(212 days)
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Not Found
No
The summary describes a TENS device for pain management and does not mention any AI or ML capabilities.
Yes
The device is described as being used for the "symptomatic relief and management of chronic, intractable pain" and as an "adjunctive treatment in the management of post surgical and post traumatic acute pain problems," which are therapeutic applications.
No
Explanation: The device, TENS (Transcutaneous Electrical Nerve Stimulation), is described as being used for symptomatic relief and management of pain, indicating a therapeutic rather than diagnostic function. It does not mention identifying, analyzing, or diagnosing medical conditions.
No
The device description explicitly mentions "Besmed various models of TENS, BE-550 / BE-660," which are hardware devices (Transcutaneous Electrical Nerve Stimulators). The summary does not indicate that the submission is solely for software controlling these devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) unit. TENS devices are used to deliver electrical impulses to the body for pain relief, not to analyze samples from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Mentioning any reagents, calibrators, or controls used in laboratory testing.
In summary, the device's function and intended use clearly fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Specific indications: it is used for the symptomatic relief and management of ● chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
Product codes
GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified health professionals prior to the applications of the device at home or hospital facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of a human profile with three overlapping figures, resembling a bird in flight, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 28 2003
Besmed Health Business Corp. C/o Ke-Min Jen, Ph.D. R.O.C. Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K031374
Trade Name: Besmed various models of TENS, BE-550 / BE-660 Regulation Numbers: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: September 5, 2003 Received: September 15, 2003
Dear Dr. Jen:
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 - Ke-Min Jen, Ph.D.
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. 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,
Mark N. Millerson
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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4. INDICATIONS FOR USE STATEMENT
Applicant : Besmed Health Business Corp.
510(k) Number :
Device Name : Besmed various models of TENS, BE-550 / BE-660
Indications for Use :
- Specific indications: it is used for the symptomatic relief and management of ● chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use OR Per 21 CFR 801.109 Format 1-2-96) i. Restorative Curological () Number.