The H-Wave® model H4 consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic stimulation at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

AI/ML Overview

Here's an analysis of the provided text regarding the H-Wave® Electrical Stimulator (model H4) and its acceptance criteria, structured according to your request:

Acceptance Criteria and Device Performance Study for the H-Wave® H4 Electrical Stimulator

Based on the provided 510(k) summary (K112485), the acceptance criteria for the H-Wave® H4 device are primarily demonstrated through compliance with recognized consensus standards and by establishing substantial equivalence to previously cleared predicate devices. The study proving the device meets these criteria is a bench testing/technical comparison study, not a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from recognized standards & predicate comparison)	Reported Device Performance (from H-Wave® H4)	Met/Not Met
Safety - Electrical	IEC 60601-2-10 1987/Amendment 1 2001: Particular requirements for the safety of nerve and muscle stimulators.	Complies with IEC 60601-2-10 1987/Amendment 1 2001	Met
	IEC 60601-1 1988/Amendment 1 1991/Amendment 2 1995 subclause 56.3(c): General Requirements for Safety.	Complies with IEC 60601-1 1988/Amendment 1 1991/Amendment 2 1995 subclause 56.3(c)	Met
Safety - EMC	IEC 60601-1-2 2001: Electromagnetic Compatibility - Requirements and Tests.	Complies with IEC 60601-1-2 2001	Met
Safety - Leakage Current	Normal condition patient leakage current = 0	0 µA	Met
	Single fault condition patient leakage current = 0	0 µA	Met
Safety - DC Current	Average DC current through electrodes (device on, no pulses) = 0	0 µA	Met
Safety - Isolation	Line Current Isolation: Battery operated	Yes (battery operated)	Met
	Method of Channel Isolation: Galvanic	Galvanic	Met
Performance - Intended Use	Treatment of chronic pain, acute pain, postsurgical pain, and temporary pain (Substantially similar to predicate devices).	Indicated for treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.	Met
Performance - Frequency Range	Within accepted therapeutic ranges and comparable to predicate devices.	1-70 Hz	Met (comparable to predicates 14-66 Hz, 1-70 Hz, 2-60 Hz)
Performance - Power Source	Rechargeable battery	Ni-MH rechargeable battery (7.2 V; 1800 mA/h)	Met (comparable to predicates)
Performance - Output Channels	Multiple output channels (comparable to predicate devices)	2 channels	Met (comparable to predicates 1, 2, 3 channels)
Performance - Alternating Output	Alternating channels	Alternating	Met
Performance - Current Control	Regulated Voltage	Regulated Voltage	Met
Features - Software/Firmware	Presence of software/firmware/microprocessor.	Yes	Met (comparable to K103738 and K021496 predicates)
Features - Automatic No-Load Trip	Presence of Automatic No-Load Trip feature.	Yes	Met (comparable to K103738, an improvement over K813601 and K021496)
Features - Patient Override Control	Presence of patient override control.	Yes	Met (comparable to all predicates)
Features - Indicator Display	On/Off Status, Low Battery, Voltage/Current Level indicators.	Yes for all three	Met (comparable to predicates)
Features - Timer Range	Programmable timer.	0-60 minutes	Met (comparable to predicates, e.g., 0-60 min and 10-60 min)
Labeling Compliance	Complies with 21 CFR Part 898 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components) (Note: This seems like a slight misreference for a stimulator, but it's listed as a compliance point.)	Yes	Met
Physical Characteristics	Weight, dimensions, housing materials comparable to predicate devices.	Weight: 1.6 lb, Dimensions: 7" x 4.5" x 1.5", Housing: ABS plastic	Met (comparable to predicates)

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" here refers to the device itself being tested against standards and compared to predicate devices in a bench environment.
Data Provenance: The data comes from the technical specifications and testing of the H-Wave® H4 device itself, and comparison against the technical specifications of three predicate devices as documented in their 510(k) clearances. This is primarily retrospective in terms of referencing predicate devices and their cleared specifications, combined with prospective bench testing of the new device against recognized standards. The country of origin for the H-Wave® H4 device is implied to be the USA (Electronic Waveform Lab, Inc. of Huntington Beach, CA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated as part of the submission documentation.
Qualifications of Experts: The ground truth for compliance with recognized standards (IEC 60601 series) would be established by experts in electrical safety, electromagnetic compatibility, and medical device performance testing, typically within a certified testing laboratory. For the substantial equivalence comparison, the "experts" were the reviewers at the FDA's Office of Device Evaluation (Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices), who are physicians and scientific reviewers responsible for assessing medical device safety and effectiveness.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This submission relies on compliance with objective performance standards and direct comparison of technical specifications against predicate devices, rather than subjective interpretation by multiple human readers that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No.
Effect Size of Human Readers: Not applicable, as this is a physical electrical stimulator and the submission focuses on its technical characteristics and safety, not on diagnostic performance or human-in-the-loop clinical interpretation tasks.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study Done: Yes, in a sense. The "standalone" performance is assessed through the device's compliance with the cited IEC standards (IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2) which are objective tests of the device's electrical safety and performance parameters without human intervention or interpretation during the testing. The comparison table also provides standalone technical characteristics of the device.

7. Type of Ground Truth Used

Type of Ground Truth:
- Recognized Consensus Standards: For electrical safety and electromagnetic compatibility (IEC 60601 series).
- Predicate Device Specifications: The technical specifications (e.g., frequency, power source, channels, features) of legally marketed, cleared predicate devices (K813601, K103738, K021496).
- Device Technical Specifications: The measured or designed technical specifications of the H-Wave® H4 device itself.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for this device would be its engineering and design process, ensuring it meets technical specifications.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device's submission. The closest analogy would be the engineering design requirements and regulatory standards that guide the device's development to ensure it meets its intended function and safety profiles.

Summary

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510(k) SUMMARY

Electronic Waveform Lab Inc.'s H-Wave® Electrical Stimulator (model H4)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Electronic Waveform Lab, Inc. 5702 Bolsa Ave. Huntington Beach, CA 92649

Phone: (800) 874-9283 Facsimile: (714) 500-4092

Contact Person: Ryan P. Heaney, President

Date Prepared: October 4, 2011

Name of Device

H-Wave® (model H4)

Common or Usual Name/Classification Name

Transcutaneous Electrical Nerve Stimulator for Pain Relief 21 C.F.R. § 882.5890 (Product Code GZJ)

Predicate Devices

Model P, Electronic Waveform Lab, Inc. (K813601) Model H-Wave® H4, Electronic Waveform Lab, Inc. (K103738) Model HMS DHR-3, Home Medical Services, Inc. (K021496)

Intended Use / Indications for Use

The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.

Technological Characteristics

Performance Data

The H-Wave conforms to the following recognized consensus standards:

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K112485

IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment -. Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.
. IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 subclause 56.3(c).
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (2001).

Substantial Equivalence

A chart comparing the similarities and differences between the H-Wave® H4 and its predicate devices is included below:

	EWL H-Wave H4(ProposedDevice)	EWL P-Tens(K813601)	EWL H-Wave H4(K103738)	HomeMedicalServicesHMS-DHR 3(K021496)
Frequency	1-70 Hz	14-66 Hz	1-70 Hz	2-60 Hz(+/- 20%)
Power Source	Ni-MHrechargeablebattery (7.2 V;1800 mA/h)	Ni-MHrechargeablebattery (7.2 V;1800 mA/h)	Ni-MHrechargeablebattery (7.2 V;1800 mA/h)	Ni-MHrechargablebattery(3.6V)
Line CurrentIsolation	Yes(batteryoperated)	Yes(batteryoperated)	Yes(batteryoperated)	Yes(batteryoperated)
Patient Leakage Current
Normal condition	0	0	0	0
Single faultcondition	0	0	0	0
Average DCcurrent throughelectrodes whendevice is on but nopulses are beingapplied (µA)	0	0	0	0
Number of outputmodes	N/A	N/A	N/A	N/A
Number of outputchannels	2	1	2	3
Synchronous oralternating	Alternating	Alternating	Alternating	Alternating
Method of ChannelIsolation	Galvanic	Galvanic	Galvanic	Galvanic
Regulated Currentor RegulatedVoltage	RegulatedVoltage	RegulatedVoltage	RegulatedVoltage	RegulatedVoltage
Software/firmware/microprocessor	Yes	No	Yes	Yes
AutomaticOverload Trip	No	No	No	No

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	EWL H-Wave H4(ProposedDevice)	EWL P-Tens(K813601)	EWL H-Wave H4(K103738)	HomeMedicalServicesHMS-DHR 3(K021496)
Automatic No-Load Trip	Yes	No	Yes	No
Automatic Shut Off	No	No	No	Yes
Patient OverrideControl	Yes	Yes	Yes	Yes
Indicator Display
On/Off Status	Yes	Yes	Yes	Yes
Low Battery	Yes	Yes	Yes	No
Voltage/CurrentLevel	Yes	Yes	Yes	Yes
Timer Range(minutes)	0-60	N/A	0-60	10-60 (5minintervals)
Compliance withVoluntaryStandards	IEC 60601-2-101987/Amendment 1 2001, Medicalelectricalequipment - Part2-10: Particularrequirements forthe safety ofnerve andmusclestimulatorsIEC 60601-1Medical ElectricalEquipment - Part1: GeneralRequirements forSafety, 1988;Amendment 1,1991-11,Amendment 2,1995 subclause56.3(c)IEC 60601-1-2:Medical ElectricalEquipment - Part1-2: GeneralRequirements forSafety -CollateralStandard:Electromagnetic	N/A	IEC 60601-2-101987/Amendment1 2001, Medicalelectricalequipment - Part2-10: Particularrequirements forthe safety ofnerve and musclestimulatorsIEC 60601-1Medical ElectricalEquipment - Part1: GeneralRequirements forSafety, 1988;Amendment 1,1991-11,Amendment 2.1995 subclause56.3(c)IEC 60601-1-2:Medical ElectricalEquipment - Part1-2: GeneralRequirements forSafety -CollateralStandard:ElectromagneticCompatibility	Unknown
	EWL H-Wave H4(ProposedDevice)	EWL P-Tens(K813601)	EWL H-Wave H4(K103738)	HomeMedicalServicesHMS-DHR 3(K021496)
	Requirementsand Tests (2001)		Requirementsand Tests (2001)
Compliance with21CFR Part 898	Yes	Yes	Yes	Yes
Weight	1.6 lb	2lb	1.6 lb	1lb
Dimensions	7" x 4.5" x 1.5"	6"x2.34"x6"	7" x 4.5" x 1.5"	6.625"Lx4"Wx1.75"H
Housing materialsand constructions	ABS plastichousing fastenedwith screws	ABS plastichousingfastenedwith screws	ABS plastichousing fastenedwith screws	Molded ABS

\\DC - 067728/000001 - 3305802 v1

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K112485

The H-Wave® H4 has the same intended uses and substantially similar output parameters as the predicate devices. Specifically, the H-Wave H4 has the same intended uses and substantially similar output parameters as other legally marketed electrical nerve stimulators: the EWL model P (K813601) and the Home Medical Services, Inc. HMS DHR-3 (K021496). In addition, as the H-Wave H4 is technologically identical to the predicate H-Wave® H4 device, the technological characteristics and principles of operation of the H-Wave H4 do not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

DEC - 6 2011

Electronic Waveform Lab, Inc. c/o Mr. Ryan P. Heaney President 5702 Bolsa Ave. Huntington Beach, CA 92649

Re: K112485

Trade/Device Name: H-Wave® H4 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: October 4, 2011 Received: October 4, 2011

Dear Mr. Heaney:

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 10 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, line rec. 1 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

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Page 2 - Mr. Ryan P. Heaney

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

K112485

Device Name: H-Wave® H4

Indications for Use:

The H-Wave® H4 is indicated for the treatment of chronic pain, post-surgical pain, and temporary pain.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

[K112485](https://510k.innolitics.com/device/K112485)
510(k) Number

Page of

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).