The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics.

The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space (optional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example Stimul.ong and Stimulong Tsui-Method.

Pajunks Injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.

Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.

Device Description

Pajunk GmbH Medizintechnologie is submitting this 510(k) for the Pajunk StimuLong Tsui Method Set. The Tsui-Test is a well known technique in epidural anesthesia. It combines the advantages of epidural anestesia and stimulation via catheter in order to verify the area anesthesia is applied to. The Tsui test makes epidural anesthesia much more safe and effective as demonstrated and proven in several studies and articles published since the 1990 % (see section 20 of this submission. Physicians until now had to combine different devices in order to get a "self-made set acc. Tsui". Dr. Tsui combined Pajunks StimuLong set and technique deared for perifical use and Prayinks Epilong set and technique for epidural use to have a striking safe and effective alternative to "selfmade in-house devices". The devices for epidural Anesthesia (EpiLong) and peripheral Anesthesia employing stimulation via catheter (StimuLong) are already cleared for market seperately without claiming specific patient populations. The basis of this submission in the indications for use of this two cleared device: peripheral and epidural stimulation guided anesthesia. The components which are part of the subject device kit have already gained market clearance. They are combined under a new indication on customers demands. The predicate devices are Pajunks own products cleared for a non specified population, i.e. for use with adult patients. In order to demonstrate safety and effectiveness Pajunk provides clinical lieterature from Dr. Tsui as well as a clinical evaluation. Pajunks StimuLong Tsul Method Set are single use, sterile, non-pyrogenic and latex free medical device kits. They are intended for continuous peripheral or epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. An electrical stimulus may be applied via catheter in order to precisely identify the area anesthesia is intended to be applied to.

The Pajunks StimuLong Tsui Method Set provides a coated Tuohy cannula, a StimuLong catheter, StimuLong adaptor, valve, adaptor cables, injection hose, filter, LOR-syringe, catheter fixation device, FixoLong and tightning adaptors. The coating on the cannula is laqueur or NanoLine coating, which has been cleared in K053283. The catheter comes with a catheter container, steel stylett and introductory aid for better handling and shape security. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylett. There is no change in components compared to the StimuLong and EpiLong set already cleared for market. All components are available seperately. Within the indications for use and the components cleared for market the StimuLong Tsui method set is customizable.

AI/ML Overview

This document is a 510(k) Premarket Notification Submission for Pajunks StimuLong Tsui Method Set. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Summary of Acceptance Criteria and Device Performance:

The primary acceptance criterion for this submission is demonstrating substantial equivalence to existing predicate devices already cleared for market. The study proving this involves a comparison of technology characteristics and a review of clinical literature.

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Conclusion: The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are at least as safe and effective as, and substantially equivalent to, the predicate devices. The submission emphasizes that there are "no change in technology or material" compared to the predicate devices.
Device Components	The Pajunks StimuLong Tsui Method Set provides a coated Tuohy cannula, a StimuLong catheter, StimuLong adaptor, valve, adaptor cables, injection hose, filter, LOR-syringe, catheter fixation device, FixoLong and tightening adaptors. The coating on the cannula is lacquer or NanoLine coating, which has been cleared in K053283. The catheter comes with a catheter container, steel stylett, and introductory aid for better handling and shape security. The catheter is closed at the tip and equipped with three lateral holes, optional with an open tip, an integrated spiral (for enhanced stability), and a stylett. There is no change in components compared to the StimuLong and EpiLong sets already cleared for the market. All components are available separately. Within the indications for use and the components cleared for market, the StimuLong Tsui method set is customizable.
Sterilization Method	Method: EtO. The contract sterilizer and the sterilizing process are identical to those used for all of Pajunk's devices provided sterile, which have been cleared for the US market in several Premarket Notification submissions. Annual validation, quarterly verification, and shelf-life testing demonstrate the sterilization procedure is safe and effective.
Indications for Use	The device is intended for continuous conduction anesthesia to the epidural space as well as optionally to peripheral nerves and plexus. The catheter must be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician in precisely and safely pinpointing the area of application in peripheral use, an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripherally, an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics. This indication for use is a combination of the indications of the predicate devices (Pajunks StimuLong Set for peripheral use and Pajunks EpiLong Set for epidural use).
Technological Characteristics	The device components (coated Tuohy cannula, StimuLong catheter, etc.) are already cleared. The key technological characteristic is the combination of existing cleared components to create a "Tsui-Method Set" which facilitates a known technique in epidural anesthesia. The submission explicitly states "Because there is no change in technology or material the focus is set on the clinical literature review".

Study Details:

The submission does not describe a traditional clinical study with a test set, ground truth experts, or formal adjudication. Instead, it relies on a literature review and comparison to predicate devices to demonstrate substantial equivalence.

Sample size used for the test set and data provenance:
- No explicit "test set" in the sense of patient data is described. The evaluation relies on a comparison with predicate devices and existing clinical literature.
- Data provenance is primarily from "clinical literature from Dr. Tsui" and "several studies and articles published since the 1990's" (referred to in Section 20 of the submission, though not provided in the excerpt) related to the Tsui-Test technique and the predicate devices. The country of origin for the studies is not specified in the provided text. The submission itself is from a German manufacturer (Pajunk GmbH Medizintechnologie).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No direct ground truth establishment by experts for a novel test set is described. The efficacy and safety are inferred from the existing body of clinical literature and the established use of the technique (Tsui-Test) and the predicate devices. The clinical literature cited refers to Dr. Tsui, implying his expertise underpins the technique.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is relevant or described, as there isn't a new test set requiring expert review and consensus.
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 MRMC study was conducted. This device is a medical instrument (catheter set) and not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device, not an algorithm.
The type of ground truth used:
- The "ground truth" for the device's safety and effectiveness is established through:
  - Clinical literature review: Citing published studies and articles (e.g., from Dr. Tsui) supporting the safety and effectiveness of the "Tsui-Test" technique and the use of stimulation via catheter for precise application of anesthesia.
  - Predicate device history: The components and the general techniques (epidural and peripheral anesthesia with stimulation) are already cleared and established through the predicate devices (Pajunks StimuLong Set and Pajunks EpiLong Set).
The sample size for the training set:
- Not applicable. This is a medical device submission, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Premarket Notification Submission

Image /page/0/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below this, in smaller white letters, is the word "MEDIZINTECHNOLOGIE".

510(k) Premarket Notification Submission:

Summary of Safety and Effectiveness According to 21 CFR 807.92 Date of Preparation: December 21st, 2006

Sterilizer:

JAN 1 2 2007

078

Submitter Information/ production site:

Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605

SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Moerfelden Germany

Contact:

Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com Establishment Registration Number: 9611612

US Contact:

Stefan Dayagi Fon: +01(0)770-493-9305

E-Mail: stefan.dayagi@pajunk-usa.com

Device Information:

Trade Names:	Pajunks StimuLong Tsui-Method Set
Common Name:	Epidural and peripheral stimulation catether set
Classification Name:	Anesthesia Conduction Kit
ClassificationReference:	21 CFR § 868.5140, April 1, 2005,
PoposedClassification:	Regulatory Class II
Proposed ProductClassification Code:	CAZ, Kit, Conduction Anesthesia
Panel:	Anesthesiology
Predicate Devices:	1. Pajunks StimuLong Set K033018, K0431302. Pajunks EpiLong Set K060311

{1}------------------------------------------------

Premarket Notification Submission

Image /page/1/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, "MEDIZINTECHNOLOGIE" is written in smaller, black letters.

077

ltem 03

Section 05 Revised 510(k) Summary of Safety and Effectiveness

This section of the submission for Pajunks StimuLong Tsui Method Set contains

The summary of safety and effectiveness .
. Submitter Information
t Device Information
. Device Description
. Predicate devices
. Sterilization
Technology Characteristics �
Safety and Effectiveness: Conclusion

The 510(k) Summary may be copied and submitted to interested parties as required by 21 CFR 807.92.

{2}------------------------------------------------

Premarket Notification Submission

Image /page/2/Picture/2 description: The image shows the word "PAJUNK" in bold, white letters against a black background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, black letters. The text appears to be a logo or brand name, possibly for a medical technology company.

Device Description

Physicians until now had to combine different devices in order to get a "self-made set acc. Tsui". Dr. Tsui combined Pajunks StimuLong set and technique deared for perifical use and Prayinks Epilong set and technique for epidural use to have a striking safe and effective alternative to "selfmade in-house devices".

The devices for epidural Anesthesia (EpiLong) and peripheral Anesthesia employing stimulation via catheter (StimuLong) are already cleared for market seperately without claiming specific patient populations. The basis of this submission in the indications for use of this two cleared device: peripheral and epidural stimulation guided anesthesia.

The components which are part of the subject device kit have already gained market clearance. They are combined under a new indication on customers demands.

The predicate devices are Pajunks own products cleared for a non specified population, i.e. for use with adult patients. In order to demonstrate safety and effectiveness Pajunk provides clinical lieterature from Dr. Tsui as well as a clinical evaluation.

Pajunks StimuLong Tsul Method Set are single use, sterile, non-pyrogenic and latex free medical device kits.

They are intended for continuous peripheral or epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. An electrical stimulus may be applied via catheter in order to precisely identify the area anesthesia is intended to be applied to.

Predicate Devices

The devices Pajunk claims substantial equivalence with are Pajunks StimuLong Set and UP cannulas cleared under K000722, K033018, K043130, K 040965 and Pajunks EpiLong Set cleared under K060311.

The indications of StimuLong and EpiLong are already cleared for market.

Because the devices are technical cleared this submission concentrates on the clinical discussion of the combination of advantages of epidentiation of the cirinear

The detailed disoussion of substantial eqivalence can be found in Section 12 of this submission. Because there is no change in technology or material the focus is set on the clinical liferature review in section 10 of this submission.

Sterilization

Sterilization method: EtO

The contract sterilizer and the sterilizing process are identical to the ones used for all of Pajunks devices provided sterile, essee continue production devices cleared for the US market in several Premarket Notification submissions.

By annual validation and quarterly verification as well as by shelflife testing the sterilization procedure is claimed to be safe and effective for several years now.

{3}------------------------------------------------

Premarket Notification Submission

Image /page/3/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE".

080

Technology Characteristics:

The catheter comes with a catheter container, steel stylett and introductory aid for better handling and shape security. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylett. There is no change in components compared to the StimuLong and EpiLong set already cleared for market.

All components are available seperately. Within the indications for use and the components cleared for market the StimuLong Tsui method set is customizable.

Conclusion:

The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are at least as safe and effective as, and substantially equivalent to the predicate devices. A rationale for the method is included this sumbission.

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Image /page/4/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 wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christian Quass Regulatory Affairs Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 Geisingen, Baden-Wurttemberg Germany 78187

JAN 1 2 2007

Re: K062900

Trade/Device Name: Pajunks StimuLong Tsui Method Set; Anesthesia Conducting Stimulation Catheter, Epidural and Peripheral; Anesthesia Conducting Epidural Stimulation Catheter; Anesthesia Conducting Peripheral Stimulation Catheter; Stimulation Adapter, Adapter Cable; Injection Valve and Injection Hose; Peripheral Coated Cannulas (NanoLine)

· Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: CAZ Dated: December 21, 2006 Received: December 26, 2006

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.

{5}------------------------------------------------

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 (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) 276-0115. 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,

Syitte Y. Michael Omd

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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Premarket Notification Submission

Image /page/6/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE".

Indications for use

510(k) Number:	K062900
-----------------------	----------------

Device Name:

Pajunks StimuLong Tsui Method Set

Indications for Use:

The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus.

The catheter has to be removed or replaced after 72 hours.

Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle.

After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter.

The set is to be used with adults and in pediatrics.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

070

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

menthesiology, General I Sontrol, Demal De

Yclane

{7}------------------------------------------------

Premarket Notification Submission

Image /page/7/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE".

Indications for use
510(k) Number:	K062900
Device Name:	peripheral	Anesthesia conducting stimulation Catheter, epidural and
Indications for Use:
The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space(otional: peripheral) to precisely identify the target area and to facilitate a longer anestheticeffect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip canremain for as long as determined by the professional anesthetist and the instructions for use. Ithas to be removed or replaced after 72 hours.




Prescription Use(Per 21 CFR 801.109)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)



· Factor Baneral Hospital.
Infection Control, is inter 1981085
	510/k) Number Kata Jack


Page 1 of 1

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Premarket Notification Submission

Image /page/8/Picture/2 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, white letters.

072

Indications for use

510(k) Number: K062900
Anesthesia conducting epidural stimulation Catheter

Indications for Use:

Device Name:

The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect.

After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suse Runk

Division of General Hospital,
Infectious Disease and AIDS

S. Gregory Carmichael

Klu Jace

{9}------------------------------------------------

Premarket Notification Submission

Image /page/9/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, black letters.

Indications for use

510(k) Number: K062900

Device Name: Anesthesia conducting peripheral stimulation Catheter

Indications for Use:

The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Siser Rinn

i. D.V.R.Y.
ii. D.V.R.Y. and D.V.R.Y. and D.V.R.Y.

KNOWLEDGE

{10}------------------------------------------------

Premarket Notification Submission

Image /page/10/Picture/2 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, white letters.

074

Indications for use

510(k) Number:

Device Name:

K062900

Stimulation Adapter, Adaptor cable

Indications for Use:

Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example Stimul.ong and Stimulong Tsui-Method.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suse Burrows

$
$

{11}------------------------------------------------

Premarket Notification Submission

K062900

Image /page/11/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner, black letters.

Indications for use

510(k) Number:

A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Injection valve and injection hose

Indications for Use:

Device Name:

Pajunks Injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suze Quon

Page 1 of 1

{12}------------------------------------------------

Premarket Notification Submission

Image /page/12/Picture/2 description: The image shows the word "PAJUNK" in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner, black letters. The text appears to be a logo or heading, possibly for a company or organization related to medical technology. The contrast between the white text and black background makes the words stand out.

076

Indications for use
510(k) Number:	K062900
Device Name:	Peripheral coated Cannulas (NanoLine)
Indications for Use:	Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.
Prescription Use(Per 21 CFR 801.109)	X

AND/OR

Over-The-Counter Use(21 CFR 801 Subpart C)	_________________
------------------------------------------------	-------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Page 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).