PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotlcs to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous. The sterile components are available seperately. The kit is available in two basic designs: Design 02 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Puncture needle, Permanent teflon cannula, Flat filter) and Design 01 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Tear-cannula (also referred to as Split-cannula), Flat filter).

AI/ML Overview

The InfiltraLong Wound infiltration catheter kit from PAJUNK® underwent a 510(k) Premarket Notification Submission. The submission focused on establishing substantial equivalence to predicate devices already marketed, confirming the safety and effectiveness of the proposed device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific quantitative acceptance criteria for device performance in a table format. Instead, the "Conclusion" section within "Technology Characteristics" states:

Criterion/Performance Aspect	Reported Device Performance
Material/Component Compliance	Catheter complies with ISO10555 (Sterile, single-use intravascular catheters) and EN1618 (Catheters for intravascular catheters - Test methods for common properties). Needles comply with ISO7864, ISO594, and ISO9626.
Sterilization Process	Same as used for all PAJUNK® products already cleared for market; monitored by FDA; complies with DIN EN ISO 11135 (Ethylene oxide sterilization).
Packaging	Identical to PAJUNK®'s kits for regional spinal and epidural anesthesia already approved for marketing in the US.
Overall Safety and Effectiveness	Comparison with predicate devices and results of bench testing demonstrate that the device is "identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of clinical data for performance evaluation.
The evaluation relies on "Bench Testing" for technical characteristics and comparison with existing predicate devices.
The data provenance is for the manufacturing and testing of the device itself rather than clinical patient data. The manufacturer is Pajunk GmbH, located in Germany, and the document indicates their US contact and contract sterilizer are also identified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts or a "ground truth" establishment in the context of clinical performance data for a test set in this 510(k) submission.
The assessment is based on compliance of the device components with established international standards (ISO, EN) and comparison to predicate devices, which implies an expert understanding of these standards by the device manufacturer's regulatory and R&D teams.

4. Adjudication Method for the Test Set

No adjudication method is described because there is no multi-expert review or clinical performance test set analysis mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a medical catheter kit, not an AI-assisted diagnostic or treatment system. The document does not discuss AI or human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone (algorithm-only) performance study was done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on compliance with international standards (ISO, EN) for medical devices and components, and the established safety and effectiveness of predicate devices. The claim of substantial equivalence is the central "ground truth" or foundational assertion for FDA clearance.
There is no mention of pathology, outcomes data, or expert consensus in a clinical trial context.

8. The Sample Size for the Training Set

No training set is applicable or mentioned. This is not a machine learning or AI device. The submission focuses on bench testing and comparison to predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device type.

Summary

{0}------------------------------------------------

PAJUNK®'s InfiltraLong Wound infiltration catheter kit 510(k) Premarket Notification Submission

Image /page/0/Picture/1 description: The image shows the number K080675 at the top. Below that is the word "PAJUNK" in large white letters against a gray background. Underneath that is the word "MEDIZINTECHNOLOGIE" in smaller black letters.

Section 05

JUN 2 0 2008

510(k) Summary of Safety and Effectiveness

This section of the submission for PAJUNK®´s InfiltraLong Wound infiltration catheter kit contains

. The summary of safety and effectiveness
. Submitter Information
. 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.

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

Image /page/1/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE". The background of the image is a textured pattern of black and white.

510(k) Premarket Notification Submission:

Summary of Safety and Effectiveness

Date of Preparation: June 6th 2008

Submitter Information/ production site:		USA Contact:
Pajunk GmbH		Pajunk Medical Systems
Karl-Hall-Strasse 01		German American Trade Center
78187 Geisingen, Germany		5126 South Royal Atlanta Drive
Fon: +49(0)7704-9291-586		30084 Tucker, Georgia
Fax: +49(0)7704-9291-605		USA
Establishment Registration Number: 9611612
Contact:		Contact
Christian Quass, Director Regulatory Affairs		Stefan Dayagi
Fon: +49(0)7704-9291-586		Fon: +01(0)770-493-9305
Fax: +49(0)7704-9291-605
E-Mail: christian.quass@pajunk.com		E-Mail: stefan.dayagi@pajunk-usa.com
		Contract Sterilizer:
		STERIGENICS GERMANY GMBH
		Rheingaustrasse 190-196
		65203 Wiesbaden, GERMANY
		Registration Number: 3002807090
Device Information:		Operations: Contract Sterilizer
Device/ Trade Name:	InfiltraLong Wound infiltration catheter, Pain Management
Common Name:	Anesthesia conduction catheter
Classification Name:	Catheter, conduction, anaesthetic
Classification Reference:	21CFR 868.5120
Establishment Registration
Number:	9611612
Regulatory Class:	II
Product Code:	BSO
Subsequent product code	MRZ
Subsequent Classification	21CFR880.5725
Reference:	Accessories, Pump, infusion
Panel:	General Hospital
Predicate Devices	1.	K022869 Soaker catheter (I-Flow, On-Q)
	2.	K051401 Soaker catheter (I-Flow, On-Q)

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

PAJUNK®'s InfiltraLong Wound infiltration catheter kit 510(k) Premarket Notification Submission

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

Device Description: Indications for use

Contraindications: Intravascular and intra-arterial-, as well as application in the vicinity of the spinal cord. Application of liquids which are not analgesics. Draining of wound fl uid.

Complications: Systemic toxicity of the local anaesthetics used (observe dosage!), infection. The contraindications and complications in accordance with medical literature corresponding to the state of education shall also apply. The placement of the catheter should, as a rule, not exceed 72 hours due to the increased risk of infection.

Predicate Devices:

Predicate devices with identical or at least similar indications for use are:

1. K022869 Soaker catheter (I-Flow, On-Q)

1. K051401 Soaker catheter (I-Flow, On-Q)
  The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.

The components are cleared in PAJUNK®'s own 510(k)'s (e.g. K040965, K013041, K063697, K060563) for use in regional anaesthesia and to be used contacting cerebrospinal fluid.

Sterilization and Packaging

The contract sterilizer and the process of sterilization is the same as it is used for all PAJUNK - Products already cleared for market. The contract sterilizer is monitored by FDA and listed in the FDA database for sterilization services. The process complies with DIN EN ISO 11135 Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

The packaging is identical to the packaging of PAJUNK®'s kits for regional spinal and epidural anaesthesia already approved for being marketed in the US.

Technology Characteristics:

The kit is available in two basic designs:

Design 02	Design 01
• Coiled catheter (1x/ 2x)• Y-connector• FixoLong Catheter fixation device• Adapter• Puncture needle• Permanent teflon cannula• Flat filter	• Coiled catheter (1x/ 2x)• Y-connector• FixoLong Catheter fixation device• Adapter• Tear-cannula (also referred to as Split-cannula)• Flat filter

Bench Testing

The catheter complies with ISO10555 Sterile, single-use intravascular catheters and EN1618 Catheters r fo cather compular catheters - Test methods for common properties. The needles comply with ISO7864, ISO594 and ISO9626.

Conclusion:

The comparison between the predicate devices and the proposed devices in section 12 of this submission r no ounpandon botween the zation process and the results of the bench testing demonstrates that the as well as the validated stomization process that the predicate devices and identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective.

PMN InfiltraLong

mitraLong	R&D	Resp.	SAG
	Regulatory	Resp.	CQ

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2008

Mr. Christian Quass Director Regulatory Affairs Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Baden-Wuerttemberg GERMANY

Re: K080675

Trade/Device Name: PAJUNK Wound Infiltration Catheter Kit, InfiltraLong Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO, MRZ Dated: May 1, 2008 Received: May 7, 2008

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.

{4}------------------------------------------------

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) 276-0120. 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.

Suite Y.M., Alan Ord.

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

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

PAJUNK®'s InfiltraLong Wound infiltration catheter kit 510(k) Premarket Notification Submission

Image /page/5/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters. Below this word, in a smaller font size, is the word "MEDIZINTECHNOLOGIE". The background of the image is a textured pattern of black and white pixels, which gives the image a slightly grainy appearance. The text is centered horizontally within the image.

510(k) Number:
Device Name:	PAJUNK®'s Wound Infiltration Catheter kit, InfiltraLong
Indications for Use:

The sterile components are available seperately.

Prescription Use X(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)

Signature

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K080675
----------------	---------

Page 1 of 1

R&D

Regulatory

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

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