(39 days)
The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction cathter to its tip via the catheter adapter.
The Paiunk Stimulong Plus Catheter Sets and Plexalong sets are single use, sterile, non-pyrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Stimulong Plus Catheter sets and Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, a catheter and catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for a conductive ring tip. Continuous delivery is accomplished using the catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the tip of the conduction needle and after placement of the conduction catheter (Stimulong Plus catheter) to its tip via the catheter adapter.
The provided text describes a 510(k) premarket notification for the "Pajunk Stimulong Plus Catheter Sets" and does not contain a study demonstrating device performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, this document focuses on demonstrating substantial equivalence to predicate devices through conformance to recognized consensus standards and biocompatibility testing.
Here's a breakdown based on the information provided and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from standards) | Reported Device Performance (as implied by successful conformance) |
|---|---|---|
| Material & Physical Properties | Luer fittings w/wo locking feature (DIN 13090/ISO 594) | Conforms |
| Medical injection cannula (DIN 13097 Part 1 & 3) | Conforms | |
| Steel for medical instruments (DIN 17442/ISO 9626) | Conforms | |
| 6% Luer cone connections (DIN EN 1707) | Conforms | |
| Cannula tube of non-rusting steel (SS) (DIN EN/ISO 9626) | Conforms | |
| Stainless Steels (DIN 17440) | Conforms | |
| Single entry IV cannula (BS 4843) | Conforms | |
| Sterilization & Packaging | Sterilization of med. Prod.; Validation & routine controls for sterilization with ETO (DIN EN 550) | Conforms |
| Requirements for medical products that are labeled "sterile" (DIN EN 556) | Conforms | |
| Packaging materials for sterilization of packaged goods (PrEN 868-1, DIN EN 868-2) | Conforms | |
| Biocompatibility | Biological evaluation of medical products - instructions for selection of tests (DIN EN ISO 10993-1) | Biocompatibility testing of conductive tip, wire, and alternate plastic material located in Section 7 (of the full submission, not provided here) |
| Risk Management | Risk analysis for medical products (DIN EN 1441) | Conforms |
| Risk Management (EN ISO 14971) | Conforms | |
| Quality Management & Labeling | Guidance on the application of EN29001 and EN46001 for non-active medical products (DIN EN 724) | Conforms |
| Graphic symbols for marking medical products (DIN EN 980) | Conforms | |
| Particular requirements for medical products (DIN EN 46001) | Conforms |
Important Note: The document states that "The testing included verifying conformance to these standards." This implies the device met the criteria outlined in these standards. The acceptance criteria themselves are the specific requirements within each standard. No numerical performance metrics (like accuracy, sensitivity, specificity) are provided as this is not a diagnostic device or a device with a quantifiable performance output in that manner.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text.
- The primary "testing" referenced is conformance to recognized standards, which might involve material testing or functional testing per those standards, but not a "test set" in the context of an AI/ML algorithm or clinical study.
- The document describes device components and their equivalence to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided.
- This device is a medical instrument (catheter sets, needles) and does not involve AI or image analysis where expert-established ground truth would be relevant.
- The "ground truth" here is adherence to engineering standards and safety/biocompatibility requirements.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
- There's no mention of a "test set" or adjudication in the context of human interpretation for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided.
- This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not provided.
- This device does not involve an algorithm, so a standalone performance study in that context is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness determination is established through:
- Conformance to Recognized Consensus Standards: This implies the device meets pre-defined engineering, material, sterilization, and quality requirements. Examples include ISO 594 for Luer fittings, DIN EN 550 for ETO sterilization, and DIN EN ISO 10993-1 for biocompatibility.
- Biocompatibility Testing: Specifically mentioned for the conductive tip, wire, and alternate plastic material, per DIN EN ISO 10993-1.
- Substantial Equivalence: Comparison to predicate devices (K033018, K013041, K000722, K023218, K030937) for existing design elements and materials.
8. Sample Size for the Training Set
This information is not applicable and not provided.
- This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
- As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary: K043130 is a 510(k) premarket notification for a medical device (anesthesia conduction kits) aimed at demonstrating substantial equivalence to legally marketed predicate devices. The "study" proving it meets acceptance criteria primarily involves showing conformance to a list of recognized national and international consensus standards related to materials, manufacturing, sterilization, biocompatibility, and risk management. It does not involve clinical studies with outcome measures or performance evaluations typical of diagnostic or AI-driven technologies.
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DFC 21 2004
510(k) Summary of Safety and Effectiveness
Submitter Information:
PAJUNK GmbH Karl Hall Straße 1 D78187 Geisingen Germany
USA Contact:
Mr. Burk A. Brandt CE Consultancy, Inc. 5010 NW Crescent Valley Dr. Corvallis, OR 97330 - USA
Phone: (541) 752-3953 Fax: (541) 752-3972
Device Name:
Trade Name: Stimulong Plus Catheter Sets Plexalong Sets Unipolar Needles Common Name: Anesthesia Conduction Kit Anesthesia Conduction Needle (W/Wo Introducer) Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5140, April 1, 2003), Anesthesia Conduction Needle (Reference, 21CFR, 868.5140, April 1, 2003)
Predicate Devices:
The Stimulong Plus Catheter sets and Plexalong sets consist of a Pajunk Unipolar needle (conduction cannula with nerve stimulus connector and tubing), and an open ended conduction catheter and a catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for the conductive ring tip. The Stimulong Plus Catheter sets have been cleared for market by the FDA under 510(k) number K033018. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market under 510(k) number K023218.
The packaging materials used to package the Stimulong Plus Catheter, Pajunk Plexolong sets, and cannula has not changed. The contract sterilizer, other than a company name change (was Griffith Micro Science, now Sterigenics) and sterilizing process is the same.
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Device Description:
The Paiunk Stimulong Plus Catheter Sets and Plexalong sets are single use, sterile, non-pyrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Stimulong Plus Catheter sets and Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, a catheter and catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for a conductive ring tip. Continuous delivery is accomplished using the catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the tip of the conduction needle and after placement of the conduction catheter (Stimulong Plus catheter) to its tip via the catheter adapter.
Intended Use:
The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction catheter to its tip via the catheter adapter.
Technology Characteristics:
Except for the insulating material used to coat the needles, the Pajunk conduction cannula, including the physical dimensions, connector, tubing, metal and plastics, have been cleared under 510(k) numbers K000722. K013041 and K023218. The materials used to manufacture the Pajunk catheter and catheter adapter except for the conductive catheter tip and wire are identical to the materials used to manufacture the catheter and catheter adapter of the predicate devices described earlier in this 510(k) Summary of Safety and Effectiveness. Biocompatibility testing of the conductive tip, wire and alternate plastic material is located in Section 7 of this submission. Use of a conduction catheter was cleared by FDA under 510(k) No. K030937. The Stimulong Plus Catheter Sets are supplied in polypropylene containers that are sealed to assure sterility.
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Summary of Performance Testing
The Pajunk Stimulong Plus Catheter 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 controlsfor sterilization with ETO |
| DIN EN 556 | 01.1995 | Sterilization of medical products, requirements formedical products that are labeled "sterile" |
| DIN EN 724 | 12.1994 | Guidance on the application of EN29001 and EN46001for non-active medical products |
| PrEN 868-1 | 10.1996 | Packaging materials for the sterilization of packagedgoods. Part 1: general requirements for the validationof the packaging of sterilized end-packaged products |
| DIN EN 868-2 | 03.1993 | Packaging materials for the sterilization of packagedgoods. Part 2: sterilization packaging, requirementsand tests. |
| DIN EN 980 | 08.1996 | Graphic symbols for marking medical products |
| DIN EN 1441 | 08.1994 | Risk analysis for medical products |
| EN ISO 14971 | 2000 | Risk Management |
| DIN EN 1707 | 01.1997 | 6% Luer cone connections for injection cannula andparticular medical equipment |
| DIN EN/ISO 9626 | 06.1995 | Cannula tube of non-rusting steel (SS) for themanufacture of medical products |
| DIN EN ISO 10993-1 | 08.2003 | Biological evaluation of medical products - instructionsfor 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 Stimulong Plus Catheter 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.
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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Pajunk GmbH c/o Mr. Burk A. Brandt President CE Consultancy, Incorporated 5010 NW Crescent Valley Drive Corvallis, Oregon 97330
Re: K043130
Trade/Device Name: Pajunk Stimulong Plus Catheter Sets Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSP Dated: December 3, 2004 Received: December 6, 2004
Dear Mr. Brandt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becater of 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 interstate connifetee prior to ria, 20, 177, 1978, 1978, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 199 Alliendinens, or to de rises and in tic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Ocommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (soch additional controls. Existing major regulations affecting (1 MA), it may of subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the weat nouncements concerning your device in the Federal Register.
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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 modifined into may Federal statutes and regulations administered by other Federal agencies. or the Act of all, I 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 ifsuing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as between as 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 premained with a medicate 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), rr you 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 maj South Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address lttp://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chiu Lin, Ph.D.
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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Indications for Use
510(k) Number (if known):K043130
Device Name: Pajunk Stimulong Plus Catheter Sets
Indications For Use:
The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction cathter to its tip via the catheter adapter.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Sta Senille
Division Sign-Off
Anes ു. General Hospital. Infection Control. Jer tal Devices
510(k) Number: _ Ko 9313
Page 1 of 1
§ 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).