K Number
K993202
Device Name
EIM-107 PREP-CHECK
Manufacturer
Date Cleared
1999-12-17

(84 days)

Product Code
Regulation Number
882.1540
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EIM-107 is indicated for use whenever it is desired to measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets for algorithms. The device description is also not available.

No
The device is used to measure the impedance and offset voltage of electrodes, which are diagnostic/assessment functions, not therapeutic.

Yes
The device is indicated to "measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient," which implies it is used to obtain information for a diagnosis or to monitor a condition.

Unknown

The provided summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.

Based on the provided information, the EIM-107 is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • EIM-107 Intended Use: The EIM-107 is indicated for measuring or assessing the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient. This involves direct interaction with the patient's skin, not the analysis of a sample taken from the patient.

Therefore, the EIM-107 falls under the category of a medical device used for patient monitoring or assessment, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The EIM-107 is indicated for use whenever it is desired to measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient.

Product codes

IKJ

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

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)

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

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

0

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

DEC 1 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Smith President General Devices 1000 River Street Ridgefield. New Jersey 07657

Re: K993202

Trade Name: EIM-107 Prep-Check Electrode Impedance Meter Regulatory Class: II Product Code: IKJ Dated: September 22, 1999 Received: September 24, 1999

Dear Mr. Smith:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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.

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.

1

Page 2 - Mr. Michael Smith

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) 594-4595. 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,

Kleine Zimme

& - James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

INDICATIONS FOR USE STATEMENT

PMN 510(k) Number: K 993202

Device Name: EIM-107 Prep-Check Electrode Impedance Meter

Indications For Use:

The EIM-107 is indicated for use whenever it is desired to measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

und "June fy J 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / 2 / r Division Sign-Off) ision of General Restorative Devices 16993003 510(k) Number

Prescription Use ర్లు (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)