(241 days)
MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum.
MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest.
MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure.
Medax Bone Marrow Biopsy and Aspiration System portfolio is composed by single use devices intended to obtain biopsy samples from bone for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length.
The provided document is a 510(k) Premarket Notification for the Medax Bone Marrow Biopsy and Aspiration System. It seeks to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving that a new device meets specific, novel acceptance criteria through a clinical study.
Therefore, the document does not contain the kind of information requested in the prompt, which typically relates to the performance validation of a new, often AI-driven, medical device against a defined set of clinical acceptance criteria. Specifically, it does not include:
- A table of acceptance criteria and reported device performance based on clinical outcomes.
- Sample sizes used for test sets, data provenance (country, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- Sample sizes or ground truth establishment for training sets.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of:
- Intended Use and Indications for Use: The devices are stated to be identical to predicate devices in these aspects.
- Technological Characteristics: Detail is provided on aspects like regulation number, device description, target population, mechanics of operation (all manual instruments), available models (gauge and length), patient/tissue contact materials (Stainless steel AISI 304), biocompatibility requirements (ISO 10993), and sterilization methods (Ethylene Oxide).
- Performance Testing (Non-clinical/Bench Tests): This primarily refers to in vitro tests carried out according to FDA guidance and applicable ISO/ASTM standards (e.g., ISO 9626 for stainless steel needle tubing, ISO 10993 for biocompatibility, ISO 11607-1 for packaging, ISO 11737-1 for sterility, and tests for EtO residuals). The document states that "Results from these performances evaluation demonstrated that the Medax Bone Marrow Biopsy and Aspiration System devices met the acceptance criteria defined in the product specification and performed comparably to the predicate device." However, it does not list these specific acceptance criteria in a quantitative manner or provide the raw performance data from these tests.
In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance study details, as it is a 510(k) submission based on substantial equivalence to existing devices through comparison of design and non-clinical performance, not a clinical performance study with defined quantitative acceptance criteria against a ground truth on a test set.
§ 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.