MODIFICATION TO: PLEXALONG SETS

K042979 · Pajunk GmbH · BSP · Dec 21, 2004 · Anesthesiology

Device Facts

• Record ID: K042979
• Device Name: MODIFICATION TO: PLEXALONG SETS
• Applicant: Pajunk GmbH
• Product Code: BSP · Anesthesiology
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pajunk Plexalong Sets 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 connectors to assist the physician pinpoint the area of application.

Device Story

Plexalong sets are single-use, sterile, non-pyrogenic, latex-free kits for continuous peripheral nerve and plexus anesthesia. Components include a conduction needle (facet, Sprotte, or Tuohy tip), stylet, polyamide indwelling catheter, and catheter adapter. Stylet prevents tissue clogging during insertion; stylet material is polycarbonate. Physician uses nerve stimulus connector to apply electrical current to needle tip for anatomical localization. Device used in clinical settings by physicians. Output is localized anesthesia delivery via indwelling catheter for up to 72 hours. Benefits include sustained pain management through continuous infusion.

Clinical Evidence

Bench testing only. No clinical data provided. Testing verified conformance to recognized consensus standards including DIN 13090/ISO 594 (Luer fittings), DIN 13097 (cannula), DIN 17442/ISO 9626 (steel), and various sterilization/packaging standards (DIN EN 550, 556, 868).

Technological Characteristics

Single-use conduction anesthesia kit. Materials: Polyamide (catheter), Polycarbonate (stylet), Stainless steel (cannula per DIN 17440/ISO 9626). Components: needle, stylet, catheter, adapter. Connectivity: electrical nerve stimulus connector. Sterilization: ETO (per DIN EN 550). Packaging: Polypropylene containers. Standards: ISO 594 (Luer), ISO 9626 (cannula), EN ISO 14971 (risk management).

Indications for Use

Indicated for delivery of 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 needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• Plexalong sets (K013041)
• Unipolar needles (K000722)
• Unipolar needles with Tuohy tip (K023218)

Reference Devices

• Pajunk conduction needles (K033018)

Submission Summary (Full Text)

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DEC 2 1 2004

K0429i79

# 510(k) Summary of Safety and Effectiveness

#### Submitter Information:

PAJUNK GmbH Karl Hall Straße 1 D78187 Geisingen Germany

#### USA Contact:

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

Phone: [phone] Fax: [phone]

### Device Name:

Trade Name: Plexalong Sets Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5140, April 1, 2003), Anesthesia Conduction Needle (Reference, 21CFR, 868.5140, April 1, 2003)

#### Predicate Devices:

Plexalong sets consist of a Paiunk Unipolar needle (conduction cannula with nerve stimulus connector and tubing), stylet, and an open end catheter and a catheter adapter. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market under 510(k) number K023218.

The packaging materials used to package the Pajunk Plexalong sets, and needles have not changed. The contract sterilizer, other than a company name change (was Griffith Micro Science, now Sterigenics) and sterilizing process is the same.

510(k) Summary

046

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### Device Description:

The Pajunk Plexalong sets are single use, sterile, non-pvrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, stilett, a catheter and catheter adapter. The stylet is used to stop tissue from clogaing the needle (during insertion) by blocking the opening at the tip of the needle. Pajunk changed the stilett material from a surgical stainless steel to polycarbonate. The Unipolar needles used in the Plexalong sets are available in three tip configurations. A Unipolar needle with a facet tip, Sprotte tip or Unipolar needle with a Tuohy tip. Only Plexalong sets with the Tuohy needles are affected by the stilett material change. To assist the physician pinpoint the area of application, an electrical stimulus can be applied to the tip of the conduction needle via a nerve stimulus connector.

### Intended Use:

The Pajunk Plexalong Sets 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 connectors to assist the physician pinpoint the area of application.

## Technology Characteristics:

The Pajunk conduction needles, including the physical dimensions. connector, tubing, metal and plastics, have been cleared under 510(k) numbers K000722, K013041. K023218. and K033018. The material used to manufacture the Pajunk catheter and catheter adapter are identical to the materials used to manufacture the catheter and catheter adapter of the predicate devices described earlier in this 510(k) Summary of Safety and Effectiveness. The Plexalong Sets are supplied in polypropylene containers that are sealed to assure sterility.

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# Summary of Performance Testing

The Pajunk Plexalong Sets were designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards.

:

| Standard | Issue Date | Title |
|--------------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIN 13090/ISO 594 | 08.1984 | Luer fittings w/wo locking feature |
| DIN 13097 Part 1 | 01.1980 | Medical injection cannula |
| DIN 13097 Part 3 | 11.1979 | Medical cannula |
| DIN 17442/ISO 9626 | 10.1977 | Steel for medical instruments |
| DIN EN 550 | 07.1993 | Sterilization of med. Prod.; Validation & routine controls<br>for sterilization with ETO |
| DIN EN 556 | 01.1995 | Sterilization of medical products, requirements for<br>medical products that are labeled "sterile" |
| DIN EN 724 | 12.1994 | Guidance on the application of EN29001 and EN46001<br>for non-active medical products |
| PrEN 868-1 | 10.1996 | Packaging materials for the sterilization of packaged<br>goods. Part 1: general requirements for the validation<br>of the packaging of sterilized end-packaged products |
| DIN EN 868-2 | 03.1993 | Packaging materials for the sterilization of packaged<br>goods. Part 2: sterilization packaging, requirements<br>and tests. |
| DIN EN 980 | 08.1996 | Graphic symbols for marking medical products |
| DIN EN 1441 | 08.1994 | Risk analysis for medical products |
| EN ISO 14971 | 2000 | Risk Management |
| DIN EN 1707 | 01.1997 | 6% Luer cone connections for injection cannula and<br>particular medical equipment |
| DIN EN/ISO 9626 and<br>A1:2001 | 06.1995 | Cannula tube of non-rusting steel (SS) for the<br>manufacture of medical products |
| BS 6196 | 1889 | Sterile epidural catheters and introducer needles for<br>single use |
| DIN EN 30993-1 | 12.1994 | Biological evaluation of medical products - instructions<br>for selection of tests |
| DIN EN 46001 | 12.1993 | Particular requirements for medical products |
| DIN 17440 | 09.1996 | Stainless Steels |
| BS 4843 | | Single entry IV cannula |

# Conclusion:

The PAJUNK Plexalong Sets are as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices.

:

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Image /page/3/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

PAJUNK GmbH C/O Mr. Burk A. Brandt CE Consultancy, Incorporated 5010 NW Crescent Valley Drive Corvallis, Oregon 97330

Re: K042979

Trade/Device Name: Pajunk Plexalong Sets Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: December 4, 2004 Received: December 7, 2004

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. 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), 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/dsma/dsmamain.html

Sincerely yours.

Quts

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: Køy2977 7 -----------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Pajunk Plexalong Sets

#### Indications for use:

The Pajunk Plexalong Sets 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 Polvamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connectors 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 | xx |
|----------------------|----|
| (Per 21 CFR 801.109) | |

| OR Over-The-Counter | |
|---------------------|--|
|---------------------|--|

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________