(301 days)
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.
Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.
The provided text describes a 510(k) summary for a medical device called "Quick Relax Pro," a transcutaneous electrical nerve stimulator (TENS) for pain relief.
However, the provided document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or analytical testing, especially not in the context of an AI/algorithm-based device as implied by the prompts' structured questions (e.g., ground truth, MRMC study, training sets).
This document focuses on:
- Device Identification and Classification: Name, applicant, contact, classification, product code, CFR reference.
- Predicate Device Comparison: Detailed comparison of the Quick Relax Pro to a legally marketed predicate device (HealthmateForever® Pro-8AB) in terms of intended use, technical characteristics (battery, isolation, output modes, waveform, software, functions), and specific parameters (voltage, current, pulse duration, frequency).
- Non-Clinical Testing: Mentions biocompatibility testing (ISO 10993-5, -10, -12), product safety testing (IEC 60601-1), and electromagnetic compatibility testing (IEC 60601-1-2). It states that the "results... were satisfactory, and serve to demonstrate the safety and effectiveness."
- Substantial Equivalence Argument: The core of the 510(k) submission, arguing that the Quick Relax Pro is substantially equivalent to the predicate device, emphasizing safety due to fewer features (no software, single mode).
- FDA Communication: The letter from the FDA stating their "substantial equivalence" determination and regulatory responsibilities.
Therefore, I cannot provide the requested information about acceptance criteria and specific performance study details for an AI/algorithm-based device because the document describes a hardware medical device (TENS unit) and its regulatory submission, not an AI or software algorithm that would involve the kind of performance studies, ground truth establishment, or training/test sets typically associated with AI/ML medical devices.
The acceptance criteria mentioned in the document are implicitly met by:
- Substantial Equivalence: The device is deemed safe and effective because its technological characteristics are substantially equivalent to a legally marketed predicate device.
- Compliance with Standards: Satisfactory results from non-clinical testing (biocompatibility, product safety, EMC) against established international standards (ISO, IEC).
There is no mention of:
- A table of acceptance criteria and reported device performance (in the context of AI/ML metrics like sensitivity, specificity, etc.)
- Sample sizes for test sets or data provenance (as no clinical performance study for an algorithm is described).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (pathology, outcomes data, etc.).
- Training set size or ground truth establishment for a training set.
The document's structure is typical for a 510(k) premarket notification for a Class II medical device, focusing on comparison to a predicate and non-clinical safety testing, rather than an AI/ML clinical validation study.
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K131956
Section 005 – 510(k) Summary
APR 2 4 2014
.
Applicant or Sponsor Information
| Name: | Healthcare Innovations, LLC |
|---|---|
| Address: | 12889 Coco Plum Lane |
| Naples, FL 34119-8530 | |
| Contact: | Dr. John Ricci |
| Phone: | (239) 593 - 9570 |
| Fax: | (239) 593 - 9570 |
| E-mail: | jriccirx@earthlink.net |
| Establishment Registration: | TBD |
| Date of Submission: | 23 June, 2013 |
Submission Correspondent (Preparer's) Information
| Name: | Shepard G. Bentley, RACPresident, Bentley Biomedical Consulting, LLCConsultant to Healthcare Innovations, LLC |
|---|---|
| Address: | 28241 Crown Valley ParkwaySuite 510(k)Laguna Niguel, CA 92677 |
| Device Information | |
| Device Common Name: | Transcutaneous electrical nerve stimulator for pain reliefintended for over the counter use |
| Device Trade Name: | Quick Relax Pro |
| Device Classification Name: | Stimulator, nerve, transcutaneous, over-the -counter |
(
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| Device Class: | Class II | |
|---|---|---|
| Product Code: | NUH | |
| CFR Reference: | 882.5890 | |
| Predicate Device | K121757 | HealthmateForever® |
Design and Use of the Device
Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.
Technological Characteristics Comparison
| Technical Characteristics | Quick Relax Pro | HealthmateForever® Pro-8AB |
|---|---|---|
| Intended Use | To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,neck, upper extremities (arm),and lower extremities (leg)due to strain from exercise ornormal household workactivities | To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,neck, upper extremities (arm),and lower extremities (leg)due to strain from exercise ornormal household workactivities |
| Battery Powered | 1.5V DC | 3.7V DC |
| Method of Line CurrentIsolation | Type BF | Type BF |
| Number of Output Modes | 1 | 8 |
| Waveform | Asymetrical Biphasic | Asymetrical Biphasic |
| Software | No | Yes |
| Functions | Single | Multiple |
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| Parameter | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(k) Number | K131956 | K121757 | |
| Device Name and Model | Quick Relax Pro | HealthmateForever | |
| Manufacturer | HealthcareInnovations, LLC | HealthmateInternational, LLC | |
| Power Source(s) | Battery, singleAA dry cell | Battery, single drycell | |
| -Method of Line Current Isolation | N/A | N/A | |
| -Patient Leakage Current | N/A | N/A | |
| -Normal Condition (μC) | N/A | N/A | |
| -Single Fault Condition (µC) | N/A | N/A | |
| Average DC current through electrodes when device ison but no pulses are being applied (µC) | N/A (pulsesalways appliedwhen on) | N/A (pulses alwaysapplied when on) | |
| Number of Output Modes | 1 | 2 | |
| Number of Output Channels | Synchronous orAlternating?Method ofChannelIsolation | N/A | N/A |
| Regulated Current or RegulatedVoltage? | N/A | N/A | |
| Software/Firmware/Microprocessor Control? | No | Yes | |
| Automatic Overload Trip? | No | No | |
| Automatic No-Load Trip? | No | No | |
| Automatic Shut Off? | No | No | |
| User Override Control? | No | Yes | |
| Indicator Display: | On/Off Status?Low Battery?Voltage/CurrentLevel? | YesNoYes | YesYesYes |
| Timer Range (minutes) | N/A | Yes | |
| Compliance with Voluntary Standards? | Yes | Yes | |
| Compliance with 21 CFR 898? | N/A | Presumed | |
| Weight (lbs., oz.) | 4.5 oz | 3.9 oz | |
| Dimensions (in) [W x H x D] | 8.75" x 2" x1.75" | 3.75" x 2" x .5" | |
| Housing Materials and Construction | Flame ret. ABS,stainless steel | Metal, LCD | |
| Parameter | Subject Device | Predicate Device | |
| Mode or Program Name | Output | Pro-8AB | |
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed biphasic (asymmetrical unbalanced) | Pulsed biphasic (asymmetrical unbalanced) | |
| Shape (e.g., rectified, spike, rectified sinusoidal) | Rectified sinusoidal (with undershoot) | Rectangular with taper | |
| Maximum Output Voltage (volts) (+/-5%) | 58.4v @ 500Ω220v @ 2KΩ995v @ 10KΩapplies measure prior to EnCadis' clarification - revised calculation is approx 300v @ 10KΩ | 70v @ 500Ω90v @ 2KΩ100v @10KΩ | |
| Maximum Output Current (mA) (+/- 5%) | 117 mA @ 500Ω110 mA @ 2KΩ100 mA @ 10KΩ | 140 mA @ 500Ω45 mA @ 2KΩ10 mA @ 10KΩ | |
| Duration of primary (depolarizing) phase (µSec) | N/A | unknown | |
| Pulse Duration (µSec) | 11 µSec | 10 mSec | |
| Frequency (Hz) | 30 Hz (max amplitude) | 100 Hz | |
| For multiphasic waveforms only:Symmetrical phases?Phase Duration | NoPositive Phase:11 µSecNegative Phase:2 µSec (@ min amplitude, 500Ω load)25 µSec (@ max amplitude, 10KΩ load) | NoVarious, all are longer than Quick Relax Pro | |
| Net Charge (microCoulombs (µC) per pulse) | 0.78 µC * | Various, higher | |
| Maximum Phase Charge (µC) | 0.82 µC * | 15.66 µC | |
| Maximum Current Density (mA/cm2, r.m.s.) | 3.37 mA/cm2 r.m.s. | 7.2 mA/cm2 @500Ω | |
| Parameter --------------- | Subject Device | Predicate Device | |
| Maximum Average Current (average absolute value)mA | 0.220 mA | Not measured | |
| Maximum Average Power Density (W/cm2) | 803 µW/cm2 | Not measured | |
| Burst Mode | (a) Pulses perburst | N/A | Various |
| (b) Bursts persecond | N/A | Various | |
| (c) Burstduration | N/A | Various | |
| (d) Duty Cycle:Line b x Line c | N/A | Various | |
| ON Time (Sec) | N/A | 1,200 default | |
| OFF Time (Sec) | N/A | N/A | |
| Additional Features | N/A | Unknown |
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Summary of Technological Characteristics Comparison
The foregoing comparison of the technological characteristics of the subject and predicate devices confirms that the devices are substantially equivalent with respect to intended uses, method of powering, physical descriptions, method of isolation and waveforms.
The differences regarding battery power, material descriptions, number of output modes, presence of software and overall numbers of functions confer an added degree of safety to the subject device.
Therefore, the subject device is at least as safe if not safer than the predicate device, and substantially equivalent with regard to the relevant comparators of the devices.
Summary of Non-Clinical Testing
The Quick Relax Pro has undergone biocompatibility testing of its tissue-contacting electrode in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-12. In addition, the Quick Relax Pro has undergone Product Safety testing in compliance to IEC 60601-1 and Electromagnetic Compatibility testing in compliance to IEC 60601-1-2. The results of each of the foregoing sets of test requirements were satisfactory, and serve to demonstrate the safety and effectiveness of the Quick Relax Pro.
The product safety, electromagnetic compatibility and biocompatibility test results provide assurance that the subject device performs as well or better than the predicate device.
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The introduction of the Quick Relax Pro into interstate commerce does not raise any new issues of safety or effectiveness.
and the comments of the count
100 - 100 - 100 -
:
END OF 510(K) SUMMARY
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Healthcare Innovations, LLC c/o Shepard G. Bentley, RAC Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677
Re: K131956
Trade/Device Name: Quick Relax Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 4, 2014 Received: March 25, 2014
Dear Mr. Bentley:
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.
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
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Page 2 - Mr. Shepard Bentley
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDcvices/Safety/ReportalProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Peña AS
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131956
Device Name
Quick Relax Pro
Indications for Use (Describe)
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.
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)
...
:
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
.
Carlos Pena -S
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
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§ 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).