(114 days)
The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a high intensity lamp intended for various pain relief type applications by emitting light in the wavelength range 650-690nm (near-IR) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.
Instead, the documents are part of a 510(k) submission for the LumaCare LC-122M Non-coherent Light Source. This submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a direct study as might be done in a clinical trial.
Therefore, most of the requested information cannot be extracted from the provided text because it describes a different regulatory pathway (510(k) substantial equivalence) than what the questions are looking for (performance against acceptance criteria via a study).
However, I can extract information related to the device description and the basis of its FDA clearance:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific acceptance criteria through a performance study.
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. No test set or data provenance for a performance study is mentioned.
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. No test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is mentioned.
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. No MRMC study or AI component is mentioned. This is a light therapy device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware light therapy device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for device performance is mentioned. The clearance is based on substantial equivalence to a predicate device.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment is mentioned.
Information that can be extracted from the document related to the device submission:
- Predicate Device: Quantum WARP 10 Light Delivery System (K032229)
- Basis for Substantial Equivalence:
- Same intended use.
- Same general and specific indications for use.
- Similar or same spectral output, mode of operation, and general operating principles.
- Differences in method of light production and delivery do not raise new questions of safety or efficacy.
- Pre-clinical Testing Mentioned (for safety, not performance against criteria):
- Electrical Performance Data: Safety and EMC testing, including requirements of IEC 60601-1:1988/A1/A2 and IEC 60601-1-2:2002.
- Date of Preparation of 510(k) Summary: 6th July 2007
- FDA Clearance Date: November 16, 2007 (as indicated by the letter)
- 510(k) Number: K072048
{0}------------------------------------------------
Appendix A3 The 510(k) Summary
| Applicant & Submitter : | Lynton Lasers Limited |
|---|---|
| Address : | Lynton House, Manor Lane,Holmes Chapel, Cheshire, CW4 8AF, UK |
| Telephone : | +44 (0)1477 536977 |
| Fax : | +44 (0)1477 536978 |
| Contact Person : | Dr. Andrew J BerryAJBerry@lynton.co.uk |
| Preparation Date : | 6th July 2007 |
| Device Submitted : | LumaCare LC-122MNon-coherent Light Sourceand LUM-P Fibre Optic Probe (FOP) |
| Common Name : | Light Therapy Device |
| Classification Name : | Lamp, Infrared, Therapeutic Heating |
| Product Code : | ILY |
| Predicate Device : | Quantum WARP 10 Light Delivery Systemmanufactured by Quantum Devices, Inc.PO Box 848, Grayslake, IL 60030 (K032229) |
| Device Description : | The LumaCare LC-122M Non-coherent LightSource, used in conjunction with a LUM-PFiber Optic Probe (FOP) Set, is a high intensitylamp intended for various pain relief typeapplications by emitting light in the wavelengthrange 650-690nm (near-IR) with fluences oforder 10-100mW/cm². The principle parts ofthe system comprise of a desktop base unitand a Fibre Optic Probe (FOP) deliverysystem. The base unit contains a mainssupplied power supply unit which powers a250W halogen bulb, the duration of theillumination being controlled by a timing pcbwith user-accessible controls. The FOPdelivery system comprises of a ruggedised |
{1}------------------------------------------------
fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
The LumaCare LC-122M Non-coherent Light Intended Use : Source is intended to provide therapeutic near-IR light to the body
- The LumaCare LC-122M Non-coherent Light Indications for Use : Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
- The pre-clinical testing includes Electrical Performance Data : Safety and EMC testing including the requirements of IEC 60601-1:1988/A1/A2 "Medical electrical equipment - General requirements for safety" and "IEC 60601-1-2:2002 "Medical electrical equipment - General requirements for safety. Collateral standard -Electromagnetic compatibility. Requirements and tests"
- Substantial Equivalence : The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is substantially equivalent to the previously cleared Quantum WARP 10 Light Delivery System. The LumaCare LC-122M has the same intended use and the same general and specific indications for use as the Quantum WARP 10 Light Delivery System. The spectral output, mode of operation and general operating principles for the LumaCare LC-122M are similar to or the same as the Quantum WARP 10 Light Delivery System. The LumaCare LC-
{2}------------------------------------------------
122M and the Quantum WARP 10 Light Delivery System are both light therapy devices that are used for the treatment of chronic pain by exposing the surface of the skin to light at precise wavelengths. Although there are some differences in method by which each device produces light and is delivered to the treatment area, these differences do not raise new questions of safety of efficacy. Thus, the LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is substantially equivalent to the Quantum WARP 10 Light Delivery System.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lynton Lasers Limited % Dr. Andrew J. Berry Technical Director Lynton House, Manor Lane Holmes Chapel, Cheshire United Kingdom CW4 8AF
Re: K072048
Trade/Device Name: LumaCare LC-122M Non-coherent Light Source and LUM-P Fibre Optic Probe (FOP) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 29, 2007 Received: October 31, 2007
Dear Dr. Berry:
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
{4}------------------------------------------------
Page 2 - Dr. Andrew J. Berry
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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Muller
Mark N. Melkerson Director
e 18107
ii
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known) : |(072048
- LumaCare LC-122M Non-coherent Light Source and Device Name : LUM-P Fibre Optic Probe (FOP).
- Indications for Use : The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Prescription Use ブ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P/2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072048
§ 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.