(66 days)
The Imbibe Bone Marrow Aspiration Needle is for use in aspirating Bone Marrow or Autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Bone Marrow Aspiration Needle consists of an 8ga or 11ga needle, trocar tip stylet of corresponding size, and bullet tip stylet of corresponding size. The needle will be manufactured in two lengths measuring 10cm or 15cm from tip to molded handle. A female luer is provided on the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. One version of the 8ga needle provides fenestrated holes on the distal end of the needle. The fenestrated holes in the distal end of the needle are designed to provide more area for bone marrow or blood to enter the needle during aspiration. The bullet tip stylet must be inserted into the needle, after initial needle placement, if repositioning of the needle is required. If required, the needle can be lightly tapped with a surgical hammer for placement.
The provided 510(k) summary for the Imbibe Bone Marrow Aspiration Needle indicates that performance data was collected, but the specific acceptance criteria and detailed study results are not explicitly provided in the publicly available summary.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Established specifications (specifics not provided) | Met all established specifications |
| Substantial equivalence to predicate devices for bone marrow aspiration (specifics not provided beyond intended use and technological characteristics) | Demonstrated substantial equivalence to predicate devices; no new issues of safety or effectiveness raised; as safe and effective as predicate devices. |
Missing Information: The document states that the device "met all of the established specifications" and "mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent." However, it does not provide a table or list of what those specific "established specifications" were, nor does it detail the quantitative results of the "mechanical and performance testing."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The summary only generally refers to "Performance testing." It does not mention the type, size, or origin of any test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The device is an aspiration needle; performance testing would typically involve engineering/mechanical tests and possibly pre-clinical (animal) or clinical use cases to assess factors like ease of use, aspiration success rate, and safety, rather than expert-derived ground truth based on image interpretation or similar diagnostic tasks.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As above, adjudication methods are typically relevant for diagnostic devices that rely on human interpretation of outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not applicable and not provided. MRMC studies are generally used for diagnostic devices where human readers interpret results. This is a surgical/procedural device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done
This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
This is not explicitly stated as "ground truth." However, given the nature of the device, the "performance data" would likely be based on:
- Mechanical and Material Testing: Evaluating tensile strength, torque, bending, fluid flow rates, material biocompatibility, sterility, etc.
- Functional Testing: Assessing the ability to aspirate bone marrow or blood effectively in a controlled environment or in preclinical models.
- Comparison to Predicate Devices: Benchmarking against the performance characteristics of the K940025, K001132, and K041991 devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided. "Training set" refers to data used to train algorithms, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. See point 8.
Summary of the Study and Acceptance Criteria (Based on Provided Text):
The 510(k) summary states that "Performance testing provided in the submission indicates that the Imbibe Bone Marrow Aspiration Needle met all of the established specifications. Mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices for bone marrow aspiration and does not raise any new issues of safety and effectiveness."
The "study" that proves the device meets the acceptance criteria is referred to as "Performance testing" and "Mechanical and performance testing." The primary acceptance criterion was demonstrating substantial equivalence to the predicate devices (Manan Medical's Bone Marrow Harvest Needle K940025, Promex's Bone Biopsy Needle K001132, and Isotis Orthobiologics' Aspirex - Bone Marrow Aspiration Kit K041991) in terms of intended use, indications, technological characteristics, principles of operation, and overall safety and effectiveness.
Key takeaway: While the summary confirms that performance testing was performed and the device met its specifications and substantial equivalence requirements, the specific details of these tests, including quantitative acceptance criteria, actual performance values, sample sizes, and methodologies, are not included in this high-level 510(k) summary. Such details would typically be found in the full 510(k) submission document, which is not publicly released in its entirety.
§ 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.