(218 days)
The BIOFLEX LD-R100 Treatment head 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.
The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.
This document describes a 510(k) premarket notification for the BIOFLEX LD-R100 Treatment Head. The submission demonstrates substantial equivalence to predicate devices rather than providing a study specifically proving the device meets individual acceptance criteria through performance metrics.
Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth types related to a study proving specific performance) are not applicable or cannot be extracted from this type of regulatory document.
However, based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria with reported device performance in the way a clinical study would for efficacy targets. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are the regulatory requirements for substantial equivalence, which include similar indications for use, technological characteristics (power density, wavelength, optical power, power source), and similar size and weight.
The reported "performance" is that the device meets these general equivalence criteria and is considered "safe and effective" based on its similarity to the predicate devices.
Table of Equivalence Claims (extracted from the document):
| Criterion | BIOFLEX LD-R100 Treatment Head Claim |
|---|---|
| Indications for Use | 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. (Claimed "Same Indications for use" as predicates) |
| Key Design Technical Characteristics | Contains LED lasers applied on the surface of the human skin. (Claimed "Similar key design technical characteristics" as predicates) |
| Power Density, Wavelength, Optical Power | "Same/similar power density, wavelength, and optical power" as predicates. |
| Size, Weight, Power Source, and Performance | "Similar size (hand held), weight, power source, and performance" as predicates. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical study with a test set of patient data. There is no information regarding sample sizes or data provenance in the context of a performance study.
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 ground truth establishment for a patient test set is described or required for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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. This is not an AI/software device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (treatment head for laser therapy), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this submission is the regulatory precedent set by the legally marketed predicate devices. The device is deemed safe and effective because its characteristics and intended use are substantially equivalent to devices that have already been cleared by the FDA.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
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Image /page/0/Picture/0 description: The image shows the logo for Meditech International Incorporated. The word "Meditech" is written in a large, bold, black font. Below the word "Meditech" is the phrase "INTERNATIONAL INCORPORATED" written in a smaller, bold, black font. The logo is simple and professional.
Image /page/0/Picture/2 description: The image shows a logo with the word "BIOFLEX" written vertically on the left side. To the right of the text, there are three curved lines stacked on top of each other, with a circle above them. The word "BIO" is stacked on top of the word "FLEX".
411 HORNER AVE., UNIT #1, TORONTO, ONTARIO, CANADA M8W 4W3 • TELEPHONE: (416) 251-1055 • FACSIMILE: (416) 251-2446
510(k) Summary of Safety and Effectiveness
Submitter:
Dr. Fred Kahn President Meditech International Inc 411 Horner Ave. Unit 1, Toronto, Ontario, Canada M8W 4W3 Tel: 416-251-1055 Fax: 416-251-2446
Contact:
Dr. Fred Kahn President Tel: 416-251-1055 Fax: 416-251-2446
Date: April 30, 2008
Classification Name: Lamp, infrared
Common/Usual Name: Infrared laser
Product Code/Regulation #: ILY/21 CFR part 890.5500
Proprietary Name: BIOFLEX LD-R100 Treatment head
Predicate Devices:
We are making the claim that the BioFlex LD-R100 is substantial equivalent to the predicated devices listed in the chart below.
| LEGALLYMARKETEDPREDICATE DEVICE | MANUFACTURENAME | REGULATORYCLASS ANDPRODUCTCODE | 510(K)REGISTRATIONNUMBER |
|---|---|---|---|
| BioFlex PrescriptionUnit and relatedTreatment Heads | MeditechInternational Inc | Class II/ ILY | K051875 |
| BioFlex LD-175 andLD-1200 TreatmentHeads | MeditechInternational Inc | Class II/ ILY | K041885 |
Image /page/0/Picture/17 description: The image shows the text "MEDITECH INTERNATIONAL INC" at the bottom. Above this text, there is a circular logo with the letters "UL" inside. To the left of the logo is the text "A12233", and to the right is the text "ISO 134" and "ISO 900".
Image /page/0/Picture/19 description: The image shows a circular logo with the text "FDA Cleared" inside. The letters "FDA" are stacked on top of the word "Cleared". The logo is black and white and appears to be a stamp or seal of approval.
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Image /page/1/Picture/0 description: The image shows the logo for Meditech International Incorporated. The logo is in black and features a stylized, bold font. The word "Meditech" is prominently displayed in a large font size, with "INTERNATIONAL INCORPORATED" written in a smaller font size below it.
Image /page/1/Picture/1 description: The image shows a logo for a company called "BIOFLEX". The logo has the word "BIO" stacked vertically on the left side of the image, and the word "FLEX" stacked vertically below it. To the right of the text is a graphic that includes three curved lines and a circle above them. A horizontal line is below the word "FLEX".
411 HORNER AVE, UNIT #1, TORONTO, CANADA M8W 4W3 • TELEPHONE: (416) 251-1055 • FACSIMILE: (416) 251-2446
The rationale of declaring the new BioFlex LD-R100 is substantial equivalent to the above 2 predicate devices are based on the following:
-
Same Indications for use: 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.
-
Similar key design technical characteristics- All contain LED lasers that are applied on the surface of the human skin.
- Same/similar power density, wavelength, and optical power
-
Similar size (hand held), weight, power source, and performance
Description:
The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.
Indications for Use:
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.
Technological Comparison to the Predicate:
Technologically, the BIOFLEX LD-R100 is substantially equivalent to the listed 2 predicated devices above. The risks, safety or effectiveness and benefits for the BIOFLEX LD-R100 are also comparable. The table of Comparison in Section 5.1 will provide additional information illustrating that the new BIOFLEX LD-R100 is substantially equivalent to the BioFlex Prescription Unit and related Treatment Heads and the BioFlex LD-I75 and LD-I200 Treatment Heads.
Conclusion:
As stated above, Meditech International's conclusion is that the BioFlex LD-R100 is safe and effective and complies with the appropriate medical standards and is substantially equivalent to the above-identified predicate devices.
Image /page/1/Picture/16 description: The image shows the text "MEDITECH INTERNATIONAL INC" at the bottom. Above this text, there is a UL registered firm logo. To the left of the logo, the text "A12233" is visible. To the right of the logo, the text "ISO 134" and "ISO 900" are stacked on top of each other.
Image /page/1/Picture/18 description: The image shows a circular logo with the text "FDA Cleared" inside. The letters "FDA" are stacked on top of the word "Cleared". The logo appears to be a stamp or seal of approval.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
Meditech International Inc. % Mr. Mark Slonchka Director of Product Development and Technical Services 411 Horner Avenue, Unit #1 Toronto, Ontario, Canada M8W 4W3
Re: K081355
Trade/Device Name: BIOFLEX LD-R100 Treatment Head Regulation Number: 21 CFR 890.5500 Regulation Name: Infrarcd lamp Regulatory Class: II Product Code: ILY Dated: November 19, 2008 Received: November 20, 2008
Dear Mr. Slonchka:
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
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Page 2 - Mr. Mark Slonchka
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Meditech International Incorporated. The word "Meditech" is written in a bold, sans-serif font, with the letters slightly overlapping each other. Below the word "Meditech", the words "INTERNATIONAL INCORPORATED" are written in a smaller, sans-serif font. The logo is black and white.
Image /page/4/Picture/1 description: The image shows a logo for BioFlex. The logo consists of the word "BIO" stacked vertically on the left, followed by a stylized image of three curved lines resembling waves or a fingerprint. To the right of the curved lines is a circle. Below the curved lines and circle, the word "FLEX" is written.
411 HORNER AVE., UNIT #1, TORONTO, ONTARIO, CANADA M8W 4W3 • TELEPHONE: (416) 251-1055 • FACSIMILE: (416) 251-2446
Indications for Use
510(k) Number (if known): KK81355
Device Name: BIOFLEX LD-R100 Treatment Head
Indications for Use:
The BIOFLEX LD-R100 Treatment head 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.
Prescription Use __ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila P. Dahl
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K081355
Image /page/4/Picture/16 description: The image shows the text "MEDITECH INTERNATIONAL INC" at the bottom. Above this text, there are two logos. The logo on the left contains the text "A12233". The logo on the right contains the text "ISO 13485 ISO 9001".
Image /page/4/Picture/18 description: The image shows a circular logo with the text "FDA Cleared" inside. The letters "FDA" are stacked on top of the word "Cleared". The logo is enclosed in a thin, black circle.
§ 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.