(293 days)
The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosseous aspiration of viscous bone marrow material in the human body.
The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.
The Bio-MAC™ Bone Marrow Aspiration Cannula System is an 11 gauge cannula needle system in various lengths (currently 25,45,60,80 and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a viscous bone marrow aspiration/collection procedure.
The Bio-CORE™ Bone Marrow Biopsy Cannula is an 11guage cannula needle system in various lengths (currently of 60, 80, and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a bone marrow solid core biopsy procedure.
The provided text describes a 510(k) premarket notification for the Bio-MAC™ and Bio-CORE™ Intraosseous Cannula Systems. It establishes substantial equivalence to a predicate device, the ONCONTROL Bone Marrow Biopsy System (K072045), based on technological characteristics and performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format with pass/fail thresholds. Instead, it relies on demonstrating substantial equivalence to the predicate device through comparisons of design characteristics and performance testing. The "reported device performance" is essentially a statement that the devices functioned as safe and effective as the predicate.
| Characteristic/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | In line with predicate device | "No Deviations - The submitted devices indications are in line with the predicate device." |
| Needle Design (Material/Gauge) | Similar to predicate device | Bio-MAC and Bio-CORE use 304 Stainless Steel / Polyetherimide (Ultem); 11 gauge. Predicate uses 304 Stainless Steel; 11 gauge. |
| Technique | Similar to predicate device | Implied to be similar based on device descriptions (power drill insertion, syringe aspiration/biopsy). |
| Sterility | Packaged sterilized, similar to predicate | Both submitted devices and predicate are Packaged Sterilized. |
| Single Use | Single use, similar to predicate | Both submitted devices and predicate are Single Use Device. |
| Anatomical Location | Similar to predicate | Bio-MAC: Proximal Humerus, Proximal Tibia, Posterior Iliac Crest, Anterior Iliac Crest, Vertebral Body. Predicate: Proximal Humerus, Proximal Tibia, Distal Tibia, Iliac Crest. (Overlap exists, some differences noted but deemed equivalent). Bio-CORE: Iliac Creat. Predicate: Iliac Crest. |
| Method of Device Insertion | Drill/Driver, functionally equivalent | Submitted devices use customer-owned drill via adapter. Predicate uses provided reusable battery-powered drill. Deemed equivalent. |
| Method of Aspiration | Attached syringe to Luer Lock, similar to predicate | Both submitted devices and predicate use Attached syringe to Luer Lock on cannula hub. |
| Physical Testing (Torque/Pullout) | Perform as safe and effective as the predicate device | "The results indicated the submitted devices perform as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that bench testing was performed.
- Sample Size for Test Set: "Utilizing a predicate device of the largest size and the BTI Bio-MAC and Bio-CORE smallest and largest size bench testing was accomplished." This implies a limited number of devices were tested (at least one of each specified size for the submitted devices and one largest size for the predicate). A specific numerical sample size is not provided.
- Data Provenance: The document does not explicitly state country of origin for the data or whether it was retrospective or prospective. Given it's bench testing conducted for a premarket submission, it would be considered prospective data generated for the submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts or establishing ground truth in the context of clinical studies, as the performance testing described is bench testing.
4. Adjudication Method for the Test Set
As the performance testing described is bench testing, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. The submission relies on bench testing and comparison of technological characteristics to a predicate device.
6. Standalone (Algorithm Only) Performance Study
Not Applicable. This device is an intraosseous cannula system, a physical medical device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study was not conducted or described.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/image analysis (e.g., pathology, expert consensus) does not directly apply to the bench testing described for this physical device. The "truth" for the performance tests would be the measured physical properties (e.g., torque to turn, pullout force) and whether they met engineering specifications or performed comparably to the predicate device.
8. Sample Size for the Training Set
Not Applicable. This document describes the 510(k) submission for a physical medical device, not an AI/ML algorithm. There is no training set involved.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no ground truth establishment for a training 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.