(27 days)
The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.
The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.
The I-Style Bone Marrow Aspiration Needle consists of an 8ga - 15ga needle and a triple sharpened atraumatic tip stylet of corresponding size. The needle is manufactured in lengths upto 2" with an adjustable depth stopper and graduated scale which allow for the adjustment of the penetration length of the needle. A luer lock connection is provided in the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. The needle will be provided as sterile, single use, disposable device. They will be packaged individually or included in Bone Marrow Biopsy Tray.
The provided document describes the K061570 submission for the I-Style Bone Marrow Aspiration Needle. This is a 510(k) summary, which generally involves demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria and a device performance study as one might see for novel high-risk devices or software as a medical device (SaMD).
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Same intended use | Met: "Same intended use" |
| Same flow rate | Met: "Same flow rate" |
| Same bonding strength | Met: "Same bonding strength" |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Summary of Tests performed to prove the substantial equivalence of the Aspiration Needles with the predicate device." This is a comparison-based assessment rather than a performance study against predefined numerical benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing requirements" and "materials ... evaluated through biological qualification safety tests" and tests done to prove substantial equivalence. These are likely bench tests and material characterization, not patient-based clinical studies with a 'test set' of clinical data in the traditional sense.
- Data Provenance: Not explicitly stated. Given the nature of the device (a bone marrow aspiration needle) and the types of tests mentioned (biocompatibility, flow rate, bonding strength), the "data" would be generated from laboratory and bench testing, not clinical data from a specific country or collected retrospectively/prospectively from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of device and submission, there is no mention or requirement for experts to establish a "ground truth" for a test set in the context of clinical data interpretation (e.g., from images). The evaluation is based on engineering and material performance specifications.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of medical image interpretation or clinical outcome assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The I-Style Bone Marrow Aspiration Needle is a mechanical device, not an AI or diagnostic tool.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical instrument. The "tests" performed were for material safety and equivalence to a predicate device's mechanical characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "tests" performed, the ground truth would be based on established material specifications, engineering requirements, and performance data of the predicate device. For biocompatibility, established biological safety standards serve as the ground truth. For flow rate and bonding strength, the measured values are compared directly to the predicate device's characteristics. There's no "expert consensus," "pathology," or "outcomes data" ground truth in this context.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned or relevant for this 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.