(158 days)
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Double or single channel that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operations.
The provided document is a 510(k) summary for the HealthmateForever TENS and Powered Muscle Stimulator device. It describes the device, its intended use, and its substantial equivalence to a predicate device (JQ-5C).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in terms of specific performance metrics that need to be met for the device to be considered safe and effective in a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of various electrical output parameters.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (HealthmateForever Models) | Predicate Device (JQ-5C) Performance |
|---|---|---|
| Electrical Output Parameters within Safe & Effective Range Compared to Predicate | ||
| Max Voltage over 10kΩ, V | 100 | 84 |
| Max. Current over 10kΩ, mA | 10 | 8.4 |
| Max. Voltage over 2.2KΩ, V | 90 | 79.2 |
| Max. Current over 2.2KΩ, mA | 45 | 39.6 |
| Max. Voltage over 500Ω, V | 70 | 62.4 |
| Max. Current over 500Ω, mA | 140 | 124.8 |
| Pulse Width, µseconds | 90 | 100 |
| Pulse period, msec | 10-836 | 16.3-781 |
| Max. Pulse Frequency, Hz | 100 | 61.3 |
| Max Charge per Phase over 500Ω, µC | 15.66 | 17.92 |
| Max Current Density over 500Ω, mA/cm2 (Various Modes) | See table in Section 7 | 9.92 |
| Max. Average Power Density over 500Ω, mW cm2 (Various Modes) | See table in Section 7 | 2.72 |
| Max Current Density over 500Ω, mA/cm2 (Various Modes) | See table in Section 7 | 9.92 |
| Max. Average Power Density over 500Ω, mW cm2 (Various Modes) | See table in Section 7 | 2.72 |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10 | (Implied for predicate to be cleared) |
| Software Verification | Carried out according to FDA Guidance | (Not specified for predicate) |
| No new safety or effectiveness issues | "The differences that exist between the devices are insignificant in the terms of safety or effectiveness." | (Implied for predicate to be cleared) |
| No adverse events reported | Over 100,000 units sold since 2007 in Europe and Asia with no adverse effects reported. | (Not specified for predicate) |
| Improved muscle performance and temporary pain reduction | Supported by "customer reviews" | (Implied for predicate effectiveness) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a traditional clinical study with a "test set" of patients or data to evaluate effectiveness. The primary basis for equivalence is non-clinical testing and comparison of technical specifications to a predicate device.
- Sample Size for Test Set: Not applicable for a traditional clinical study as presented.
- Data Provenance: The document mentions "over 100,000 units sold without a prescription in Europe and Asia" since 2007 with no adverse events reported. This suggests retrospective market surveillance data for safety. The "customer reviews" for effectiveness are not quantifiable in terms of sample size or provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth establishment for effectiveness or diagnosis is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
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 TENS and PMS device, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical electrotherapy device; it does not involve algorithms for interpretation or without-human-in-the-loop performance measurement in the context of AI. The "software verification" mentioned is for the device's internal control software, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For safety, the "ground truth" relies on the absence of reported adverse events from extensive market use in Europe and Asia (outcomes/real-world data).
For effectiveness, the claim is supported by "customer reviews," which are anecdotal and not considered a rigorous form of ground truth in clinical studies. The primary justification for effectiveness is via substantial equivalence to a predicate device, meaning the predicate's established effectiveness serves as the basis.
8. The Sample Size for the Training Set
Not applicable. No training set for an AI/machine learning model is mentioned or described.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/machine learning model is mentioned or described.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented here is a 510(k) Premarket Notification which aims to demonstrate substantial equivalence to a previously cleared predicate device (JQ-5C). This is a regulatory pathway that largely relies on comparing the new device's technological characteristics, intended use, and safety profile to a legally marketed device, rather than conducting new, extensive clinical trials for effectiveness in many cases.
The evidence for meeting acceptance criteria (which are primarily implied by the substantial equivalence framework) includes:
- Comparison of Technical Specifications: A detailed table (Section 7) is provided comparing various electrical output parameters (voltage, current, pulse width, frequency, charge per phase, current density, power density) of the new HealthmateForever models to the predicate device (JQ-5C). The submission states that the differences are "insignificant in the terms of safety or effectiveness."
- Compliance with Voluntary Standards: The device underwent non-clinical tests to comply with several IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10).
- Software Verification: Software verification was performed adhering to FDA guidance.
- Real-world Safety Data (Retrospective Market Surveillance): For safety, the submission highlights the sale of "over 100,000 units" in Europe and Asia since 2007 with "no adverse effects reported." This serves as a retrospective, large-scale safety assessment.
- Customer Reviews (Effectiveness Support): For effectiveness, the submission briefly mentions "customer reviews" demonstrating improved muscle performance and temporary pain reduction. This is a weak form of evidence and is secondary to the substantial equivalence claim, which assumes effectiveness based on the predicate.
- Intended Use Alignment: The intended uses for both TENS and PMS functions are identical to those of the predicate device.
In essence, the "study" is a systematic comparison to a predicate device combined with non-clinical bench testing for safety standards and retrospective real-world safety data, rather than a prospective clinical trial with a defined test set and ground truth established by experts.
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HealthmateForever ® Healthmate International, LLC
709 E 97th St. , Kansas City MO 64131 Tel: 816 248 1318
Section 5 510(k) Summary
1. Submitter's Identifications
Submission type: abbreviated Basis for submission: New device Submitter's Name: Healthmate International, LLC Address: 709 East 97th Street, Kansas City MO 64131 Contact Person: Mei Dodson Contact Email: maykc816@yahoo.com Tel: 816 248 1318 Prepared date: 9/28/2012
2. Correspondent's Identifications
Correspondent's Name: Healthmate International, LLC Address: 709 East 97th Street, Kansas City MO 64131 Contact Person: Mei Dodson Contact Email: maykc816@yahoo.com Tel: 816 248 1318
3. Name of the Device
Device Classification Name: Stimulator, Muscle, Powered, Over-the-Counter Device Name: TENS and Powered Muscle Stimulator Models: Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L, iTone Trade Name: HealthmateForever ® Regulation Number: 21 CFR 882.5890 OTC & 21 CFR 882.5850. Product Code: NUH & NGX Device Classification: Class II
4. The Predicate Device
| K102598 | JQ-5C | TENS | 21 CFR 882.5890 OTC |
|---|---|---|---|
| K102598 | JQ-5C | PMS | 21 CFR 882.5850 OTC |
5. Device Description
Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.
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Double or single channel that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operations. The electrodes that we choose to use with the devices, and that any technical characteristics that are
NOV 2 . 0 2012
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HealthmateForever ® Healthmate International, LLC 709 E 97th St., Kansas City MO 64131 Tel: 816 248 1318
dependent on the chosen electrodes are consistent with the electrodes that we choose to use with the devices.
6. Intended Use of Device
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The intended use is the same as the predicate device.
7. Summary of Substantial Equivalence
Table: The difference between a series of new devices and Predicate JQ-5C.
| Quantity | Pro-8AB, Pro-8IS, Plus-6AB,Plus-6IS, TCM-6L, iTone | JQ-5C |
|---|---|---|
| Max Voltage over 10kΩ, V | 100 | 84 |
| Max. Current over 10kΩ, mA | 10 | 8.4 |
| Max. Voltage over 2.2KΩ, V | 90 | 79.2 |
| Max. Current over 2.2KΩ, mA | 45 | 39.6 |
| Max. Voltage over 500,V | 70 | 62.4 |
| Max. Current over 500, mA | 140 | 124.8 |
| Pulse Width, useconds | 90 | 100 |
| Pulse period, msec | 10-836 | 16.3-781 |
| Max. Pulse Frequency, Hz | 100 | 61.3 |
| Max Charge per Phase over 500Ω, µC | 15.66 | 17.92 |
| Max Current Density over 500Ω, mA/cm2 | M1: 6.48@500ΩM2: 5.6@500ΩM3: 7.2@500ΩM4: 5.6@500ΩM5: 5.6@500ΩM6: 7.2@500Ω5.6@500Ω6.48@500ΩM7: 5.76@500ΩM8: 6.48@500Ω5.6@500Ω7.2@500Ω | 9.92 |
| 5.6@500Ω | ||
| 5.6@500Ω | ||
| Max. Average Power Density over 500Ω,mW cm2 | M1: 0.52@500ΩM2: 0.39@500ΩM3: 0.65@500ΩM4: 0.39@500ΩM5: 0.39@500ΩM6: 0.65@500Ω0.39@500Ω0.52@500ΩM7: 0.41@500ΩM8: 0.52@500Ω0.39@500Ω0.65@500Ω0.39@500Ω0.39@500Ω | 2.72 |
| Max Current Density over 500Ω, mA/cm2 | M1: 3.6@500ΩM2: 3.1@500ΩM3: 4@500ΩM4: 3.1@500ΩM5: 3.1@500ΩM6: 4@500Ω3.1@500Ω3.6@500ΩM7: 3.2@500ΩM8: 3.6@500Ω3.1@500Ω4@500Ω3.1@500Ω3.1@500Ω | 9.92 |
| Max. Average Power Density over 500Ω,mWcm2 | M1: 0.29@500ΩM2: 0.22@500ΩM3: 0.36@500ΩM4: 0.22@500ΩM5: 0.22@500ΩM6: 0.36@500Ω0.22@500Ω0.29@500ΩM7: 0.23@500ΩM8: 0.29@500Ω0.22@500Ω0.36@500Ω0.22@500Ω0.22@500Ω | 2.72 |
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HealthmateForever ® Healthmate International, LLC 709 E 97th St., Kansas City MO 64131 Tel: 816 248 1318
8. Substantial Equivalence
The electrical stimulation provided by a series of model Pro-8AB, Pro-81S, Plus-6AB, Plus-6IS, TCM-6L and iTcne are substantially equivalent to that commonly employed by muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling: i.e., for OTC sale. The pulses in the wave form combinations are restricted in amplitude and duration to values consistent with the other device quoted above.
Technological characteristics, features, specifications, materials and intended uses of the series of model Pro-8AB. Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone are substantially equivalent to the quoted predicate device.
The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Model Pro-8AB, Pro-8IS, Plus-6IS, TCM-6L and iTone modes that offer substantially equivalent technical specifications, features and effective results as the predicate tisted.
9. Non-Clinical Tests Performed
Compliance to applicable voluntary standards include: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5 and ISO 10993-10.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software in Medical Devices.
10. Conclusion:
The electrical stimulation provided by a series of model Pro-8AB. Pro-8IS, Plus-615, TCM-6L and iTone are similar to the commonly employed muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling.
These models have the same intended use and the similar technological characteristics as this OTC predicate. Moreover, verification and validation tests contained in this submission demonstrate that the differences in these models still maintain the same safety and effectiveness as that of the cleared
device.
In other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
Concerns of safe and proper use of electrodes and electrode pad placement have been fully addressed by making the use conscious of the proper placement of the electrodes and proper operations of the device through detail in the User's Instruction Manual.
We believe that there are no new safety or effectiveness issues concerning this device to be introduced.
The safety of the device, to be used for the proposed indications without medical prescriptions or supervision, is established by the fact that no adverse events have been reported since 2007 with over 100,000 units sold without a prescription in Europe and Asia.
Over 100,000 units sold with no adverse effects reported, proves its specific technical, safety measures and features are safe and effective when used without medical supervision.
The effectiveness of the device for the proposed indications is supported by a number of customer re
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views, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction.
Technological characteristics, features, specifications, materials and intended uses of the series of model Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone are substantially equivalent to the quoted predicate device.
The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Model Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone offer substantially equivalent technical specifications, features and effective results as the predicate listed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image contains the word "November" in a bold, sans-serif font. The word is positioned on a white background, and there is a black line above the word. The text is clear and legible.
November 21, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Healthmate International, LLC % Ms. Mei Dodson 709 E. 97th Street Kansas City, Missouri 64131
Re: K121757
Trade/Device Name: HealthmateForever Pro-8AB; Plus-6AB; Plus-6AB; Plus-6IS; TCM-6L; and iTone Models Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 9, 2012 Received: November 14, 2012
Dear Ms. Dodson:
This letter corrects our substantially equivalent letter of November 20, 2012.
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 (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.
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
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Page 2 - Ms. Mei Dodson
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.
Sincerely yours,
Kesia Y. Alexander
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Healthmate International, LLC HealthmateForever ®
Td: 816 248 1318 709 E 97ª St. , Kansan City MO 64131
Section 4 Indications for Use
510 (k) Number (if known): K121757 Device Name: TENS & PMS Models: Pro-8AB, Pro-81S, Plus-6AB, Plus-6IS, TCM-6L & Tone Indications for use:
TENS (Transcutaneous Electrical Nerve Stimulation)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulator)
It is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
Prescription Use (Part 2) CFR 801 Subpart D) ' AND/OR .
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANTOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J
(Division Sign-Off) Division of Neurological and Pl Medicine Devices S10(k) Number
§ 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).