The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Description

The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.

AI/ML Overview

Here's an analysis of the provided text regarding the Staodyn® Max Preset TENS Device, focusing on acceptance criteria and study information:

Key Takeaway: The provided document explicitly states that clinical testing was not required to demonstrate substantial equivalence for the Staodyn® Max Preset TENS Device. Therefore, many of the requested elements related to clinical study design and outcomes are not present.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for a TENS device) and the explicit statement that clinical testing was not required, there isn't a table of specific clinical acceptance criteria with corresponding device performance metrics in the document. Instead, the "acceptance criteria" are implied by the non-clinical testing and the comparison to an already marketed predicate device.

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Non-clinical Electrical Performance:
- Symmetric biphasic pulse	Virtually identical to predicate: Symmetric biphasic pulse
- Peak voltage up to 50 Volts on 500 ohms load	Up to 50 Volts on 500 ohms load (matches predicate)
- User-selectable preset programs	24 preset programs available
- Adjustable intensity (1-20)	Intensity adjustable from 1 to 20
- Two controllable output channels	Two controllable output channels
- Lead open detection	Has lead open detection
- Auto shut-off feature	Has Auto shut-off feature
Non-clinical Mechanical Performance:
- Meets product specifications over operating and storage conditions	Verification and validation testing conducted to show device meets product specifications and user needs.
Intended Use Equivalence:
- Symptomatic relief and management of chronic intractable pain	States "used for symptomatic relief and management of chronic intractable pain"
- Relief of pain associated with arthritis	States "relief of pain associated with arthritis"
- Adjunctive treatment in post-surgical and post-traumatic pain	States "adjunctive treatment in the management of post-surgical and post-traumatic pain"
Safety and Effectiveness:
- Safe and effective	Non-clinical testing demonstrates device is "safe, effective, and performs as well as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set data is reported. The non-clinical testing would have involved engineering samples and lab tests, not a patient test set in the clinical sense.
Data Provenance: Not applicable for clinical data. The non-clinical testing was performed by the manufacturer/OEMs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical ground truth was established, as no clinical study was performed or required. The "ground truth" for the device's performance was its ability to meet engineering specifications and demonstrate equivalence to a predicate device through non-clinical means.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set, thus no adjudication method needed.

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 TENS stimulator, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. No MRMC study was conducted or relevant.

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

Not applicable. This device is a medical device for pain relief, not an algorithm. Its performance is inherent to its physical and electrical characteristics.

7. The Type of Ground Truth Used

Engineering Specifications and Equivalence to Predicate: The "ground truth" for this submission is that the device's electrical and mechanical characteristics meet its design specifications and are substantially equivalent to a legally marketed predicate TENS device. The intended use, function, and performance were compared to the American Imex Premier Plus - K032003.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the computational sense. The device's design is based on established TENS technology and the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used. The device's functionality is based on its hardware design and the established principles of transcutaneous electrical nerve stimulation, which have been validated through decades of use in this product category.

Summary

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KO 615/6

510(k) Summary

Compex Technologies Inc. Staodyn® Max preset TENS Device

510(k) Number 061516

Date of Summary Preparation:

April 4, 2006

FEB 6 2007

Submitter/Contact Person:

Carl Beaurline Global Vice President Regulatory Affairs COMPEX Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112

Phone: (651) 389-0771 Fax: (651) 638-0477

Device Name and Classification:

Trade Name: Staodyn® Max Preset Common Name: Transcutaneous Electrical Nerve Stimulator Classification Name: TENS device Product Code: GZJ , NYN Classification: Class II - 21CFR 882.5890

Manufacturing Location:

OEM: Tyece, Ltd. Establishment Registration Number: N/A Room 502-3, Po Hing Centre 18 Wang Chiu Road, Kowloon Bay Hong Kong Telephone: 852-2349-7456 Fax: 852-2349-9166

Axelgaard MFG. Co. LTD. Establishment Registration Number: 2025066 329 West Aviation Rd. Fallbrook, CA 92028 Tel: 720-723-7554 Fax:

COMPEX Technologies Establishment Registration Number: 2126518 1811 Old Highway 8

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New Brighton, MN 55112 Tel: 651-389-0771 Fax: 651-638-0477

Predicate Devices:

American Imex Premier Plus -K032003

Intended Use:

Device Description:

Comparison to predicate:

The Staodyn® Max Preset TENS is substantially equivalent to the IMEX Premier Plus TENS device. The function, performance, and intended use of the Staodyn® Max Preset device is very similar to the Premier Plus. Both systems are designed to relieve pain. The outputs are virtually identical. Each can produce a symmetric biphasic pulse with peak voltage up to 50 Volts on 500 ohms load. Both devices allow the user to select preset programs and set the intensity from 1 to 20 by using a keypad and LCD display of the devices. Both devices have the ability to detect when the lead were open and have Auto shut off feature.

Non-clinical Testing:

Verification of the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes testing to show the device meets user needs according to marketing requirements.

Clinical Testing:

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COMPEX Technologies. Inc.

The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device does not require clinical testing in order to determine substantial equivalence to the predicate devices.

Conclusion:

The non-clinical testing demonstrates that the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is safe, effective, and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

. . .

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carl Beaurline Vice President, Regulatory Affairs Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, Minnesota 55112

FEB 6 2007

Re: K061516

Trade/Device Name: Staodyn® Max Preset, Model 4470 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: December 7, 2006 Received: December 8, 2006

Dear Mr. Beaurline:

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 (1 mr 1), it a 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

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Page 2 - Mr. Carl Beaurline

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mar J. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1 Indication for Use Statement

Indications for Use

510(k) Number (if known): __ K061516

Device Name: The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device

Indications for Use:

... ... ......................................................................................................................................................................

Prescription Use(Part 21 CFR 801 Subpart D)	X
	AND/OR	Over-the-Counter Use(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONT(Division Sign-Off IF NEEDED))

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number: 11061511

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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).