The PAJUNK® Sono-Series Kits SonoLong, SonoLong Sono, PlexoLong Sono, StimuLong Sono, SonoLong NanoLine and SonoLong Curl Sono are intended for delivery of continuous conduction anesthesia and/ or analgesia of peripheral nerves for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. Optionally an electrical stimulus may be applied to assist the physician pinpoint the area of application.

Device Description

The PAJUNK® Sono-Series Kits are single use sterile and non-pyrogenic kits basically consisting of catheters and cannulas as well as of optional components like Adapter, syringe, filter, filter fixation device and common hospital supply; used to gain entry or puncture the tissue micil inter fination do no continuous regional anesthesia anesthesia and analgesia for pain relief.

An electrical stimulus may be applied to the tip of the cannula/ needle (former PlexoLong series) An Cleunoul caffinale may of the cather (former StimuLong series) via cable and connector to assist the physician pinpoint the area of application.

The Sono-Cannulas/ needles are standard cannulas/ needles (cleared by several PMNsubmissions) equipped with the CornerStone technique in order to significantly enhance ultrasound visibility.

The Sono-catheters are standard anaesthesia conducting catheters equipped with an inner coil (cleared by several PMN-submissions) in order to enhance ultrasound visibility and device stability/ ergonomical features.

This submission of a 510(k) merely is due to new brand names than to introduce new techniques or technologies.

AI/ML Overview

The provided document (K113188 Premarket Notification Submission for Sono-Series Kits) describes the device and its intended use, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, this 510(k) submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices. The core argument for safety and effectiveness is that the Sono-Series Kits are essentially the same as existing devices, with the main change being new brand names and, for some components, enhanced ultrasound visibility features (CornerStone technique for cannulas/needles and an inner coil for catheters).

Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided text. The document explicitly states: "This submission of a 510(k) merely is due to new brand names than to introduce new techniques or technologies."

Here's a breakdown of what is in the document related to substantial equivalence:

1. Device Information:

Device Name: Sono-Series Kits (needles, catheters)
Trade Names: SonoLong, SonoLong Sono, SonoLong Curl Sono, StimuLong Sono, PlexoLong Sono, SonoLong NanoLine
Intended Use: For delivery of continuous conduction anesthesia and/or analgesia of peripheral nerves for up to 72 hours, using a Polyamide indwelling catheter. Optionally, electrical stimulus may be applied.
Device Description: Single-use, sterile, non-pyrogenic kits consisting of catheters and cannulas, and optional components. The Sono-Cannulas/needles are equipped with the CornerStone technique for enhanced ultrasound visibility. The Sono-catheters have an inner coil for enhanced ultrasound visibility and device stability.

2. Predicate Devices (for establishing substantial equivalence):

K033018 PAJUNK® StimuLong Plus Catheter sets
K013041 PAJUNK® PlexoLong Anaesthesia sets
K111374 PAJUNK® SonoPlex STIM SONO-SERIES CORNERSTONE TECHNIQUE

3. Basis for Substantial Equivalence (instead of performance criteria):
The submission argues that the new Sono-Series Kits are substantially equivalent to the predicate devices because:

The components are already cleared in the predicate devices' 510(k)s, with new brand names.
The sterilization process (Ethylene Oxide) and contract sterilizer are identical to those used for all PAJUNK® devices already cleared.
The CornerStone-technique and catheter coil do not influence sterilization or shelf life.
Cleaning and sterilization methods, ensuring SAL of 10^-6, compliance with limits for chemical burden, bioburden, pyroburden, and EtO residuals, and shelf life, have been validated and are safe and effective. Shelf-life is set to 5 years, validated for 10 years.
Biocompatibility: All cannulas comply with ISO 10993-1, 2nd and 3rd edition.
Technology Characteristics: Shelf life and impact of component arrangement have been proven.
Conclusion: The comparison to predicate devices, validated sterilization, biocompatibility testing, and bench testing demonstrate that the devices are substantially equivalent (identical) to devices already cleared for market and thus safe and effective. It specifically states: "the safety and efficacy of the CornerStone/Sono-technique is demonstrated for each type of kit" based on clinical evaluation, biocompatibility testing, and bench testing. However, no details about these studies (clinical evaluation, bench testing, what "demonstrated" means in terms of metrics/criteria) are provided in the excerpt.

Therefore, the requested table and study details cannot be provided from the given information. The document primarily serves to explain why the device is considered substantially equivalent to existing devices, rather than presenting a novel performance study against specific acceptance criteria for a new technology or claim.

Summary

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Premarket Notification Submission 510(k)

K113188

MEDIZINTECHNOLOGIE

Summary of Safety and Effectiveness

Date of Preparation: October 27th 2011

Submitter Information/ production site:

Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612

Contact:

Christian G. H. Quass Director Regulatory Affairs, Safety Official Patricia Weisbrod, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com

USA Contact:

PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 100 Norcross, GA 30071 Phone: (770) 493 - 6832 ext.111 (678) 514 - 3388 Fax: (770) 330 - 2724 Cell: richard.fischer@pajunk-usa.com

Contact

Richard Fischer MD President Fon: +01(0)770-493-6832 Ext 111 Fax: 678 5143388 E-Mail: Richard.fischer@pajunk-usa.com

Device Information:	Contract Sterilizer:
Device Name:	Ethylene Oxide;
	External service provider, validated procedure.
Trade Names:	Sono-Series Kits (needles, catheters)
	SonoLong, SonoLong Sono, SonoLong CurlSono, StimuLong Sono, PlexoLong Sono,SonoLong NanoLine
Components:	Kits consisting of catheter, cannula/needle,filter, syringe, filter fixation device, adapter andcommon hospital supplies
Availability:	The components are available separately; nonsterile, to be sterilized with EO for kit suppliers
Common Name:	SonoLong set, needles and catheters
Classification Name:	Anesthesia conduction kit
Classification Reference:	21 CFR §868.5140, April 1, 2011
1st Subsequent Classification Name	Anesthesia conduction needle
1st Subsequent Classification Reference	21 CFR §868.5150, April 1, 2011

510(k) Sono-Series Kit

R&D Regulatory

Resp. HE Resp. CQ/PAW 2011/10/27

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2nd Subsequent Classification Name	Anesthesia conduction catheter
2nd Subsequent Classification Reference	21 CFR §868.5120, April 1, 2011
Product Code:	CAZ, BSP, BSO
Establishment Registration Number:	9611612
Regulatory Class:	II
Panel:	Anesthesiology
Predicate Devices:	1) K033018 PAJUNK® StimuLong Plus Catheter setsPAJUNK® GmbH Medizintechnologie, Geisingen2) K013041 PAJUNK® PlexoLong Anaesthesia setsPAJUNK® GmbH Medizintechnologie, Geisingen3) K111374 PAJUNK® SonoPlex STIM SONO-SERIES CORNERSTONE TECHNIQUE,PAJUNK® GmbH Medizintechnologie, Geisingen

Indications for use:

Device Description:

The Sono-Cannulas/ needles are standard cannulas/ needles (cleared by several PMNsubmissions) equipped with the CornerStone technique in order to significantly enhance ultrasound visibility.

This submission of a 510(k) merely is due to new brand names than to introduce new techniques or technologies.

510(k) Sono-Series Kit R&D

Regulatory

2011/10/27

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Premarket Notification Submission 510(k)

Image /page/2/Picture/1 description: The image contains the word "PAJUNK" in a bold, sans-serif font. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in a smaller, sans-serif font. The words are stacked on top of each other, with "PAJUNK" being the larger and more prominent word.

Predicate Devices:

The components the Sono-Series Kits consist of are already cleared in the predicate devices ' 510(k) but now are assigned a new brand name.

Predicate devices with identical or at least partial identical indications of use are:

1. K033018 PAJUNK® StimuLong Plus Catheter sets, Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen
1. K013041 PAJUNK® PlexoLong Anaesthesia sets, Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen
1. K11374 PAJUNK® SonoPlex STIM SONO-SERIES CORNERSTONE TECHNIQUE, Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen

The detailed discussion of substantial equivalence can be found in Section 12 of this submission.

Sterilization

The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured and purchased devices which are already cleared for market or exempt.

Neither Cornerstone-technique nor the coil inside the catheter do neither influence sterilization process nor shelf life properties.

Cleaning and Sterilization method, which ensures an SAL of 10° as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtO-residuals as well as shelf life have been validated and are safe and effective.

Efficacy of sterile product's lifecycle has been validated for a period of 10 years now. Shelflife is set to 5 years.

Biocompatibility :

All cannulas comply with ISO 10993-1, 2nd and 3rd edition.

Technology Characteristics:

The components are listed in a table in section 11 of this submission. Shelf life and impact of r he components arrage on the devices has been proven and found to be safe and effective.

Each component shall be available separately, sterile and non-sterile, to be used with kit packaging in different configurations.

Conclusion:

The comparison between the predicate devices and the subject device in section 12 of this The companson between the products derilization process and the results of the bench testing and Submission as well as the validatou commoned devices are substantially equivalent (identical) to belien manting dominities the the technical description to devices already cleared for market and therefore demonstrated to be safe and effective.

Based on the clinical evaluation, the biocompatibility testing and the bench testing conducted, based on the cirincal evaluation, the firesty of the Cornerstonel Sono-technique is demonstrated for each type of kit.

2011/10/27

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Christian G. Quass Director Regulatory Affairs, Safety Official Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen GERMANY

MAR - 1 2012

Re: K113188

Trade/Device Name: Sono-Series Kits for Anaesthesia / Analgesia Conduction Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSP, BSO Dated: February 15, 2012 Received: February 21, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anton D. avant

Anthony D. Watson, B.S., M.S., M.B.A. 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:

Device Name:

Brand name:

Sono-Series Kits for anaesthesia/ analgesia conduction SonoLong, SonoLong Sono, PlexoLong Sono, SonoLong Curi Sono, StimuLong Sono, SonoLong NanoLine

Indications for Use:

The PAJUNK® Sono-Series Kits SonoLong, SonoLong Sono, PlexoLong Sono, The 1 760Tht - Sono Sono Rits St.ine and SonoLong Curl Sono are intended for OtimaLong Ocher, Ochonomic on anesthesia and/ or analgesia of peripheral nerves denvery of ochtinuous conduction were for up to 72 hours is accomplished using the Polyamide indwelling catheter. Optionally an electrical stimulus may be applied to assist the physician pinpoint the area of application.

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)

L. Schuttler

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

510(k) Number: K113188

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).