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.

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.

AI/ML Overview

The document provided is a 510(k) summary for a medical device (Collagentex Rx-6). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.

Therefore, the available information does not contain the following data for a typical clinical study evaluating device performance and acceptance criteria:

A table of acceptance criteria and reported device performance.
Sample size for a test set, its provenance, or retrospective/prospective nature.
Number of experts for ground truth establishment or their qualifications.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
Standalone (algorithm only) performance results.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

However, based on the provided text, here's what can be extracted regarding the device's validation for substantial equivalence:

The "Performance Data" section primarily addresses safety and electrical compatibility standards compliance, not clinical efficacy acceptance criteria.

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of performance-based acceptance criteria related to efficacy (e.g., pain reduction percentage, visual analog scale score improvement) or specific reported performance against such criteria. Instead, it asserts substantial equivalence based on technical characteristics and compliance with safety standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set or data provenance is mentioned for establishing efficacy or performance against clinical acceptance criteria. The performance data refers to compliance with voluntary recognized standards.

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, as no clinical test set requiring expert-established ground truth is described for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set requiring expert 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. The device is an infrared lamp, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical infrared lamp, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable for clinical efficacy. The "ground truth" here is compliance with established safety and electrical standards.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of available "Performance Data" and "Conclusion" from the document regarding meeting safety and electrical standards (not clinical efficacy acceptance criteria):

The device (Collagentex Rx-6) was tested for and complied with the following recognized standards:

IEC60601-1-2 3rd edition: Electromagnetic compatibility requirements.
NRTL, CSA, ANSI: Electrical safety standards.
ANSI/IESNA RP-27.1-05: Photobiological safety standards for the device.
ANSI/IESNA RP-27.3-07: Photobiological safety standards for eye protection.

The conclusion states that the Collagentex RX-6 model is substantially equivalent to its predicate device (K162022, Collagentex RX-1) because it uses:

The same technology (Quartz Lamp with filter)
Outputs the same wavelength spectrum (580nm to 1500nm)
Has the same irradiation intensity (44.2 miliWatt/sqcm or 2.6 Joule/minute)
Has the same treatment time (20 minutes per site/per patient)
Identical testing (referring to the listed safety and electrical standards compliance).
Also notes the same skin surface temperature rise (1.8°C max).

The primary evidence presented is the technical equivalence to a predicate device which itself has been cleared for marketing, and compliance with relevant safety and electrical performance standards. There isn't a study proving the device meets clinical efficacy acceptance criteria provided in this 510(k) summary; rather, it hinges on substantial equivalence for the stated indications for use.

Summary

{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);

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K180585

Device Name Collagentex Rx-6

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{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

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 (2.6Joule/minute)	44.2 miliWatt/sqcm (2.6Joule/minute)
Power supply	220 VAC or 240 VAC	120 VAC or 240 VAC
Design Principle	Quartz halogen lamp with afilter	Quartz halogen lamp with afilter
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
ElectromagneticCompatibility	60601-2 (3rd ed.)	60601-2 (3rd ed.)
Risk Analysis	According to ISO13485/14971:2007	According to ISO13485/14971:2007
Photobiological safety ofthe device	IESNA/ANSI RP-27.1-05	IESNA/ANSI RP-27.1-05
Photobiological safety ofeyewear	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.

{5}------------------------------------------------

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.

Regulation Number and Section

§ 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.