The intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.

Device Description

The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.

AI/ML Overview

This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device. The device is intended for pain relief.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Functional Performance	Complies with EN 60601-1, -1-2, -1-4, -1-6, -1-2-10
Electrical Safety	Complies with EN 60601-1, -1-2, -1-4, -1-6, -1-2-10
Software Verification	Carried out according to FDA software guidance
Usability	Labeling sufficient for users to operate device safely (demonstrated by Usability Study)
Substantial Equivalence to Predicate Device	Same intended use, similar technological characteristics, minimal differences that do not present safety/effectiveness issues compared to Well-Life Model WL-2402 (K063660)

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

The provided 510(k) summary does not specify a sample size for a test set related to clinical performance. The studies mentioned are primarily related to engineering standards, software verification, and a usability study. There is no mention of a clinical test set from patients.

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

The document does not mention experts used to establish ground truth for a clinical test set. The validation appears to be primarily technical and based on compliance with international standards, software guidance, and a usability study.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set requiring expert review, there is no adjudication method described.

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

No MRMC comparative effectiveness study was done or reported. The device is a TENS unit, not an AI-assisted diagnostic tool that would typically involve a multi-reader study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a TENS unit, a physical medical device, not an algorithm or AI system for diagnosis or interpretation that would operate in a "standalone" mode. The software component refers to its internal control, not an interpretative algorithm.

7. Type of Ground Truth Used

For the safety and performance evaluation:

Technical Specifications/Standards: Compliance with various EN 60601 standards for electrical safety and functional performance.
FDA Software Guidance: Used for software verification.
Usability Study Observations: Used to determine if labeling was sufficient for safe operation.
Predicate Device Comparison: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device (Well Life-Healthcare LTD. OTC TENS for Back Pain Relief, Model WL-2407, K063660).

8. Sample Size for the Training Set

The document does not specify a training set sample size related to clinical performance or algorithm development. The device is a TENS unit, and its development seems to have followed engineering design principles and compliance with standards rather than machine learning methodologies that would involve training sets.

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

Since there is no mention of a training set in the context of an algorithm, this question is not applicable. The device's "training" would be its design, manufacturing, and testing to meet established engineering and safety standards.

Summary

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K 113321

510(K) SUMMARY

SEP 4 2012

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.90(e).

1.0 Submitter Information

Establishment Registration Name and Number:

SAVIA LTD. 4th Industry District, Fenghuang, Fuyong County, Baoan Shenzhen, Guangdong 518103 China Registration Number: 3007752599 .

Contact Person (US Agent/Official Correspondent) of the Applicant:

Mr. Guenter Ginsberg

(President) Media trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135 Tel: 239 948-2001 Fax: 239 948-2002 e-mail: g.ginsberg@gmx.net

Device Information

Basis:	New device
510(k) submission type:	Traditional
Device Common Name:	Transcutaneous Electrical Nerve Stimulator
Trade Name:	Savia OTC TENS Device
Model:	EM-38
Classification Name:	TENS Device
Review Panel:	Neurology
Product Code:	NUH
Regulation Class:	Class II
Regulation Number:	882.5890

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Page - 2 -

2.0 Predicate device Information

Sponsor: Well Life-Healthcare LTD. Device: OTC TENS for Back Pain Relief, Model WL-2407 510(k) No: K063660

3.0 Device Description

The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.

4.0 Intended Use

The standard format for the statement of indications and contradictions for use are provided hereafter.

5.0 Performance Summary

Testing of the Savia OTC TENS Device, Model EM-38 includes functional performance testing and electrical safety testing. The device is manufactured to comply with the following international standards:

EN 60601-1, Medical Equipment - part 1: General Requirements for Safety, 1990+A1;1993+A2;1995+A13;1996

EN 60601-1-2: 2007

EN 60601-1-4; 1996+A1;1999

EN 60601-1-6;2004

EN 60601-1-2-10:2000+A1;2001

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance. Furthermore it was demonstrated by a Usability Study that the labeling was sufficient for users to operate the device safely.

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Page -3-

6.0 Comparison to predicate device and conclusion

Compared with the predicate device, the Well-Life Model WL-2402, the Savia OTC TENS Device, Model EM-38, has the same intended use and similar technological characteristics. The differences between the two devices are minimal and do not present any safety and effectiveness issues. It is therefore concluded that the Savia OTC TENS Device, Model EM-38 is substantially equivalent to the predicate device.

Question	YES	NO
Is the device intended for prescription use (21 CFR 801 Subpart D)?A		X
Is the device intended for over-the-counter use (21 CFR 807 Subpart C)?A	X
Does the device contain components derived from a tissue or other biologic source?		X
Is the device provided sterile?		X
Is the device intended for single use?		X
Is the device a reprocessed single use device?		X
If yes, does this device type require reprocessed validation data?		X
Does the device contain a drug?		X
Does the device contain a biologic?		X
Does the device use software?	X
Does the submission include clinical information?		X
Is the device implanted?		X

Design and Use of the Device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

SEP 4 2012

Savia Ltd. c/o Mr. Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135

Re: K113321

Trade/Device Name: TENS Back Pain Relief System, Model EM-38 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 17, 2012 Received: August 24, 2012

Dear Mr. Ginsberg:

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.

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Page 2 - Mr. Guenter Ginsberg

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 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,
Kesia Alexander

Image /page/4/Picture/7 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with looping strokes and connected letters. The overall impression is that of a quick, fluid signature, possibly representing the initials or name of an individual.

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 Form

510(k) Number (if known):	K113.321
Device Name:	SAVIA OTC TENS Model EM-38

Indications for Use:

Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Zack Adan

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number

Page 1 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).