CytonPro-5000

K213524 · Cytonsys, Inc. · ILY · Aug 10, 2022 · Physical Medicine

Device Facts

• Record ID: K213524
• Device Name: CytonPro-5000
• Applicant: Cytonsys, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

Device Story

CytonPro-5000 is a non-invasive diode laser system for professional healthcare use. Device consists of a control unit and a treatment probe connected via optic fiber. System requires connection to a laptop running proprietary software to operate. Mechanism of action involves emitting infrared energy at 1064nm wavelength, supplemented by a 650nm red pointing diode (<3 mW). The probe is held 8 cm from the patient's skin. The device delivers topical heating to elevate tissue temperature, which provides temporary relief of muscle/joint pain, muscle spasms, and stiffness, while increasing blood circulation and relaxing muscle tissue. Healthcare providers operate the device, controlling treatment cycles (10 cycles of 1 minute each). The device benefits patients by providing therapeutic heat for pain management.

Clinical Evidence

Bench testing only. Testing included software verification and validation, electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 60601-2-22, IEC 60825-1), and temperature testing. Temperature testing on five subjects demonstrated the device successfully induced therapeutic topical heating within 100 seconds at 800mW/cm^2 and within four minutes at 300mW/cm^2, with skin temperature maintained within controlled limits.

Technological Characteristics

Infrared laser diode system; 1064nm therapeutic wavelength; 650nm pointing diode. Materials: aluminum and steel. Energy source: 12Vdc adapter (Max 180W). Connectivity: USB/laptop interface. Dimensions: 4.8kg system weight, 2m umbilical. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of muscle and joint pain, muscle spasm, and stiffness associated with arthritis; also indicated to increase blood circulation and relax muscle tissue.

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

• Cell Gen CG-4000 laser (K080084)

Submission Summary (Full Text)

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August 10, 2022

Cytonsys Inc Li-Da Huang President 7801 N. Lamar Blvd. ste C-59 Austin, Texas 78752

Re: K213524

Trade/Device Name: CytonPro-5000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: October 28, 2021 Received: November 3, 2021

Dear Li-Da Huang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213524

Device Name CytonPro-5000

Indications for Use (Describe)

The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10px">☐ Over-The-Counter Use (21 CFR 801 Subpart G)</span> |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

#### 1. SUBMITTER INFORMATION

Name: CytonSys Inc. 7801 N. Lamar Blvd, Suite C-59 Austin TX 78752 Tel: [phone] Date Prepared: August 9, 2022

#### 2. DEVICE

Name of Device: CytonPro-5000 Common or Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Regulation Number: II Product Code: ILY

### 3. PREDICATE DEVICE

- Cell Gen CG-4000 laser cleared under K080084 dated April 21, 2008 a.
## 4. INDICATIONS FOR USE

The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

## 5. DEVICE DESCRIPTION

- a. Device Identification:
The CytonPro-5000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.

- b. Device Characteristics:
- · Software
- c. Environment of Use: professional healthcare facility
- Brief Written Description of the Device: d.
- Explanation of how the device works/principle of operation:
- (a). Connect the CytonPro-5000 with your laptop.
- (b). Switch the toggle switch on the back panel.
- (c). Insert the key on the back panel too, and turn it on (horizontal).

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- Put the CD into the CD-ROM, and open the folder to view files. (d).
- Double click the "CytonPro" icon, and run the software (for (e). detailed operation, please refer to the Operator's manual).
- -Mechanism of action: the laser beam emitted by the CytonPro-5000 Laser System is a wavelength combination of 1064nm and 650nm (pointing diode). The 1064nm wavelength is invisible, and the 650nm (red) pointing diode power output is less than 3 mW and spread out over the treatment area. The suggested distance between treatment head and patients' skin is 8 cm.
- Energy source: An adapter (12Vdc, 15A, Max. 180W).
- Materials of Use e.
- General type of material used: aluminum and steel ●
- Duration and type of contact: the laser is set for 10 cycles, of 1 minute ● and 0 seconds each.
- Key Performance Specifications/Characteristics of the Device f. The CytonPro-5000 has the same wavelength with predicated devices.

# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The CytonPro-5000 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR890.5500. These devices use infrared laser diodes to generate topical heating for temporary relief of muscle and joint pain. The overall safety and effectiveness of the CytonPro-5000 is not affected by differences in design from the predicate devices.

| Performance<br>Characteristic | CytonPro-5000 | Cell Gen CG-4000 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not assigned | K080084 |
| Indications for Use | The model CytonPro-5000<br>laser emits energy in the<br>infrared spectrum to provide<br>topical heating to elevate<br>tissue temperature for<br>temporary relief of muscle<br>and joint pain, muscle spasm<br>and stiffness associated with<br>arthritis. It also increases<br>blood circulation and relaxes | The model CG-4000 Cell<br>Gen laser emits energy in the<br>infrared spectrum to provide<br>topical heating to elevate<br>tissue temperature for<br>temporary relief of muscle<br>and joint pain, muscle spasm<br>and stiffness associated with<br>arthritis. It also increases<br>blood circulation and relaxes |

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| | muscle tissue | muscle tissue. |
|--------------------------------------|--------------------------------------|------------------------------------|
| Wavelength | 1064nm | 1064nm |
| Spectral Width | +/-5nm | +/- 5 nm |
| Beam Size | 50mm | 40mm +/- 5mm |
| Max Output Power from Treatment head | 20W | 20W |
| Max Power | 800mW/ cm^2 | 1.6 W/ cm^2 |
| Coupling | 200um optical fiber | Integrated Fiber |
| Umbilical Length | 6 ft (2 meters) | 6 ft (2 meters) |
| Minimum Bend Radius | 3 in. (75mm) | 3 in. (75mm) |
| Expected Lifetime | > 25,000 hrs | >5000 hrs |
| Max Input Power | 180W | 650VA |
| Input Voltage | 100-240VAC, 50/60 Hz | 120 V, 60Hz 5A |
| Temperature Range | Device: 20C ~ 50C<br>Skin: 30C ~ 45C | Device: 20C~ 50C<br>Skin: 30C~ 45C |
| System Weight | 4.8kg | 14kg (30.86lbs) |

The above comparison table indicates that the CytonPro-5000 is substantially equivalent to the predicate device. In addition, CytonPro-5000 passed all the electrical and safety testing according to national and international testing standards.

The wavelength of the CytonPro-5000 is exactly the same as the predicate device. The input voltage ranges from 100~240v, same as the predicate devices as well.

The max output power of the treatment head is the same as the predicate device Cell Gen CG-4000. The max power density of the CytonPro-5000 is 800mW/cm^2, less than the CG-4000, due to the slightly wider aperture of CytonPro-5000. This advanced lens design produces more evenly distributed and lower peak power density at the center.

The consumed power of the CytonPro-5000 is far less than the prior predicate device, and the weight is much lighter as well.

From the above side-by-side comparison, obviously the CytonPro-5000 is substantially equivalent to the predicate device and safer.

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## 7. PERFORMANCE TESTING (non-clinical)

Testing of the CytonPro-5000 include Software verification and validation testing. electrical safety testing, and laser testing in accordance with all applicable standards for this type of medical device.

The following testing of standards were provided in support of the substantial equivalence determination.

- a. Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

- b. Electrical Safety Testing
The CytonPro-5000 device complies with the applicable voluntary standards for Electromagnetic Compatibility and Safety. The device passed all the electrical and safety testing according to national and international standards, as below:

ANSI/AAMI ES60601-1:2005/A1:2012 IEC 60601-1-2:2014 IEC60601-1-6:2010/A1:2013 IEC 62304:2015 IEC 60601-2-22 IEC 60825-1

- Temperature Testing c.
The CytonPro-5000 induced therapeutic topical heating on the hand and foot of five subjects within 100 seconds for the 800mW/cm2 setting, and within four minutes for the 300mW/cm2 power density setting. Afterwards, the temperature of this therapeutic heating level is kept and slightly increases during this treatment protocol. However, the skin temperature is under very well controlled.

#### 8. CONCLUSION

In Consideration of the testing and comparison to the predicate device, the CytonPro-5000 has similar function, performance, energy source and intended use to the predicate device. This laser is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature. Therefore, the CytonPro-5000 is substantially equivalent to the Cell Gen CG-4000.