The device is a Transcuteneous Electrical Nerve Stimulator. This devices utilizes battery power to produce square wave pulsed energy through electrodes placed on the body. The device has multiple modes of application, which are software controlled by the patient. The outputs are limited by design, so that hazardous energy cannot be delivered to the patient.

AI/ML Overview

The provided 510(k) summary for the Shenzhen Dongdixin Technology Co., Ltd. DX6605E-G and DX6609-G TENS device indicates that its acceptance criteria and the study proving it meets these criteria are based on conformance to established medical device standards and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Electrical Safety (EMC)	Compliance with IEC60601-1-2 2nd edition, EN55011:1998+A2:2002, EN6100-3-3:1995+A1:2001 for Electrical Immunity.	The DX6609-G (representative) complies with all these requirements.
Biocompatibility	Compliance with ISO10933 parts [parts not specified, but likely referring to a series like 5, 10, 100, 1000, etc. based on the numerical sequence provided] for toxicology of device accessories.	The device accessories were tested to ISO10933 parts 5, 10, 100, 1000, etc. and comply with all requirements.
Product Performance	Compliance with AAMI/ANSI NS-4 (specific to TENS devices).	The device complies with all requirements of this standard.
Safety and Effectiveness	Substantial equivalence to the predicate device: GEM-TWIN TENS, Model GM3XY/Z (GM320PT) (K042559). This implies that the new device should have the same intended use, technological characteristics, and perform as safely and effectively as the predicate without raising new questions of safety or effectiveness.	The conclusion states the DX6605E-G and DX6609-G are "safe and effective, comply with the appropriate medical device standards, and are substantially equivalent to the earlier identified predicate devices." The comparison table (not fully provided in the extract, but referenced) would detail the technical similarities to the predicate.
Intended Use	For symptomatic relief of chronic intractable pain (prescription device).	The device's stated intended use matches this criterion.
Energy Output Limitations	Designed to limit outputs so that hazardous energy cannot be delivered to the patient.	Device description explicitly states: "The outputs are limited by design, so that hazardous energy cannot be delivered to the patient."

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

The document does not mention specific test sets or patient data (retrospective or prospective) for clinical performance validation. The performance testing described is hardware-centric and focuses on compliance with international and national standards for electrical safety, biocompatibility, and product performance.

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

Not applicable. The evaluation is based on technical standards compliance and substantial equivalence to a predicate device, not on expert-adjudicated clinical data for the device itself.

4. Adjudication method for the test set

Not applicable, as expert-adjudicated test sets are not described.

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

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-assisted diagnostic or imaging device that would involve human "readers."

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

Not applicable. As a physical medical device, not an algorithm, the concept of "standalone" algorithm performance does not apply in this context. The device's performance is inherently its "standalone" functionality.

7. The type of ground truth used

The "ground truth" for this device's acceptance is primarily compliance with established medical device standards and demonstrated substantial equivalence to a legally marketed predicate device. The standards themselves define the "truth" of performance and safety for various aspects (electrical, biocompatibility, functional).

8. The sample size for the training set

Not applicable. This device is a TENS unit, a hardware device, and does not involve AI or machine learning models that would 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 device.

Summary

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K082057

510(k) Summary of Safety and Effectiveness

FEB 2 6 2009

Submitter

Company Name: ShenZhen Dongdixin Technology Co., Ltd. Company Contact: Zhigang Zhao Date Summary Prepared: January 16, 2009

Device Name

Trade Name:	DX6605E-G, DX6609-G
Common Name:	TENS
Classification Name:	Transcutaneous Electrical Nerve Stimulator
Classification:	Class II

Predicate Devices (Legally Marketed Devices)

The predicate device for the DX6605E-G and DX6609-G is the GEM-TWIN TENS, Miodel GM3XY/Z (GM320PT) manufactured by Genmore Technology Company, LTD. The 510(k) registration number is K042559.

Device Description

Intended Use

The purpose and function of the DX6605E-G, DX6609-G device is as follows:

This device is a prescription device and only for symptomatic relief of chronic intractable pain. . Summary of Technical Characteristics of the Device Compared to the Predicate Davices (Legally Marketed Devices)

Summary of Performance Testing: The DX6609-G (representative of the DX6605E-G) Series 2:1005 LA1 2001 Co Flast of IEC60601-1-2 2nd edition, EN55011:1998+A2:2002, EN6100-3-3:1995+A1:2001 for Electrical Immunity. The device accessories were tested to ISO10933 parts 5 100 10 10 100 100 100 100 100 1000 1000 100 1000 1000 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 10.10971 At 2012 10:1987+A1: 2001 and AAMI/ANSI NS-4 for product performance. The device compliss with all requirements of these standards.

Conclusions

As stated above, the DX6605E-G and DX6609-G are safe and effective, comply with the appropriate medical device standards, and are substantially equivalent to the earlier identified predicate devices.

End of Section -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the top of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Dongdixin Technology Co., Ltd. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

FEB 2 6 2009

Re: K082057

Trade Name: DX6605E-G and DX6609-G Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: February 10, 2009 Received: February 11, 2009

Dear Mr. Job:

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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkersen Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_

Device Name: DX6605E-G and DX6609-G

Indications For Use:

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082057

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).