(126 days)
The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures.
The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.
The provided text describes a 510(k) premarket notification for a medical device called "Disposable Veress Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, the requested information about acceptance criteria and a study proving device performance (especially points relevant to AI/ML such as test set size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
The document primarily discusses non-clinical testing for physical properties, biocompatibility, sterilization, and shelf-life of a physical medical instrument (a Veress needle), not an AI/ML diagnostic or predictive tool.
Here's a breakdown of what can be extracted, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states, "The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria." However, the specific numerical or qualitative acceptance criteria (e.g., "puncture force must be within X to Y Newtons") are not explicitly detailed in the provided text. Instead, categories of tests are listed.
- Reported Device Performance: The document only states that the device "performs as well as the predicate device" after these tests. No specific performance results (e.g., actual measured tip pull force, switch operation timing, etc.) are provided.
| Acceptance Criteria Category | Reported Device Performance Statement |
|---|---|
| Tip Pull Test | Demonstrated performance as well as the predicate device |
| Switch Operation | Demonstrated performance as well as the predicate device |
| Spring Obturator Operation | Demonstrated performance as well as the predicate device |
| Needle Puncture Force Test | Demonstrated performance as well as the predicate device |
| Biocompatibility (Cytotoxicity) | Evaluated in accordance with ISO 10993-5:2009 |
| Biocompatibility (Skin Sensitization) | Evaluated in accordance with ISO 10993-10:2021 |
| Biocompatibility (Intracutaneous Reactivity) | Evaluated in accordance with ISO 10993-23:2021 |
| Biocompatibility (Acute Systemic Toxicity) | Evaluated in accordance with ISO 10993-11:2017 |
| Biocompatibility (Pyrogenicity) | Evaluated in accordance with ISO 10993-11:2017 |
| Sterilization Validation | Validated in accordance with ISO 11135:2014 |
| Sterilant Residuals | Evaluated in accordance with ISO 10993-7:2019 |
| Simulated Distribution Testing | Performed in accordance with ASTM D4169 |
| Packaging Integrity (ASTM F1886/F1886M-16) | Performed in accordance with ASTM F1886/F1886M-16 |
| Packaging Integrity (ASTM F88/F88M-15) | Performed in accordance with ASTM F88/F88M-15 |
| Packaging Integrity (ASTM F1929-15) | Performed in accordance with ASTM F1929-15 |
| Shelf-life | 3 years, determined after aging per ASTM F1980-21 |
Regarding points 2-9, which are highly relevant for AI/ML device evaluations, the information is not present in this document because it describes a physical medical device, not an AI/ML algorithm.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a study involving data sets for an AI/ML algorithm. The "test set" here refers to physical units of the device subjected to non-clinical tests. The number of samples for each physical test (e.g., how many needles were tested for tip pull) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth definition by experts is not relevant for the non-clinical physical and biological tests described for a Veress needle.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for expert consensus on AI/ML ground truth, not for physical device testing.
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 / Not provided. This is explicitly for AI-assisted diagnostic devices and does not apply to a standalone physical surgical instrument like a Veress needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is for AI algorithms, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" for the physical device tests would be objective measurements against an engineering standard or predicate device performance, not expert consensus on medical findings.
8. The sample size for the training set
- Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set or ground truth establishment method for it.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 § 884.9.