This TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Device Description

The device is used to transmit electrical pulses through the skin to the underlying peripheral nerves to help in the blockage of the pain signal traveling to the brain.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the 1818 TENS Unit is substantially equivalent to the Diamond Medical TX-3 TENS Unit (K#883188). This means the acceptance criteria are implicitly that the new device performs at least as well and has the same technological characteristics and intended use as the predicate device, without raising new questions of safety or effectiveness.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Substantial Equivalence	Same intended use as predicate device	Met (same intended use as TX-3 TENS Unit)	Non-Clinical, Bench Testing, Limited Clinical
	Same technological characteristics as predicate device	Met (same technological characteristics as TX-3 TENS Unit)	Non-Clinical, Bench Testing
	No new questions of safety or effectiveness	Met (Bench testing and clinical testing demonstrate no new questions)	Non-Clinical, Bench Testing, Limited Clinical
Non-Clinical Testing	All required sections of AAMI/ANSI NS-4 Standard met	Met	Bench Testing
	All required IEC 60601-1 testing met	Met	Bench Testing
	All required IEC 60601-1-2 testing met	Met	Bench Testing

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." This suggests no specific human clinical test set was used for the 1818 TENS Unit itself to establish its unique performance against a benchmark through a formal clinical trial with a defined sample size. Instead, its equivalence to a predicate device, which likely had its own supporting data, was the primary mechanism for clearance.
- The "clinical testing supplied" mentioned in the conclusions is likely referring to the information available for the predicate device, or very limited (non-formal study) observational data rather than a dedicated clinical trial for the new device.
- Therefore, information on sample size, country of origin, or retrospective/prospective nature of a dedicated test set for the 1818 TENS Unit is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- As no formal clinical test set or study is described for the 1818 TENS Unit itself, this information is not applicable/not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As no formal clinical test set or study is described, this information is not applicable/not provided.
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:
- The device is a TENS unit, which is an electrical stimulation device for pain relief, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a physical TENS unit, not an algorithm. Therefore, an algorithm-only standalone performance study is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the ground truth was likely established by adherence to established industry standards (AAMI/ANSI NS-4, IEC 60601-1, IEC 60601-1-2).
- For the "clinical testing supplied," if any, it would likely refer to pain relief outcomes associated with the predicate device, but no specific outcome data or methodology for ground truth establishment for the 1818 TENS Unit is provided.
The sample size for the training set:
- As this is not an AI/machine learning device, there is no training set in the conventional sense. The "training" for the device's design would come from engineering principles and compliance with standards.
How the ground truth for the training set was established:
- As there is no training set for this type of device, this is not applicable.

Summary

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EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

138 Medical Supplies Inc. 313 Butler Street Brooklyn, NY 11217

Date Summary Prepared:

August 9, 1999 Contact: Ms. Isabelle Liang

2. Name of the Device:

1818 TENS Unit

റ്റ് Predicate Device Information:

The 1818 TENS Unit is substantially equivalent to the Diamond Medical TX-3 TENS Unit, K#883188.

4. Device Description:

The device is used to transmit electrical pulses through the skin to the underlying peripheral nerves to help in the blockage of the pain signal traveling to the brain.

5. Intended Use:

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6. Comparison to Predicate Devices:

The 1818 TENS Unit is substantially equivalent to the Diamond Medical TX-3 TENS Unit.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

All required sections of the AAMI/ANSI NS-4 Standard were met. All required IEC 60601-1 and IEC 60601-1-2 testing was met.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

The 1818 TENS Unit has the same intended use and technological characteristics as the TX-3 TENS Unit device. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that technological characteristics do not raise any new questions of safety or effectiveness. Thus, the 1818 TENS Unit is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three parallel lines that curve and resemble a bird or a symbol representing health and human services.

Public Health Service

NOV - 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

138 Medical Supplies, Inc. c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K992709 Trade Name: 1818 TENS Unit Regulatory Class: II Product Code: GZJ Dated: August 9, 1999 Received: August 11, 1999

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan D. Goldstein-Falk

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 2 - Ms. Susan D. Goldstein-Falk

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): __K 99 a 7 o 7 138 Medical Supplies Inc. 1818 TENS Unit DEVICE NAME: INDICATIONS FOR USE:

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-95)

Pacella

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).