(60 days)
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.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.