(106 days)
No
The document describes a TENS and heat device with standard electrical stimulation and heating elements controlled by software. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes.
The device is intended for the relief and management of pain, which is a therapeutic purpose.
No
Explanation: The device is intended for pain relief and management, not for diagnosing medical conditions. It delivers electrical nerve stimulation and heat.
No
The device description clearly states it is a "small battery operated OTC device" that provides TENS and heat, and includes physical components like electrodes, an electrode cord, and an external power adaptor. While software controls are mentioned, the device is fundamentally a hardware device with integrated software.
Based on the provided text, the Omron Heat Pain Pro Model PM311B is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the relief and management of pain through transcutaneous electrical nerve stimulation (TENS) and superficial heat. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation and heat to the body surface. It does not mention any interaction with biological samples (like blood, urine, or tissue) which is characteristic of IVD devices.
- Lack of IVD Characteristics: The text does not mention any of the typical features of an IVD device, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Using reagents or assays.
The device is a therapeutic device used for pain relief, falling under the category of medical electrical equipment for nerve and muscle stimulation.
N/A
Intended Use / Indications for Use
The Omron Heat Pain Pro Model PM311B is intended for: The relief of pain associated with sore or aching, musices of the lower back, arm, 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 Tap, Shoulder, Arm or Leg mode of stimulation.
Product codes
NUH, NYN
Device Description
The Heat Pain Pro (PM311B) is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10. Stimulation from PM311B is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls and indicators. Software controls waveform characteristics. The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the PM311B. These are the identical accessories cleared under K160115 for the Model PM311.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, arms, legs, shoulder, or foot
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinics, hospital and home environments.
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
Non-Clinical Testing Summary:
Compliance with standards: The PM 311B and predicates comply with the same standards: AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11.
The device has been tested to ensure that 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 as part of IEC 60601-1-11.
Patient Contacting Materials: The patient contacting materials of the PM311B are the PM-GELs. The PM-GELs are exactly the same as cleared with the PM311( K160115).
Clinical Testing Summary: No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2018
Omron Healthcare, Inc. % Paul Dryden Consultant ProMedic, LLC. 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K181992
Trade/Device Name: Heat Pain Pro Model PM311B 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 9, 2018 Received: October 10, 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
1
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
for Carlos L. Peña, PhD, MS 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) K181992
Device Name Heat Pain Pro Model PM311B
Indications for Use (Describe)
The Omron Heat Pain Pro Model PM311B is intended for:
The relief of pain associated with sore or aching, musices of the lower back, arm, 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 Tap, Shoulder, Arm or Leg mode of stimulation.
Environment 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 | |
|---|---|
| Date: | November 8, 2018 |
| Sponsor: | |
| Omron Healthcare, Inc. | |
| 1925 West Field Court | |
| Lake Forest, IL 60045 USA | Tel - 847-247-5626 |
| Fax- 847-680-6269 | |
| Official Contact: | Renee Thornborough – Executive Director QA/RA |
| Proprietary or Trade Name: | Heat Pain Pro Model PM311B |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain relief |
| CFR / Code / Classification Name / Class: | 21CFR 882.5890 |
| NUH - stimulator, nerve, transcutaneous, over-the-counter | |
| NYN - stimulator, electrical, transcutaneous, for arthritis | |
| Class II | |
| Device Name: | Heat Pain Pro Model PM311B |
| Primary Predicate: | |
| Secondary Predicate: | K160115– Omron – Heat Pain Pro (Model PM311) |
| K172079- Omron - Avail (PM601) |
510/1-) C---------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Description:
The Heat Pain Pro (PM311B) is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion batterv. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
Stimulation from PM311B is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls and indicators. Software controls waveform characteristics.
The Omron Heat Pain Pro Model PM311B 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 Tap, Shoulder, Arm or Leg mode of stimulation.
The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the PM311B. These are the identical accessories cleared under K160115 for the Model PM311.
4
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The PM311B is identical to the PM311 cleared under 510(k) K160115, this submission is for expanded indications under product code NYN.
The PM311 and PM311B are considered - OTC devices.
Patient Population
Adults
Indications for Use:
The Omron Heat Pain Pro Model PM311B 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 Tap, Shoulder, Arm or Leg 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:
The PM311B is compared to the predicates in the device comparison table below.
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Device Comparison
| Feature | Proposed
Omron
PM311B | Primary Predicate
Omron
PM311
K160115 | Secondary Predicate
Omron
Avail
K172079 | Discussion of Differences | |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Indications for Use | The Omron Heat Pain Pro Model
PM311B 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
Tap, Shoulder, Arm or Leg mode
of stimulation. | The Omron Heat Pain Pro 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. | The Avail is intended for the
relief of pain associated with
sore or aching muscles of the
lower back, arms, legs,
shoulders or feet 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 Tap, Shoulder,
Arm or Leg mode of stimulation. | Indications between Omron
PM311B and predicate
PM311 are identical except
for the addition indication for
chronic, intractable pain and
relief of pain associated with
arthritis which is identical to
that of the Avail. | |
| Environments of Use: Clinics,
hospital and home environments
Patient Population: Adult | Environments of Use: Clinics,
hospital and home environments
Patient Population: Adult | Environments of Use: Clinics,
hospital and home environments
Patient Population: Adult | | | |
| Classification - Regulation | 21 CFR §882.5890,
Transcutaneous electrical nerve
stimulator for pain relief | 21 CFR §882.5890.
Transcutaneous electrical nerve
stimulator for pain relief | 21 CFR §882.5890,
Transcutaneous electrical nerve
stimulator for pain relief | Identical | |
| Classification - Product Code | Primary: NUH - Transcutaneous
electrical nerve stimulator for
pain relief
Secondary: NYN -
Transcutaneous
electrical nerve stimulator for
pain relief. | NUH - Transcutaneous
electrical nerve stimulator for pain
relief | Primary: NUH - Transcutaneous
electrical nerve stimulator for
pain relief
Secondary: NYN -
Transcutaneous
electrical nerve stimulator for
pain relief. | Proposed device adds product
code NYN | |
| Over-the-Counter (OTC) | Yes | Yes | Yes | Identical to predicate PM311
K160115 | |
| Feature | Proposed
Omron
PM311B | Primary Predicate
Omron
PM311
K160115 | Secondary Predicate
Omron
Avail
K172079 | Discussion of Differences | |
| Power Source(s) | External supply Lithium-ion
battery | External supply Lithium-ion
battery | Lithium-ion battery | Identical to predicate PM311
K160115 | |
| - Method of Line Current Isolation | N.A.(internal power source) | N.A.(internal power source) | N.A.(internal power source) | Identical to predicate PM311
K160115 | |
| - Patient Leakage Current | --- | --- | --- | --- | |
| - Normal Condition (uA) | 1 | 1 |