PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT

K082164 · PAJUNK GmbH Medizintechnologie · CAZ · Oct 27, 2008 · Anesthesiology

Device Facts

• Record ID: K082164
• Device Name: PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: CAZ · Anesthesiology
• Decision Date: Oct 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia is intended for the administration of regional anaesthesia to the peripheral plexus, single-shot or continuous technique, optional localization via electrical stimulus.

Device Story

Convenience tray containing pre-cleared or exempt medical devices for regional anesthesia of peripheral plexus; includes needles, catheters, and related accessories. Used by clinicians in clinical settings to facilitate anesthesia administration. Components assembled into kits; sterilized using validated EtO process. Device supports single-shot or continuous nerve block procedures; optional electrical stimulation for nerve localization. Output is the physical delivery of anesthetic agents via needle or catheter placement. Benefits include procedural efficiency and standardized supply management for anesthesiologists.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence relies on the established safety and effectiveness of the individual predicate components and validation of the tray assembly and sterilization processes.

Technological Characteristics

Convenience kit containing various needles, catheters, and accessories. Materials comply with ISO 10993-1. Sterilization via EtO, validated for SAL 10^-6. Shelf life validated for 5 years. No active electronic components integral to the tray itself; electrical stimulation capability provided by included predicate nerve stimulation components.

Indications for Use

Indicated for patients requiring regional anesthesia of the peripheral plexus via single-shot or continuous catheter techniques, with optional electrical nerve localization. Prescription use only.

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

• NanoLine (K053283)
• PlexoLong (K013041, K023218, K042979)
• StimuLong (K033018, K043130)
• StimuLong Tsui Method (K062900)
• StimuLong Sono (K062900)

Submission Summary (Full Text)

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Y082164

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 dark, textured background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, thinner letters.

# 510(k) Premarket Notification Submission:

## Summary of Safety and Effectiveness

Date of Preparation: July 21st 2008

OCT 2 7 2008

| Submitter Information/ production site: |
|-------------------------------------------------------|
| Pajunk GmbH |
| Karl-Hall-Strasse 01 |
| 78187 Geisingen, Germany |
| Fon: [phone] |
| Fax: [phone] |
| Establishment Registration Number: 9611612 |
| Contact: |
| Christian G. H. Quass, Director Regulatory<br>Affairs |
| Fon: [phone] |
| Fax: [phone] |
| E-Mail: [e-mail] |

## USA Contact:

Pajunk Medical Systems German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA

### Contact

Stefan Dayagi Fon: +01(0)770-493-9305 E-Mail: [e-mail]

### Contract Sterilizer:

1) Sterigenics Germany GmbH 2) HA2 Halberstadt

| Device Information: | |
|---------------------------|----------------------------------------------------------------------------------------|
| Device Name: | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus |
| Trade Names: | StimuLong, PlexoLong, Sono, Several generic, e. g. Basis Set, Spinal Set, Customer Set |
| Common Name: | Convenience Tray for Regional Anesthesia |
| Classification Name: | Kit, conduction anesthesia |
| Classification Reference: | 21CFR868.5140, revised April 1st 2007 |
| Establishment | |
| Registration Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | CAZ |
| Panel: | Anesthesiology |
| Predicate devices | K053283 NanoLine |
| | K013041, K023218, K042979 PlexoLong |
| | K033018, K043130 StimuLong |
| | K062900 StimuLong Tsui Method, StimuLong Sono |

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## Generic Convenience Tray for Regional Anaesthesia

## 510(k) Premarket Notification Submission

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#### Device Description:

The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in Anaesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits".

The devices made available for this tray are listed in section 11 of this submission.

#### Predicate Devices:

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

- 1. K053283 NanoLine
- 2. K013041, K023218, K042979 PlexoLong
- 3. K033018, K043130 StimuLong
- 4. K062900 StimuLong Tsui Method, StimuLong Sono

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

#### Sterilization

The contract sterilizer and the sterilizing process is the same as used for all PAJUNK® manufactured and purchased devices which are already cleared for market or exempt and which may be contained in a convenience tray.

Sterilization method, which ensures an SAL of 10° as well as limits for bioburden, pyroburden (i. e. LAL) and EtO-residuals and shelf life have been validated and effective. Efficacy of sterile product's lifecycle has been proven for a periode of 10 years now. Shelf life is set to 5 vears.

#### Biocompatibility

All devices comply with ISO 10993-1, FDA-modified version also.

#### Technology Characteristics:

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

#### Conclusion:

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

The tray components are marketed in similar combinations in Europe for more than ten years now and are safe and effective. Efficacy of manufacturing, tray assembly, sterilization, storage and shelf life has been proven.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christian G. H. Quass Director Regulatory Affairs PAJUNK® GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen GERMANY

OCT 2 7 2008

Re: K082164

Trade/Device Name: PAJUNK® s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus Continuous

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure Supply

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus: Single Shot

Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 29, 2008 Received: July 31, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act, However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misling a and adulteration.

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Page 2 - Mr. Quass

If your device is classified (sec 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.

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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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.dsma/dsmamain.html.

Sincerely yours.

M Samuels-Ferdinand - for //

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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#### Indications for use

| 510(k) Number: | |
|----------------|--|
| Device Name: | |

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous

Indications for Use:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous is intended for the administration of regional anaesthesia to the peripheral plexus employing continuous technique via catheter, also including optional localization via electrical stimulus.

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. Aymond.

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

510(k) Number:

Page 1 of 1

PMN Spinal Convenience Kit R&D Regulatory

Resp. SAG Resp. CQ

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Image /page/5/Picture/1 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters on a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, white letters.

### Indications for use

510(k) Number: Device Name:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply

Indications for Use:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of regional anaethes ia. Neither needle nor catheter is included.

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. Hom
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082169

Page 1 of 1

PMN Spinal Convenience Kit R&D Regulatory

Resp. SAG Resp. CQ

23/134 2008/07/21

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MEDIZINTECHNOLOGIE

### Indications for use

| 510(k) Number: | |
|----------------|--|
| Device Name: | |

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus

Indications for Use:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia is intended for the administration of regional anaesthesia to the peripheral plexus, single-shot or continuous technique, optional localization via electrical stimulus.

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. Aciamd.

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

510(k) Number: K082164

Page 1 of 1

PMN Spinal Convenience Klt R&D Regulatory

Resp. SAG Resp. CQ

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Image /page/7/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 this, in smaller white letters, is the word "MEDIZINTECHNOLOGIE".

### Indications for use

510(k) Number: Device Name:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus: single shot

Indications for Use:

PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus single shot is intended for the administration of regional anaesthesia to the peripheral plexus employing single-shot technique also including optional localization via electrical stimulus.

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082164

Page 1 of 1

PMN Spinal Convenience Kit R&D Regulatory

Resp. SAG Resp. CQ