The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Description

The Basba E-Machine is a non-invasive, transcutaneous electrical stimulation device, which is intended for use as an adjunctive treatment for individuals suffering from chronic intractable pain. The system consists of a.TENS Unit, AC-DC adapter to power the unit and a serial RS-232 connection cable. The Unit is approximately 17 cm x 15 cm x 4 cm. Two light emitting diodes (LED) are located on the faceplate of the Unit. The green LED indicates the working status of the device and the red LED is the power indicator. There are four sockets located on the faceplate of the Unit: three of them labeled "OUT" provide the output electrical current for 3 different types of connectors and the fourth socket is the ground socket labeled GND.

AI/ML Overview

The Basba E-Machine is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The provided document is a 510(k) premarket notification summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting an efficacy study with acceptance criteria and performance data in the typical sense of a clinical trial.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly filled from this document. This submission primarily relies on comparing technical characteristics and intended use to already cleared devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific acceptance criteria or performance metrics (e.g., pain reduction scores, percentage of users experiencing relief) in a quantifiable manner as would be expected from a clinical efficacy study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technical, functional, and performance characteristics to existing predicate devices.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance
Safety: Device operates without raising new safety concerns.	"The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." Functional performance testing and electrical safety testing were conducted.
Functional Performance: Operates as intended for a TENS device.	"The Basba E-Machine has comparable technical and performance characteristics as currently marketed TENS devices." "The E-Machine and the referenced predicate devices use similar electronic components to provide electrical stimulation via paired electrodes to the subject. All of these devices are operated at continuous wave duty cycles."
Efficacy: Performs comparably to predicate TENS devices for intended use.	"The Basba E-Machine is designed to comply with the generally accepted performance specifications for TENS devices." "The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." It has the "same intended uses and similar technical, functional and performance characteristics" as predicate devices.
Electrical Safety: Compliant with relevant standards.	Electrical safety testing was conducted. (Specific standards or results not detailed in this summary.)
Intended Use: Matches predicate devices for pain relief.	"The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain." This matches the general intended use of predicate TENS devices.

2. Sample Size for Test Set and Data Provenance

The document describes functional performance and electrical safety testing of the device itself, but does not describe a clinical study on a human test set. Therefore, information like sample size, country of origin, or retrospective/prospective nature for clinical data is not applicable or provided.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission does not involve expert-adjudicated ground truth from a clinical study.

4. Adjudication Method

Not applicable. This submission does not involve clinical data requiring adjudication.

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

No. An MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than a direct comparative clinical trial against a "without AI" arm.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is not an algorithm or AI system. It's a physical TENS device. The performance described (functional and electrical safety testing) is inherently "standalone" in the sense that it refers to the device's own operation.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily the technical specifications and established safety/efficacy profiles of the predicate devices. The Basba E-Machine's tests (functional performance and electrical safety) demonstrate its compliance with, and similarity to, these established benchmarks. There is no biological or clinical "ground truth" established for individual cases as would be found in diagnostic device studies.

8. Sample Size for Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. No training set for an AI/ML algorithm is involved.

Summary

{0}------------------------------------------------

K041172

Basba E-Machine 510(k) Notification
April 30, 2004.

NOV 1 8 2004

APPENDIX A

510(k) PREMARKET NOTIFICATION SUMMARY

(Per 21 CFR 807.92)

I. Applicant: Teresa Yang Basba Inc. 15342-B East Valley Blvd. City of Industry CA 91746 626 / 336-9737 telephone 626 / 336-9237 facsimile Email: TY1688@yahoo.com
- Key Contact: M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile Email: tabsii@msn.com

II. Device Name

Proprietary Name:	Basba E-Machine
Common / Usual Name:	TENS Device
Classification Name:	Transcutaneous electrical nerve stimulator
Product Code:	GZJ

III. Predicate Device

The Basba E-Machine is substantially equivalent to other Transcutaneous Electrical Nerve Stimulator (TENS) devices currently in commercial distribution such as the Apex Medical Corporation's Apex Medical Digital TENS TS1211, TS1212 (K021755) and Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model Bmls03-5 (K033455).

IV. Intended Use of the Device

The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

V. Description of the Device

{1}------------------------------------------------

Summary of the Technical Characteristics of the Basba E-Machine as VI. Related to the Referenced Predicate Devices.

The Basba E-Machine has comparable technical and performance characteristics as currently marketed TENS devices. The E-Machine and the referenced predicate devices use similar electronic components to provide electrical stimulation via paired electrodes to the subject. All of these devices are operated at continuous wave duty cycles.

VII. Testing

Testing of the Basba E-Machine includes functional performance testing and electrical safety testing.

VIII. Conclusions

In comparison to the predicate devices, the Basba E-Machine has the same intended uses and similar technical, functional and performance characteristics. The Basba E-Machine is designed to comply with the generally accepted performance specifications for TENS devices.

The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues.

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three flowing lines representing the body and arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Basba Inc. C/o Mrs. M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Boulevard, #A Houston, Texas 77047

Re: K041172

Trade/Device Name: Basba E-Machine Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: November 9, 2004 Received: November 15, 2004

Dear Mrs. M. Joyce Heinrich:

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.

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.

{3}------------------------------------------------

Page 2 - Mrs. M. Joyce Heinrich

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) 276-0120. 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 vours.

R. Mark McMullen

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

{4}------------------------------------------------

KO41172

APPENDIX B

Indications for Use

510(k) Number (if known):

Pending

Device Name: Basba E-Machine

Indications for Use:

The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Prescription Use: X (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 (ODpE)

Mark A. Millerson

torative, and Netti

K041172

510(k) Number-

000020

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).