PLEXOLONG SETS

K013041 · Pajunk GmbH · CAZ · Jun 11, 2002 · Anesthesiology

Device Facts

• Record ID: K013041
• Device Name: PLEXOLONG SETS
• Applicant: Pajunk GmbH
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

Device Story

Plexolong sets comprise unipolar conduction needle, plastic cannula, and polyamide indwelling catheter; used for continuous peripheral nerve/plexus anesthesia delivery (up to 72 hours). Physician uses electrical stimulation via cable/connector to assist needle placement; catheter remains indwelling for anesthetic delivery. Device used in clinical settings by physicians. Benefits include localized, continuous anesthesia management. Not for ablation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use, sterile, latex-free, non-pyrogenic anesthesia conduction kit. Components: unipolar needle, plastic cannula, polyamide indwelling catheter, catheter adapter. Electrical stimulation capability via cable/connector. Materials identical to predicates (K000722, K840287). Supplied in sealed polypropylene containers or polypropylene/styrol paper envelopes.

Indications for Use

Indicated for patients requiring continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Not intended for RF ablation or any other type of ablation procedure.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Pajunk Unipolar needle (K000722)
• B Braun Medical Inc. plastic cannula, catheter with stylet and catheter adapter (K840287)

Submission Summary (Full Text)

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JUN 1 2002

K013041

# 510(k) Summary of Safety and Effectiveness

## Submitter Information:

PAJUNK GmbH AM Holzplatz 5-7 78187 Geisingen Germany

USA Contact:Mr. Burk A. Brandt CE Consultancy, Inc. 5010 NW Crescent Vly Dr Corvallis, OR 97330 - USA

Phone: [phone] Fax

### Device Name:

Trade Name: Plexolong Sets Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5140, April 1, 2000)

## Predicate Device:

The Plexus Anesthesia sets consist of a Pajunk Unipolar needle (with nerve stimulus connector and tubing), a plastic cannula, front-end open tip catheter with Teflon coated stylet and catheter adapter. The Unipolar needles (with nerve stimulus connector and tubing) have been cleared for market by the FDA under 510(k) number K000722.

The plastic cannula, front-end open tip catheter with Teflon coated stylet and catheter adapter are substantially equivalent to the plastic cannula. catheter with stylet and catheter adapter contained in identical sets manufactured by B Braun Medical Inc. that were cleared by the Food and Drug Administration under 510(k) number K840287.

The contract sterilizer and sterilizing process are identical to those used for the Pajunk Unipolar needles. The packaging materials are also the same as those used to package the Pajunk Unipolar needles. The difference is that the packaging is slightly larger to accommodate the plastic cannula, catheter with stylet and catheter adapter.

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# Device Description:

The PAJUNK Plexolong sets are single use sterile, Latex free and nonpvrogenic needles, with a plastic cannula and catheter intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

### Intended Use:

The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

### Warning:

The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure.

# Technology Characteristics:

The PAJUNK Unipolar needles, which include the physical dimensions, coating, connector, tubing, metal and plastics, have been cleared under 510(k) number K000722. The material used to manufacturer the Pajunk catheter and catheter adapter are identical to the material used to manufacture the catheter and catheter adapter of the predicate device described earlier in this 510(k) Summary of Safety and Effectiveness. The Plexolong Anesthesia Sets are supplied in sealed polypropylene containers or polypropylene and styrol paper envelopes that are sealed to assure sterility.

### Conclusion

The Pajunk Plexolong Anesthesia Sets are as safe and effective as the predicate device when used in accordance with the instructions supplied with the device.

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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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2002

Pajunk GmbH Mr. Burk A. Brandt c/o CE Consultancy, Inc. 5010 NW Crescent Valley Drive Corvallis, OR 97330

Re: K013041 Plexolong Sets Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II (two) Product Code: CAZ Dated: June 5, 2002 Received: June 6, 2002

Dear Mr. Brandt:

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 - Mr. Burk A. Brandt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Dan O'Toole

Donna-Bea Tillman. Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

## 510(k) Number: K013041

Device Name: Pajunk Plexalong Anesthesia Sets

### Intended Use:

The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

### Warning:

The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR Over-The-Counter___________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.10)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01304
vascular & Respiratory D