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.

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.

AI/ML Overview

The information provided describes the PainTB/PainTJ Laser systems. Here's a breakdown of the acceptance criteria and study details based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific numerical acceptance criteria for performance like a certain percentage reduction in pain score with a corresponding confidence interval. Instead, it relies on demonstrating statistical significance in pain reduction compared to a mock device and claiming substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safety	No adverse effects observed during the clinical study. Complies with general safety, EMC, usability, home healthcare, medical laser equipment, and laser product safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-22, IEC 60825-1). Biological evaluation (cytotoxicity, skin sensitization, skin irritation) meets ISO 10993 standards.
Effectiveness for Pain Relief (Low-back pain)	The difference in VAS scores before and after treatment for Group B (Active Laser + exercise treatment) and Group C (Mock Laser + exercise treatment) was statistically significant (p-value < 0.05).
Technical Equivalence to Predicate	Wavelength: While the predicate (THØR DDII 830CL3) used 830nm, PainTB/PainTJ uses 670nm, 830nm, and 910nm. The 830nm wavelength in PainTB/PainTJ (24.1mW) is within the acceptable range compared to the predicate's 30mW. The other wavelengths are considered "supporting performance."
	Indications for Use (IFU): Both the predicate and PainTB/PainTJ are indicated for adjunctive use in the temporary relief of wrist pain associated with Carpal Tunnel Syndrome. PainTB/PainTJ also includes low-back pain.
	Device Class/Regulation/Product Code: All are Class II, 21 CFR 890.5500, NHN.
Clinical Equivalence to Predicate	The predicate device was used for pain treatment and reduced pain, similar to PainTB/PainTJ. The clinical study further supports the effectiveness for low back pain, addressing the expanded IFU.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: 60 adult patients
Data Provenance: Single-center study conducted in South Korea. The study was prospective and randomized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth regarding the patients' pain levels. It mentions "VAS measurement has used as pain level scale," which is a subjective patient-reported outcome. The study was "rater blind," meaning the individuals assessing the VAS scores were unaware of the treatment group, but it doesn't specify if these "raters" were experts.

4. Adjudication method for the test set:

Not explicitly mentioned. The study likely relied on patient-reported VAS scores as the primary outcome.

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:

This is not applicable to the described device. PainTB/PainTJ is a therapeutic laser system, not an AI-powered diagnostic imaging tool involving human readers.

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

Not applicable. The PainTB/PainTJ is a medical device that delivers laser therapy; it is not an algorithm that performs a task autonomously. Its performance is evaluated through patient outcomes and safety.

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

The primary ground truth for effectiveness was outcomes data, specifically:

Patient-reported Visual Analog Scale (VAS) scores for pain relief.
Observation for adverse effects.

8. The sample size for the training set:

Not applicable. The PainTB/PainTJ device is a physical laser therapy system and does not involve AI or machine learning models that require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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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

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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

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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)

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510(K) summary

The assigned 510(k) number: K203337

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.

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7. Device description

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 - 0.3AOutput: DC5V, 1.2A
Rated power of embedded battery	DC 3.7V 2000mAh lithium polymer
Protection type and degree against electricshock	Class II and internally powered source device,Type BF applied part
Protection against hazardous penetration ofwater and particles	IP22
Operating conditions	Temperature: 10 ℃ - 40 ℃, Humidity: 30 - 85%R.HAtmospheric pressure: 700 - 1,060 hPa
Transport and storage conditions	Temperature: -10℃ - 50℃, Humidity: 30 -85% R.H.,Atmospheric pressure: 700 - 1,060 hPa
Weight of main body/recharging adapter	PMD-PB230:250g, PMD-PJ230:201gAdapter: 70g
Size of main body	PMD-PB230: 152mm x 245mm (thickness15mm)PMD-PJ230:106mm x 136mm (thickness40mm)
Laser module	Model Name: COB-CO-1509AWavelength: 670nm, 830nm, 910nmNo. of laser diodes per module:3 per wavelength, total 9No. of modules: PMD-PB230 8, PMD-PJ230 6Laser class: 3B
Laser operating time	20/40/60 minutes

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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 Name510(k)#	Thor DD2 830cl3(K030226)	PMD-PB230,PMD-PJ230(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	FDAProduct code	NHN	NHN
7	IFU	The THOR DDII 830CL3 LaserSystem is a non-heating infraredlamp and is indicated foradjunctive use in the temporaryrelief of hand and wrist painassociated with Carpal TunnelSyndrome	PainTB and PainTJ Laser systems are indicatedfor adjunctive use in the temporary relief of low-back pain and wrist pain associated with CarpalTunnel Syndrome.
8	CE status	CE certified	CE certified

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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]670nm: .8830nm:8910nm: 8[PMD-PJ230]670nm: .6830nm:6910nm: 6
14	Treatment time		Not Publicly Available	Depends on the therapist choice
15	Technical	Power supply	Not Publicly Available	Input:AC100-240VOutput: DC 5V, 1.2A
16		Average Output	830nm:3X30mW	[PMD-PB230]670nm: .8x4.5mW830nm:8x24.1mW910nm: 8x3mWTotal 252.8mW[PMD-PJ230]670nm: .6x4.5mW830nm:6x24.1mW910nm: 6x3mWTotal 188.6mW
17		Spot Size	Not Publicly Available	1.7mm (Circular)
18		Energy Fluency (mW/cm2, mJ/cm2))	Not Publicly Available	670nm: .66mW/cm2830nm: 354mW/cm2910nm: 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

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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.

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.