(94 days)
The Imbibe Aspirating XIA TapsTM are 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 Aspirating XIA TapsTM are also for use as bone screw starters and bone taps.
The Imbibe Aspirating XIA Taps™ are manually operated surgical instruments used to assist with aspiration of bone marrow (BMA) and autologous blood by use of a syringe. The taps will be provided in 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5mm, and 7.5mm diameters. The instruments are cannulated with fenestrated distal ends which serve as ports of entry for the BMA and autologous blood. The proximal end of the taps contain an over molded Luer-Lock fitting for syringe connection and BMA/autologous blood extraction. The tips are also threaded to assist in bone preparation and bone screw starter. The main body of the Imbibe Aspirating XIA Taps™ is manufactured from medical grade stainless steel and the Luer-Lock fitting from acrylonitrile butadiene styrene (ABS). The subject device is not intended to be used as a delivery unit.
All materials used have acceptable biocompatibility results as per ISO 10993. The devices will be provided as single-use, sterile packed instruments.
The provided text describes the Stryker Imbibe Aspirating XIA Taps™ and its FDA 510(k) submission, comparing it to a predicate device. The information focuses on proving substantial equivalence to the predicate device rather than presenting a study demonstrating new device performance against defined acceptance criteria. Therefore, several requested fields cannot be directly extracted from this document, as it's not a study report in that sense.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format for the new device as it does for a clinical trial. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is stated in terms of compliance with ISO standards and successful outcomes in pre-clinical animal testing.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Luer Lock Fitting strength and integrity | Passed Luer Lock Fitting (ISO 594-2) |
| Air Leakage | Passed Air Leakage (ISO 594-2) |
| Separation Force of Luer Lock Fitting | Passed Separation Force (ISO 594-2) |
| Unscrewing Torque | Passed Unscrewing Torque (ISO 594-2) |
| Resistance to Overriding | Passed Resistance to Overriding (ISO 594-2) |
| Bone marrow/autologous blood aspiration | Demonstrated substantial equivalency in animal model |
| Bone screw starter/bone tap functionality | Demonstrated substantial equivalency in animal model |
| Biocompatibility: | |
| Material Biocompatibility | All materials used have acceptable biocompatibility results as per ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for each test. For the pre-clinical animal model, the sample size is not specified.
- Data Provenance: The pre-clinical testing was conducted in a laboratory setting. The country of origin of the data is not specified in the provided text. The testing appears to be prospective as it was conducted specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document describes pre-clinical engineering and animal model testing, not studies requiring expert review of data for ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers evaluate cases, such as in image-based diagnostic studies, to establish ground truth or resolve discrepancies. This document focuses on device performance metrics and an animal model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on the substantial equivalence of the device's functional and material characteristics to a predicate device, not on comparing human reader performance with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a medical device (surgical instrument), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the functional tests like Luer Lock fitting and air leakage, the "ground truth" is adherence to the specified ISO standard thresholds. For the pre-clinical animal model, the "ground truth" would be the successful aspiration of bone marrow/autologous blood and the ability to function as a bone screw starter/tap, demonstrated by the animal study results.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI or machine learning model that requires a training set. The "training set" concept is not relevant to proving substantial equivalence for a mechanical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.