(179 days)
No
The summary describes a mechanical device for delivering anesthesia and mentions electrical stimulation for localization, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes.
The device delivers continuous conduction anesthesia, which is a therapeutic intervention for pain management.
No
Explanation: The device is intended for delivering continuous conduction anesthesia and assisting in pinpointing the area of application through electrical stimulation, not for diagnosing a condition or disease.
No
The device description explicitly mentions physical components like needles, tubing, catheters, cables, and connectors, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of continuous conduction anesthesia of peripheral nerves and plexus". This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details needles, tubing, cannulas, and catheters used for delivering anesthesia. These are instruments used directly on the patient for a medical procedure, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) for a medical procedure.
N/A
Intended Use / Indications for Use
The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle, or a Tuohy conduction needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
Product codes (comma separated list FDA assigned to the subject device)
CAZ, BSP
Device Description
The PAJUNK Plexolong sets contain single use sterile and non-pyrogenic needles with tubing. with or without a plastic cannula and catheters intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves and plexus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / Not Found
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)
The PAJUNK Plexolong Sets were designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards.
| Standard | Issue Date | Title |
|---|---|---|
| DIN 13090/ISO 594 | 08.1984 | Luer fittings w/wo locking feature |
| DIN 13097 Part 1 | 01.1980 | Medical injection cannula |
| DIN 13097 Part 3 | 11.1979 | Medical cannula |
| DIN 17442/ISO 9626 | 10.1977 | Steel for medical instruments |
| DIN EN 550 | 07.1993 | Sterilization of med. Prod.; Validation & routine controls for sterilization with ETO |
| DIN EN 556 | 01.1995 | Sterilization of medical products, requirements for medical products that are labeled "sterile" |
| DIN EN 724 | 12.1994 | Guidance on the application of EN29001 and EN46001 for non-active medical products |
| PrEN 868-1 | 10.1996 | Packaging materials for the sterilization of packaged goods. Part 1: general requirements for the validation of the packaging of sterilized end-packaged products |
| DIN EN 868-2 | 03.1993 | Packaging materials for the sterilization of packaged goods. Part 2: sterilization packaging, requirements and tests. |
| DIN EN 980 | 08.1996 | Graphic symbols for marking medical products |
| DIN EN 1441 | 08.1994 | Risk analysis for medical products |
| DIN EN 1707 | 01.1997 | 6% Luer cone connections for injection cannula and particular medical equipment |
| DIN EN/ISO 9626 | 06.1995 | Cannula tube of non-rusting steel (SS) for the manufacture of medical products |
| DIN en 30993-1 | 12.1994 | Biological evaluation of medical products - instructions for selection of tests |
| DIN EN 46001 | 12.1993 | Particular requirements for medical products |
| DIN 17440 | 09.1996 | Stainless Steels |
| BS 4843 | Not Found | Single entry IV cannula |
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.
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
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
Submitter Information:
PAJUNK GmbH AM Holzplatz 5-7 78187 Geisingen Germany
USA Contact:Mr. Burk A. Brandt CE Consultancy, Inc. 5010 NW Crescent Vly Dr Corvallis, OR 97330 - USA
Phone: (541) 752-3953 Fax : (541) 752-3972
Device Name:
Trade Name: Plexolong Sets Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5140, April 1, 2000)
Predicate Device:
These Plexus Anesthesia sets consist of a Paiunk Touby needle (with nerve stimulus connector and Luer lock), tubing (with Luer locks)}, catheter (with Teflon coated stylet), catheter adapter.and filter. The set, including the packaging is identical to the Plexolong Sets cleared for market under 510(k) number K013041. except for the Touhy needles with nerve stimulus connector. The Touhy needle is identical to the Unipolar needle, included in these sets, except for the needle tip. The Touhy needle tip configuration is same as the B Braun Touhy needle, cleared for market under 510(k) number K813186 as referenced in their submission number K013610.
The intended use statement, except for a reference to the Tuohy needle, is identical to the intended use statement in K013041. Except for the shape of the needle tip, the materials, construction and manufacturing processes are also identical to the cleared Pajunk Anesthesia Sets.
The contract sterilizer and sterilizing process are identical to those used for the Pajunk Plexolong sets. The packaging materials are also the same as those used to package the Pajunk previously cleared Plexolong sets.
Device Description:
The PAJUNK Plexolong sets contain single use sterile and non-pyrogenic needles with tubing. with or without a plastic cannula and catheters intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
Intended Use:
The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle, or a Tuohy conduction needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
1
Warning:
The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure.
Technology Characteristics:
The PAJUNK Unipolar needles, which include the physical dimensions, coating, connector, tubing, metal and plastics, have been cleared under 510(k) number K000722. The Touhy needle is identical to the Unipolar needle, included in these sets, except for the shape of the needle tip. The Touhy needle tip configuration is same as the B Braun Touhy needle, cleared for market under 510(k) number K813186 as referenced in their submission number K013610. The Plexolong Sets are supplied in sealed polypropylene containers or polypropylene and styrol paper envelopes that are sealed to assure sterility.
2
Summary of Performance Testing:
The PAJUNK Plexolong Sets were designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards.
| Standard | Issue Date | Title |
|---|---|---|
| DIN 13090/ISO 594 | 08.1984 | Luer fittings w/wo locking feature |
| DIN 13097 Part 1 | 01.1980 | Medical injection cannula |
| DIN 13097 Part 3 | 11.1979 | Medical cannula |
| DIN 17442/ISO 9626 | 10.1977 | Steel for medical instruments |
| DIN EN 550 | 07.1993 | Sterilization of med. Prod.; Validation & routine controls for |
| sterilization with ETO | ||
| DIN EN 556 | 01.1995 | Sterilization of medical products, requirements for medical |
| products that are labeled "sterile" | ||
| DIN EN 724 | 12.1994 | Guidance on the application of EN29001 and EN46001 for |
| non-active medical products | ||
| PrEN 868-1 | 10.1996 | Packaging materials for the sterilization of packaged goods. |
| Part 1: general requirements for the validation of the | ||
| packaging of sterilized end-packaged products | ||
| DIN EN 868-2 | 03.1993 | Packaging materials for the sterilization of packaged goods. |
| Part 2: sterilization packaging, requirements and tests. | ||
| DIN EN 980 | 08.1996 | Graphic symbols for marking medical products |
| DIN EN 1441 | 08.1994 | Risk analysis for medical products |
| DIN EN 1707 | 01.1997 | 6% Luer cone connections for injection cannula and |
| particular medical equipment | ||
| DIN EN/ISO 9626 | 06.1995 | Cannula tube of non-rusting steel (SS) for the manufacture of |
| medical products | ||
| DIN en 30993-1 | 12.1994 | Biological evaluation of medical products - instructions for |
| selection of tests | ||
| DIN EN 46001 | 12.1993 | Particular requirements for medical products |
| DIN 17440 | 09.1996 | Stainless Steels |
| BS 4843 | Single entry IV cannula |
Conclusion:
The PAJUNK Plexolong Sets are as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2003
PAJUNK GmbH C/O Mr. Burk A. Brandt CE Consultancy, Incorporated 5010 NW Crescent Valley Drive Corvallis, Oregon 97330
Re: K023218
Trade/Device Name: Pajunk Plexolong Sets Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSP Dated: February 25, 2003 Received: February 27, 2003
Dear Mr. Brandt:
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.
4
Page 2 - Mr. Brandt
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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number: K023218________________________________________________________________________________________________________________________________________________
Device Name: Pajunk Plexolong Sets
Indications for use:
The Pajunk Plexolong sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connectors to assist the physician pinpoint the area of application.
Warning:
The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
V Prescription Use or Over-The- Counter _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
S.H. Ward
nesthesiology. General Hospital.
510(k) Number: