(157 days)
This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation. Environments of Use: Clinics, hospital and home environments Patient Population: Adult
The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11. The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics. 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 nor connection to any other device.
The provided text describes the 510(k) summary for the Omron Healthcare Maxpower Relief Model PM3032B. This is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief. The submission aims to demonstrate substantial equivalence to predicate devices, K141978 (Omron MaxPower Relief) and K172079 (Omron Avail), to expand its indications for use.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for device performance. Instead, it demonstrates substantial equivalence by comparing various features of the new device to two predicate devices. The "performance" is generally described as "identical" or "equivalent" to the predicates, and compliance with recognized standards.
| Feature/Criterion | New Device (Omron Healthcare Maxpower Relief Model PM3032B) Performance | Comment (Relative to Predicates) |
|---|---|---|
| Indications for Use | Relief of pain associated with sore or aching muscles of lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. Added: Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Shoulder mode). | Identical to primary predicate (K141978) for initial indications. Similar to secondary predicate (K172079) for expanded indications. |
| Environments of Use | Clinics, hospital, and home environments | Identical |
| Patient Population | Adult | Identical |
| Regulation Number | 21 CFR §882.5890 | Identical |
| Product Codes | Primary: NUH (stimulator, nerve, transcutaneous, over-the-counter) Secondary: NYN (stimulator, electrical, transcutaneous, for arthritis) | Shares NUH with primary predicate, shares NUH and NYN with secondary predicate. |
| Prescriptive | No, OTC | Identical |
| Contraindications | Identical to predicates (cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device) | Identical |
| Single Use (Pads) | Pads are for single patient use | Identical to primary predicate. |
| Sterility | External contacting device, nonsterile | Identical |
| Power Source | Two AAA alkaline batteries | Identical to primary predicate. |
| Line Current Isolation | N.A. (internal power source) | Identical |
| Patient Leakage Current - Normal Condition | 1 µA | Identical to primary predicate (vs. <10µA for secondary). |
| Patient Leakage Current - Single Fault Condition | 8.9 max µA | Identical to primary predicate (vs. <50µA for secondary). |
| Average DC current through electrodes (no pulse) | 0 µA | Identical |
| Number of Output Modes | 9 TENS modes | Identical to primary predicate (vs. 9 TENS + 1 Microcurrent for secondary). |
| Number of Output Channels | 1 Ch (Synchronous or Alternating) | Identical |
| Method of Channel Isolation | None | Identical |
| Regulated Current/Voltage | Regulated Current | Identical |
| Software/Firmware/Microprocessor Control | Microprocessor | Identical |
| Automatic Overload Trip | No | Identical |
| Automatic No-Load Trip | Yes | Identical |
| Automatic Shut Off | Yes | Identical |
| User Override Control | Yes, Power On/Off button | Identical to primary predicate. |
| Indication Display | ON/Off status, Low Battery, Voltage/Current Level | Identical to primary predicate (secondary predicate had App display). |
| Timer Range (minutes) | 15 minutes | Identical to primary predicate (vs. 5-60 and 30-180 for secondary). |
| Compliance with Voluntary Standards | ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | Identical |
| Compliance with 21 CFR 898 | Yes | Identical to primary predicate (secondary N/A). |
| Weight | Approx. 100g (incl. batteries) | Identical to primary predicate. |
| Dimensions (W x H x D) | 52 x 112 x 25mm | Identical to primary predicate. |
| Operating Conditions | 10 to 40 °C, 30 to 80 %RH, 700 to 1060 hPa (non-condensing) | Similar to primary predicate, same as secondary. |
| Charging Conditions | N/A (Battery-operated) | Identical to primary predicate. |
| Transporting Conditions | -20 to 60 °C, 10 to 95% RH, 700 to 1060 hPa (non-condensing) | Identical to primary predicate. |
| Electrode Style | Long Life Pad, Reusable | Identical to primary predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was performed" (Page 11). Therefore, there is no test set sample size or data provenance to report. The evaluation relies heavily on bench testing and comparison to predicate devices, which had already established their safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was performed, there was no ground truth requiring expert establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing or test set was used for this device.
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 Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm, but a physical TENS unit. Its performance relies on its electrical stimulation capabilities, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No specific ground truth (expert consensus, pathology, outcomes data) was generated for this application as no new clinical studies were conducted. The "ground truth" for demonstrating substantial equivalence is based on the previously established safety and effectiveness of the predicate devices and the physical/electrical conformity of the new device to those predicates and relevant electrical safety standards.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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January 10, 2019
Omron Healthcare, Inc. % Paul Dryden Consultant Omron Healthcare, Inc. c/o ProMedic, LLC. 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K182120
Trade/Device Name: Omron Healthcare Maxpower Relief Model PM3032B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: October 11, 2018 Received: October 12, 2018
Dear Paul 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott -S
Carlos L. Peña, PhD, MS 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) K182120
Device Name
Omron Healthcare Maxpower Relief Model PM3032B
Indications for Use (Describe)
This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.
Environments of Use: Clinics, hospital and home environments Patient Population: Adult
| 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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510(k) Summary Page 1 of 10 1/7/2019
| Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA | Tel - 847-247-5626 |
|---|---|
| Fax- 847-680-6269 | |
| Official Contact: | Renee Thornborough – Executive Director QA/RA |
| Proprietary or Trade Name: | Omron Healthcare Maxpower Relief Model PM3032B |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Classification Name/Code:21CFR 882.5890 | NUH - stimulator, nerve, transcutaneous, over-the-counterNYN - stimulator, electrical, transcutaneous, for arthritisClass II |
| Device Name: | Omron Healthcare Maxpower Relief Model PM30321 |
| Predicate Devices: | K141978 - Omron - PM3032K172079 – Omron - Avail |
Device Description:
The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11.
The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The specifications of each mode will be discussed in greater detail later in this section.
The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics.
This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.
The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. These are identical to the accessories cleared in K141978.
As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.
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510(k) Summary Page 2 of 10 1/7/2019
This submission is for expanding the indications for use to include indications associated with product code NYN. The device is identical to the Maxpower Relief (Model PM3032) cleared under K141978 except the CPU and related components are changed for cost saving purpose. UDI has also added on the main unit and the packaging. There are no other changes (appearance, dimension, materials, waveforms, modes). The accessories are identical to the Maxpower Relief (Model PM3032) cleared under K141978
We have provided the information suggested in Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use from April 5, 2010. A checklist in accordance with this guidance can be found in Section 2 of this submission
Intended User OTC
Patient Population
Adults
Indications for Use:
This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.
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.
Predicate Device Comparison:
Table 1 outlines the features of the Omron Healthcare Maxpower Relief Model PM3032B and compares it to the predicates that are being used to establish substantial equivalence.
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510(k) Summary
Device Comparison
| New Device | Primary Predicate | Secondary Predicate | Comment | ||
|---|---|---|---|---|---|
| Feature | Omron HealthcareMaxpower Relief Model | DevicePM3032 | DeviceOmron Avail | ||
| PM3032B | (MaxPower relief) | K172079 | |||
| K141978 | |||||
| Indications for use | This device is intended for therelief of pain associated withsore or aching, muscles of thelower back, arms, legs,shoulder, or foot due to strainfrom exercise or normalhousehold work activities.When used for thesymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis,use the Shoulder mode ofstimulation.Environments of Use: Clinics,hospital and homeenvironmentsPatient Population: Adult | This device is intendedfor the relief of painassociated with sore oraching, muscles of thelower back, arms, legs,shoulder, or foot due tostrain from exercise ornormal household workactivities.Environments of Use:Clinics, hospital andhome environmentsPatient Population: Adult | The Avail is intended forthe relief of painassociated with sore oraching muscles of thelower back, arms, legs,shoulders or feet due tostrain from exercise ornormal household workactivities.When used for thesymptomatic relief andmanagement of chronic,intractable pain and reliefof pain associated witharthritis, use the Tap,Shoulder, Arm or Legmode of stimulation.Environments of Use:Clinics, hospital andhome environmentsPatient Population: Adult | Identical toMaxpower Relieffor temporaryrelief of pain withsore and achingmuscles.Similar to Availwith respect tosymptomatic reliefand managementof chronic,intractable pain,and relief of painassociated witharthritis. | |
| Environments of Use: | Clinics, hospitals and homeenvironments | Clinics, hospitals andhome environments | Clinics, hospitals andhome environments | Identical | |
| Patient Population | Adult | Adult | Adult | Identical | |
| Classification - Regulation | 21 CFR §882.5890,Transcutaneous electrical | 21 CFR §882.5890,Transcutaneous electrical | 21 CFR §882.5890,Transcutaneous electrical | Identical | |
| Feature | New DeviceOmron HealthcareMaxpower Relief ModelPM3032B | Primary PredicateDevicePM3032(MaxPower relief)K141978 | Secondary PredicateDeviceOmron AvailK172079 | Comment | |
| nerve stimulator for painrelief | nerve stimulator for painrelief | nerve stimulator for painrelief | |||
| Classification - Product Code | Primary: NUH - stimulator,nerve, transcutaneous, over-the-counterSecondary: NYN - stimulator,electrical, transcutaneous, forarthritis. | NUH - stimulator, nerve,transcutaneous, over-the-counter | Primary: NUH -stimulator, nerve,transcutaneous, over-the-counterSecondary: NYN -stimulator, electrical,transcutaneous, forarthritis. | Proposed deviceand secondarypredicate devicehave the samemedical deviceproduct code. | |
| Prescriptive | No, OTC | No, OTC | No, OTC | Identical | |
| Contraindications/Warning/Precautions | ContraindicationsDo not use this device if youhave a cardiac pacemaker,implanted defibrillator, orother implanted metallic orelectronic device. Such usecould cause electric shock,burns, electrical interference,or death. | ContraindicationsDo not use this device ifyou have a cardiacpacemaker, implanteddefibrillator, or otherimplanted metallic orelectronic device. Suchuse could cause electricshock, burns, electricalinterference, or death. | ContraindicationsDo not use this device ifyou have a cardiacpacemaker, implanteddefibrillator, orotherimplanted metallicor electronic device. Suchuse could cause electricshock, burns, electricalinterference, or death. | Identical | |
| Single Use | Pads are for single patient use | Pads are for single patientuse | Patient-contacting Padsare for single patient use | Identical toMaxPower Relief | |
| Sterility | External contacting device,nonsterile | External contactingdevice, nonsterile | External contactingdevice, nonsterile | Identical | |
| Over-the-Counter (OTC) | Yes | Yes | Yes | Identical | |
| 1/7/2019 | |||||
| Feature | New DeviceOmron HealthcareMaxpower Relief ModelPM3032B | Primary PredicateDevicePM3032(MaxPower relief)K141978 | Secondary PredicateDeviceOmron AvailK172079 | Comment | |
| Power Source(s) | Two AAA alkaline batteries | Two AAA alkalinebatteries | Rechargeable lithium Ionbattery | Identical toMaxpower Relief | |
| - Method of Line Current Isolation | N.A.(internal power source) | N.A.(internal powersource) | N.A.(internal powersource) | Identical | |
| Patient Leakage Current - NormalCondition (uA) | 1 | 1 | <10uA | Identical toMaxpower Relief | |
| Patient Leakage Current - Single FaultCondition (uA) | 8.9 max | 8.9 max | <50uA | Identical toMaxpower Relief | |
| Average DC current through electrodeswhen device is on but no pulse arebeing applied (uA) | 0 (uA) | 0 (uA) | 0 (uA) | Identical | |
| Number of output Modes | 9 TENS modes | Same | 9 TENS modes1 Microcurrent mode | Identical toMaxpower Relief | |
| Number of outputchannels | Synchronous orAlternating | 1 ch | 1 ch | 1 ch | Identical |
| Method of ChannelIsolation | None | None | None | Identical | |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Regulated Current | Identical | |
| Software/Firmware/MicroprocessorControl | Microprocessor | Microprocessor | Microprocessor | Identical | |
| Automatic Overload Trip | No | No | No | Identical | |
| Automatic No-Load Trip | Yes | Yes | Yes | Identical | |
| Automatic shut Off | Yes | Yes | Yes | Identical | |
| Feature | New DeviceOmron HealthcareMaxpower Relief ModelPM3032B1/7/2019 | Primary PredicateDevicePM3032(MaxPower relief)K141978 | Secondary PredicateDeviceOmron AvailK172079 | Comment | |
| User over ride control | Yes, Power On/Off button | Yes, Power On/Offbutton | Yes, Power On/Offbutton on the device andin the App software | Identical toMaxpower Relief | |
| Indication display | ON/Off status | Yes | Yes on App and LEDindicator on main unit | Identical toMaxpower Relief | |
| Low Battery | Yes | Yes on App | Identical toMaxpower Relief | ||
| Voltage/CurrentLevel | Yes | Yes on App | Identical toMaxpower Relief | ||
| Timer Range (minutes) | 15 (minutes) | 15 (minutes) | 5-60 (minutes) and30-180 (minutes) | Identical toMaxpower Relief | |
| Compliance with Voluntary standards | ES60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11 | ES60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11 | ES60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11 | Identical | |
| Compliance with 21 CFR 898 | Yes | Yes | N/A (no patient cable) | Identical toMaxpower Relief | |
| Weight | Approx. 100g (incl. batteries) | Approx. 100g (incl.batteries | Device: Approx. 42 g(Both units have sameweight)Pad-L: Approx. 21 gPad-M: Approx. 17.5gCharger: Approx. 100g | Identical toMaxpower Relief | |
| Dimensions (W x H x D) | 52 x 112 x 25mm | 52 x 112 x 25mm | Device: Approx. 60 × 72× 15.5mm (Both unitshave samedimensions)Charger: Approx. 158 x90 x 20.5mmPad-L: Approx. 219 ×83.5 x 9.3mm | Identical toMaxpower Relief | |
| 1/7/2019 | |||||
| New Device | Primary Predicate | Secondary Predicate | Comment | ||
| Feature | Omron HealthcareMaxpower Relief ModelPM3032B | DevicePM3032(MaxPower relief)K141978 | DeviceOmron AvailK172079 | ||
| Operating conditions | 10 to 40 °C30 to 80 %RH700 to 1060 hPa (non-condensing) | 10 to 40 °C30 to 80 %RH | 10 to 40 °C30 to 80 %RH700 to 1060 hPa (non-condensing) | Similar toMaxpower Reliefand same as Avail | |
| Charging conditions | N/A (Battery-operated) | N/A (Battery-operated) | 7 to 35 °C (non-condensing) | Identical toMaxpower Relief | |
| Transporting conditions | -20 to 60 °C10 to 95% RH,700 to 1060 hPa (non-condensing) | -20 to 60 °C10 to 95% RH,700 to 1060 hPa (non-condensing) | -20 to 60 °C10 to 90% RH,700 to 1060 hPa (non-condensing) | Identical toMaxpower Relief | |
| Electrode style | Long Life PadReusable | Long Life PadReusable | HV-WPAD-M or HV-WPAD-L reusable | Identical toMaxpower Relief |
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510(k) Summary Page 8 of 10 1/7/2019
In Table 1 we have compared the Omron Healthcare Maxpower Relief Model PM3032B to the predicates for equivalence of:
Indications -
The indications for the Omron Healthcare Maxpower Relief Model PM3032B for the indications related to ProCode - NUH are identical to the predicate PM3032 (K141978). The added indications of "When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation." is similar to the predicate Avail (K172079) which also includes the ProCode - NYN.
Discussion - These indications are substantially equivalent to the predicates.
Prescriptive -
The Omron Healthcare Maxpower Relief Model PM3032B and predicates are all OTC.
Design, Technology and Principle of Operation -
The Omron Healthcare Maxpower Relief Model PM3032B is identical to the Maxpower Relief (K141978) as well as it has the equivalent design and features when compared to the Omron Avail (K172079).
Performance and Specifications -
The Omron Healthcare Maxpower Relief Model PM3032B is identical to the Maxpower Relief (K141978) and has equivalent performance specifications when compared to the Omron Avail (K172079).
Compliance with standards -
The Omron Healthcare Maxpower Relief Model PM3032B and predicate devices declare compliance with standards: AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11 for home settings.
Materials -
The patient contacting materials (the LongLife Pads) of the PM3032B and predicate Maxpower Relief (K141978) are identical.
Patient Population -
The Omron Healthcare Maxpower Relief Model PM3032B and predicates are indicated for adults
Environment of Use -
Clinics, hospital and home environments, identical to the predicates
Differences -
There are no differences between the proposed device and the predicate devices that raise safety and efficacy concerns.
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510(k) Summary Page 9 of 10 1/7/2019
Non-Clinical Testing Summary -
Bench testing
The device has been tested to ensure that it all requirements have been met, this includes:
- . Testing of all controls
- Testing of all indicators ●
- Testing of battery state indicators ●
- . Testing of waveforms
The device has also been tested to the requirements of the following standards:
- AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: ● general requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical Electrical Equipment Part 1-2: General Requirements for ● Safety - Collateral standard: Electromagnetic Disturbances - Requirements and Tests
- . IEC 60601-1-11: 2015, medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-2-10: 2016 Medical electrical equipment - part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The device has also been tested for drop, vibration and environmental temperature and humidity in accordance with IEC 60601-1-11
Clinical Testing Summary -
No clinical testing was performed
Usability -
Usability testing has not been performed on the PM3032B as it is identical to the predicate device Maxpower Relief (K141978)
This submission is for expanded indications as discussed in Sections 5 and 11, the expanded indications do not impact use of the device,
Biocompatibility of Patient Contacting Materials -
In accordance with ISO 10993-1 this is a surface device, skin (un-breached, not compromised), limited duration (<24 hours)
The patient contacting materials of the Omron Healthcare Maxpower Relief Model PM3032B and predicate Maxpower Relief (K141978) are identical.
Differences -
There are no differences between the proposed device and the predicate devices that raise any new safety and efficacy concerns. The results demonstrate that the devices perform as intended
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510(k) Summary Page 10 of 10 1/7/2019
are substantially equivalent to the performance of the predicate and in accordance with applicable standards.
Substantial Equivalence Conclusion
The Omron Healthcare Maxpower Relief Model PM3032B is substantially equivalent to the predicates in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise new or different questions of safety and effectiveness.
§ 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).