirements.
- Leveraging existing clinical experience and research on the predicate devices and the modality of therapeutic heating.
§ 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.