EPILONG KIT FOR ANESTHESIOLOGY

K060311 · PAJUNK GmbH Medizintechnologie · CAZ · Jun 13, 2006 · Anesthesiology

Device Facts

• Record ID: K060311
• Device Name: EPILONG KIT FOR ANESTHESIOLOGY
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia. The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours). The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration. The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid. The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device.

Device Story

EpiLong is a single-use, sterile, non-pyrogenic, latex-free anesthesia conduction kit. Components include a Tuohy cannula for epidural space access, an epidural catheter for anesthetic delivery, a LOR-syringe for needle placement verification, a flat filter for particulate removal, and a Tuohy-Borst adapter for catheter fixation. Used in clinical settings by professional anesthetists. The anesthetist inserts the Tuohy cannula into the epidural space, verifies placement using the LOR-syringe, and threads the catheter through the cannula. The cannula is removed, leaving the catheter in situ for up to 72 hours. The filter minimizes particulate contamination during anesthetic injection. The adapter secures the catheter and allows connection to infusion devices. The system facilitates prolonged anesthetic administration, potentially improving patient comfort and pain management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-use, sterile, non-pyrogenic, latex-free kit. Components: Tuohy cannula, epidural catheter, LOR-syringe, microporous flat filter, Tuohy-Borst adapter. Materials are consistent with previously cleared anesthesia conduction kits. Mechanical assembly; no energy source or software.

Indications for Use

Indicated for patients requiring epidural anesthesia administration. Used by professional anesthetists to facilitate anesthetic delivery via catheter placement in the epidural space for up to 72 hours. Includes components for needle placement verification (LOR-syringe), fluid filtration, and catheter fixation.

Regulatory Classification

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.

Predicate Devices

• BBrauns Perifix (K813186)
• BBrauns Espocan (K932400)

Reference Devices

• Pajunk Stimulong Plus Plexus Catheter (K043130)
• Pajunk Stimulong Plus Plexus Catheter (K033018)
• Pajunk Plexolong Sets (K042979)
• Pajunk Plexolong Sets (K023218)
• Pajunk Plexolong Sets (K013041)
• Anesthesia conduction cannulae (K040965)

Submission Summary (Full Text)

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# JUN 1 3 2006

K060311

# EpiLong Premarket Notification Submission

MFDizin TECHNOLOGIE

## 510(k) Premarket Notification Submission:

### Summary of Safety and Effectiveness

### Date of Preparation: June 2006

### Submitter Information/ production site: Sterilizer: Pajunk GmbH Medizintechnologie SteriPro Lab & EO Facility Karl-Hall-Strasse 01 Dreieichstrasse. 7 78187 Geisingen 64546 Mörfelden Germany Germany Fon: [phone] Tel [phone] or [phone] Fax: [phone] Fax [phone] Contact: Christian Quass, Regulatory Affairs Fon: [phone]

Fax: [phone] E-Mail: [e-mail] Establishment Registration Number:

9611612

### Device Information:

| Trade Names: | EpiLong, EpiLong Set, EpiLong II Safety Kit |
|------------------------------------------|--------------------------------------------------------------------------|
| Common Name: | Anesthesia Conduction Kit |
| Classification Name: | Anesthesia Conduction Kit |
| Classification<br>Reference: | 21 CFR § 868.5140, April 1, 2005, |
| Poposed<br>Classification: | Regulatory Class II |
| Proposed Product<br>Classification Code: | CAZ, Kit, Conduction Anesthesia |
| Panel: | Anesthesiology |
| Predicate Devices: | 1. BBrauns Perifix K813186 (also included in BBrauns Espocan<br>K932400) |

CQ 2006-02-06

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### Device Description

Paiunk's EpiLong set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a epidural anesthesia kit consisting of a needle for insertion into the epidural space (a special Tuohy Cannula), a catheter for anesthesia administration to the epidural space, a flat filter as well as an adapter.

After administration of immediate epidural anesthesia, the epidural catheter may be placed via the cannula into the epidural space. The cannula is then withdrawn, leaving the Epidural Catheter tip in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).

### Predicate Devices

The devices we claim substantial equivalence with is BBrauns Perifix K813186 (also included in BBrauns Espocan K932400).

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

### Sterilization

The contract sterilizer and the sterilizing process other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) is the same as that used for anesthesia conduction cannulae cleared for market by FDA under 510(k) number K040965 and Kit Products Pajunks Stimulong Plus Plexus Catheter K043130, K033018 Pajunks Plexolong Sets K042979, K023218, K013041.

### Technology Characteristics:

The EpiLong kit provides a Tuohy Cannula with special tip through which the catheter is inserted directly in the epidural space for immediate administration of epidural anesthesia.

The epidural catheter is placed for prolonged (up to 72 hours) administration of epidural anesthesia. Safety is optimized by the use of the fixation adapter, Tuohy-Borst adapter and flat filter provided in the kit.

### Conclusion:

The comparison between the predicate device and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2006

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

Re: K060311

Trade/Device Name: EpiLong Sets for Anesthesiology, Anesthesia Conducting Catheter, LOR-Syringe, Flat Filter, Tuohy Borst Adaptor Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSO Dated: June 2, 2006 Received: June 5, 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.

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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.

Syltie Y. Michau Orns.

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

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Image /page/4/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 "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters. The logo appears to be for a medical technology company.

| Indications for use |
|---------------------|
|---------------------|

| 510(k) Number: | K060311 |
|----------------------|---------------------------------|
| Device Name: | EpiLong Sets for Anesthesiology |
| Indications for Use: | |

The Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia.

| 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)


| Sign-Off | |
|------------------------------------------|---------|
| Div of Anesthesiology, General Hospital, | |
| sion Control, Dental Devices | |
| Number | K060311 |

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Image /page/5/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, black letters. The text appears to be a logo or brand name, possibly related to medical technology.

### Indications for use

K060311 510(k) Number:

Device Name:

14:10 pm 11 to 11 am 11 am

Anesthesia conducting Catheter

Indications for Use:

The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect.

After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 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)

Aver Smecom

47-610 n of Anesthesiology, General Hospital. con Control, Dental Devic

Number K060311

Page 1 of 1

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Image /page/6/Picture/1 description: The image shows the logo for PAJUNK, a company that specializes in medical technology. The word "PAJUNK" is written in large, bold letters at the top of the image. Below the company name, the word "MEDIZINTECHNOLOGIE" is written in smaller letters. The logo is simple and professional, and it conveys the company's focus on medical technology.

### Indications for use

510(k) Number: K060311

#### Device Name: LOR-Syringe

### Indications for Use:

The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks.

These syringes are not intended for injection or aspiration.

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)

Cure Suom

oi Anesthesiotogy, General Hospita

K060311

Page 1 of 1

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Image /page/7/Picture/1 description: The image shows the logo for PAJUNK. The logo is in white text on a black background. Below the logo is the word "MEDIZINTECHNOLOGIE" in a smaller font.

| Indications for use |
|---------------------|
|---------------------|

| 510(k) Number: | K060311 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Flat Filter |
| Indications for Use: | The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid. |

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|----------------------|---|--------|------------------------|
| (Per 21 CFR 801.109) | | | (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)

Number: K060311

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CQ 2006-04-27

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Image /page/8/Picture/1 description: The image shows the logo for PAJUNK, a company specializing in medical technology. The word "PAJUNK" is displayed in large, bold, white letters against a black background. Below the company name, the words "MEDIZINTECHNOLOGIE" are printed in a smaller, sans-serif font.

### Indications for use

### 510(k) Number:

K060311

### Device Name:

Tuohy Borst Adaptor

### Indications for Use:

The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device.

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)

Jum Sookeour

II of Anesthesiology, General Hos Control, D i ::nher

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