PAJUNK MULTISTIM SENSOR NERVE STIMULATORS

K061172 · PAJUNK GmbH Medizintechnologie · BXN · Oct 17, 2006 · Anesthesiology

Device Facts

• Record ID: K061172
• Device Name: PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: BXN · Anesthesiology
• Decision Date: Oct 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

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 Story

MultiStim SENSOR is a hand-held, battery-powered peripheral nerve stimulator used by anesthesiologists in clinical settings. It facilitates nerve identification via stimulation needles and percutaneous localization using adhesive skin electrodes. The device generates negative, monophasic pulses. A built-in microprocessor functions as a constant-current source (0-60mA range), dynamically adapting output voltage to compensate for varying patient tissue resistance. This ensures consistent stimulation current delivery despite skin impedance. The output assists clinicians in interpreting muscular feedback to assess muscle relaxant levels or locate nerves, aiding in regional anesthesia procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing of the constant-current stimulation performance.

Technological Characteristics

Hand-held, battery-powered peripheral nerve stimulator. Constant-current source architecture using a microprocessor to adapt voltage based on patient resistance. Output: 0-60mA, negative monophasic pulses. Interfaces with peripheral nerve stimulation needles or adhesive skin electrodes.

Indications for Use

Indicated for adult patients requiring peripheral nerve stimulation for nerve identification and percutaneous localization during anesthesia delivery, including relaxation monitoring.

Regulatory Classification

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.

Predicate Devices

• MultiStim VARIO Nerve Stimulators (K011308)

Submission Summary (Full Text)

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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: [e-mail]

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

68

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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:

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.

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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 [phone]. 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 [phone] or [phone] 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:

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.

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

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