(154 days)
Not Found
No
The device description focuses on light emission parameters, physical design, and user-controlled timer, with no mention of AI/ML algorithms for data processing, decision making, or adaptive control.
Yes.
The device is intended to provide temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, which is a therapeutic purpose.
No
The intended use of the device is to provide temporary relief of minor chronic neck and shoulder pain using light energy, not to diagnose a condition.
No
The device description clearly outlines a physical device with a lamp, power source, and mounting options, indicating it is hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Collagentex RX-1 model is a light therapy device that emits near-infrared light directly onto the body for pain relief. It does not analyze any biological specimens.
- Intended Use: The intended use is for temporary relief of pain, not for diagnosing a condition based on analyzing samples.
The device description and intended use clearly indicate it's a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Product codes
NHN
Device Description
Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and shoulder
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
The subject device has been tested and complied with the following voluntary recognizable standards IEC60601-1-2 3rd edition Electromagnetic compatibility requirements as well NRTL, CSA, ANSI electrical safety standards and ANSI/IESNA RP-27.1-05 and ANSI/IESNA RP-27.3-07 photobiological safety standards for the device and the eye protection.
According to the test result in this submission, the irradiation distance is 20 cm and the irradiation time is 20 minutes and the skin temperature is less than 42 C degrees.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Tanses Technologies. Inc. Mr. Kirk Kiremitci President 4450 Highway 13 Laval, Quebec, Canada H7R 6E9
Re: K162022
Trade/Device Name: Collagentex Rx-1 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: November 25, 2016 Received: November 29, 2016
Dear Mr. Kiremitci:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Collagentex RX-1
Indications for Use (Describe)
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared
August 1, 2016
Submitter Information
Tanses Technologies inc. 4450 Highway 13 Laval, Quebec H7R 6E9 Canada Tel: 450-622-4004 Fax number: 450-622-1540 Contact name: Kirk Kiremitci Email: kirk@tanses.com
Device Information
| Device Trade Name: | Collagentex |
|---|---|
| Device Model Name: | RX-1 |
| Common /Usual Name: | Near Infrared Lamp |
| Regulation Name: | Lamp, non heating, for adjunctive use in pain relief |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 890.5500 |
| Product Code: | NHN |
| Panel: | Physical Medicine |
Predicate Device
| Submitter: | Bioptron AG, Switzerland |
|---|---|
| Manufacturer: | Bioptron AG, Switzerland |
| Trade Name: | Bioptron |
| Model: | Bioptron Pro Light Therapy system, |
| Bioptron Compact III Light Therapy System | |
| Product Code: | NHN |
| 510(k): | K032216 |
Device Description
Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any
4
emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp
replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
Intended Use
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Technical Characteristics
| Characteristics | Collagentex Rx-1 | Bioptron Pro Light &
Compact III |
|-----------------------------------------|------------------------------------------|----------------------------------------|
| Light source | Quartz Lamp | Quartz Lamp |
| Light Source Power | 500 W | 90 W |
| Exposure area | 23cm diameter (4.37 times
larger) | 11cm diameter |
| Emitted light wavelength
(effective) | 580nm to 1500nm | 590nm to 1550nm |
| Emitted light polarization | Not polarized | Polarized >95% |
| Indications of use | temporary pain relief | temporary pain relief |
| Product code | NHN | NHN |
| Emitted light intensity | 44.2 miliWatt/sqcm (2.6
Joule/minute) | 40 miliWatt/sqcm (2.4
Joule/minute) |
| Power supply | 120 VAC or 240 VAC | 120 VAC or 240 VAC |
| Design Principle | Quartz halogen lamp with a
filter | Quartz halogen lamp with a
filter |
| Skin Surface Temperature | Under 42 C | Under 42 C |
| Treatment Time | 20 minutes | 20 minutes |
| Patient Contact | No contact to human body | No contact to human body |
| Biocompatibility | No contact to human body | No contact to human body |
| Electrical Safety | NRTL, CSA, ANSI | CE |
| Electromagnetic
Compatibility | 60601-2 (3rd ed.) | CE |
| Risk Analysis | According to ISO
13485/14971:2007 | CE |
| Photobiological safety of
the device | IESNA/ANSI RP-27.1-05 | CE |
| Photobiological safety of
eyewear | IESNA/ANSI RP-27.3-07 | CE |
From the comparison form above, the subject device and the predicate device have the same indications for use, operation principle, skin temperature, wavelength spectrum, irradiation intensity and treatment time.
5
The subject device has been tested and complied with the following voluntary recognizable standards IEC60601-1-2 3rd edition Electromagnetic compatibility requirements as well NRTL, CSA, ANSI electrical safety standards and ANSI/IESNA RP-27.1-05 and ANSI/IESNA RP-27.3-07 photobiological safety standards for the device and the eye protection.
According to the test result in this submission, the irradiation distance is 20 cm and the irradiation time is 20 minutes and the skin temperature is less than 42 C degrees.
Conclusion
Collagentex RX-1 model is substantially equivalent to the predicate device in K032216.