PainTB, PainTJ

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 11, 2022 Ptech Co., Ltd. Yosung Choi CEO 35, Wondogok-gil, Poseung-eup Pyeongtaek-si, Gyeonggi-do 13449 Korea, South Re: K203337 Trade/Device Name: PainTB, PainTJ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: October 13, 2020 Received: January 10, 2022 Dear Yosung Choi: 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 avare 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 {1}------------------------------------------------ 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) 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 medical devices and radiation-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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203337 Device Name PainTB, PainTJ Indications for Use (Describe) Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome. X 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 The assigned 510(k) number: K203337 1. Date Prepared: February 11, 2022 #### 2. Application Company Name: Ptech Co., Ltd. Address: 35, Wondogok-gil, Poseung-eup, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Tel: +82-07-4140-9595 Fax: +82 504-218-7344 Email: thomasc@p-tech.co.kr #### 3. Submission Correspondent Thomas Choi Ptech Co., Ltd Tel: +82-10-4051-7344 Fax: +82 504-218-7344 Email: thomasc@p-tech.co.kr #### 4. Proposed Device Identification Proprietary Name: PainTB, PainTJ Model Name:PMD-PB230, PMD-PJ230 Classification name: Infrared Lamp Device Class: Class II Regulation number: 21 CFR 890.5500 Product Code: NHN ### 5. Predicate devices Manufacturer: THØR International Ltd. Brand Name: THØR DDII 830CL3 FDA 510(K) number: K030226 ### 6. Indication for use PainTB and PainTJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome. {4}------------------------------------------------ # 7. Device description PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it. | Product name | PainTB/PainTB | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model name | PMD-PB230/ PMD-PJ230 | | Product Code | NHN | | Regulation Number | 21 CFR 890.5500 | | Device Class | Class II | | Rated power of recharging adapter | Input: 100 - 240V, 50/60Hz, 0.6 - 0.3A<br>Output: DC5V, 1.2A | | Rated power of embedded battery | DC 3.7V 2000mAh lithium polymer | | Protection type and degree against electric<br>shock | Class II and internally powered source device,<br>Type BF applied part | | Protection against hazardous penetration of<br>water and particles | IP22 | | Operating conditions | Temperature: 10 ℃ - 40 ℃, Humidity: 30 - 85%<br>R.H<br>Atmospheric pressure: 700 - 1,060 hPa | | Transport and storage conditions | Temperature: -10℃ - 50℃, Humidity: 30 -<br>85% R.H.,<br>Atmospheric pressure: 700 - 1,060 hPa | | Weight of main body/recharging adapter | PMD-PB230:250g, PMD-PJ230:201g<br>Adapter: 70g | | Size of main body | PMD-PB230: 152mm x 245mm (thickness<br>15mm)<br>PMD-PJ230:106mm x 136mm (thickness<br>40mm) | | Laser module | Model Name: COB-CO-1509A<br>Wavelength: 670nm, 830nm, 910nm<br>No. of laser diodes per module:<br>3 per wavelength, total 9<br>No. of modules: PMD-PB230 8, PMD-PJ230 6<br>Laser class: 3B | | Laser operating time | 20/40/60 minutes | {5}------------------------------------------------ | Packaging | 1 Set | |-------------------|-------------------| | Country of origin | Republic of Korea | ## 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The mechanism for pain treatment using Non-heating Infrared ramp has been studied for a long time, and various products have cleared FDA 510(K) and are being used as medical devices for treatment. Our product have three wavelength's diode laser(670nm, 839nm, 910nm) and they are cross irradiated so don't be overlay to another wavelength when it is working. Also, each wavelength is generally used in pain treatment, and we can easily find similar product in the market. The following is the result of comparing our product with the similar product in clinical literatures chosen. At the technical aspect, light sources and wavelength optical power were compared. The similar product used diode Laser and its wavelength was 830nm so it is same wave length as ours. Optical power of similar product is 30mW and our 830nm is 24.1mW so it is within the acceptable range. Thus, this product and our product have technical equivalence. In addition, the application range and the effect of the product were compared at the clinical aspect. The predicate device was used at pain treatment and reduced pain so it is same as ours. Thus, this product and our product have clinical equivalence. There is some gap in comparison with similar products because our product have 2 more wavelength laser used. Although 830nm is major and other 670nm and 910nm laser is lower power for supporting performance of the treatment, it is showing gap with predicate device. | No. | Item | device #1 | Our product | |-----|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Manufacturer | Thor International | Ptech Co.,Ltd. | | 2 | Model Name<br>510(k)# | Thor DD2 830cl3<br>(K030226) | PMD-PB230,<br>PMD-PJ230<br>(K203337) | | 3 | Laser Class | Not Publicly Available | 3B | | 4 | Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 | | 5 | Regulatory class | 2 | 2 | | 6 | FDA<br>Product code | NHN | NHN | | 7 | IFU | The THOR DDII 830CL3 Laser<br>System is a non-heating infrared<br>lamp and is indicated for<br>adjunctive use in the temporary<br>relief of hand and wrist pain<br>associated with Carpal Tunnel<br>Syndrome | PainTB and PainTJ Laser systems are indicated<br>for adjunctive use in the temporary relief of low-<br>back pain and wrist pain associated with Carpal<br>Tunnel Syndrome. | | 8 | CE status | CE certified | CE certified | {6}------------------------------------------------ | 9 | Picture | | Not Publicly Available | Image: Two medical devices | |----|--------------------|----------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 10 | Light sources used | | Diode | Diode | | 11 | Operation mode | | Not Publicly Available | pulse | | 12 | Wavelengths used | | 830nm | 670nm, 830nm, 910nm Cross irradiate | | 13 | Number of Diode | | 3 | [PMD-PB230]<br>670nm: .8<br>830nm:8<br>910nm: 8<br>[PMD-PJ230]<br>670nm: .6<br>830nm:6<br>910nm: 6 | | 14 | Treatment time | | Not Publicly Available | Depends on the therapist choice | | 15 | Technical | Power supply | Not Publicly Available | Input:AC100-240V<br>Output: DC 5V, 1.2A | | 16 | | Average Output | 830nm:3X30mW | [PMD-PB230]<br>670nm: .8x4.5mW<br>830nm:8x24.1mW<br>910nm: 8x3mW<br>Total 252.8mW<br>[PMD-PJ230]<br>670nm: .6x4.5mW<br>830nm:6x24.1mW<br>910nm: 6x3mW<br>Total 188.6mW | | 17 | | Spot Size | Not Publicly Available | 1.7mm (Circular) | | 18 | | Energy Fluency (mW/cm2, mJ/cm2)) | Not Publicly Available | 670nm: .66mW/cm2<br>830nm: 354mW/cm2<br>910nm: 44mW/cm2 | | 19 | | Application | Pain Area(hand & wrist) | Pain area (low back, wrist) | # 9. Performance standard Our products voluntarily comply with the standards below. | General Safety standard: | IEC 60601-1:2005/AMD1:2012 | |--------------------------------------|------------------------------| | EMC | 60601-1-2:2014 | | Usability: | IEC 60601-1-6:2010, | | Home Health Care: | AMD1:2013 IEC | | Medical Laser Equipment: | 60601-1-11:2015 | | Safety of laser products: | IEC 60601-2-22:2007 +A1:2012 | | Biological evaluation(Cytotoxicity): | IEC 60825-1:2014 | | | ISO 10993-5:2009 | {7}------------------------------------------------ | Biological evaluation (Skin Sensitization): | ISO 10993-10:2010 | |---------------------------------------------|-------------------| | Biological evaluation (Skin Irritation): | ISO 10993-10:2010 | ## 10. Summary of Clinical Information The PainTB was evaluated in a prospective, rater blind, randomized study that compared the "Active" Laser with a "Mock" Laser. The single-center study was conducted in the South Korea. In the test, 60 adult patients of back pain whose VAS score is 4 or higher are recruited as subiects. PainTB alone test and exercise treatment combined with PainTB use and "Mock" device use are conducted, and VAS measurement has used as pain level scale. ### Clinical Data Analysis and Results Statistical analyses (one-way ANOVA) were performed by generally accepted statistical techniques to evaluate the differences between the VAS scores before and after treatment follow up for patients in Group B (Active Laser + exercise treatment) and Group C (Mock Laser + exercise treatment). The statistical analyses of the data demonstrate that the difference between the two treatment groups over time is statistically significant (p-value < 0.05). No adverse effects from the laser treatments were observed by the principal Investigators during the clinical investigational study. ## 11. Conclusion In conclusion, PainTB/PainTJ and predicate device are products with the same technical characteristics and IFU that share the same. Although there are some gap, with reviewing the submitted clinical report, it can be seen that the gap does not affect basic effectiveness and safety equivalence of the products, it is also effective for low back pain.