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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Pajunk Plexalong Sets, a medical device intended for continuous conduction anesthesia. The document details the device description, intended use, and a summary of performance testing based on recognized consensus standards. However, it does not contain the kind of detailed study information (e.g., sample sizes, expert qualifications, specific performance metrics with numerical values) typically found in a clinical study report or a multi-reader, multi-case study that would enable the filling out of the requested table and answering questions 2-9.

The "Summary of Performance Testing" section primarily lists consensus standards that the device was designed to conform to. It does not provide specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures) nor does it report the device's performance against such criteria. Instead, it implies conformance through meeting recognized standards, which are often related to material properties, sterility, and mechanical integrity, rather than clinical effectiveness or diagnostic accuracy.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer the questions based only on the provided information, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to DIN 13090/ISO 594 (Luer fittings w/wo locking feature)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN 13097 Part 1 (Medical injection cannula)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN 13097 Part 3 (Medical cannula)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN 17442/ISO 9626 (Steel for medical instruments)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 550 (Sterilization of med. Prod.; Validation & routine controls for sterilization with ETO)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 556 (Sterilization of medical products, requirements for medical products that are labeled "sterile")	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 724 (Guidance on the application of EN29001 and EN46001 for non-active medical products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to PrEN 868-1 (Packaging materials for the sterilization of packaged goods. Part 1: general requirements for the validation of the packaging of sterilized end-packaged products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 868-2 (Packaging materials for the sterilization of packaged goods. Part 2: sterilization packaging, requirements and tests.)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 980 (Graphic symbols for marking medical products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 1441 (Risk analysis for medical products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to EN ISO 14971 (Risk Management)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 1707 (6% Luer cone connections for injection cannula and particular medical equipment)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN/ISO 9626 and A1:2001 (Cannula tube of non-rusting steel (SS) for the manufacture of medical products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to BS 6196 (Sterile epidural catheters and introducer needles for single use)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 30993-1 (Biological evaluation of medical products - instructions for selection of tests)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN EN 46001 (Particular requirements for medical products)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to DIN 17440 (Stainless Steels)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Conformance to BS 4843 (Single entry IV cannula)	Designed to conform to this standard. (No specific performance data provided beyond this statement).
Safety and effectiveness comparable to predicate devices.	Stated as "as safe and effective as the predicate devices when used according to the instructions".

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The performance testing refers to conformance to standards, not a specific clinical test set.
Data Provenance: Not specified. The document is from Pajunk GmbH in Germany, implying the device development and initial testing might be based there, but no details on data origin (e.g., country of origin of data, retrospective or prospective) for any specific study are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The performance testing focuses on engineering and material standards rather than expert-adjudicated clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable as there is no mention of a human-adjudicated test set or a clinical study that would require such a method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an anesthesia conduction kit, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing cited is conformance to established engineering, material, and sterilization consensus standards (e.g., DIN, ISO, EN, BS standards for Luer fittings, cannula, sterilization). There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) in this 510(k) summary.

8. The sample size for the training set

Not applicable/Not specified. This is a physical device, and the summary does not refer to a machine learning model or a training set.

9. How the ground truth for the training set was established

Not applicable/Not specified. (See explanation for #8).

Summary

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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: (541) 752-3953 Fax: (541) 752-3972

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:

Intended Use:

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 controlsfor sterilization with ETO
DIN EN 556	01.1995	Sterilization of medical products, requirements formedical products that are labeled "sterile"
DIN EN 724	12.1994	Guidance on the application of EN29001 and EN46001for non-active medical products
PrEN 868-1	10.1996	Packaging materials for the sterilization of packagedgoods. Part 1: general requirements for the validationof the packaging of sterilized end-packaged products
DIN EN 868-2	03.1993	Packaging materials for the sterilization of packagedgoods. Part 2: sterilization packaging, requirementsand 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 andparticular medical equipment
DIN EN/ISO 9626 andA1:2001	06.1995	Cannula tube of non-rusting steel (SS) for themanufacture of medical products
BS 6196	1889	Sterile epidural catheters and introducer needles forsingle use
DIN EN 30993-1	12.1994	Biological evaluation of medical products - instructionsfor 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 (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 (301) 443-6597 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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).