PAJUNKS STIMULONG TSUI-METHOD SET
Device Facts
| Record ID | K062900 |
|---|---|
| Device Name | PAJUNKS STIMULONG TSUI-METHOD SET |
| Applicant | PAJUNK GmbH Medizintechnologie |
| Product Code | CAZ · Anesthesiology |
| Decision Date | Jan 12, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5140 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics.
Device Story
Kit for continuous epidural or peripheral nerve anesthesia; includes coated Tuohy cannula, Polyamide indwelling catheter, stimulation adapter, cables, injection valve/hose, filter, and fixation devices. Physician inserts cannula to place catheter; electrical stimulus applied via cannula or catheter tip to verify target nerve/plexus location before anesthetic delivery. Enables precise needle/catheter placement; reduces risk of misplacement. Used in clinical settings by anesthesiologists. Catheter requires removal/replacement after 72 hours. Single-use, sterile, non-pyrogenic, latex-free.
Clinical Evidence
No clinical data generated for this submission; substantial equivalence based on clinical literature review of the Tsui-Method and established safety/effectiveness of predicate components.
Technological Characteristics
Components: Polyamide catheter (closed tip, 3 lateral holes, optional open tip, integrated spiral, steel stylett), NanoLine or lacquer-coated Tuohy cannula (K053283), stimulation adapters/cables, injection valve/hose. Sterilization: EtO. Single-use. No software or electronic processing; electrical stimulation provided via external nerve stimulator (not part of kit).
Indications for Use
Indicated for adults and pediatric patients requiring continuous epidural or peripheral nerve/plexus anesthesia. Used to facilitate precise identification of target areas via electrical stimulation and to provide prolonged anesthetic delivery.
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 Set (K033018, K043130)
- Pajunks EpiLong Set (K060311)
- Pajunks UP cannulas (K000722, K040965)
Submission Summary (Full Text)
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Premarket Notification Submission
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 black background. Below this, in smaller white letters, is the word "MEDIZINTECHNOLOGIE".
## 510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness According to 21 CFR 807.92 Date of Preparation: December 21st, 2006
Sterilizer:
JAN 1 2 2007
078
l
## Submitter Information/ production site:
Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605
SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Moerfelden Germany
## Contact:
Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com Establishment Registration Number: 9611612
A
US Contact:
Stefan Dayagi Fon: +01(0)770-493-9305
E-Mail: stefan.dayagi@pajunk-usa.com
## Device Information:
| Trade Names: | Pajunks StimuLong Tsui-Method Set |
|------------------------------------------|-----------------------------------------------------------------------------|
| Common Name: | Epidural and peripheral stimulation catether set |
| 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. Pajunks StimuLong Set K033018, K043130<br>2. Pajunks EpiLong Set K060311 |
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Premarket Notification Submission
Image /page/1/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, "MEDIZINTECHNOLOGIE" is written in smaller, black letters.
077
# ltem 03
## Section 05
## Revised 510(k) Summary of Safety and Effectiveness
This section of the submission for Pajunks StimuLong Tsui Method Set contains
- The summary of safety and effectiveness .
- . Submitter Information
- t 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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Premarket Notification Submission
Image /page/2/Picture/2 description: The image shows the word "PAJUNK" in bold, white letters against a black background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, black letters. The text appears to be a logo or brand name, possibly for a medical technology company.
### Device Description
Pajunk GmbH Medizintechnologie is submitting this 510(k) for the Pajunk StimuLong Tsui Method Set. The Tsui-Test is a well known technique in epidural anesthesia. It combines the advantages of epidural anestesia and stimulation via catheter in order to verify the area anesthesia is applied to. The Tsui test makes epidural anesthesia much more safe and effective as demonstrated and proven in several studies and articles published since the 1990 % (see section 20 of this submission.
Physicians until now had to combine different devices in order to get a "self-made set acc. Tsui". Dr. Tsui combined Pajunks StimuLong set and technique deared for perifical use and Prayinks Epilong set and technique for epidural use to have a striking safe and effective alternative to "selfmade in-house devices".
The devices for epidural Anesthesia (EpiLong) and peripheral Anesthesia employing stimulation via catheter (StimuLong) are already cleared for market seperately without claiming specific patient populations. The basis of this submission in the indications for use of this two cleared device: peripheral and epidural stimulation guided anesthesia.
The components which are part of the subject device kit have already gained market clearance. They are combined under a new indication on customers demands.
The predicate devices are Pajunks own products cleared for a non specified population, i.e. for use with adult patients. In order to demonstrate safety and effectiveness Pajunk provides clinical lieterature from Dr. Tsui as well as a clinical evaluation.
Pajunks StimuLong Tsul Method Set are single use, sterile, non-pyrogenic and latex free medical device kits.
They are intended for continuous peripheral or epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. An electrical stimulus may be applied via catheter in order to precisely identify the area anesthesia is intended to be applied to.
## Predicate Devices
The devices Pajunk claims substantial equivalence with are Pajunks StimuLong Set and UP cannulas cleared under K000722, K033018, K043130, K 040965 and Pajunks EpiLong Set cleared under K060311.
The indications of StimuLong and EpiLong are already cleared for market.
Because the devices are technical cleared this submission concentrates on the clinical discussion of the combination of advantages of epidentiation of the cirinear
The detailed disoussion of substantial eqivalence can be found in Section 12 of this submission. Because there is no change in technology or material the focus is set on the clinical liferature review in section 10 of this submission.
## Sterilization
### Sterilization method: EtO
The contract sterilizer and the sterilizing process are identical to the ones used for all of Pajunks devices provided sterile, essee continue production devices cleared for the US market in several Premarket Notification submissions.
By annual validation and quarterly verification as well as by shelflife testing the sterilization procedure is claimed to be safe and effective for several years now.
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Premarket Notification Submission
Image /page/3/Picture/2 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".
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## Technology Characteristics:
The Pajunks StimuLong Tsui Method Set provides a coated Tuohy cannula, a StimuLong catheter, StimuLong adaptor, valve, adaptor cables, injection hose, filter, LOR-syringe, catheter fixation device, FixoLong and tightning adaptors. The coating on the cannula is laqueur or NanoLine coating, which has been cleared in K053283.
The catheter comes with a catheter container, steel stylett and introductory aid for better handling and shape security. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylett. There is no change in components compared to the StimuLong and EpiLong set already cleared for market.
All components are available seperately. Within the indications for use and the components cleared for market the StimuLong Tsui method set is customizable.
#### Conclusion:
The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are at least as safe and effective as, and substantially equivalent to the predicate devices. A rationale for the method is included this sumbission.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christian Quass Regulatory Affairs Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 Geisingen, Baden-Wurttemberg Germany 78187
JAN 1 2 2007
Re: K062900
Trade/Device Name: Pajunks StimuLong Tsui Method Set; Anesthesia Conducting Stimulation Catheter, Epidural and Peripheral; Anesthesia Conducting Epidural Stimulation Catheter; Anesthesia Conducting Peripheral Stimulation Catheter; Stimulation Adapter, Adapter Cable; Injection Valve and Injection Hose; Peripheral Coated Cannulas (NanoLine)
· Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: CAZ Dated: December 21, 2006 Received: December 26, 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 (240) 276-0115. 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,
Syitte Y. Michael Omd
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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Premarket Notification Submission
Image /page/6/Picture/2 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
| <b>510(k) Number:</b> | <b>K062900</b> |
|-----------------------|----------------|
|-----------------------|----------------|
Device Name:
Pajunks StimuLong Tsui Method Set
Indications for Use:
The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus.
The catheter has to be removed or replaced after 72 hours.
Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle.
After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter.
The set is to be used with adults and in pediatrics.
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
070
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
menthesiology, General I Sontrol, Demal De
Yclane
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Premarket Notification Submission
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Image /page/7/Picture/2 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: | K062900 | | | |
| Device Name: | peripheral | Anesthesia conducting stimulation Catheter, epidural and | | |
| Indications for Use: | | | | |
| The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space<br>(otional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic<br>effect. | | | | |
| After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can<br>remain for as long as determined by the professional anesthetist and the instructions for use. It<br>has to be removed or replaced after 72 hours. | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Prescription Use<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)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
| | | | | |
| | | | | |
| | | | | |
| · Factor Baneral Hospital. | | | | |
| Infection Control, is inter 1981085 | | | | |
| | 510/k) Number Kata Jack | | | |
| | | | | |
| | | | | |
| Page 1 of 1 | | | | |
:
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Premarket Notification Submission
Image /page/8/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, white letters.
072
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## Indications for use
- 510(k) Number: K062900
Anesthesia conducting epidural stimulation Catheter
## Indications for Use:
Device Name:
The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 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)
Suse Runk
Division of General Hospital,
Infectious Disease and AIDS
S. Gregory Carmichael
Klu Jace
{9}------------------------------------------------
Premarket Notification Submission
Image /page/9/Picture/2 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, black letters.
## Indications for use
#### 510(k) Number: K062900
#### Device Name: Anesthesia conducting peripheral stimulation Catheter
## Indications for Use:
The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 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)
Siser Rinn
i. D.V.R.Y.
ii. D.V.R.Y. and D.V.R.Y. and D.V.R.Y.
KNOWLEDGE
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Premarket Notification Submission
Image /page/10/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, white letters.
074
## Indications for use
#### 510(k) Number:
Device Name:
K062900
## Stimulation Adapter, Adaptor cable
#### Indications for Use:
Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example Stimul.ong and Stimulong Tsui-Method.
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)
Suse Burrows
\$
\$
.
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Premarket Notification Submission
K062900
Image /page/11/Picture/2 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, thinner, black letters.
## Indications for use
510(k) Number:
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Injection valve and injection hose
Indications for Use:
Device Name:
Pajunks Injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.
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)
Suze Quon
E.
Page 1 of 1
.
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Premarket Notification Submission
Image /page/12/Picture/2 description: The image shows the word "PAJUNK" in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner, black letters. The text appears to be a logo or heading, possibly for a company or organization related to medical technology. The contrast between the white text and black background makes the words stand out.
076
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| Indications for use | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K062900 |
| Device Name: | Peripheral coated Cannulas (NanoLine) |
| Indications for Use: | Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method. |
| Prescription Use<br>(Per 21 CFR 801.109) | X |
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)
![]()Signature
![]()Signature
Page 1 of 1
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