(198 days)
No
The description focuses on basic electrical stimulation and hardware components, with no mention of AI/ML terms, data processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as providing "symptomatic relief and management of chronic and acute pain" and "adjunctive treatment in the management of post-surgical and post-traumatic pain," which are therapeutic applications. Additionally, it is a "transcutaneous electrical stimulation device," a modality commonly used for therapeutic purposes.
No
The Basba E-Machine is described as a non-invasive, transcutaneous electrical stimulation device intended for symptomatic relief and management of pain, not for diagnosing medical conditions.
No
The device description explicitly states that the Basba E-Machine is a "non-invasive, transcutaneous electrical stimulation device" and lists hardware components such as a TENS Unit, AC-DC adapter, serial RS-232 connection cable, LEDs, and sockets. This indicates it is a hardware device, not software-only.
Based on the provided text, the Basba E-Machine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "symptomatic relief and management of chronic and acute pain" and "adjunctive treatment in the management of post-surgical and post-traumatic pain." This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a "non-invasive, transcutaneous electrical stimulation device." This is consistent with a device that delivers electrical impulses to the body for therapeutic effect, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Diagnostic purposes (identifying diseases, conditions, etc.)
Therefore, the Basba E-Machine is a therapeutic device, specifically a TENS (Transcutaneous Electrical Nerve Stimulation) unit, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
GZJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Basba E-Machine includes functional performance testing and electrical safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Apex Medical Digital TENS TS1211, TS1212 (K021755), Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model Bmls03-5 (K033455)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
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.
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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
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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
510(k) Number-
000020