The NeuroCalm Transcutaneous Electrical Nerve Stimulator Device is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Description

The NeuroCalm device is a battery-powered portable TENS device intended for the relief of chronic intractable pain and adjunctive treatment of postsurgical or post-traumatic acute pain. The device is small, portable and lightweight. The device is available in two configurations: Model 1 and Model 2. The Model 1 configuration provides a 10-second treatment using a proprietary wave form while Model 2 provides a 35-second treatment using a slightly different waveform to alleviate pain. The NeuroCalm TENS device is powered by a 12-volt battery. The power source provides ample power for the 10-course treatment. The device has a two-year shelf life. Treatment is provided by passing AC and DC current through noble metal (gold) electrodes. Treatment cycles are controlled by software-controlled printed circuit board assemblies. Electrical output and waveforms are optimized depending on the treatment duration desired. A complete course of treatment consists of a 10 x 10-second treatment for Model 1 and a 10 x 35second treatment for Model 2. After the conclusion of the tenth treatment, the device is inoperable and may be discarded (discard as one would discard a battery).

AI/ML Overview

The provided text describes a Traditional 510(k) Summary for the NeuroCalm Transcutaneous Nerve Stimulator (TENS) Device. The 510(k) pathway establishes substantial equivalence to predicate devices, rather than requiring extensive clinical trials to "prove" meeting acceptance criteria in the same way a PMA (Premarket Approval) process would. Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, and ground truth establishment, as typically found in clinical performance studies, is largely not present in this type of submission.

Here's a breakdown of what can be extracted and what is missing based on your request:

Acceptance Criteria and Reported Device Performance

The NeuroCalm TENS device is deemed substantially equivalent based on its intended use, design, and function being similar to predicate devices. The "acceptance criteria" here implicitly relates to proving this substantial equivalence, primarily by demonstrating similar electrical output, waveforms, and pain relief mechanisms.

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Symptomatic relief and management of chronic, intractable pain; Management of post-surgical pain; Management of post-traumatic pain.	The NeuroCalm device is indicated for "symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain," which directly matches the intended use of predicate TENS devices.
Design and Function Equivalence: TENS device that provides pain relief by generating small electrical currents of varying waveforms; battery-powered; software-controlled.	"NeuroMed Corporation's TENS device... are similar in intended use, design and function. All are TENS devices... and provide pain relief by generating small electrical currents of varying waveforms applied directly to the area experiencing pain. The proposed and predicate devices share the same regulatory classification (Class II, classification code GZJ), are battery powered, and are all software-controlled TENS units that provide the user with pain reduction."
Regulatory Classification Equivalence: Class II, product code GZJ.	The NeuroCalm device holds the same regulatory classification (Class II, product code GZJ) as the predicate devices.
Performance (Implicit): Expected to provide pain relief similar to predicate TENS devices.	The submission states that the device "provides the user with pain reduction," drawing equivalence to predicate devices which also perform this function. Specific performance metrics (e.g., pain reduction scores) are not provided as this is a 510(k) substantiation.
Technical Specifications (Implicit): Output parameters (waveform, current, voltage) comparable to predicate devices.	"...generate small electrical currents of varying waveforms..." This implies technical comparison, but specific parameters, and how they meet "acceptance criteria" through a study, are not detailed in this summary. Model 1 provides a 10-second treatment with a proprietary waveform, and Model 2 provides a 35-second treatment using a slightly different waveform.

Information Not Available in the Provided Text:

The nature of a 510(k) summary, particularly for a TENS device, focuses on substantial equivalence rather than a full clinical trial with performance metrics against pre-defined acceptance criteria. Therefore, the following information is not present in the provided document:

Sample size used for the test set and the data provenance: No clinical performance study on a "test set" is described. The basis for substantial equivalence relies on comparison to predicate devices, not new clinical data with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no described clinical test set requiring ground truth establishment by experts.
Adjudication method for the test set: Not applicable for the same reason as above.
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 unit, not an AI-assisted diagnostic or interpretive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS unit, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no ground truth for a clinical study is established or needed for this 510(k) submission.
The sample size for the training set: Not applicable, as there is no training set mentioned in the context of a clinical study or AI model.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, this 510(k) application for the NeuroCalm TENS Device relies on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, sample sizes, and ground truth establishment as would be required for novel or high-risk devices. The "study" here is primarily a technical and functional comparison to existing, cleared devices.

Summary

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K090866

Traditional 510(k) Summary

NeuroCalm Transcutaneous Nerve Stimulator (TENS) Device

1. Sponsor
  NeuroMed Corporation 29461 Troon St.

Laguna Niguel, CA 92677

Contact Person: Robert Seiple Telephone: (940) 390 0961

Date Prepared: 15 February 2009

Device Name

Proprietary Name NeuroCalm TENS Device Common/Usual Name Transcutaneous Nerve Stimulator

Classification Name Transcutaneous Electrical Nerve Stimulator for Pain Relief

3. Predicate Devices:

1. Biowave Corporation's, "Homewave Neuromodulation Pain Therapy Device" PMN # K072123,
1. AEMED, Inc. "StimPad™ TENS System" #K071120

র্বা Intended Use

Symptomatic relief and management of chronic, intractable pain ●
. Management of post-surgical pain
. Management of post-traumatic pain.

ട. Device Description

The device is available in two configurations: Model 1 and Model 2. The Model 1 configuration provides a 10-second treatment using a proprietary wave form while Model 2 provides a 35-second treatment using a slightly different waveform to alleviate pain.

The NeuroCalm TENS device is powered by a 12-volt battery. The power source provides ample power for the 10-course treatment. The device has a two-year shelf life.

NeuroMed Devices

Inc.

29461 Troon St, Laguna Niguel, CA 92677 (tel) 949-495-4274 (fax) 949-606-8191

OCT 21 2009

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NeuroMed Devices, Inc. - NeuroCalm TENS Traditional 510(k)

Treatment is provided by passing AC and DC current through noble metal (gold) electrodes. Treatment cycles are controlled by software-controlled printed circuit board assemblies. Electrical output and waveforms are optimized depending on the treatment duration desired. A complete course of treatment consists of a 10 x 10-second treatment for Model 1 and a 10 x 35second treatment for Model 2. After the conclusion of the tenth treatment, the device is inoperable and may be discarded (discard as one would discard a battery).

Basis for Substantial Equivalence: 6.

NeuroMed Corporation's TENS device, Biowave's neuromodulation device and AEMED, Inc. "StimPad"m TENS System are similar in intended use, design and function. All are TENS devices (of which there are over 500 cleared devices) and provide pain relief by generating small electrical currents of varying waveforms applied directly to the area experiencing pain. The proposed and predicate devices share the same regulatory classification (Class II, classification code GZJ), are battery powered, and are all softwarecontrolled TENS units that provide the user with pain reduction. The NeuroCalm device is intended for use in pain relief. The conclusion of the technical comparison is that the NeuroCalm TENS device is substantially equivalent to the predicate devices for the indication specified.

29461 Troon St, Laguna Niguel, CA 92677 (tel) 949-495-4274 (fax) 949-606-8191

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with three stylized lines representing its wings and body. The eagle faces to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NeuroMed Corporation c/o Mr. Daniel W. Lehtonen Senior Staff Engineer - Medical Devices Intertek Testing, Services NA, Inc. 23047 E. Aurora Road Unit B7 Twinsburg, OH 44087

OCT 21 2009

Re: K090866

Trade/Device Name: NeuroCalm TENS Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: September 9, 2009 Received: October 6, 2009

Dear Mr. Lehtonen:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090866

NeuroCalm Transcutaneous Electrical Nerve Stimulator Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

Bruce Drum

(Division Sign-O Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K090866

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).