(210 days)
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Not Found
No
The summary describes a simple electrode accessory for TENS devices and contains no mention of AI, ML, or related concepts.
No
The device is described as an accessory electrode for TENS generators, which are therapeutic devices, but this specific device itself is not described as providing therapy.
No
Explanation: The device description states it is an "accessory device intended to be used as an electrode" for TENS generators. It does not mention any diagnostic capabilities.
No
The device description explicitly states it is an "Auricular Electrode," which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "accessory device intended to be used as an electrode" for use with TENS generators. This indicates it's a device applied externally to the body for therapeutic purposes (likely electrical stimulation), not for testing samples taken from the body.
- Device Description: The description reinforces its function as an electrode.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information about a patient's health status through in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The KimStim Auricular Electrode is designed as an accessory device intended to be used as an auricular (ear) electrode. The KimStim® Auricular Electrode is designed in an ergonomic design sized for a single patient use and is reuseable.
General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.
Product codes
GXY, BWK
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
auricular (ear)
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
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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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC 2 7 2001
Image /page/0/Picture/2 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 design of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kim Institute for Rehabilitation Medicine, P.C. C/O Donald F. Grabarz Managing Director International Regulatory Consultants, L.C. Mid Valley Professional Plaza 7651 S. 700 West, Suite 105 Salt Lake City, Utah 84047-7101
Re: K011691/S1
Trade/Device Name: KimStim Auricular Electrode Regulation Number: 21 CFR 882.1320 and Unclassified Regulation Name: Cutaneous Electrode and Electro-Acupuncture Regulatory Class: Class II Product Code: GXY and BWK Dated: October 11, 2001 Received: October 15, 2001
Dear Mr. Grabarz:
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
1
Page 2 - Mr. Donald F. Grabarz
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse organizatial equivalence of your device of your device to a legally premaired 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 11 you desire specific acres on of for in vitro diagnostic devices), please contact the Office of adultionally 21 Of I F I ar 659. Additionally, for questions on the promotion and advertising of Compinance at (301) 591-1097 Office of Compliance at (301) 594-4639. Also, please note the your device, picaso commovand o by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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,
R. Mark A. Milken
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
2
Page of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_
Indications For Use:
510(k) Number: K011691 Supplement: December 19, 2001
Intended Use (Indications for Use):
The KimStim Auricular Electrode is designed as an accessory device intended to be used as The KimStilli Autonal Electrode is assigned in an eversionized for a single patient use and is reuseable.
General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliman
Division of General, Restorative and Neurological Devices KO11691
510(k) Number_
(Optional Format 3-10-98)