EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV

K060563 · Pajunk GmbH · CAZ · Jun 2, 2006 · Anesthesiology

Device Facts

• Record ID: K060563
• Device Name: EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
• Applicant: Pajunk GmbH
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional Combined Spinal-Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for insertion into the spinal and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the cather tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to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).

Device Story

EpiSpin is a single-use, sterile, latex-free Combined Spinal-Epidural (CSE) anesthesia kit. It utilizes needle-through-needle technology: a specialized Tuohy cannula with a 'backeye' aperture in the curved tip allows a Sprotte cannula to pass through into the spinal space without bending or metal-on-metal friction. The kit includes the Tuohy cannula, Sprotte cannula, LOR-syringe for verifying epidural space placement, Tuohy-Borst adapter, flat filter for particulate minimization, and Fixolong fixation device for catheter stabilization. Used in clinical settings by anesthesiologists to administer regional anesthesia. The Sprotte needle is removed after spinal injection, while the epidural catheter remains for up to 72 hours to provide prolonged anesthetic effect. The system facilitates precise needle placement and secure catheter management, benefiting patients by enabling both immediate spinal and extended epidural anesthesia.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and technological comparison to legally marketed predicate devices.

Technological Characteristics

Single-use, sterile, non-pyrogenic, latex-free kit. Components: Tuohy cannula (with backeye), Sprotte cannula, LOR-syringe, Tuohy-Borst adapter, flat filter, Fixolong fixation device. Needle-through-needle mechanical insertion principle. Sterilization via ethylene oxide (EO) process consistent with previously cleared Pajunk anesthesia conduction cannulae.

Indications for Use

Indicated for patients requiring regional Combined Spinal-Epidural (CSE) anesthesia; intended for use by professional anesthetists for needle insertion into spinal/epidural spaces and epidural catheter placement for anesthetic administration up to 72 hours.

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

• Pajunks Stimulong Plus Plexus Catheter (K043130, K033018)
• Pajunks Plexolong Sets (K042979, K023218, K013041)
• Pajunk Sprotte and various Anesthesia conduction cannulas (K040965, K911202, K911260, K911221)
• BBrauns Espocan (K932400) (including BBrauns Perifix K813186)

Submission Summary (Full Text)

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EpiSpin Premarket Notification Submission

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# 510(k) Premarket Notification Submission:

JUN - 2 2006

# Summary of Safety and Effectiveness

Date of Preparation: December 1, 2005

# Submitter Information/ production site:

Sterilizer:

Pajunk GmbH Medizintechnologie Karl-Hall-Straße 01 78187 Geisingen Germany Fon: [phone] Fax: [phone]

# SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel [phone] or [phone] Fax [phone]

## Contact:

Christian Quaß, Regulatory Affairs Fon: [phone] Fax: [phone] E-Mail: [e-mail] Establishment Registration Number: 9611612

# Device Information:

| Trade Names: | EpiSpin, EpiSpin Set, EpiSpin II Safety Kit |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Anesthesia Conduction Kit |
| Classification Name: | Anesthesia Conduction Kit |
| Classification Reference: | 21 CFR § 868.5140, April 1, 2005, |
| Proposed Classification: | Regulatory Class II |
| Proposed Product Classification Code: | CAZ, Kit, Conduction Anesthesia |
| Panel: | Anesthesiology |
| Predicate Devices: | 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018<br>2. Pajunks Plexolong Sets K042979, K023218, K013041<br>3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221<br>4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) |

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Image /page/1/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, the word "MEDIZINTECHNOLOGIE" is written in smaller, white letters.

### Device Description:

Pajunk's EpiSpin set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a Combined Spinal-Epidural (CSE) anesthesia kit consisting of two needles, one for insertion into the epidural space (a specialized Tuohy Cannula) and one for insertion into the spinal space (a Sprotte Cannula). This needle through-needle technology is accomplished using an aperture in the curved tip of the specialized Tuohy Cannula (called the "backeye"), for advancement of the Sprotte Cannula into the spinal space. The Spinal needle does not bend at all, but passes easily thru the Tuohy needle. There is no significant friction of metal against metal involved at all.

#### Predicate Devices:

The devices we claim substantial equivalence with are Pajunks Stimulong Plus Plexus Catheter cleared under K043130, K033018, Pajunks Plexolong Sets cleared under K042979, K023218, K013041 for the whole Kit and cleared kit components and BBrauns Espocan K932400 (including BBrauns Perifix K813186) especially for the Kit components Tuohy Back-Eye and the LOR-Syringe as well as the intended use of the whole Kit.

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 anesth esia 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 K1042879, K023218, K013041.

#### Technology Characteristics:

The EpiSpin kit provides needle-through-needle technology, employing the use of a Tuohy Cannula featuring a backeye, through which a Sprotte Cannula can be inserted in the spinal space for immediate administration of spinal anesthesia. The Sprotte Cannula is then removed, and the epidural catheter is then placed for prolonged (up to 72 hours) administration of epidural anesthesia. Safety is optimized by the use of the catheters fixation adapter, Tuohy-Borst adapter, flat filter, Fixolong catheter fixation device, and optional Introducer Aid provided in the kit.

#### Conclusion:

The comparison between the predicate devices 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

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

Re: K060563

Trade/Device Name: EpiSpin Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 19, 2006 Received: May 22, 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 and inoments 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,

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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K060563 510(k) Number:

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.

Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801.109)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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

K060563 510(k) Number:

Fixolong Fixation device Device Name:

#### Indications for Use:

The Pajunk Fixolong is an adhesive disk with catheter clips and flat filter attachment point on top. It is employed for fixing the catheter during long term anesthesia conduction.

The adhesive is hypo-allergenic and prevents accidental removal of epidural catheter. The catheter fastening clips allows stabilization of epidural catheter and prevents accidental movement. On the top there is an attachment site for flat filter to protect fixation

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)

Ainy Dalton

nesthesiology, General H

: Number: K0601

Page 1 of 1

01 :

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510(k) Number: K060563

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 |
|----------------------|---|
| (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)

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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 the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters.

# Indications for use K060563 510(k) Number: Tuohy Borst Adaptor Device Name: Indications for Use: The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures The I agains Tuony Doroth laster is common of a Luer Lock syringe or infusion device. Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aury Suliom

g. Off
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
Number: K060563

Page 1 of 1

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K060563

Image /page/8/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 that, in smaller letters, is the word "MEDIZINTECHNOLOGIE".

#### Indications for use

510(k) Number:

Device Name:

EpiSpin Kits for Anesthesiology

#### Indications for Use:

The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional The Pagain Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for Combined opinal Lpharrir (002) and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect.

After the anesthesia conduction needle has been withdrawn from the patient, the cather 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 | 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)

Amy Solomon

1 .. 45-011) n of Anesthesiology, I .on Control. Dental D

Number: K060563

Page 1 of 1

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Image /page/9/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, the word "MEDIZINTECHNOLOGIE" is written in smaller, white letters.

510(k) Number: K060563

Device Name:

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 **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)

**Page 1 of 1**

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i Anesthesiology, General Hospital on Control. De

K060563

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