netwaye Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation or Neuromuscular Electrical Stimulation.

In the Interferential Current Mode, netwave is indicated for the following conditions:

. Symptomatic relief of acute pain
Symptomatic management and relief of chronic pain
. Adjunctive treatment for the management of post traumatic and Post-surgical pain

In the Neuromuscular Stimulation Mode, netwave 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.

Device Description

The Ryan Telemedicine netwave Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Prescribed by a physician, netwave gives the clinician a variety of electrotherapy modes to treat a range of indications. netwaye is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. netwave incorporates the following features:

independent stimulation channels, which provide true ● Two interferential current and neuromuscular stimulation.
Continuous or pulsed stimulation. Adjustable sweep and ramp times. ●
. Adiustable amplitude and frequency
Four programmable therapy protocols
. Five preset therapy protocols
. Adjustable on and off times
Pause button to allow temporary cessation of treatment and a . resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
Easy to connect, easy to handle, patient lead wire/cable assembly . with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
. Timed therapy sessions.
. Robust rechargeable Nickel Metal Hydride battery system with rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
. Charging / communicating cradle which serves as "home base" for netwave and provides a simple recharging system for the user/patient. The use of the charging cradle ensures netwave is always at peak battery power.
The communication functions of the cradle allow for the uploading of patient data (compliant with HIPAA requlations) to an Internet data server for use by the patient's authorized caregivers. NO INDIVIDUALLY IDENTIFIABLE PATIENT DATA is transmitted.
netwave user interface incorporates a touch screen Liquid Crystal Display (LCD) as the main device/user interface.

AI/ML Overview

The provided document is a 510(k) summary for the netwave Interferential Stimulator, which is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The core of this submission is not a clinical study with acceptance criteria and reported device performance in the way typically associated with AI/software devices. Instead, it's a comparison to a legally marketed predicate device (RTM 1000 Interferential Stimulator) to show that the new device is "substantially equivalent" in design, features, function, and intended therapy.

Therefore, many of the requested items (sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the relevant information and structure it as if there were "acceptance criteria" based on the comparison made in the document.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Substantial Equivalence Claim)	Reported netwave Device Performance
Therapy Output and Performance Characteristics (to be identical to predicate)	"Bench testing was performed on the marketed device and netwave and the therapy output and performance characteristics for both units was identical."
Intended Use (to match predicate device indications)	netwave's stated Indications For Use match the types of indications for previously cleared interferential stimulators and neuromuscular stimulators. Specific conditions for Interferential Current Mode include: symptomatic relief/management of chronic pain, adjunctive treatment for post-surgical/post-traumatic pain. Specific conditions for Neuromuscular Stimulation Mode include: relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining/increasing range of motion.
Design, Features, and Function (to be similar to predicate, with improvements detailed)	- Similarities: Multifunction device for muscle/nerve stimulation, two therapy modes (Interferential Current Stimulation, Neuromuscular Electrical Stimulation), identical preprogrammed treatment protocols, ability to customize protocols within parametric ranges and save to memory. - Improvements over predicate: Simplified battery charging, lower charging temperature, improved safety (no therapy while charging), simplified user interface, easy-to-read screens, large "Pause" and "Quit" buttons, "Initial Activation Code" for compliance, HIPAA "Patients Rights" acknowledgment, detailed treatment compliance data, bi-directional communication, secure HTTPS communication.
Safety and Effectiveness (to deliver intended therapy in a safe and effective manner)	Claimed to "provide the intended therapy in a safe and effective manner" based on substantial equivalence to the legally marketed predicate device. Safety improvements (like preventing therapy during charging) are highlighted.

2. Sample Size used for the test set and the data provenance

Sample Size: Not applicable. This document describes bench testing comparing a new device (netwave) to a predicate device (RTM 1000 Interferential Stimulator). It does not involve a "test set" of patient data or clinical samples.
Data Provenance: Not applicable. The "study" mentioned is bench testing, which would have been conducted by the manufacturer, Ryan Telemedicine, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "ground truth" derived from expert consensus on patient data for this type of submission. The ground truth for the bench testing would be the measured electrical output and performance characteristics of the devices themselves, verified against engineering specifications.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the electrical and functional equivalence of the device, not on reader performance or AI assistance.

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

Not applicable. This device is an electrical stimulator, not an algorithm, and its performance inherently involves human interaction (patient placement of electrodes, clinician programming, etc.). The "performance" assessment was through bench testing of its electrical output.

7. The type of ground truth used

For the "study" (bench testing), the ground truth was the measured electrical output and performance characteristics of both the netwave device and the predicate RTM 1000 Interferential Stimulator, compared against their respective design specifications and industry standards for such devices.

8. The sample size for the training set

Not applicable. This device does not use an AI algorithm that requires a "training set."

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

Not applicable. No training set was used.

Summary

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K031884

JUN 3 0 2003

Image /page/0/Picture/2 description: The image shows the logo for Ryan Telemedicine. The word "RYAN" is in large, bold, black letters. Below that, in smaller letters, is the word "TELEMEDICINE". The logo is surrounded by a circle of black dots.

510(k) Summary for netwave Interferential Stimulator

1. Sponsor

Ryan Telemedicine, LLC 1011 Brioso Drive Suite 102 Costa Mesa, Ca 92627

Contact Person:	Jim Klett
Telephone:	(800) 495-7926
Fax:	(949) 645-1145

June 12, 2003 Date Prepared:

2. Device Name

Proprietary Name:	netwave Interferential Stimulator
Common/Usual Name:	Electrical Muscle and Nerve Stimulator
Classification Names:	Interferential Current Stimulator, Powered
	Muscle Stimulator
Classification Panel:	Physical Medicine
Panel/Product Code:	890.5850 / IPF

Legally Marketed Device to Which Equivalence is Claimed 3.

Proprietary Name:	RTM 1000 Interferential Stimulator
Common/Usual Name:	Electrical Muscle and Nerve Stimulator
Classification Names:	Interferential Current Stimulator, PoweredMuscle Stimulator
Classification Panel:	Physical Medicine
Panel/Product Code:	890.5850 / IPF

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4. Intended Use

In the Interferential Current Mode, netwave is indicated for the following conditions:

. Symptomatic relief of acute pain
Symptomatic management and relief of chronic pain
. Adjunctive treatment for the management of post traumatic and Post-surgical pain

In the Neuromuscular Stimulation Mode, netwave 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.

5. Device Description

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independent stimulation channels, which provide true ● Two interferential current and neuromuscular stimulation.
Continuous or pulsed stimulation. Adjustable sweep and ramp times. ●
. Adiustable amplitude and frequency
Four programmable therapy protocols
. Five preset therapy protocols
. Adjustable on and off times
Pause button to allow temporary cessation of treatment and a . resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
Easy to connect, easy to handle, patient lead wire/cable assembly . with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
. Timed therapy sessions.
. Robust rechargeable Nickel Metal Hydride battery system with rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
. Charging / communicating cradle which serves as "home base" for netwave and provides a simple recharging system for the user/patient. The use of the charging cradle ensures netwave is always at peak battery power.
The communication functions of the cradle allow for the uploading of patient data (compliant with HIPAA requlations) to an Internet data server for use by the patient's authorized caregivers. NO INDIVIDUALLY IDENTIFIABLE PATIENT DATA is transmitted.
netwave user interface incorporates a touch screen Liquid Crystal Display (LCD) as the main device/user interface.

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6. Basis for Substantial Equivalence

netwave is substantially equivalent to the legally marketed device and is similar in design, features and function and provides the intended therapy in a safe and effective manner. Both devices offer identical preprogrammed treatment protocols and the clinician or patient can choose one or more of these pre-set options. Furthermore, both allow the clinician to customize a treatment protocol for each individual patient within the parametric ranges and save the treatment into memory.

Bench testing was performed on the marketed device and netwave and the therapy output and performance characteristics for both units was identical.

7. Differences Between the Marketed Device and netwave

netwave incorporates several improvements over the legally marketed device, including:

. Simplified battery charging system. There is no need to connect a charging cable to the device. The user places the device in the charging cradle to begin the charging process.
Equal recharge time at a lower charging temperature. The battery . charging circuitry has been removed from the device and relocated in the charging cradle.
Improved safety due to the device software preventing therapy . treatment while connected to wall current (recharging). Once the stimulator is removed from the cradle it is no longer connected to wall current.
. Greatly simplified user interface with a minimum number of steps to begin therapy treatment.
. Easy to read interface screens with full descriptions of available options and settings.
Large "Pause" and "Quit" buttons on the interface ensure quick . cessation of treatment.
. The stimulator now incorporates an "Initial Activation Code" to be entered by the user. The code is embedded in the instruction manual in the "Warnings and Precautions" section thereby encouraging the user to read the Indications, Contraindications, Precautions, Warnings and Adverse Effects section of the Instruction Manual.

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The stimulator includes a HIPAA "Patients Rights" acknowledgement . process which encourages the education of the patient as to their patient rights.
Treatment compliance data is recorded in greater detail and is . available within 24 hours of the first treatment.
. Bi-directional communication system which enables greater communication between patient, Physician and Clinician and virtually immediate reporting of patient compliance data.
Communications are fully compliant with HIPAA regulations and are . secure using HTTPS (security) protocols.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with wavy lines below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2003

Ryan Telemedicine c/o Mr. Donald James Sherratt Intertek Testing Services 70 Codman Hill Rd Boxborough, MA 01779

Re: K031884

Trade/Device Name: Interferential Stimulator, Model netwave Regulation Number: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: Class II Product Codes: IPF Dated: June 16, 2003 Received: June 18, 2003

Dear Mr. Sherratt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. D. J. Sherratt

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

Page 1 of 1

K031884 510(k) Number (if known):_

Device Name: netwave Interferential Stimulator

Indications For Use:

Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.

Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

(Optional Format 3-10-98)

510(k) Number -

K03/884

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).