(67 days)
Not Found
No
The device description details a light therapy device with mechanical controls and standard electrical components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended to provide temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, which classifies it as a therapeutic device.
No
The device is intended to emit light energy for temporary relief of minor chronic neck and shoulder pain, which is a therapeutic function, not a diagnostic one. It does not mention any capability to identify, detect, or characterize a disease or condition.
No
The device description clearly outlines physical hardware components including towers, a control console with buttons and counters, a lamp module with quartz lamps, and actuators. It is a standalone light device, not software.
Based on the provided information, the Collagentex RX-6 model is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is 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." This describes a therapeutic use of light energy applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical light-emitting device designed to be positioned over a patient. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
In summary, the Collagentex RX-6 is a therapeutic device that uses light energy for pain relief, not a diagnostic device that analyzes samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
Collagentex RX-6 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 (comma separated list FDA assigned to the subject device)
NHN
Device Description
The Collagentex Rx-6 is a stand alone light device which emits polychromatic visible to near infrared light in the 580 to 1500 nanometer range. The light is non-collimating and non-pulsing. There are a total of 6 exposure areas, each set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute at the minimum distance of 8 inches.
The device measures 96 inches long by 27.68 inches wide by 96 inches tall and is made up of 3 main sections. There are 2 vertical towers positioned 84 inches apart. The towers are made of metal and house the main electrical components for the device. A control console which includes a set timer, emergency stop button, oscillating on/off switch and a mechanical hour counter is mounted on left positioned tower.
In between the towers, positioned horizontally is a lamp module. The lamp module is made up of 6 individual lamp assemblies placed inline. The lamps are all 500w quartz type and each cover an exposure area of 23cm diameter. The height of the lamp module is adjustable via actuators positioned in the vertical columns. The actuators are controlled by a wired remote control. The device is to be mounted on the floor above a massage table provided by the device owner.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Not Found
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 11, 2018
Tanses Technologies Inc. Kirk Kiremitci President 4450 Highway 13 Fabreville, H7R 6E9 Canada
Re: K180585
Trade/Device Name: Collagentex Rx-6 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: February 1, 2018 Received: March 5, 2018
Dear Kirk 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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -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-6
Indications for Use (Describe)
Collagentex RX-6 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
February 1, 2018
Submitter Information
Tanses Technologies inc. 4450 Highway 13 Laval, Quebec H7R 6E9 Canada Tel: 450-622-4004 Fax: 450-622-1540 Contact name: Kirk Kiremitci Email: kirk@tanses.com
Device Information
| Device Trade Name: | Collagentex |
|---|---|
| Device Model Name: | RX-6 |
| Common /Usual Name: | Near Infrared Lamp |
| Requlation Name: | Lamp, non heating, for adjunctive use in pain relief |
| Requlatory Class: | Class II |
| Requlation Number: | 21 CFR 890.5500 |
| Product Code: | NHN |
| Panel: | Physical Medicine |
Predicate Device
| Submitter: | Tanses Technologies Inc. Canada |
|---|---|
| Manufacturer: | Tanses Technologies Inc. |
| Trade Name: | Collagentex |
| Model: | RX-1 |
| Regulation Number: | 21 CFR 890.5500 |
| Product Code: | NHN |
| 510(k): | K162022 |
Device Description
The Collagentex Rx-6 is a stand alone light device which emits polychromatic visible to near infrared light in the 580 to 1500 nanometer range. The light is non-collimating and non-pulsing. There are a total of 6 exposure areas, each set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute at the minimum distance of 8 inches.
The device measures 96 inches long by 27.68 inches wide by 96 inches tall and is made up of 3 main sections. There are 2 vertical towers positioned 84 inches apart. The towers are made of metal and house the main electrical components for the device. A control console which includes a set timer, emergency stop button, oscillating on/off switch and a mechanical hour counter is mounted on left positioned tower.
In between the towers, positioned horizontally is a lamp module. The lamp module is made up of 6 individual lamp assemblies placed inline. The lamps are all 500w quartz type and each cover an exposure area of 23cm diameter. The height of the lamp
4
module is adjustable via actuators positioned in the vertical columns. The actuators are controlled by a wired remote control. The device is to be mounted on the floor above a massage table provided by the device owner.
Device Use
Once the user lays down on the massage table, the operator then adjusts the height of the lamp module using the remote control. The operator is instructed to ensure a minimum distance of 8 inches between the lamps and user. The operator then sets the desired treatment time and presses the start button to active the device. An oscillation system can be turned on which allows the light module to pivot side to side by 15 degrees. This allows for better overall coverage. At the end of the treatment time the device turns off and enters a 4 minute cool down mode.
Intended Use
Collagentex RX-6 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-6 | Collagentex Rx-1 |
|---|---|---|
| Light source | Quartz Lamp | Quartz Lamp |
| Light Source Power | 500 W | 500 W |
| Exposure area | 23cm diameter * 6 modules | 23cm diameter |
| Emitted light wavelength | ||
| (effective) | 580nm to 1500nm | 580nm to 1500nm |
| Emitted light polarization | Not polarized | Not polarized |
| Indications of use | temporary pain relief | temporary pain relief |
| Product code | NHN | NHN |
| Emitted light intensity | 44.2 miliWatt/sqcm (2.6 | |
| Joule/minute) | 44.2 miliWatt/sqcm (2.6 | |
| Joule/minute) | ||
| Power supply | 220 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 | 1.8C max. skin temp rise | 1.8C max. skin temp rise |
| Treatment Time | 20 minutes per site | 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 | NRTL, CSA, ANSI |
| Electromagnetic | ||
| Compatibility | 60601-2 (3rd ed.) | 60601-2 (3rd ed.) |
| Risk Analysis | According to ISO | |
| 13485/14971:2007 | According to ISO | |
| 13485/14971:2007 | ||
| Photobiological safety of | ||
| the device | IESNA/ANSI RP-27.1-05 | IESNA/ANSI RP-27.1-05 |
| Photobiological safety of | ||
| eyewear | IESNA/ANSI RP-27.3-07 | IESNA/ANSI RP-27.3-07 |
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.
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Performance Data
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.
Conclusion
Collagentex RX-6 model is substantially equivalent to the predicate device in K162022. It uses the same technology, outputs the same wavelength spectrum, has the same irradiation intensity, treatment time and identical testing as the predicate device.