Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;
Increasing local blood circulation;
Muscle re-education;
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
Maintaining or increasing range of motion.

Device Description

The H-Wave® model H4 is 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 muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

AI/ML Overview

This 510(k) submission describes the H-Wave® Electrical Stimulator (model H4). The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, the H-Wave (model P-4). Therefore, the study presented focuses on verification and validation testing of changes to the device and its compliance with recognized standards, rather than a clinical trial demonstrating specific clinical performance metrics against predefined acceptance criteria for indications for use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are primarily defined by compliance with specific electrical medical equipment safety and performance standards, and comparison with the predicate device's features. The "reported device performance" refers to the H-Wave H4's demonstrated adherence to these standards and its characteristics.

Acceptance Criteria (Standard / Feature)	Reported Device Performance (H-Wave H4)
Safety and Electrical Standards Compliance:
IEC 60601-2-10 (Safety of nerve and muscle stimulators)	Conforms to IEC 60601-2-10 1987/Amendment 1 2001
IEC 60601-1 (General Requirements for Safety)	Conforms to IEC 60601-1 1988; Amendment 1, 1991-11, Amendment 2, 1995 subclause 56.3(c)
IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests)	Conforms to IEC 60601-1-2: 2001
Predicate Device Equivalence - Key Electrical Parameters:
Patient Leakage Current (Normal Condition)	0 (Matches predicate)
Patient Leakage Current (Single Fault Condition)	0 (Matches predicate)
Average DC current through electrodes (device on, no pulses)	0 (Matches predicate)
Frequency Range	1-70 Hz (Matches predicate)
Number of Output Channels	2 (Matches predicate)
Synchronous or Alternating	Alternating (Matches predicate)
Method of Channel Isolation	Galvanic (Matches predicate)
Regulated Current or Regulated Voltage	Regulated Voltage (Matches predicate)
Patient Override Control	Yes (Matches predicate)
Indicator Display (On/Off Status)	Yes (Matches predicate)
Indicator Display (Low Battery)	Yes (Matches predicate)
Indicator Display (Voltage/Current Level)	Yes (Matches predicate)
Compliance with 21 CFR Part 898 (Radiation Control for Electronic Products)	Yes (Matches predicate)
Predicate Device Equivalence - Other Features/Dimensions:
Intended Uses	Same as original cleared H-Wave (Predicate)
Output Parameters	Same as original cleared H-Wave (Predicate)
Housing materials and constructions	ABS plastic housing fastened with screws (Matches predicate)
Weight	1.6 lb (Predicate: 2 lb - a minor difference deemed not to raise new questions of safety/effectiveness)
Dimensions	7" x 4.5" x 1.5" (Predicate: 6" x 2.34" x 6" - a minor difference deemed not to raise new questions of safety/effectiveness)
Power Source	Ni-MH rechargeable battery (7.2 V; 1800 mA/h) (Predicate: NiCad rechargeable battery (10.8V; 700 mA/h) - a minor difference that required verification/validation, but deemed not to affect safety/effectiveness)
Software/firmware/microprocessor	Yes (Predicate: No - a minor difference that required software verification testing, but deemed not to affect safety/effectiveness)
Automatic No-Load Trip	Yes (Predicate: No - a minor difference that did not raise new questions of safety/effectiveness)
Timer Range	0-60 min (Predicate: N/A - a minor difference that did not raise new questions of safety/effectiveness, as it adds functionality and the device still allows for patient override control).
Automatic Overload Trip	No (Matches predicate)
Automatic Shut Off?	No (Matches predicate)
Number of output modes	N/A (Matches predicate)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for clinical performance. The testing described is primarily bench testing and software verification/validation on the device itself and its components.
Data Provenance: Not applicable, as this is not a study involving patient data. The testing is internal to the manufacturer, verifying the device's adherence to engineering specifications and regulatory standards.

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

Number of Experts: Not applicable. Ground truth, in the context of this submission, refers to the established technical specifications and recognized consensus standards (e.g., IEC standards). The "truth" is dictated by these objective, pre-defined technical benchmarks.
Qualifications of Experts: N/A for establishing "ground truth" as it would apply to a clinical study. Technical experts within the manufacturer and potentially third-party testing labs would have been involved to ensure compliance with the specified engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study that requires adjudication of findings, as it focuses on technical compliance and equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device that relies on established physiological principles of electrical stimulation and seeks substantial equivalence to a predicate device based primarily on technical specifications and safety standards, not a comparative clinical performance trial involving multiple readers or human-AI interaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The H-Wave is an electrical stimulator, not an AI/algorithm-driven diagnostic or therapeutic system that would have a "standalone" performance in the context of an algorithm. While it contains software, its function is to deliver electrical impulses, and its performance is evaluated by its adherence to specified electrical output parameters and safety.

7. The Type of Ground Truth Used

The "ground truth" for the verification and validation testing is defined by:
- Recognized Consensus Standards: IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2.
- Regulatory Requirements: 21 CFR Part 898 and general controls provisions of the Act.
- Engineering Specifications: Internal design specifications for the device's electrical output, safety features, and mechanical performance.
- Predicate Device Specifications: The technical parameters and performance characteristics of the H-Wave (model P-4) served as a benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The "training" in the device's development refers to its design and engineering process to meet specified technical parameters.

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

Not applicable, as no training set was used for an AI/ML algorithm. The "truth" for the device's design and manufacturing is established by engineering principles, regulatory compliance, and a detailed understanding of the intended physiological effects of electrical stimulation.

Summary

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1343 X

JUN - 1 2011

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: March 16, 2011

Name of Device

H-Wave® (model H4)

Common or Usual Name/Classification Name

Powered muscle stimulator 21 C.F.R. § 890.5850 (Product Code IPF)

Predicate Devices

H-Wave (model P-4), Electronic Waveform Lab, Inc. (K915230)

Device Description

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Intended Use / Indications for Use

1. Relaxation of muscle spasms;
1. Prevention or retardation of disuse atrophy;
1. Increasing local blood circulation;
1. Muscle re-education;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
1. Maintaining or increasing range of motion.

Performance Data

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

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).

Verification and validation testing of the modifications to the device, including failure analysis of both hardware and software were conducted to ensure that the changes did not affect the safety or effectiveness of the device. In addition, software verification testing was also conducted.

Substantial Equivalence

510(k) Number		(K915230)
Device Name, Model	H-Wave® (H4)	H-Wave® (P-4)
Manufacturer	Electronic Waveform Lab,Inc.	Electronic Waveform Lab,Inc.
Power Source	Ni-MH rechargeablebattery (7.2 V; 1800 mA/h)	NiCad rechargeablebattery (10.8V; 700 mA/h)
Line Current Isolation	Yes (battery operated)	Yes (battery operated)
Patient Leakage Current
Normal Condition	0	0
Single fault condition	0	0
Average DC current throughelectrodes when device is on but nopulses are being applied (µA)	0	0
Frequency	1-70 Hz	1-70 Hz
Number of output modes	N/A	N/A
510(k) Number		(K915230)
Device Name, Model	H-Wave® (H4)	H-Wave® (P-4)
Number of output channels	2	2
synchronous or alternating	alternating	alternating
Method of Channel Isolation	galvanic	galvanic
Regulated Current or RegulatedVoltage	Regulated Voltage	Regulated Voltage
Software/firmware/microprocessor	Yes	No
Automatic Overload Trip	No	No
Automatic No-Load Trip	Yes	No
Automatic Shut Off?	No	No
Patient Override Control	Yes	Yes
Indicator Display
• On/Off Status	Yes	Yes
• Low Battery	Yes	Yes
• Voltage/Current Level	Yes	Yes
Timer Range (minutes)	0-60 min.	N/A
Compliance with Voluntary Standards	IEC 60601-2-101987/Amendment 12001, Medicalelectrical equipment -Part 2-10: Particularrequirements for thesafety of nerve andmuscle stimulators.IEC 60601-1 MedicalElectrical Equipment -Part 1: GeneralRequirements forSafety, 1988;Amendment 1,1991-11, Amendment2, 1995 subclause56.3(c)IEC 60601-1-2:Medical ElectricalEquipment - Part 1-2:	N/A
510(k) Number		(K915230)
Device Name, Model	H-Wave® (H4)	H-Wave® (P-4)
	Safety - CollateralStandard:ElectromagneticCompatibility -Requirements andTests (2001)
Compliance with 21 CFR Part 898	Yes	Yes
Weight	1.6 lb	2 lb
Dimensions	7" x 4.5" x 1.5"	6"x2.34"x6"
Housing materials and constructions	ABS plastic housingfastened with screws	ABS plastic housingfastened with screws

A detailed chart comparing the H-Wave H4 with the predicate H-Wave P-4 is included below:

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The H-Wave® configuration covered by this submission has the same intended uses and output parameters as the original cleared H-Wave. The minor differences in the H-Wave's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the H-Wave model H4 is substantially equivalent to its predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and prevention. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Electronic Waveform Lab, Inc. % Mr. Ryan P. Heaney President 16168 Beach Boulevard Suite 232 Huntington Beach, California 92647

JUN - 1 2011

Re: K103738

Trade/Device Name: H - Wave (Model H4) Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 6, 2011 Received: May 9, 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 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. Iisting 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

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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,

Euisd Kett

for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative 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): __

Device Name: H-Wave®

Indications for Use:

The H-Wave® is indicated for the following conditions:

Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;
Increasing local blood circulation;
Muscle re-education;
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
Maintaining or increasing range of motion.

Prescription Use × (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of Sirentive Devices

510(k) Number K103738

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).