(218 days)
No
The summary describes a low-level laser therapy device for topical heating and pain relief. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended to provide topical heating for the temporary relief of pain and stiffness associated with various conditions, promoting relaxation of muscle tissue, which aligns with the definition of a therapeutic device.
No
The device is described as a treatment head that emits energy for therapeutic purposes, such as pain relief, and does not mention any function related to identifying or diagnosing medical conditions.
No
The device description explicitly states it is a "Treatment head device" that "apply energy," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating for the temporary relief of pain and muscle issues. This is a therapeutic application, not a diagnostic one.
- Device Description: The description mentions applying energy to penetrate tissues and trigger cellular functions. This aligns with a therapeutic mechanism, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a Class II Low Level Laser treatment head used for therapeutic purposes on the surface of the human skin.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
| LEGALLY
MARKETED
PREDICATE DEVICE | MANUFACTURE
NAME | REGULATORY
CLASS AND
PRODUCT
CODE | 510(K)
REGISTRATION
NUMBER |
|-------------------------------------------------------------|-------------------------------|--------------------------------------------|----------------------------------|
| BioFlex Prescription
Unit and related
Treatment Heads | Meditech
International Inc | Class II/ ILY | K051875 |
| BioFlex LD-175 and
LD-1200 Treatment
Heads | Meditech
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.
1
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.
2
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
3
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.