SMARTWAVE MS 2000 by NEWWAVE MEDICAL LLC

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
1. Maintaining or increasing range of motion

Device Description

The Smartwave MS 2000 Muscle Stimulator is a Square wave generator designed for neuromuscular electrical stimulation (NMES). The MS 2000 stimulates neuromuscular tissues through cutaneous electrodes connected by lead wires to the generator.

AI/ML Overview

This 510(k) submission (K041063) for the Smartwave MS 2000 Muscle Stimulator does not contain a study that demonstrates the device meets specific acceptance criteria through performance evaluation. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Staodyn EMS +2, K926510).

The acceptance criteria are implied by the comparison to the predicate device, where the new device is expected to have similar technological characteristics and performance specifications for its intended use. There are no explicit performance metrics stated as "acceptance criteria" against which the new device's performance is measured in a clinical or analytical study within this document.

Here's an breakdown of the information based on the provided text, keeping in mind the absence of a direct study proving performance against explicit acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit "acceptance criteria" presented as objective performance targets in this document, and no direct performance study, this table cannot be fully populated as requested. However, a comparison of the new device's specifications against the predicate device's specifications (which serve as the de-facto "acceptance criteria" for substantial equivalence) can be presented:

Feature/Parameter	Acceptance Criteria (Predicate Device K926510 - Staodyn EMS +2)	Reported Device Performance (Smartwave MS 2000)
Power Source	9V	9V
Optional Wall Adapter	No	Yes (100-120vac, 50-60Hz)
Method of Line Current Isolation	Transformer coupled	Transformer coupled
Patient Leakage Current	Not specified	Normal condition: 3.2uA; Single fault: 6.5uA (with adapter)
# of Output Modes	Pulsed DC, AC	Pulsed DC, AC, Russian Stim
# of Output Channels	1 or 2	1 or 2
Synchronous Output	Yes	Yes
Reciprocal Output	No	No
Computerized	No	No
Software Provided	No	No
Constant Current (+5%)	Yes	Yes
Constant Voltage	No	No
Max Output Current (500Ω)	95.2mA	57.2mA
Max Output Current (2KΩ)	46.8mA	17.8mA
Max Output Current (10KΩ)	9.63mA	3.8mA
Max Output Voltage (500Ω)	47.6V	28.6V
Max Output Voltage (2KΩ)	93.6V	35.5V
Max Output Voltage (10KΩ)	96.3V	38.3V
Channel Isolation	Capacitor coupled	Independent isolation transformer
Line Current Isolation	N/A	Transformer coupled
Automatic Overload Trip	No	No
Automatic No Load Trip	No	Yes (turns off after 10 min if not used)
Patient Override Control	Yes (by turning off unit)	Yes (by turning off unit)
Indicator Display	No (rotary dials)	LCD (0 to 35 displayed intensity level)
Unit Functioning Indicator	Yes (red LEDs)	Yes
Low Battery Indicator	Yes (yellow LED on)	Yes (Lo b displayed @ <6.0V)
UL544 Compliance	Not specified (implied by predicate)	Yes (complies with UL544 Safety Standard for Medical Equip.)
Timer Settings (range)	15, 30, 60 min, constant on	0-60 min, 0 is constant on
Automatic Shut Off	Yes	Yes
Weight	9.8 oz.	6.24 oz.
Dimensions	5.4L x 3.2W x 1.15H	4.68L x 2.77W x 1.01H
Housing Materials	ABS plastic vacuum molded	ABS plastic injection molded

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

No specific test set or associated sample size is reported for a performance study. The submission relies on comparative analysis of specifications against a legally marketed predicate device (Staodyn EMS +2, K926510).
Data Provenance: The data provided is from the device manufacturer (Newwave Medical, LLC) comparing its product's technical specifications to those of a predicate device. This is a retrospective comparison based on existing device specifications rather than prospective data collection from a new study.

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

Not applicable. There was no formal "test set" in the context of a clinical or performance study requiring a ground truth established by experts. Substantial equivalence is determined by regulatory review based on documented technical specifications.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was conducted.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices to assess human reader performance with and without AI assistance, which is not relevant for a muscle stimulator based on this submission.

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

Not applicable. This device is a hardware muscle stimulator, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

Not applicable. As there was no performance study with a test set, there was no ground truth to be established in the context of pathology, outcomes data, or expert consensus. The "truth" in this submission relates to the adherence of the new device's specifications to those of the predicate and generally accepted electrical safety and performance standards for a muscle stimulator.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device.

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

Not applicable. There is no training set or associated ground truth.

Summary

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K04/063

neuromuscular tissues through cutaneous electrodes connected by

lead wires to the generator.

Relaxation of muscle spasms.

DEC

C - 1 2004
	Attachment A
	510(k) Summary of Safety and Effectiveness
Date Prepared:	April 19, 2004
Submitter:	Newwave Medical, LLC
	620 Haggard ST. STE 614Plano, TX 75074(972) 516-8383
Contact Person:	Robert Armstrong
Trade (Proprietary) Name:	Smartwave MS 2000
Common/Classification Name:	Powered Muscle Stimulator
Device Classification:	Class II
Predicate Device:	Staodyn, Inc.
Description of Device:	The Smartwave MS 2000 MuscleStimulator is a Square wavegenerator designed forneuromuscular electrical stimulation(NMES). The MS 2000 stimulates

Statement of Intended Use:

Prevention of retardation of disuse Atrophy. Increasing local blood circulation. Muscle re-education. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of Motion. Technological Characteristics: The new device has the same Technological characteristics as the Predicate device. See table 1 (next Page) for a summary of the Technological characteristics of the New device in comparison to those of The predicate device.

A 2

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Comparison of the Smartwave MS 2000 and Staodyn EMS +2
	New Device	Marketed Device
1) 510 (k) Number	This Submission	K926510
2) Device Name	Smartwave MS 2000	EMS +2
3) Manufacturer	Newwave Medical, LLC	Staodyn Inc.
4) Power Source	9V	9V
Optional wall adapter	100-120vac, 50-60Hz	no
Method of line currentIsolation	Transformer coupled
Patient leakage current(w/adapter)
Normal condition	3.2uA
Single fault	6.5uA
5) # of output modes	Pulsed DC, AC, Russian Stim	Pulsed DC, AC
6) # of output channels	1 or 2	1 or 2
Synchronous	yes	yes
Reciprocal	no	no
7) Computerized	no	no
8) Software Provided	no	no
9) Constant Current (+5%)	yes	yes
10) Constant Voltage	no	no
11) Max Output Currenteach channel	57.2mA-500~17.8mA-2K~	95.2mA-500~46.8mA-2K~
(+5%)	3.8mA-10K~	9.63mA-10K~
12) Max Output Voltagebaseline-to-peak	28.6V-500~35.5V-2K~38.3V-10K~	47.6V-500~93.6V-2K~96.3V-10K~
13) Channel isolation	Independent isolation transformer	Capacitor coupled
14) Line Current isolation	Transformer coupled	N/A
15) Automatic overload trip	no	no
16) Automatic no load trip	yes(when the unit is turned on, ifit is not used, it will turn itself offafter 10 minutes.)	no
17) Patient override control	yes (by turning off unit)	yes (by turning off unit)
18) Max leakage current (uA)chassis (input)	N/A	N/A
electrodes (output)	N/A	N/A
19) Indicator display	LCD	no
unit functioning	yes	yes (red LEDs)
low battery indicator	yes (Lo b displayed @ <6.0V)	yes (yellow LED on @ <6.0V)
intensity level20) UL544	yes (0 to 35 displayed)(complies with UL544 SafetyStandard for Medical Equip.)	rotary dials
21) Timer Settings (range) (+1%)	0-60 min., 0 is constant on	15, 30, 60 min. and constant on
22) Automatic shut off	yes	yes
23) Weight	6.24 oz.	9.8 oz.
24) Dimensions (in.)	4.68L x 2.77W x 1.01H	5.4L x 3.2W x 1.15H
25) Housing materials andconstruction	ABS plastic injection molded	ABS plastic vacuum molded

Attachment A Table 1 Comparison of the Smartwave MS 2000 and Staodyn EMS +2

: 2

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wavy lines emanating from it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Mr. Robert Armstrong President Newwave Medical, LLC 620 Haggard Street, Suite 614 Plano, Texas 75074

Re: K041063

Trade/Device Name: Smartwave MS 2000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: October 29, 2004 Received: October 29, 2004

Dear Mr. Armstrong:

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 mav 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); 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.

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Page 2 - Mr. Robert Armstrong

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 (240) 276-0115. 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 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 yours.

Sincerely yours,

Murle A. Mellersen
for

Colie M. Witte, Ph.D., M.P.

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

510(k) Number (if known): 长۵4106 3 Device Name: Smart USA & M $ 2000 Indications For Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark A. Mulkersen

Division Sion-Division of General, Restorative, and Neurological Devices

Page 1 of __

510(k) Number K041063

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).