(447 days)
Not Found
No
The device description details a standard TENS device with a "search mode" that locates points of low resistance. This is a common electrical property measurement and does not indicate the use of AI or ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and provides no information about training or test sets, which are typical for AI/ML devices.
Yes
The device is used for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
The device is indicated for temporary relief of pain and operates as a Transcutaneous Electrical Nerve Stimulator (TENS); it does not provide a diagnosis.
No
The device description explicitly states it is a handheld, battery-powered hardware device with a metal probe tip and ground, and an ancillary wrist strap. It is a physical TENS device, not software.
Based on the provided information, the Dolphin Neurostim™ OT C is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) that applies electrical current to the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dolphin Neurostim™ OT C does not fit this description.
N/A
Intended Use / Indications for Use
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. The intended use of the Dolphin Neurostim OTC is to deliver transcutaneous electrical nerve stimulation (TENS).
Product codes
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back, arms, and legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Painmaster MCT Patch K130114, TENS Pro 900 K023726
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The profiles are stacked on top of each other, creating a sense of depth and unity.
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
1
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)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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 Nerve | ||
| Stimulator for Pain Relief | Yes | Yes |
| Intended Use | This device is intended for the 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. | The Painmaster MCT Patch is indicated for | |
| temporary relief of pain associated with sore | ||
| and aching muscles in the lower back due to | ||
| strain from exercise or normal household and | ||
| work activities. This intended use is a subset | ||
| of the intended use for the device when it was | ||
| cleared for prescription use, and is also | ||
| identical to that of other OTC cleared TENS | ||
| devices. | ||
| technological characteristics | Stimulation current delivered to electrodes | |
| applied to skin. | 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 | single non-programmable milliamp | |
| mode, delivering a pulsed biphasic waveform | ||
| that provides electrical stimulation | ||
| to the body to relieve pain. | single non-programmable microcurrent | |
| mode, delivering a pulsed monophasic | ||
| waveform that provides electrical stimulation | ||
| to the body to relieve pain. | ||
| maximum average power density | ||
| watts/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.