Pajunks's MultiStim SENSOR is intended for nerve stimulation during anaesthesia delivery; first for percutaneous identification of peripheral nerves and second for percutaneous localizations. This device is indicated for adults only.

Device Description

The MultiStim SENSOR devices are hand-held, battery-driven peripheral nerve stimulators for this purpose. The devices can be used for:

. Nerve finding with peripheral nerve stimulation needles
Percutaneous localization .
In relaxation monitoring for general anesthesia, the peripheral nerve stimulation technique is used to interpret the muscular feedback to stimulation pulses applied through adhesive skin electrodes in regards to the level of muscle relaxing drugs in the patient. Special functions do support this. Due to the fact, that the stimulation is done through the skin, much more electrical power is needed. That's why a stimulation current range of 0-60mA is needed.
In both applications, negative, monophasic pulses are to be generated by the devices and applied to humans either through peripheral nerve stimulation needles or through selfadhesive stimulation electrodes on the skin. Since the human body acts as a variable resistor and the anesthesiologist sets the device to a certain stimulation current, the nerve stimulator has to act as a constant-current-source. A built in microprocessor constantly adapts the voltage applied to the patient in order to compensate the varying patient's resistance and to provide a constant current through the patient.

AI/ML Overview

I am sorry, but the provided text from the 510(k) summary (K061172) does not contain the detailed acceptance criteria and study information typically found in a clinical study report for device performance.

The document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly describes the device, its intended use, and indicates that it is substantially equivalent to another Pajunk device (K011308).

Therefore, I cannot extract the specific information you requested, such as:

A table of acceptance criteria and reported device performance: This detail is absent. The document focuses on equivalence, not setting and reporting performance against specific acceptance metrics.
Sample size used for the test set and data provenance: No information about a specific test set or clinical study for performance evaluation is provided.
Number of experts used to establish ground truth and qualifications: Not mentioned.
Adjudication method: Not mentioned.
Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
Standalone algorithm performance: Not mentioned, as this is a physical medical device (nerve stimulator), not an AI algorithm.
Type of ground truth used: Not applicable in the context of this 510(k) submission approach.
Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How ground truth for the training set was established: Not applicable.

The 510(k) process for a device like a nerve stimulator often relies on engineering testing, compliance with standards (e.g., electrical safety, EMC), and comparative testing to show that the new device performs "as well as" or "similarly to" the predicate device for its intended use, rather than a clinical study with detailed performance metrics against a defined ground truth as would be seen for a diagnostic or AI-enabled device.

Summary

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Ko61172

Section 6.0

510(k) Summary of Safety and Effectiveness

This section contains the 510(k) Summary of Safety and Effectiveness. (This document can be copied and submitted to interested parties as required by 21CFR 807.92).

510(k) Summary of Safety and Effectiveness

Submitter's Information:

Pajunk Medical Technology GmbH Karl-Hall-Str. 1 78187 Geisingen Germany

OCT 1 7 2006

USA Contact:

Lynette Howard (Pajunk's USA agent) Lyle Howard Corporation 106 East 5th Ave. Mount Dora, Florida 32757 USA P 908.788.4580 F 352.383.8338 e-mail: Lylehoward@aol.com

Device Name:

Trade Names: MultiStim SENSOR

Common Names: Peripheral Nerve Stimulator

Classification Name: Electrical Peripheral Nerve Stimulator (Reference, 21 CFR, 868.2775)

Product Class: Class II

Product Code: KOI

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Predicate Devices:

Pajunk's MultiStim SENSOR Nerve Stimulators are substantially equivalent to Pajunk's MultiStim VARIO Nerve Stimulators marketed under 510(k) number K011308.

Device Description:

The MultiStim SENSOR devices are hand-held, battery-driven peripheral nerve stimulators for this purpose. The devices can be used for:

. Nerve finding with peripheral nerve stimulation needles
Percutaneous localization .

In relaxation monitoring for general anesthesia, the peripheral nerve stimulation technique is used to interpret the muscular feedback to stimulation pulses applied through adhesive skin electrodes in regards to the level of muscle relaxing drugs in the patient. Special functions do support this. Due to the fact, that the stimulation is done through the skin, much more electrical power is needed. That's why a stimulation current range of 0-60mA is needed.

In both applications, negative, monophasic pulses are to be generated by the devices and applied to humans either through peripheral nerve stimulation needles or through selfadhesive stimulation electrodes on the skin. Since the human body acts as a variable resistor and the anesthesiologist sets the device to a certain stimulation current, the nerve stimulator has to act as a constant-current-source. A built in microprocessor constantly adapts the voltage applied to the patient in order to compensate the varying patient's resistance and to provide a constant current through the patient.

Intended Use:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2006

Pajunk GmbH Medizintechnologie C/O Ms. Lynette L. Howard Lyle Howard Corporation 106 East 5th Avenue Mount Dora, Florida 32757

Re: K061172

Trade/Device Name: Pajunk Anesthesia MultiStim SENSOR-Nerve Stimulators Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: September 22, 2006 Received: September 26, 2006

Dear Ms. Howard:

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.

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Page 2 - Ms. Howard

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.

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Pajunk Anesthesia MultiStim SENSOR - Nerve Stimulators Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Replacement for original pages 8 & 27

Aun Saffron

Jl Siam-CM

u of Anesthesielogy, General Hospital con Control, Dental Devices

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).