(125 days)
No
The description focuses on the physical components and intended use of a standard epidural anesthesia kit, with no mention of AI or ML capabilities.
No.
The device facilitates the administration of an anesthetic, but it does not directly treat a disease or condition itself.
No
The device is an epidural anesthesia kit used for administering anesthesia and facilitating its longer effect. While one component (LOR-Syringe) is used to verify needle placement, its primary function is not to diagnose a condition, but to ensure proper therapeutic administration.
No
The device description clearly outlines a kit containing physical components such as a needle, catheter, filter, and adapter, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pajunk EpiLong anesthesia conduction kit is used for the administration of anesthesia directly into the epidural space of a patient. It is a device used in vivo (within the living body) for a therapeutic purpose (pain relief through anesthesia).
- Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient to provide diagnostic information.
The device is clearly described as a kit for delivering medication and maintaining access to the epidural space, which falls under the category of medical devices used for treatment and intervention, not diagnosis.
N/A
Intended Use / 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 After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up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.
Product codes (comma separated list FDA assigned to the subject device)
CAZ, BSO
Device Description
Pajunk'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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional anesthetist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K040965, K043130, K033018, K042979, K023218, K013041
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
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.(b)
Classification. Class II (performance standards).
0
JUN 1 3 2006
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: +49(0)7704-9291-533 Tel +49 6105 23091 or +49 (0) 6105 93470 Fax: +49(0)7704-9291-605 Fax +49 6105 24760 Contact: Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-533
Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com 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 | |
| Reference: | 21 CFR § 868.5140, April 1, 2005, |
| Poposed | |
| Classification: | Regulatory Class II |
| Proposed Product | |
| Classification Code: | CAZ, Kit, Conduction Anesthesia |
| Panel: | Anesthesiology |
| Predicate Devices: | 1. BBrauns Perifix K813186 (also included in BBrauns Espocan |
| K932400) |
CQ 2006-02-06
1
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
2
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.
3
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) 276-0120. 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 (240) 276-3150 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
4
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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:
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5
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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6
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
Page 1 of 1
7
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
Page 1 of 1
CQ 2006-04-27
-.
8
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:
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
Page 1 of 1