(308 days)
Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.
The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.
The provided text describes the K102274 510(k) submission for the RaviNeedle™ Aspiration Instrument. However, it does not contain a detailed study report with specific acceptance criteria, numerical performance data against those criteria, or a description of the methodology for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report.
The document states: "Testing showed the device meets all design criteria as well as the requirements of surgical users." and "In-vitro and in-vivo testing demonstrates that the device will perform as stated in the indications for use."
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Tissue Penetration Forces | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Laparoscopic Visualization | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Cage deployment/retraction Forces | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Removal from Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Flow Rate | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Leak Rate | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Pneumoperitoneum Loss | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Security in Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Damage to Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Damage to Device | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
Missing Information (Not available in the provided text):
- Specific quantitative acceptance criteria (e.g., "Flow rate must be > X mL/min").
- Specific quantitative performance results (e.g., "Achieved flow rate of Y mL/min").
- Details on how "requirements of surgical users" were quantified and assessed.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench top or in-vivo testing" but does not give the number of samples, cases, or subjects used for any of the listed tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document mentions "requirements of surgical users" but does not detail the involvement of experts in establishing ground truth or evaluating performance.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 manual aspiration instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The performance data is based on "bench top or in-vivo testing" against "design criteria" and "requirements of surgical users." These would likely involve objective measurements for mechanical, flow, and leak tests, and potentially subjective assessments by surgical users for aspects like visualization and tissue interaction. However, the specific methodology for establishing these "ground truths" (i.e., the ideal or correct performance benchmark) is not detailed.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Study Type:
The K102274 submission is for a physical medical device, the RaviNeedle™ Aspiration Instrument. The performance data provided are for engineering and biocompatibility tests (benchtop and in-vivo testing) to demonstrate the device meets design specifications and user requirements. This is typical for a 510(k) submission for a Class I device and does not involve the kind of clinical study or AI performance evaluation details (like ground truth establishment, expert adjudication, or MRMC studies) that would be relevant for diagnostic software or AI-enabled devices. The level of detail you are asking for regarding "acceptance criteria" and "study" is generally not present in a 510(k) summary for this type of device, which focuses on substantial equivalence to a predicate.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.