(245 days)
The BioFlex™ Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.
The BioFlex™ Prescription Unit and related Treatment Heads are designed for clinical applications to provide low level light therapy and and display system parameters as part of the treatment session. This device does NOT store patient data. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY.
The BioFlex™ Prescription Unit and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.
The BioFlex™ Prescription Unit and related Treatment Heads is a" multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an indications for use statement for the BioFlex Prescription Unit and related Treatment Heads.
It states that the device is substantially equivalent to predicate devices, and that factory calibration tests are conducted to verify accuracy and calibration. However, it does not provide specific acceptance criteria values, performance metrics for the device, details of a study (sample size, data provenance, ground truth, etc.), or any information about AI or human reader improvement.
Therefore, I cannot fulfill your request for the table, study details, or other specific information related to acceptance criteria and a study proving device performance based on the provided text.
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MAR 1 3 2006
Exhibit 19 Summary of Safety & Effectiveness
051875
2 May 2005 & L
The BioFlex™ Prescription Unit and related Treatment Heads are designed for clinical applications to provide low level light therapy and and display system parameters as part of the treatment session. This device does NOT store patient data. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY
This summary is submitted in behalf of:
Meditech International Inc. 411 Horner Ave., Unit #1, Etobicoke, Ontario, Canada M8W 4W3 Voice phone number 416 251 1055 Fax phone number 416 251 2446
This summary is submitted by:
ﺔ ﺍ
Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 Voice phone number (203) 329 2700) Fax phone number (203) 329 2345.
The BioFlex™ Prescription Unit and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.
The scientific concept on which this device is based is the principle that by stimulating a local area with low level laser to relieve pain.
The intended use of this device is for a trained health care professional to diagnose that specific patients would benefit from this therapy and treat patients for specific ailments using specific protocols.
The "Indications for Use" for this device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
This is a prescription only device. The labeling, instructions and user operations are designed for health care professionals.
Meditech International Inc. has determined that the BioFlex™ Prescription Unit and related Treatment Heads are substantially equivalent to the performance of these predicate devices:
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Exhibit 19 Summary of Safety & Effectiveness
- BioFlex"" Professional System consisted of four low level light therapy (LLT) treatment . heads (LEDs) powered by an electronic control unit that was driven by a P.C. using software, K023621 (completed in 10 April 2003).
- BioFlex ™ LD-175 & LD-1200 Treatment Heads consists of two laser diode treatment heads . that were designed to work with the BioFlex" Professional System. These laser diode treatment heads were determined substantially equivalent in K041885 (completed on February 24th, 2005).
A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life). The BioFlex™ Prescription Unit and related Treatment Heads has benefited from design, development, testing and production procedures that conform to Quality Systems.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. Meditech International Inc. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION:
I hereby certify this Summary of Safety and Effectiveness applies for the above indicated device.
Fred Kohn
Dr. Fred Kahn President Meditech International Inc. 411 Horner Ave., Unit #1, Etobicoke, Ontario, Canada M8W 4W3 Voice 416 251 1055 416 251 2446 Fax
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2006
Meditech International, Inc. c/o Compliance Consultants Mr. Richard Keen 1151 Hope Street Stamford, Connecticut 06907
Re: K051875
Trade/Device Name: BioFlex Prescription Unit and Related Treatment Heads Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY, GEX Dated: February 10, 2006 Received: February 14, 2006
Dear Mr. Keen:
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 Fedcral 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 – Mr. Richard Keen
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit 2 Indications for Use
510(K) Number (If known): K051875
... Device Name: BioFlex™ Prescription Unit and related Treatment heads_
Indication For Use:
The BioFlex™ Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.
The BioFlex™ Prescription Unit and related Treatment Heads is a" multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.
| Prescription Use XXX (Part 21 CFR 801 Subpart D) | AND/OR | Over - The - Counter Use (21 CFR 807 Subpart C) |
|---|---|---|
| ---------------------------------------------------- | -------- | ------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - DIVISION SIGN-OFF) CONTINUE ON ANOTHER PAGE IF NEEDED
Division of General, Restorative,
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
Sheet 1 of 1
KOGIATS 510(k) Number_
Sheet 1 of 1
§ 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.