The change of coating material from lacqueur to Parylene does not affect the Indications for use of the predicated devices marketed under K042979 (Pajunk Plexolong Sets), K033018 (Pajunk Stimulong Plus Catheter Sets), K023218 (Pajunk Plexolong Sets), K013041 (Pajunk Plexolong Anesthesia Sets), K999722 (Unipolar Needles with Standard and Sprotte-tip). The change in coating has no effect on the Indications for use of these devices already cleared for market.

Device Description

Pajunk's PlexoLong and StimuLong sets consist of a Pajunk unipolar needle, an open ended conduction catheter and a catheter adapter, as well as a filter. The coating of the needle will be chnaged to NanoLine. Pajunk's Unipolar needles marketed separately as single shot needles under the trade name UniPlex have a lacquer coating, which will be changed to NanoLine coating, Only the coating material of the needles is affected by this change. The anesthesia conduction catheters and the packaging materials are the same as those used for Pajunk's PlexoLong sets cleared for market by FDA under 510(k) numbers K013041, K023218 and K042979. The NanoLine coating is equivalent to HDC's Insul-Cote PTM needles and CLA kit (nerve stimulation) marketed under K994059. (In fact NanoLine is a better material because of a higher grade of purity. For a precise discussion of this topic see section 15 "Biocompatibility" of this submission of a special 510(k)). The contract sterilizer other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) and the stepally hame change (was film inford Sterice, and este sets.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for Pajunk's Anesthesia Conduction NanoLine Coated Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study with statistical data.

Therefore, the information required to populate the table and sections about acceptance criteria and a study proving their fulfillment is not present in the provided text. The submission indicates that the change is primarily a material change for the coating (from lacquer to NanoLine/Parylene), and the primary evidence presented is through comparison to predicate devices and biocompatibility testing. There is no mention of a clinical or performance study with specific acceptance criteria that the device's numerical performance is being compared against.

Here's a breakdown of why each requested item cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as numerical performance targets for this device. The submission aims to show "substantial equivalence" to predicate devices, implying similar performance rather than meeting new, distinct numeric thresholds.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, signal strength) are reported for the NanoLine coated needles. The document asserts that the change in coating does not affect the performance or indications for use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific test set or clinical study is described that would have a sample size mentioned. The submission relies on comparisons and biocompatibility data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No human-expert-reviewed test set is mentioned.

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

No test set requiring adjudication is mentioned.

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

This device is an anesthesia needle, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

Not applicable as this is a medical device (needle), not an algorithm.

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

No ground truth data relevant to clinical performance is discussed for a new study. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of Device Rationale from the Text:

The premise of this 510(k) submission is to demonstrate that the new NanoLine coating material for anesthesia conduction needles does not alter the fundamental safety and effectiveness of the devices compared to their previously cleared predicate devices, which used a lacquer coating. The key arguments are:

Material Change Only: The primary change is the coating material from lacquer to NanoLine (described as Parylene).
Substantial Equivalence: The NanoLine coating material is considered "substantially equivalent" to HDC's Insul-Cote PTM needles (K994059), which is a predicate device. Furthermore, NanoLine is presented as "a better material because of a higher grade of purity."
No Impact on Indications for Use: The change in coating material "does not affect the Indications for use of the predicated devices."
Biocompatibility Testing: "Biocompatibility testing of Pajunk's anesthesia conduction needles & sets... has been accomplished with best results." This is the primary "study" mentioned, confirming the safety of the new material, but specific acceptance criteria and detailed results are not provided in this summary.
Design Control Activities: Changes were "validated using the same protocols used to validate cleared devices. Results can be found in the summary of Risk-Analysis and in the Validation Reports of Section 09." (Section 09 is not provided in the extract). This implies internal testing and validation rather than a clinical performance study with external acceptance criteria.

In conclusion, the document seeks to establish substantial equivalence through material comparison, biocompatibility testing (which is a form of acceptance criteria for material safety), and leveraging the established safety and performance of predicate devices. It does not present a de novo clinical study with specific performance acceptance criteria and corresponding device performance data as would be typically found for new functional claims or diagnostic devices.

Summary

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K 053283

JAN 1 2 2006

NanoLine - Premarket Notification Submission

Image /page/0/Picture/3 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, black letters. The background of the logo is black and white.

510(k) Premarket Notification Submission: Summary of Safety and Effectiveness

Date of Preparation: October 27, 2005

Submitter Information/ production site:

Pajunk GmbH Karl-Hall-Straße 01 78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-610

Contact:

Christian Quaß, Regulatory Affairs Fon: +49(0)7704-9291-533 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com

Device Information:

Trade Names:	UniPlex NanoLine cannula,PlexoLong-NanoLine set,StimuLong-NanoLine set
Common Name:	Anesthesia conduction kit/ cannula
Classification Name:	Anesthesia conduction kit
Classification Reference:	21 CFR 868.5140, April 1. 2003
Proposed Classification:	Regulatory Class: II
Proposed Product Code:	CAZ
Predicate Devices:	1. K000722: Pajunk's Unipolar needles (UniPlex facet & Sprotte tip)
	2. K023218: Pajunk's Unipolar needles (UniPlex Tuohy tip)
	3. K033018: Pajunk's StimuLong set
	4. K013041, K023218 and K042979: Pajunk's PlexoLong set
	5. K994059: HDC's Insul-Cote PTM needles and CLA kit(nerve stimulation), includes HDC's Neuro-Trace insulated

needle.

ﯿﻨﭧ

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Image /page/1/Picture/1 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, thinner letters.

Device Description:

Pajunk's Unipolar needles marketed separately as single shot needles under the trade name UniPlex have a lacquer coating, which will be changed to NanoLine coating,

Only the coating material of the needles is affected by this change.

The anesthesia conduction catheters and the packaging materials are the same as those used for Pajunk's PlexoLong sets cleared for market by FDA under 510(k) numbers K013041, K023218 and K042979.

The NanoLine coating is equivalent to HDC's Insul-Cote PTM needles and CLA kit (nerve stimulation) marketed under K994059. (In fact NanoLine is a better material because of a higher grade of purity. For a precise discussion of this topic see section 15 "Biocompatibility" of this submission of a special 510(k)).

The contract sterilizer other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) and the stepally hame change (was film inford Sterice, and
este sets.

Intended Use:

Pajunk's electrically insulated anesthesia conduction needles -- UniPlex-NanoLine cannula -are intended for professional anesthetists to facilitate the localization of peripheral nerve bundles for transient delivery of anesthetics during regional anesthesia.

Pajunk's electrically insulated anesthesia conduction needles are also provided within PlexoLong- and StimuLong and online sets intended for professional anesthetists to facilitate the transient delivery of anesthetics during regional anesthesia.

The localization of the peripheral nerve bundle is facilitated via insulated needles and impulses from a neuro-stimulator. The electric current flows from the de-insulated needles and mights innervated by the stimulated nerve bundle will the de-insulated needle the suitable setting.

Following nerve bundle localization, a catheter may be placed through the insulated anesthesia conduction needle close to the news for longer pain relief. After the needle has been withdrawn, the anesthesia conduction to to to to for to for the fielde nate that been withdra
anesther into the negipt call relater allows for bolus injections of local anesthetics into the peripheral nervous space.

Technology Characteristics:

Pajunk's anesthesia conduction needles & sets – UniPlex-NanoLine cannula, PlexoLong- & StimuLong -NanoLine sets – have the same technological characteristics as the predicate devices identified above.

Pajunk's anesthesia conduction needles & sets – UniPlex-NanoLine cannula, PlexoLong-NanoLine set & StimuLong-NanoLine set – are equivalent (in fact they are the same) in design, physical dimensions, luer hub, stilett, metal and plastics materials of needles and catheter, filter and connect of there, there, materials of needles and
catheter, filter and connector, as well as packaging to Pajunk's PlexoLong sets cleared for

· ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/2/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters against a black background. The letters are slightly distorted, with some pixelation and jagged edges, giving the image a somewhat rough or textured appearance. The overall impression is that of a logo or brand name, possibly for a product or company.

MEDIZINTECHNOLOGIE

market by FDA under 510(k) numbers K013041, K023218 and K042979. The NanoLine coating material is substantial equivalent to HDC's Insul-Cote PTM needles and CLA hit (nerve stimulation) marketed under K994059.

Biocompatibility testing of Pajunk's anesthesia conduction needles & sets – UniPlex-NanoLine cannula, PlexoLong- & StimuLong -NanoLine sets -- has been accomplished with best results.

Summary of Design Control Activities

Changes that could affect performance of the cannula or result in a risk to the patient or the user were validated using the same protocols used to validate cleared devices. Results can be found in the summary of Risk-Analysis and in the Validation Reports of Section 09.

Conclusion:

The electrically insulating coating on the cannula is only a change in material for Pajunk GmbH products. The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective when used according to the instructions for use supplied with the devices, as well as substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2006

Mr. Christian Quaß Manager Regulatory Affairs Pajunk GmbH Karl-Hall Strasse 1 78187 Geisingen GERMANY

Re: K053283

Trade/Device Name: Pajunk Anesthesia Conduction NanoLine Coated Needles Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSP Dated: December 21, 2005 Received: December 27, 2005

Dear Mr. Quaß:

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. Quaß

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 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/industry/support/index.html.

Sincerely yours,

Ours

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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Special Premarket Notification Submission

NanoLine

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Section 04

Indications for use

510(k) Number: K053283

Device Name: Pajunk anesthesia conduction NanoLine coated needles

Indications for Use:

The change of coating material from lacqueur to Parylene does not affect the Indications for use of the predicated devices marketed under

K042979 (Pajunk Plexolong Sets)

K033018 (Pajunk Stimulong Plus Catheter Sets)

K023218 (Pajunk Plexolong Sets)

K013041 (Pajunk Plexolong Anesthesia Sets)

K999722 (Unipolar Needles with Standard and Sprotte-tip)

The change in coating has no effect on the Indications for use of these devices already cleared for market.

Prescription Use AND/OR (Per 21 CFR 801.109)

Over-The-Counter Use

(21 CFR 801 Subpan C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clues

K.053283

Page 1 of 1

PMN
CQ
2006-01-05
P 1 of 1

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).