(181 days)
The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow.
The Ranfac Bone Marrow Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
The provided text describes a 510(k) summary for the Ranfac Bone Marrow Aspiration Needle, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness or meeting specific performance criteria through a new clinical study. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, and ground truth establishment is not part of this 510(k) submission.
The document explicitly states: "Clinical Data: Not applicable" (page 3). This means no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria. Instead, the submission relies on non-clinical data and comparison to predicate devices.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was conducted for this 510(k) submission, there are no specific performance-based acceptance criteria or reported device performance metrics in the traditional sense of a clinical trial. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety.
The summary focuses on conformance to recognized standards for materials, luer lock connections, and sterilization.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Claimed Conformance) |
|---|---|
| Material: ISO 9626 (Stainless steel needle tubing) | In conformance with ISO 9626 |
| Luer Lock (General): ISO 594/1 (Conical fittings) | In conformance with ISO 594/1 |
| Luer Lock (Lock fittings): ISO 594-2 (Lock fittings) | In conformance with ISO 594-2 |
| Sterilization: ISO 11135-1 (Ethylene Oxide) | Applies to the sterilization of the finished device |
| Sterilization Residuals: ISO 10993-7 (Ethylene oxide) | Applies to the sterilization of the finished device |
| Biological Indicators: AAMI/ANSI/ISO 14161 (Guidance) | Applies to the sterilization of the finished device |
| Packaging: ISO 11607-1 (Terminally sterilized medical devices) | Applies to the sterilization of the finished device |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data is provided in this 510(k) summary (as explicitly stated by "Clinical Data: Not applicable").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set and thus no ground truth established by experts is mentioned in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. No clinical test set is mentioned in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone marrow aspiration needle, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone marrow aspiration needle, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As "Clinical Data: Not applicable" is stated, no ground truth from a clinical study is provided. The basis for clearance is substantial equivalence to predicate devices, supported by non-clinical conformance to standards and material/design comparisons.
8. The sample size for the training set
Not applicable. This device is not an AI-driven system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI-driven system requiring a training set or associated ground truth.
In summary: The provided 510(k) summary for the Ranfac Bone Marrow Aspiration Needle demonstrates substantial equivalence to predicate devices primarily through comparison of materials, design, principles of function, biocompatibility, and sterilization methods, along with conformance to relevant industry standards for medical device components and manufacturing processes. It explicitly states that clinical data is "Not applicable" for this submission.
§ 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.