(280 days)
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No
The document describes a laser device for topical heating and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.
Yes
The device is intended for temporary relief of muscle and joint pain, muscle spasm, and stiffness associated with arthritis, and it also increases blood circulation and relaxes muscle tissue, which are therapeutic claims.
No.
The device description indicates that the CytonPro-5000 laser provides topical heating for temporary relief of pain and stiffness, increases blood circulation, and relaxes muscle tissue. These are therapeutic actions, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly states it 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," indicating it is a hardware device.
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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- CytonPro-5000 Function: The CytonPro-5000 is a laser device that applies energy directly to the body (topically) to provide therapeutic heating. It does not analyze any specimens taken from the patient.
The intended use and device description clearly indicate that it is a therapeutic device used for pain relief and increasing blood circulation through direct application of laser energy to the skin and underlying tissues.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
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.
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: 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.
The CytonPro-5000 has the same wavelength with predicated devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional healthcare facility
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for the CytonPro-5000 included Software verification and validation testing, electrical safety testing, and laser testing.
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.
c. Temperature Testing: The CytonPro-5000 induced therapeutic topical heating on the hand and foot of five subjects within 100 seconds for the 800mW/cm^2 setting, and within four minutes for the 300mW/cm^2 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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: (512)572-0080 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).
- Explanation of how the device works/principle of operation:
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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
| Characteristic | CytonPro-5000 | Cell Gen CG-4000 |
|---|---|---|
| 510(k) Number | Not assigned | K080084 |
| 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 | The model CG-4000 Cell | |
| Gen 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 |
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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 | |
| Skin: 30C ~ 45C | Device: 20C~ 50C | |
| 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.