The Dolphin Neurostim™ OT C is indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.

Device Description

The Dolphin Neurostim™ OTC (DNS) is a handheld, battery powered (9V) Transcutaneous Electrical Nerve Stimulators (TENS), specifically designed for the temporary relief of muscular pain. It combines the electrical characteristics of TENS with point stimulation delivered through a metal probe tip (cathode or anode). There is a metal ground on the device and an ancillary wrist strap that plugs into the device (cathode or anode). The device has two modes of operation. In search mode it locates points of low resistance in a predetermined area. In treatment mode it applies a low-frequency (2.4-3.0 Hz) Direct Current to the skin.

AI/ML Overview

This document (K133789) is a 510(k) premarket notification for the Dolphin Neurostim™ OTC, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this document is to establish substantial equivalence to predicate devices, not typically to present detailed clinical study results establishing performance against specific acceptance criteria.

Based on the provided text, the device's acceptance criteria are primarily related to manufacturing quality, electrical safety, and performance as a TENS device, demonstrated through factory testing rather than a clinical efficacy study. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and technological characteristics.

Here's an attempt to answer your questions based on the available information:

A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the context of a clinical study or a specific performance standard that would be met by a clinical trial. Instead, it discusses the device meeting its "product specification" through "factory tests." The table below reflects what is implied to be the performance criteria (i.e., being similar to predicate devices in key aspects) and the reported characteristics of the Dolphin Neurostim.

Acceptance Criteria (Implied by equivalence claims)	Reported Device Performance (Dolphin Neurostim™ OTC)
Intended Use: Relief of pain associated with sore or aching muscles of the lower back, arms or legs due to strain from normal exercise or normal household and work activities.	Indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.
Technological Characteristics: Deliver TENS waveform to patients; Stimulation current delivered to electrodes applied to skin.	Delivers TENS waveform; Stimulation current delivered to electrodes applied to skin.
Material: Plastic case with electrodes constructed of metal.	Plastic case with electrodes constructed of metal.
Output Waveform Design: Provide electrical stimulation to the body to relieve pain. (Predicate has single non-programmable microcurrent mode, pulsed monophasic.)	Single non-programmable milliamp mode, delivering a pulsed biphasic waveform that provides electrical stimulation to the body to relieve pain.
Electrical Safety Limits: (Implied to be below safety limits, as the predicate also states "Below safety limit" for these parameters).	Maximum average power density: 0.116 watts/sq cm. Maximum current density: 0.21 amps/sq cm. Maximum charge per pulse: 0.00044 coulombs.
Regulatory Classification: Class II, Over-The-Counter (OTC).	Class II, OTC.
Quality Systems: Conformance to quality systems, design, development, testing, and production procedures.	"Benefited from design, development, testing and production procedures that conform to Quality Systems."
Factory Tests: Verification of accurate and calibrated energy pattern over useful life.	"A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."
Substantial Equivalence: No substantial differences to predicate device(s) that raise new questions of safety or effectiveness. (Demonstrated by comparison in the document).	Claimed substantially equivalent to Painmaster MCT Patch (K130114) and TENS Pro 900 (K023726). The document explicitly states, "The differences between these systems are incidental and not significant."

Sample size used for the test set and the data provenance

The document explicitly states, "Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

This indicates that the "test set" was likely a sample of manufactured devices (or the prototype), subjected to technical/electrical performance verification, rather than a clinical test set involving human subjects. Therefore, there is no sample size in terms of human patients, nor is there data provenance in terms of country of origin or retrospective/prospective type, as it was not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The testing described is factory-level technical verification, not clinical evaluation requiring expert ground truth for diagnostic accuracy or efficacy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable, as there was no clinical test set requiring adjudication.
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 information is not applicable. The Dolphin Neurostim™ OTC is a TENS device, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC comparative effectiveness study was performed in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical TENS unit, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the factory tests would be the pre-defined product specifications and engineering standards for electrical devices (e.g., specific voltage, current, waveform parameters, durability, and safety limits).
The sample size for the training set

This information is not applicable. The Dolphin Neurostim™ OTC is a physical medical device that performs TENS. It is not an AI/machine learning algorithm that requires a "training set."
How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device.

Summary

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

March 4, 2015

Acumed Medical, LTD. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford. CT 06907-1659

Re: K133789

Trade/Device Name: Dolphin Neurostim OTC Regulation Number: 21 CFR 890.5890 Regulation Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: January 31, 2015 Received: February 4, 2015

Dear Mr. Keen:

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. Isting 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aguel -S

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133789

Device Name Dolphin Neurostim™ OT C

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(k) Summary

(per 21 CFR 807.92)

3 March 2015 Sponsor

Mr. Bruce Hocking President Acumed Medical Ltd. 3679 Lakeshore Blvd. W. Toronto, ON M8W 1P7 800-567-7246 416-253-6060 416-253-1911 Fax acumedmedical(@yahoo.com

Consultant

Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com

Proprietary Name:
Common Name:
Device Classification Name:
Classification Number:

Product Code Reviewing Group Device Classification Establishment registration No. Predicate Device

Dolphin Neurostim tm OTC TENS device Transcutaneous Electrical Nerve Stimulator for Pain Relief 21 CFR 882.5890 NUH Neurological Therapeutic Devices Class II new submission Painmaster MCT Patch K130114 and TENS Pro 900 K023726

Trademark Notice: All Trademarks used other than those of ACUMED Medical are registered to their respective owners.

Device Description

The Dolphin Neurostim OTC is designed to perform transcutaneous electrical nerve stimulation (TENS) and as such is a Class II device, having Regulation Number: 882.5890 and Classification Number: NUH. The Dolphin Neurostim™ OTC (DNS) is a handheld, battery powered (9V) Transcutaneous Electrical Nerve Stimulators (TENS), specifically designed for the temporary relief of muscular pain. It combines the electrical characteristics of TENS with point stimulation delivered through a metal probe tip (cathode or anode). There is a metal ground on the device and an ancillary wrist strap that plugs into the device (cathode or anode). The device has two modes of operation. In search mode it locates points of low resistance in a predetermined area. In treatment mode it applies a low-frequency (2.4-3.0 Hz) Direct Current to the skin.

Indications For Use

The Dolphin Neurostim™ OTC is indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.

Intended Use

The intended use of the Dolphin Neurostim OTC is to deliver transcutaneous electrical nerve stimulation (TENS).

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5. 510(k) Summary

(per 21 CFR 807.92)

Substantial Equivalence

ACUMED Medical has determined that the Dolphin Neurostim, OTC is substantially equivalent to the performance of a predicate Device. The differences between these systems are incidental and not significant. Both devices use similar technological characteristics and principles.

Both devices deliver TENS waveform to patients.
both devices are sold over the counter.

The Dolphin Neurostim tm is an over the counter version to its prescription device counterpart that has been sold in the US for 20 years. The Dolphin Neurostim has been sold over the counter in other countries for over 20 years for a total of 60,000 units.

Comparable Parameter	Dolphin Neurostim	Painmaster MCT Patch,
	K133789	K 130114
Transcutaneous Electrical NerveStimulator for Pain Relief	Yes	Yes
Intended Use	This device is intended for the relief of painassociated with sore or aching muscles of thelower back, arms or legs due to strain fromnormal exercise or normal household andwork activities.	The Painmaster MCT Patch is indicated fortemporary relief of pain associated with soreand aching muscles in the lower back due tostrain from exercise or normal household andwork activities. This intended use is a subsetof the intended use for the device when it wascleared for prescription use, and is alsoidentical to that of other OTC cleared TENSdevices.
technological characteristics	Stimulation current delivered to electrodesapplied to skin.	Stimulation current delivered to electrodesapplied to skin.
Material	Plastic case with electrodes constructed ofmetal.	Plastic case with electrodes constructed ofmetal.
output waveform design	single non-programmable milliampmode, delivering a pulsed biphasic waveformthat provides electrical stimulationto the body to relieve pain.	single non-programmable microcurrentmode, delivering a pulsed monophasicwaveform that provides electrical stimulationto the body to relieve pain.
maximum average power densitywatts/sq cm	0.116	Below safety limit
maximum current density amps/sq cm	0.21	Below safety limit
maximum charge per pulse coulombs	0.00044	Below safety limit

Testing

The Dolphin Neurostim™, OTC has benefited from design, development, testing and production procedures that conform to Quality Systems. Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life. Testing has established this device is substantially equivalent to the predicates.

Conclusion

There are no substantial differences between the Dolphin Neurostim OTC defined in this 510(k) submission and the stated predicate device.

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).