BIOFLEX LD-R100 TREATMENT HEAD

K081355 · Meditech International, Inc. · ILY · Dec 18, 2008 · Physical Medicine

Device Facts

• Record ID: K081355
• Device Name: BIOFLEX LD-R100 TREATMENT HEAD
• Applicant: Meditech International, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

BIOFLEX LD-R100 is a Class II infrared laser treatment head; used as an accessory with existing BioFlex Professional and Prescription systems (K023621, K051875). Device emits infrared energy to penetrate surface tissues; triggers cellular functions via topical heating. Hand-held form factor; operated by healthcare professionals in clinical settings. Output provides therapeutic heat; aids in pain relief and muscle relaxation. Benefits include temporary relief of minor muscle/joint pain, stiffness, and spasms.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Infrared laser treatment head; LED-based; hand-held form factor. Operates via infrared spectrum energy emission for topical heating. Power density, wavelength, and optical power are consistent with predicate devices.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and for promoting relaxation of muscle tissue.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioFlex Prescription Unit and related Treatment Heads (K051875)
• BioFlex LD-175 and LD-1200 Treatment Heads (K041885)

Submission Summary (Full Text)

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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: [phone] • FACSIMILE: [phone]

# 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: [phone] Fax: [phone]

### Contact:

Dr. Fred Kahn President Tel: [phone] Fax: [phone]

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.

| LEGALLY<br>MARKETED<br>PREDICATE DEVICE | MANUFACTURE<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT<br>CODE | 510(K)<br>REGISTRATION<br>NUMBER |
|-------------------------------------------------------------|-------------------------------|--------------------------------------------|----------------------------------|
| BioFlex Prescription<br>Unit and related<br>Treatment Heads | Meditech<br>International Inc | Class II/ ILY | K051875 |
| BioFlex LD-175 and<br>LD-1200 Treatment<br>Heads | Meditech<br>International 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: [phone] • FACSIMILE: [phone]

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

#### 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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: [phone] • FACSIMILE: [phone]

## 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.