Collagentex Rx-6

K180585 · Tanses Technologies, Inc. · NHN · May 11, 2018 · Physical Medicine

Device Facts

• Record ID: K180585
• Device Name: Collagentex Rx-6
• Applicant: Tanses Technologies, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Collagentex Rx-6 is a floor-mounted, stand-alone infrared lamp system for clinical use. It emits non-collimated, non-pulsing polychromatic light (580-1500 nm) via six 500W quartz halogen lamp assemblies. The device features two metal vertical towers with an adjustable horizontal lamp module; height is controlled via a wired remote. An oscillation system pivots the module 15 degrees for coverage. Operators position the device over a massage table, ensuring a minimum 8-inch distance from the patient. The control console includes a timer, emergency stop, and mechanical hour counter. Treatment is administered by a clinician; the device automatically shuts off after the set time, followed by a 4-minute cool-down. The device provides non-heating adjunctive therapy to temporarily relieve minor chronic musculoskeletal neck and shoulder pain.

Clinical Evidence

Bench testing only. The device demonstrated compliance with IEC 60601-1-2 (EMC), NRTL, CSA, and ANSI electrical safety standards, and ANSI/IESNA RP-27.1-05 and RP-27.3-07 photobiological safety standards for the device and eye protection.

Technological Characteristics

Quartz halogen lamp source (500W); 580-1500nm wavelength; 44.2 mW/sqcm intensity. Metal construction. Dimensions: 96" x 27.68" x 96". Powered by 220/240 VAC. Non-contact device. Standards: ISO 13485/14971:2007 (risk), IEC 60601-1-2 (EMC), IESNA/ANSI RP-27.1-05/RP-27.3-07 (photobiological). No software-based algorithm.

Indications for Use

Indicated for patients experiencing minor chronic neck and shoulder pain of musculoskeletal origin requiring non-heating adjunctive light therapy.

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

• Collagentex RX-1 (K162022)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K180585

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)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☐</span> 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: [phone] Fax: [phone] Contact name: Kirk Kiremitci Email: [e-mail]

#### 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

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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<br>(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<br>Joule/minute) | 44.2 miliWatt/sqcm (2.6<br>Joule/minute) |
| Power supply | 220 VAC or 240 VAC | 120 VAC or 240 VAC |
| Design Principle | Quartz halogen lamp with a<br>filter | Quartz halogen lamp with a<br>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<br>Compatibility | 60601-2 (3rd ed.) | 60601-2 (3rd ed.) |
| Risk Analysis | According to ISO<br>13485/14971:2007 | According to ISO<br>13485/14971:2007 |
| Photobiological safety of<br>the device | IESNA/ANSI RP-27.1-05 | IESNA/ANSI RP-27.1-05 |
| Photobiological safety of<br>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.