(249 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related concepts, and the device description is not available to provide further clues.
Yes
The device is described as being used for "symptomatic relief and management of chronic intractable pain" and "as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which indicates a therapeutic purpose.
No
The provided text for "Intended Use / Indications for Use" states that the device is used for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." It does not mention any diagnostic capabilities.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a TENS device, which typically involves hardware for electrical stimulation.
Based on the provided information, the SMART TENS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as being used for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Lack of IVD Characteristics: The provided information 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 in vitro examination of samples.
- Mentioning any laboratory procedures or tests.
The SMART TENS appears to be a therapeutic device that applies electrical stimulation for pain relief, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
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).
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Body Clock Health Care Limited c/o Mr. Ng Kam Tim Chief Engineer Fuji Dynamics Ltd. ___________________________________________________________________________________________________________________________________________________________ Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon. Hong Kong
Re: K091045
Trade/Device Name: Smart TENS, Model: D-BC05T Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ . Dated: October 1, 2009 Received: October 7, 2009
DEC 1 8 2009 _
Dear Mr. Tim:
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 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); medical device 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.
1
If you desire specific advice for your device on our labeling regulation (21 GFR-Part-801);- pleasego 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
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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Indication for Use Statement 11.
510(k) Number (if known): K091045
Device Name: SMART TENS
---Indications for Use:-------------------------------------------------------------------------------------------------------------------------------------------------------
The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) . . . . . .
Danl Kauff
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091045