(47 days)
Pajunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations.
The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
Pajunk's TrokaBone and TrokaBone Sternal puncture sets consist of a modular system for single and multiple extraction of bone and bone marrow samples. Equipped with an ergonomic handle and manufactured of highgrade stainless steel, TrokaBone shows a high stability.
This looks like a 510(k) premarket notification for a medical device called TrokaBone and TrokaBone Sternal, a biopsy cannula for bone and bone marrow sampling.
The document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
Instead, this submission focuses on establishing substantial equivalence to predicate devices already on the market (K013692 TrapSystem and K051506 Sterylab Bone Biopsy). This is a common pathway for medical devices that are similar in technology and intended use to previously cleared products.
Here's why the requested information about acceptance criteria and performance studies is not present in this document:
- Substantial Equivalence: For 510(k) submissions based on substantial equivalence, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (materials, design, intended use, sterilization, etc.) and demonstrating that any differences do not raise new questions of safety or effectiveness. It typically does not require extensive clinical performance studies with specific statistical acceptance criteria for the new device as would be seen in a PMA or a de novo submission.
- Device Type: This is a biopsy cannula, which is a relatively low-risk device. Clinical trials to establish performance metrics (like accuracy for a diagnostic device) are generally not required for such devices when a suitable predicate is available. The focus is more on manufacturing quality, sterility, biocompatibility, and functional similarity to existing devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text, as this information is not included in this type of 510(k) submission.
The document primarily states:
- Pajunk's TrokaBone puncture set consists of a modular system for single and multiple extraction of bone and bone marrow samples for histological examinations.
- The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
- The comparison between the predicate devices and the proposed devices as well as the validated sterilization process demonstrates that the proposed devices are substantially equivalent to the predicate devices and safe and effective.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.