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PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.

With PrimoCut. PAJUNK® has developed a disposable cannula system which was especially designed for the extraction of biopsies from soft tissue tumors. Depending on the size of the biopsy material desired, there are two different dissecting lengths to choose from: 6 mm, or 15 mm. Different from the multiple-use biopsy system DeltaCut, the activating mechanism of the PrimoCut is directly integrated in the connecting hub of the cannula. This more economical alternative is disposed of completely after use. The PrimoCut is a semi-automated, spring loaded, sterile disposable device for soft tissue biopsies.

The provided text is a 510(k) Premarket Notification Submission for a medical device (PAJUNK®'s PrimoCut Disposable Biopsy system). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with detailed performance metrics.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and specific accuracy metrics are not available in this document.

However, I can extract information related to the device and the basis of its clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document in the format of specific, quantifiable acceptance criteria with corresponding device performance metrics. The submission relies on demonstrating substantial equivalence.

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

This information is not provided. The submission details bench testing and biocompatibility testing, but not a clinical study with a "test set" in the context of AI/diagnostic device evaluation.

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

This information is not provided. The device is a biopsy system, and its efficacy is based on its ability to extract tissue, rather than interpreting images or data that would require external expert ground truth.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging or AI devices where human readers interpret results. This submission is for a physical biopsy device.

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

No, a standalone algorithm-only study was not performed. This is not applicable to a physical biopsy device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance would primarily be established through:

• Bench Testing: Demonstrating the device's ability to mechanically cut and collect tissue effectively and consistently.
• Biocompatibility Testing: Ensuring the materials are safe for use in the human body.
• Sterilization Validation: Confirming the sterilization process renders the device sterile.

8. The Sample Size for the Training Set:

This information is not provided and is not relevant for this type of device submission. Training sets are typically associated with machine learning algorithms.

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

This information is not provided and is not relevant for this type of device submission.

Summary of Device Acceptance (as per the document):

The device gained acceptance by demonstrating substantial equivalence to existing legally marketed predicate devices, combined with positive outcomes from bench testing, biocompatibility testing, and sterilization validation.

Predicate Devices:

• K052802 Manan BioCut soft tissue Biopsy needle
• K024120 TEMNO® semi automated biopsy device, Allegiance

Study Proving Device Meets Acceptance Criteria (as per the document):

The submission states: "The comparison between the predicate devices and the subject device in section 12 of this submission as well as the validated sterilization process and the results of the bench testing and bench marking demonstrates that the proposed devices are substantially equivalent to the predicate devices and identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective. Based on the clinical evaluation, the biocompatibility testing and the bench testing conducted the efficacy of PAJUNK®'s PrimoCut is proven."

This indicates the "study" was a combination of:

• Substantial Equivalence Argument: Detailed comparison of technical characteristics to predicate devices.
• Bench Testing: To confirm the physical performance of the device (though specific results or criteria are not detailed in this summary).
• Biocompatibility Testing: To ensure the materials are safe for patient contact.
• Sterilization Validation: To confirm the device is sterile.

The outcome (K080674 clearance) confirms the FDA considered these demonstrations sufficient to establish the device's safety and effectiveness for its intended use, based on the substantial equivalence pathway.

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The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.

The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.

The provided text does not contain specific acceptance criteria or an explicit study describing the device's performance against such criteria in the format requested.

The document is a 510(k) summary for the ExiClip™ EXCS-M, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

However, I can extract information related to the device's intended use and the basis for its substantial equivalence claim, which might implicitly serve as a form of "acceptance criteria" in the context of a 510(k) submission.

Here's an attempt to derive the closest possible answers based on the provided text, acknowledging that the requested study details (sample size, experts, ground truth type, etc.) are not present for "performance against acceptance criteria" as typically found in clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no explicit 'acceptance criteria' are given in terms of numerical thresholds for device performance (e.g., accuracy, sensitivity, specificity). Instead, the substantial equivalence argument relies on functional comparisons to predicate devices.

Study Information (Based on Available Text):

The document describes a substantial equivalence claim, not a detailed performance study with the requested metrics. Therefore, many of the requested details about a "study" are not explicitly present.

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

• Not explicitly stated for a performance test set. The document focuses on comparing the design and function of the ExiClip™ to predicate devices, not on a clinical or analytical test set with a specific sample size. The statement "The ExiClip™ EXCS-M skin clip has been found to have a comparable retention force to the AutoClip® Wound Clip" implies some form of testing, but details on sample size or provenance are absent.

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

• Not applicable. The document does not describe a clinical study where ground truth would be established by experts. The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the predicate devices.

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

• Not applicable. No clinical test set requiring adjudication is described.

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:

• No. This is a medical device for biopsy and wound closure, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

• For the purposes of this 510(k), the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Shoney Scientific Disposable Punch Biopsy and AutoClip® Wound Clip with Applier Device) as demonstrated through their prior market history and regulatory clearance. The ExiClip™ is deemed substantially equivalent because its technological characteristics and intended use are similar to these established devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product and does not involve a "training set."

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

• Not applicable. As above, no training set is involved.

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The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.

STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.

The provided text, K983647, describes the ECHO-COAT™ Ultrasound Needles and their substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.

The document states:

• "STS is providing performance data to demonstrate equivalence where necessary."
• "STS Biopolymers, Inc. carried out performance testing on the ECHO-COAT™ Ultrasound Needles. This testing addressed the following issues: Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing. All of the results demonstrate substantial equivalence."

Crucially, the K983647 document summarizes that testing was done and performance was demonstrated, but it does not provide the specific acceptance criteria, the reported device performance against those criteria, sample sizes, ground truth establishment methods, or any details about multi-reader studies.

Therefore, I cannot fill out the requested table and answer many of your questions based solely on the provided input.

Based on the available information in K983647, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that "performance testing" and "imaging performance testing" were done, and that "all of the results demonstrate substantial equivalence," but it does not specify the quantitative acceptance criteria or the measured performance values for the ECHO-COAT™ Ultrasound Needles.

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

Cannot be provided. The document mentions "performance testing" but does not detail the sample sizes used for any of the tests (Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing). It also does not specify the data provenance (country, retrospective/prospective).

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

Cannot be provided. The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the use of experts for this purpose, especially in the context of imaging performance. The "imaging performance testing" is mentioned as a general category.

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

Cannot be provided. No information on adjudication methods is present.

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

Cannot be provided. This K983647 submission is for an ultrasound needle with a coating for improved visibility, not an AI-powered diagnostic device. Therefore, an MRMC study with AI assistance would not be applicable or expected for this type of device.

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

N/A. This device is a physical medical instrument (an ultrasound needle), not an algorithm or software. Standalone performance testing would refer to direct measurement of the needle's physical and imaging properties. The document implies such testing was done under "Imaging Performance Testing" but provides no details.

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

Cannot be provided. The document does not specify how ground truth was established for "Imaging Performance Testing." Given the nature of the device, it would likely involve objective measures of visibility (e.g., contrast-to-noise ratio, depth of visibility in tissue phantoms) rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

N/A. This is not an AI/machine learning device, so there is no concept of a "training set."

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

N/A. As above, no training set, so no ground truth establishment for it.

Summary of what is known from K983647:

• Device Name: ECHO-COAT™ Ultrasound Needles
• Purpose: The polymer coating (ECHO-COAT™) improves visibility of the needles in ultrasound images, assisting with positioning.
• Predicate Device: Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the "EchoTip" for ultrasound imaging visibility.
• Technological Characteristics: The coating is visible in ultrasound images, unlike the predicate which uses etching. This is identified as the key technological difference.
• Testing Performed: Sterilization, Package Integrity, Biocompatibility, and Imaging Performance Testing.
• Conclusion: All tests "demonstrate substantial equivalence."

To obtain the detailed information you requested, one would need to access the full submission documents, specifically the sections detailing the performance testing for the ECHO-COAT™ Ultrasound Needles. This 510(k) summary only provides a high-level overview.

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