For symptomatic relief and management of chronic pain
For adjunctive treatment in the management of post-surgical and post-traumatic pain
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 and normal household and work activities

Powered Muscle Stimulator

To temporarily increase local blood circulation in healthy muscles
For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Device Description

The HBOTC is an OTC electrical nerve and muscle stimulator indicated for symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow. The HBOTC consists of a portable battery-operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons for selecting the desired frequency and a dial to control the intensity of the signal. The stimulator is also supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display.

AI/ML Overview

The HBOTC Muscle and Nerve Stimulator is a Class II device (product codes NUH and NGX), and its 510(k) summary (K160255) primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with relevant safety and performance standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance in terms of sensitivity, specificity, or other outcome metrics that would typically apply to diagnostic AI/ML devices. Instead, the "acceptance criteria" are implied by the demonstration of compliance with recognized electrical safety and performance standards, and by showing that the technological characteristics of the HBOTC device are substantially equivalent to those of legally marketed predicate devices.

The "reported device performance" is framed within the context of these non-clinical tests and the comparison to predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1 (2012)	Device passed tests demonstrating basic safety and essential performance.
Compliance with IEC 60601-1-11 (2015)	Device passed tests for safety in home healthcare environment.
Compliance with IEC 60601-2-10 (2012)/Amendment 1 2001	Device passed tests for safety of nerve and muscle stimulators.
Substantial equivalence in technological characteristics to predicates (e.g., power source, output modes, channels, waveform, electrical parameters, materials)	Comparisons made in the 510(k) summary (table spanning pages 5-9) indicate that the HBOTC's characteristics are either identical or have minor differences that do not impact safety and effectiveness when compared to K131910, K112485, K103738, and K102051. For example, similar Ni-MH rechargeable batteries (7.2V), 2 output channels, alternating synchronous, galvanic isolation, biphasic spike with exponential decay waveform, similar max output voltage/current, pulse width, net charge, max phase charge, max current density, and max power density. Minor differences such as the Pain Buddy predicate using disposable AAA cells and having a different frequency range (8-80 Hz vs 1-70 Hz) and pulse width (160 μs vs 5 ms) were acknowledged but deemed non-impactful.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not describe a clinical study with a test set of patient data. The device under review is an electrical nerve and muscle stimulator, and the approval is based on non-clinical performance tests and substantial equivalence claims to existing devices, not on a study involving patient data. Therefore, this information is not applicable and not provided in the document.

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)

As no clinical study or test set involving patient data is described, there is no mention of experts establishing ground truth. The evaluation relies on engineering and regulatory assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or adjudication process for ground truth 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 an electrical stimulator, not an AI-assisted diagnostic tool or a device that involves human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware electrical stimulator, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as there are no clinical trials or patient data used in the submission to establish a "ground truth" for diagnostic or predictive performance. The "ground truth" for device safety and performance here refers to compliance with established electrical safety standards and the demonstrated equivalence of its technical specifications to similar, already approved devices.

8. The sample size for the training set

Not applicable, as this device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this device is not an AI/ML algorithm that requires a training set or ground truth establishment for training.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a stylized eagle above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

HB Medical, Inc. % Robyn Scopis CEO Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92831

Re: K160255

Trade/Device Name: HBOTC Muscle And Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 15, 2016 Received: August 16, 2016

Dear Robyn Scopis:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. 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 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,

Michael J.Hoffmann -A

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) K160255

Device Name HBOTC Muscle and Nerve Stimulator

Indications for Use (Describe)

Transcutaneous Electrical Nerve Stimulation:

1. For symptomatic relief and management of chronic pain
1. For adjunctive treatment in the management of post-surgical and post-traumatic pain

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 and normal household and work activities

Powered Muscle Stimulator

1. To temporarily increase local blood circulation in healthy muscles
1. For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Type of Use (Select one or both, as applicable)
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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 K160255 510(k) Owner HB Medical 5702 Bolsa Ave. Huntington Beach, CA 92649 Phone: (714) 330-7333 Facsimile: (714) 500-4092 Contact person Robyn Scopis Regulatory Specialists, Inc. 1801 Edgecliff Drive Fullerton, CA 92831 Phone: 949.262.0411 Fax: 949.552.2821 Email: robyn@regulatoryspecialists.com Preparation Date September 13, 2016 Primary Product Code: NUH Common Name Transcutaneous electrical nerve stimulator for pain relief Trade Name HBOTC Muscle and Nerve Stimulator stimulator, nerve, transcutaneous, Classification Name over-the-counter Regulation 882.5890 Class Class II Panel Neurology Secondary Product Code: NGX Common Name Powered muscle stimulator HBOTC Muscle and Nerve Stimulator Trade Name Classification Name stimulator, muscle, powered, for muscle conditioning Regulation 890.5850 Class Class II Panel Physical Medicine Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K102051

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Description

Intended Use

The HBOTC is intended for use as a nerve and muscle stimulator for patients wanting symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow.

Indications for Use

Transcutaneous Electrical Nerve Stimulation:

For symptomatic relief and management of chronic pain
For adjunctive treatment in the management of post-surgical and posttraumatic pain
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 and normal household and work activities

Powered Muscle Stimulator

To temporarily increase local blood circulation in healthy muscles
For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Comparison of Technological Characteristics to Predicate Devices

The predicates and the HBOTC were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not impact the safety and effectiveness of the HBOTC:

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510(k) Number	Subject Device	PrimaryPredicate	SecondaryPredicate	Third Predicate	Fourth Predicate	Regulated Current orRegulated Voltage	RegulatedVoltage	RegulatedVoltage	RegulatedVoltage	RegulatedVoltage	RegulatedVoltage
	HBOTCK160255	MPPK131910	H4K112485	H4K103738	Pain BuddyK102051	Software/firmware/microprocessor	Yes	Yes	Yes	Yes	Yes
Power Source	Ni-MHrechargeablebattery (7.2 V)	Ni-MHrechargeablebattery (7.2 V)	Ni-MHrechargeablebattery (7.2 V)	Ni-MHrechargeablebattery (7.2 V)	Two 1.5-VoltAAA disposablecells (3 V)	Automatic OverloadTrip	No	No	No	No	No
Intended Use	TranscutaneousElectrical NerveStimulation:1. Forsymptomaticrelief andmanagement ofchronic pain2. For adjunctivetreatment in themanagement ofpost-surgical andpost-traumaticpain3. For temporaryrelief of painassociated withsore and achingmuscles in theshoulder, waist,back, neck, upperextremities(arm), and lowerextremities (leg)due to strainfrom exercise andnormalhousehold and	The MPP is to beused fortemporary reliefof painassociated withsore and achingmuscles in theshoulder, waist,back, neck,upperextremities(arm), and lowerextremities (leg)due to strainfrom exerciseand normalhousehold andwork activities.The MPP isintended formuscleconditioning bystimulatingmuscle in orderto improve orfacilitate muscleperformance	The H-Wave H4is indicated forthe treatment ofchronic pain,acute pain, post-surgical pain,and temporarypain.	1. Relaxation ofmuscle spasms;2. Prevention orretardation ofdisuse atrophy;3. Increasinglocal bloodcirculation;4. Muscle re-education;5. Immediatepost-surgicalstimulation ofcalf muscles toprevent venousthrombosis;6. Maintainingor increasingrange of motion.	TENSstimulation isused forsymptomaticrelief andmanagement ofchronic painand/or as anadjunctivetreatment in themanagement ofpost-surgicaland post-traumatic pain.	Automatic No-LoadTrip	Yes	Yes	Yes	Yes	Yes
	work activities					Automatic Shut Off?	No	No	No	No	No
	Powered MuscleStimulator1. To temporarilyincrease localblood circulationin healthymuscles2. For muscleconditioning bystimulatinghealthy muscle inorder to improveor facilitatemuscleperformance					Patient OverrideControl	Yes	Yes	Yes	Yes	Yes
Line Current Isolation	Yes (batteryoperated)	Yes (batteryoperated)	Yes (batteryoperated)	Yes (batteryoperated)	Yes (batteryoperated)	Indicator Display
Patient Leakage Current						On/ Off Status	Yes	Yes	Yes	Yes	Yes
Normal Condition	0	0	0	0	0	Low Battery	Yes	Yes	Yes	Yes	Yes
Single fault condition	0	0	0	0	0	Voltage/ Current Level	Yes	Yes	Yes	Yes	Yes
Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ)	0	0	0	0	0	Weight	1.6 lb	1.6 lb	1.6 lb	1.6 lb	1.9 oz
Number of outputmodes	1	1	1	01	1	Dimensions	7" x 4.5" x 1.5"	7" x 4.5" x 1.5"	7" x 4.5" x 1.5"	7" x 4.5" x 1.5"	4.9" x 1.4" x 0.6"
Number of outputchannels	2	2	2	2	1	Housing materials andconstructions	ABS plastichousing fastenedwith screws	ABS plastichousing fastenedwith screws	ABS plastichousing fastenedwith screws	ABS plastichousing fastenedwith screws	ABS plastichousingfastened withscrews
synchronous oralternating	alternating	alternating	alternating	alternating	alternating	Waveform	biphasic	biphasic	biphasic	biphasic	biphasic
Method of ChannelIsolation	galvanic	galvanic	galvanic	galvanic	galvanic	Frequency	1-70 Hz	1-70 Hz	1-70 Hz	1-70 Hz	8-80 Hz
Beat Frequency	N/A	N/A	N/A	N/A	N/A
Shape	spike withexponentialdecay	spike withexponentialdecay	spike withexponentialdecay	spike withexponentialdecay	Asymmetrical Bi-PhasicRectangular
Maximum OutputVoltage @500Ω	21V	21V	21V	21V	29V
Maximum OutputVoltage @2kΩ	56v	56v	56v	56v	34V

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Maximum OutputVoltage @10kΩ	100V	100V	100V	100V	36V
Maximum OutputCurrent @500Ω	42 mA	42 mA	42 mA	42 mA	60 mA
Maximum OutputCurrent @2kΩ	28 mA	28 mA	28 mA	28 mA	17mA
Maximum OutputCurrent @10kΩ	10 mA	10 mA	10 mA	10 mA	4mA
Pulse Width	5 ms @ 1 k ohms	5 ms @ 1 k ohms	5 ms @ 1 k ohms	5 ms @ 1 k ohms	160 µs
Net Charge	o (equal positiveand negativepulses)	o (equal positiveand negativepulses)	o (equal positiveand negativepulses)	o (equal positiveand negativepulses)	unknown
Maximum PhaseCharge @500Ω	16.8 µC	16.8 µC	16.8 µC	16.8 µC	unknown
Maximum CurrentDensity @500Ω	2 mA/cm²	2 mA/cm²	2 mA/cm²	2 mA/cm²	unknown
Maximum PowerDensity @500Ω	0.042 W/cm²	0.042 W/cm²	0.042 W/cm²	0.042 W/cm²	unknown
Burst ModePulses per burst	N/A	N/A	N/A	N/A	unknown
Burst ModeBursts per second	N/A	N/A	N/A	N/A	unknown
ON Time (seconds)	N/A	N/A	N/A	N/A	unknown
OFF Time (seconds)	N/A	N/A	N/A	N/A	unknown

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The following non-clinical performance tests were conducted:

Software Validation

IEC 60601-1 (2012): Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance.

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 (2012)/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the HBOTC is substantially equivalent to the predicates as a powered muscle stimulator and transcutaneous electrical nerve stimulator for pain relief.

Regulation Number and Section

§ 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).