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PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotics to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous.

PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotlcs to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous. The sterile components are available seperately. The kit is available in two basic designs: Design 02 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Puncture needle, Permanent teflon cannula, Flat filter) and Design 01 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Tear-cannula (also referred to as Split-cannula), Flat filter).

The InfiltraLong Wound infiltration catheter kit from PAJUNK® underwent a 510(k) Premarket Notification Submission. The submission focused on establishing substantial equivalence to predicate devices already marketed, confirming the safety and effectiveness of the proposed device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific quantitative acceptance criteria for device performance in a table format. Instead, the "Conclusion" section within "Technology Characteristics" states:

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify a sample size for a test set in the context of clinical data for performance evaluation.
• The evaluation relies on "Bench Testing" for technical characteristics and comparison with existing predicate devices.
• The data provenance is for the manufacturing and testing of the device itself rather than clinical patient data. The manufacturer is Pajunk GmbH, located in Germany, and the document indicates their US contact and contract sterilizer are also identified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• There is no mention of experts or a "ground truth" establishment in the context of clinical performance data for a test set in this 510(k) submission.
• The assessment is based on compliance of the device components with established international standards (ISO, EN) and comparison to predicate devices, which implies an expert understanding of these standards by the device manufacturer's regulatory and R&D teams.

4. Adjudication Method for the Test Set

• No adjudication method is described because there is no multi-expert review or clinical performance test set analysis mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done. This device is a medical catheter kit, not an AI-assisted diagnostic or treatment system. The document does not discuss AI or human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No standalone (algorithm-only) performance study was done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on compliance with international standards (ISO, EN) for medical devices and components, and the established safety and effectiveness of predicate devices. The claim of substantial equivalence is the central "ground truth" or foundational assertion for FDA clearance.
• There is no mention of pathology, outcomes data, or expert consensus in a clinical trial context.

8. The Sample Size for the Training Set

• No training set is applicable or mentioned. This is not a machine learning or AI device. The submission focuses on bench testing and comparison to predicate devices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device type.

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Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies.

Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.

Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue. Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. This device is not indicated for use under MR based imaging technologies, such as MRI.

The cannulas and needles consist of medical grade steel, plastic luer hub and stylet (stabilizing mandrin inside cannula). For safety reasons, the graduated puncture cannula also has an additional depthstop installed at the shaft of the cannula.

The cannula Type Chiba Special has been developed by PAJUNK® with an approx. 1 cm matted finish of the cannula tip and three additional ring-markings.

For safety reasons, the graduated puncture cannula/ needle has an additional depth-stop installed at the shaft. As a standard, the cannulas/ needles with beveled tip are normally equipped with a handle plate and a depth stop.

This universally usable puncture cannula/ needle made of high-grade stainless steel is suitable for all percutaneous punctures with guidance wires. It is available in a 2-parted and in a 3-parted version, with and without graduation. The outer cannula has a rounded, blunt tip, and it is designed to match the inside stylet-cannula.

This cannula with a Special Sprotte tip is intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. It is an EO-sterilized, latex-free device for single use.

For better depth control, the interventional micro-cannula features graduated collars at intervals of 1 cm.

The puncture kit according Dr. Steinhoff contains a Chiba-type puncture cannula/ needle with a cannula rider and a flexible tube. The millimeter-precise introduction of the puncture needle by means of the cannula rider is facilitated with the aid of the centimeter-graduation and the corresponding markings at intervals of 5 mm. Thereby, the needle can be quided safely, without lacking the necessary flexibility.

Pajunks breast localization cannulas can be used in Mammographic procedures to obtain breast lesion tissue.

The provided document is a 510(k) Premarket Notification Submission for various soft tissue biopsy, puncture, and aspiration cannulas and needles. It is a submission seeking substantial equivalence to a predicate device, rather than a study demonstrating that a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or a performance study with reported metrics. The submission is a claim of "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a legally marketed device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) premarket notification for substantial equivalence, not a clinical study. The submission relies on a comparison to a predicate device and bench testing (e.g., sterilization, biocompatibility, packaging) rather than a clinical trial with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (cannulas and needles), not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is typically the established safety and effectiveness of the predicate device (K980211 Manan MRI Chiba, spinal, breast localization etc.). The new device aims to be substantially equivalent to this standard.

8. The sample size for the training set

Not applicable. This is a physical medical instrument, not an AI model.

9. How the ground truth for the training set was established

Not applicable.

Summary based on the provided document:

The submission explicitly states its approach:

• Acceptance Criteria (Implied): The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Manan Medical's cannulas and needles, cleared under K980211). This means showing the new device is as safe and effective as the predicate.
• Study Proving Device Meets Acceptance Criteria: The "study" is a comparative analysis documented in Section 12 of the submission (not provided here).
  • Basis of Comparison: The submission states, "The comparison between the predicate devices and the proposed device in section 12 of this submission demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate devices."
  • Key points of the comparison for substantial equivalence:
    • Identical Indications for Use: The predicate device and the proposed device share "identical indications for use" for their respective categories (e.g., breast localization, soft tissue biopsy).
    • Same Technical Specification: The proposed device has the "same technical specification in materials and grinding" as the predicate device.
    • Biocompatibility: All materials are medical grade steel and plastic, which have been cleared in previous 510(k) applications (K040965 for Anesthesia conduction, spinal and epidural) and are "deemed to be biocompatible." Testing according to ISO 10993 has been conducted successfully using identical materials.
    • Sterilization: The device uses Ethylene Oxide (EO) sterilization to a Sterility Assurance Level (SAL) of

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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.

The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space (optional: 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.

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.

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.

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.

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.

Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.

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.

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.

This document is a 510(k) Premarket Notification Submission for Pajunks StimuLong Tsui Method Set. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Summary of Acceptance Criteria and Device Performance:

The primary acceptance criterion for this submission is demonstrating substantial equivalence to existing predicate devices already cleared for market. The study proving this involves a comparison of technology characteristics and a review of clinical literature.

Study Details:

The submission does not describe a traditional clinical study with a test set, ground truth experts, or formal adjudication. Instead, it relies on a literature review and comparison to predicate devices to demonstrate substantial equivalence.

1. Sample size used for the test set and data provenance:

   • No explicit "test set" in the sense of patient data is described. The evaluation relies on a comparison with predicate devices and existing clinical literature.
   • Data provenance is primarily from "clinical literature from Dr. Tsui" and "several studies and articles published since the 1990's" (referred to in Section 20 of the submission, though not provided in the excerpt) related to the Tsui-Test technique and the predicate devices. The country of origin for the studies is not specified in the provided text. The submission itself is from a German manufacturer (Pajunk GmbH Medizintechnologie).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • No direct ground truth establishment by experts for a novel test set is described. The efficacy and safety are inferred from the existing body of clinical literature and the established use of the technique (Tsui-Test) and the predicate devices. The clinical literature cited refers to Dr. Tsui, implying his expertise underpins the technique.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • No adjudication method is relevant or described, as there isn't a new test set requiring expert review and consensus.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was conducted. This device is a medical instrument (catheter set) and not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is a medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for the device's safety and effectiveness is established through:
     • Clinical literature review: Citing published studies and articles (e.g., from Dr. Tsui) supporting the safety and effectiveness of the "Tsui-Test" technique and the use of stimulation via catheter for precise application of anesthesia.
     • Predicate device history: The components and the general techniques (epidural and peripheral anesthesia with stimulation) are already cleared and established through the predicate devices (Pajunks StimuLong Set and Pajunks EpiLong Set).

7. The sample size for the training set:

   • Not applicable. This is a medical device submission, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable.

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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.

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 provided document is a 510(k) Premarket Notification Submission for the EpiLong Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics.

Instead, the submission states:

• 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." (Page 1)
• FDA's finding: "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..." (Page 2)

In summary, there is no study described in this document that proves acceptance criteria are met, as the regulatory pathway chosen (510(k)) relies on substantial equivalence to a predicate device, not on meeting specific, pre-defined performance acceptance criteria through the types of studies typically associated with AI/software devices.

The document primarily focuses on:

• Device description and indications for use.
• Identification of predicate devices (BBrauns Perifix K813186).
• Mention of sterilization processes.
• A "detailed discussion of substantial equivalence" in a section (Section 12) that is not included in the provided text.

Without Section 12 or other detailed performance testing reports, it's impossible to extract the requested information.

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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).

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.

The provided document is a 510(k) Premarket Notification Submission for the EpiSpin Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive independent clinical study data with acceptance criteria and performance metrics typically seen for novel devices.

Therefore, the document does not contain specific acceptance criteria, comprehensive study results proving device performance against those criteria, or the detailed information on study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that you requested.

The document primarily focuses on:

• Device Description: What the EpiSpin set is and its components.
• Predicate Devices: Identifying previously cleared devices to which the EpiSpin kit claims substantial equivalence.
• Sterilization: Details about the sterilization process.
• Technological Characteristics: How the device works (needle-through-needle technology).
• Indications for Use: The intended applications for the EpiSpin kit and its individual components (LOR-Syringe, Fixolong, Flat Filter, Tuohy Borst Adaptor, Anesthesia conducting Catheter).
• Substantial Equivalence Conclusion: A statement that the device is safe, effective, and substantially equivalent to the predicate devices.
• FDA Clearance Letter: Confirmation of FDA's substantial equivalence determination.

Key Missing Information for your request:

• Acceptance Criteria Table and Reported Device Performance: This document does not present specific quantitative acceptance criteria or detailed performance data against them. The "proof" of meeting criteria is typically the claim of substantial equivalence to existing devices that have already met such criteria.
• Sample sizes for test set and data provenance: No dedicated clinical studies with test sets are described. The equivalence is based on design and material similarity and performance comparison to predicate devices, not on new clinical trials with specified sample sizes.
• Number and qualifications of experts for ground truth: No such experts are mentioned for a new study.
• Adjudication method: Not applicable as no new test set is described.
• MRMC comparative effectiveness study: No such study is mentioned or provided.
• Standalone algorithm performance: This is a physical medical device, not an AI algorithm, so standalone performance in that context is not relevant.
• Type of ground truth used: No new ground truth is established for efficacy in this submission; the basis is substantial equivalence to legally marketed devices.
• Sample size for training set and how ground truth was established for training set: These concepts are not applicable to the type of premarket notification presented for this physical medical device.

In summary, the provided document does not contain the detailed study information you are requesting because it is a 510(k) submission focused on demonstrating substantial equivalence, not on presenting novel clinical trial data with specific acceptance criteria and performance metrics.

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