(282 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
Yes
The device's intended use is "solely for the symptomatic relief of chronic intractable pain," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The 'Intended Use / Indications for Use' states that the device is "to be used solely for the symptomatic relief of chronic intractable pain," which indicates a therapeutic purpose rather than a diagnostic one.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "solely for the symptomatic relief of chronic intractable pain." This describes a therapeutic or pain management device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- 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.), detecting analytes, or providing diagnostic information.
- Focus on Symptomatic Relief: The primary function is to alleviate pain symptoms, which is a direct treatment rather than a diagnostic process.
Therefore, based on the provided text, this device falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.
Product codes
GZJ
Device Description
Not Found
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
physician licensed in the state in which he or she is practicing
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).
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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 1998
Mr. Daniel Lee President Apex Medical Corporation 10th Floor, Number 31, Lane 169 Kang Ning Street HSI Chih Chen, Taipei Hsien Taiwan R.O.C.
Re: K973978 Micro II Microcurrent TENS Trade Name: Requlatory Class: II Product Code: GZJ Dated: June 2, 1998 Received: June 4, 1998
Dear Mr. Lee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Daniel Lee
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if know) :
Device Name : MICRO-II MICROCURRENT TENS
Indications for Use :
INDICATIONS : -
This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.
CONTRAINDICATIONS :
- 1.TENS electrodes must be placed in such a position so as to pass electrical current into the carotid gland area.
- 2.TENS must not be prescribed to patients who are using a demand type cardic pacemaker.
-
- TENS electrodes must not be placed so as to pass current transcerebrally through the head.
- 4.TENS application must not be recommended before pain syndromes are diagnosed,and not before an appropriate etiology has been established.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concuurence of CDRH,Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-26)
(Optional Format 1-26)
IV