PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT

K080675 · PAJUNK GmbH Medizintechnologie · BSO · Jun 20, 2008 · Anesthesiology

Device Facts

• Record ID: K080675
• Device Name: PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: BSO · Anesthesiology
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

InfiltraLong is a wound infiltration catheter kit for delivery of local anesthetics or narcotics to surgical sites. Kit includes coiled catheter, Y-connector, fixation device, adapter, and puncture/tear-cannula. Used intraoperatively or percutaneously by clinicians to manage post-operative pain. Catheter placement typically limited to 72 hours to mitigate infection risk. Device functions as a conduit for fluid delivery; does not involve electronic processing or active sensing. Benefits include localized pain management via continuous or intermittent infusion.

Clinical Evidence

Bench testing only. Catheters tested for compliance with ISO 10555 (sterile, single-use intravascular catheters) and EN 1618 (test methods for common properties). Needles tested for compliance with ISO 7864, ISO 594, and ISO 9626. No clinical data provided.

Technological Characteristics

Kit includes coiled catheter, Y-connector, FixoLong fixation device, adapter, and puncture/tear-cannula. Materials comply with ISO 10555, ISO 7864, ISO 594, and ISO 9626. Sterilization via ethylene oxide per DIN EN ISO 11135. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites. Contraindicated for intravascular, intra-arterial, or spinal cord vicinity application; not for non-analgesic liquids or wound fluid drainage.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• Soaker catheter (I-Flow, On-Q) (K022869)
• Soaker catheter (I-Flow, On-Q) (K051401)

Submission Summary (Full Text)

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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.

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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: [phone] | | 30084 Tucker, Georgia | |
| Fax: [phone] | | USA | |
| Establishment Registration Number: 9611612 | | | |
| Contact: | | Contact | |
| Christian Quass, Director Regulatory Affairs | | Stefan Dayagi | |
| Fon: [phone] | | Fon: +01(0)770-493-9305 | |
| Fax: [phone] | | | |
| E-Mail: [e-mail] | | E-Mail: [e-mail] | |
| | | 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) | |
| | | | |

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# 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

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.

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)

- 2. 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)<br>• Y-connector<br>• FixoLong Catheter fixation device<br>• Adapter<br>• Puncture needle<br>• Permanent teflon cannula<br>• Flat filter | • Coiled catheter (1x/ 2x)<br>• Y-connector<br>• FixoLong Catheter fixation device<br>• Adapter<br>• Tear-cannula (also referred to as Split-cannula)<br>• 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 |

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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.

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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 (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 [phone]. 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 [phone] or [phone] 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

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# 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: | |

PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or
intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or
narcotics to wounds and surgical wound sites. Routes of administration may be intraoperative or
percutaneous.

The sterile components are available seperately.

| Prescription Use <u>X</u><br>(Per 21 CFR 801.109) | AND/OR | Over-The-Counter Use__________<br>(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)


(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

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

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