(332 days)
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 exercise or normal household and work activities.
The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use. The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. As above the device is battery powered there is no connection to AC mains supply.
The provided text describes a Premarket Notification 510(k) for the Omron OTC TENS device (Model PM3030). This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with acceptance criteria for device performance in the way one might for a diagnostic or therapeutic medical AI device.
Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance against a ground truth) is not applicable to this 510(k) summary. The document is primarily concerned with comparing the technical specifications and intended use of the new device to a predicate device to establish that it is as safe and effective.
Here's an analysis based on the provided text, focusing on what is available:
Acceptance Criteria and Device Performance (based on Substantial Equivalence comparison)
The "acceptance criteria" here are implicitly that the Omron PM3030 device is "substantially equivalent" to its predicate device (Endurance Therapeutics, Model T1040, K060846) in terms of safety and effectiveness. The reported device performance is presented as a comparison of specifications between the new device and the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute (Implicit Acceptance Criteria: Substantially Equivalent) | Omron PM3030 (Reported Device Performance) | Predicate: Endurance Model T1040 (K060846) | Result (Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. | Relief of pain associated with sore and aching muscles in the lower back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | Equivalent |
| Product Code | NUH | NUH, NGX, GZX | Similar (primary code matches) |
| CFR Regulation | 882.5890 | 882.5890, 890.5850 | Similar (primary code matches) |
| Patient Population | Adult | Not specified (implied adult for OTC TENS) | Equivalent |
| Prescriptive or OTC | OTC | OTC | Equivalent |
| Environment of Use | Clinics, hospital and home environments | Not specified (implied home for OTC) | Equivalent |
| Contraindications | Has standard contraindications (cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device). | Has standard contraindications. | Equivalent |
| Warnings/Precautions/Adverse Reactions | Standard warnings/precautions/adverse reactions. | Standard warnings/precautions/adverse reactions. | Equivalent |
| Power source | 2 - AAA | 3 - AAA | Difference, but not significant for safety/effectiveness |
| Number of Output modes | 3 | 10 | Difference, but deemed insignificant for safety/effectiveness |
| Number of output channels | 1 | 1 | Equivalent |
| Waveform | Biphasic | (Not specified for predicate, but TENS generally uses biphasic) | Implied similar |
| Shape | Rectangular | (Not specified for predicate) | Implied similar |
| Maximum Output Voltage (500 ohm) | 35.4 V | 40.7 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Voltage (2k ohm) | 46.7 V | 105.1 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Voltage (10k ohm) | 50.8 V | 154.1 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (500 ohm) | 4.4 mA | 81.4 mA | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (2k ohm) | 1.7 mA | 47.8 mA | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (10k ohm) | 0.4 mA | 15.4 mA | Difference, but deemed insignificant (lower output) |
| Maximum Phase charge (500 ohm) | 133 microC | 16.9 microC | Difference, but deemed insignificant (higher charge, but within safe limits for TENS) |
| Maximum Current Density (500 ohm) | 0.095 mA/cm² | 2.71 mA/cm² | Difference, but deemed insignificant (lower density) |
| Maximum Average Current (500 ohm) | 3.5 mA | Not specified | Not directly comparable, but overall output deemed safe. |
| Maximum Average Power Density (500 ohm) | 89 mW/cm² | 10.2 mW/cm² | Difference, but deemed insignificant. |
| Frequency (Hz) | < 100 Hz | 245 Hz | Difference, but not significant for safety/effectiveness |
| Burst Mode | None | (Not specified for predicate, but implies presence if not none) | Difference, but not significant for safety/effectiveness |
| Timer range (min) | 15 minutes | 30 minutes | Difference, but not significant for safety/effectiveness |
| Indication display: On/Off status | Yes | Yes | Equivalent |
| Indication display: Low battery | No | Yes | Minor difference, not impacting substantial equivalence |
| Indication display: Voltage / Current level | Yes | Yes | Equivalent |
| Indication display: Output mode | Yes | Yes | Equivalent |
| Indication display: Time to cut-off | No | Yes | Minor difference, not impacting substantial equivalence |
| Dimensions | 55 mm x 95 mm x 19 mm | 150 mm x 68 mm x 26 mm | Different, but not significant for safety/effectiveness |
| Weight | 60 grams | 90 grams | Different, but not significant for safety/effectiveness |
| Housing material | ABS | Not specified | Not significant for equivalence |
| Microprocessor control | Yes | Yes | Equivalent |
| Automatic Overload trip | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| Automatic no-load trip | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| Automatic shut-off | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| User override control | Power On/Off button | Not specified | Not significant for equivalence |
| Electrode compliance with 21 CFR 898 | Yes | Not specified | Not significant for equivalence, implied predicate also compliant or was at time of clearance. |
| Electrode cable | Yes | Yes | Equivalent |
The submission concludes that "The differences that exist between the devices are insignificant in the terms of safety or effectiveness." and "Performance testing has been performed that shows equivalent waveform characteristics."
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a 510(k) submission for a TENS device, not an AI/ML imaging or diagnostic device. There is no "test set" in the context of an algorithm's performance on clinical data. The "performance testing" mentioned refers to electrical characteristic measurements to demonstrate waveform equivalence. No patient data or clinical study data is presented for this purpose.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, there is no "test set" or ground truth based on expert review for this type of device submission.
4. Adjudication method for the test set
- Not Applicable.
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 is not an AI/ML device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device. The device is a physical TENS unit. "Performance testing" mentioned refers to engineering tests of its electrical outputs.
7. The type of ground truth used
- Not Applicable. The "ground truth" for a TENS device revolves around its electrical specifications meeting safety standards (e.g., IEC 60601-1, IEC 60601-1-2) and providing waveforms that are functionally equivalent to predicate devices for pain relief. The document states:
- "Performance testing has been performed that shows equivalent waveform characteristics."
- "The device has been tested to and meets the requirements of the following recognized consensus standards: IEC 60601-1... IEC 60601-1-2..."
- "The patient contacting materials of the electrode has been tested in accordance to ISO 10993-1 and FDA Guidance."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable.
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Omron OTC TENS
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 1 of 6 7-Jan-11
| Omron Healthcare, Inc.1200 Lakeside Dr.Bannockburn, IL 60015 | Tel - 847-247-5626 |
|---|---|
| Fax - 847-680-6911 | |
| Official Contact: | Mirna DiPano - Director of Quality & Regulatory |
| Proprietary or Trade Name: | PM3030 |
| Common/Usual Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous, over-the-counter21 CFR 882.5890 |
| Device: | PM3030 |
| Predicate Devices: | Endurance Therapeutics, Model T1040, 510(k) K060846 |
Device Description:
The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use.
The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The specifications of each mode will be discussed in greater detail later in this section.
The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part.
As above the device is battery powered there is no connection to AC mains supply.
The device has been tested to and meets the requirements of the following recognized consensus standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
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Omron OTC TENS
510(k) Summary Page 2 of 6 7-Jan-11
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic:Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
Indications for 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 exercise or normal household and work activities.
Environment of Use: Clinics, hospital and home environments
Contraindications:
- Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.
- · Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.
- · Do not use this device together with a body-worn medical electronic device such as an ECG.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
Omron OTC TENS
510(k) Summary Page 3 of 6 7-Jan-11
Summary of substantial equivalence
| Attribute | Model PM3030 | Predicate |
|---|---|---|
| Endurance Model T1040 | ||
| K060846 | ||
| Product Code | NUH | NUH, NGX, GZX |
| CFR | 882.5890 | 882.5890, 890.5850 |
| Indications for Use | This device is intendedfor the relief of painassociated with sore oraching muscles of thelower back, arms, or legsdue to strain fromexercise or normalhousehold and workactivities. | To be used for temporary relief ofpain associated with sore and achingmuscles in thelower back due to strain fromexercise or normal household workactivities chooseManual modes 1, 2, 3, 4, 5, 6 orAuto 4To be used for temporary relief ofpain associated with sore and achingmuscles in theupper extremities (arm) due to strainfrom exercise or normal householdwork activitieschoose Manual modes 1, 2, 3, 4, 5,6 or Auto 1 or Auto 3To be used for temporary relief ofpain associated with sore and achingmuscles in thelower extremities (leg) due to strainfrom exercise or normal householdwork activitieschoose Manual modes 1, 2, 6 orAutol or Auto 4Used to stimulate healthy musclesin order to improve and facilitatemuscleperformance choose Manual Mode1 or Auto Mode 2Prescription |
| Patient Population | Adult | Not specified |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Not specified |
| Contraindications - do not use if you have a cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device | Yes | Yes |
| Warnings standard | Yes | Yes |
| Precautions - standard | Yes | Yes |
| Adverse reactions - standard | Yes | Yes |
| Power source | 2 - AAA | 3 - AAA |
| Number of Output modes | 3 | 10 |
| Number of output channels | 1 | 1 |
| Waveform | Biphasic | |
| Shape | Rectangular | |
| Maximum Output Voltage (max) | ||
| 500 ohm | 35.4 V | 40.7 |
| 2k ohm | 46.7 V | 105.1 |
| 10k ohm | 50.8 V | 154.1 |
| Maximum Output Current (max) | ||
| 500 ohm | 4.4 mA | 81.4 |
| 2k ohm | 1.7 mA | 47.8 |
| 10k ohm | 0.4 mA | 15.4 |
| Maximum Phase charge (500 ohm) | 133 microC | 16.9 microC |
| Maximum Current Density (500 ohm) | 0.095 mA/cm² | 2.71 mA/cm² |
| Maximum Average Current (500 ohm) | 3.5 mA | Not specified |
| Maximum Average Power Density (500 ohm) | 89 mW/cm² | 10.2 mW/cm² |
| Frequency (Hz) | < 100 Hz | 245 Hz |
| Burst Mode | None | |
| Timer range (min) | 15 minutes | 30 minutes |
| Indication display | ||
| On/Off status | Yes | Yes |
| Low battery | No | Yes |
| Voltage / Current level | Yes | Yes |
| Output mode | Yes | Yes |
| Time to cut-off | No | Yes |
| Dimensions | 55 mm x 95 mm x 19 mm | 150 mm x 68 mm x 26 mm |
| Weight | 60 grams | 90 grams |
.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
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Omron OTC TENS
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510(k) Summary
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Omron OTC TENS
510(k) Summary Page 5 of 6 7-Jan-11
| Housing material | ABS | Not specified |
|---|---|---|
| Microprocessor control | Yes | Yes |
| Automatic Overload trip | Yes | Not specified |
| Automatic no-load trip | Yes | Not specified |
| Automatic shut-off | Yes | Not specified |
| User override control | Power On/Off button | Not specified |
| Electrode compliance with 21 CFR 898 | Yes | Not specified |
| Electrode cable | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
The Omron PM3030 OTC TENSis viewed as substantially equivalent to the predicate device because: The electrical stimulation provided by the PM3030 is substantially equivalent to that commonly employed by TENS devices that have been cleared for marketing without prescription labeling; i.e., for OTC sale. The pulses in the waveform combinations are restricted in amplitude and duration to values consistent with other cleared devices.
Technological characteristics, features, specifications, materials and intended uses of the PM3030 are substantially equivalent to the quoted predicate devices.
The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Indications -
The PM3030 and the predicate (Endurance Model T1040 K060846) are for the temporary relief of pain associated with sore and aching muscles in the upper and lower extremities and lower back due to strain from exercise or normal household and work activities and we view them as equivalent. Performance testing has been performed that shows equivalent waveform characteristics.
Technology -
- Identical both the PM3030 and the predicate provide electrically generated pulses . applied to the skin via electrodes.
Operating specifications -
- Equivalent. Section 12 provides detailed descriptions of the characteristics of the . PM3030 and the predicate. They are equivalent.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
Omron OTC TENS
510(k) Summary. Page 6 of 6 7-Jan-11
Materials –
-
The patient contacting materials of the electrode has been tested in accordance to . ISO 10993-1 and FDA Guidance.
Environment of Use - -
Both are OTC devices so assume same environment .
Patient Population -
- . PM3030 is restricted to adults
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC = 8 2011
Omron Healthcare, Inc. c/o Mr. Paul E. Dryden President, Regulatory Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134-2958
Re: K110068
Trade/Device Name: Model PM3030 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: October 25, 2011 Received: October 26, 2011
Dear Mr. Dryden:
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. 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.
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Page 2 - Mr. Paul E. Dryden
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.
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/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 Small Manufacturers, International and Consumer Assistance 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.
on
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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 Statement
Page 1 of 1
510(k) Number:
(To be assigned)
Device Name:
Model PM3030
Indications for 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 exercise or normal household and work activities.
Prescription Use (Part 21 CFR 801 Subpart D) or
Over-the-counter use XX (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mussla L. Burke Nicholas
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110068
§ 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).