(88 days)
The InsufflatOR Needle™ 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 Gynetech InsufflatOR Needle is a sterile disposable Veress needle which is available in 120mm or 150mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of gas flow. The most proximal end contains a male luer lock connector for connection to a CO2 gas line. The InsufflatOR Needle has applications in gynaecological laparoscopy and other laparoscopic procedures.
The provided document describes the Gynetech InsufflatOR Needle, a Veress needle for establishing pneumoperitoneum during laparoscopic procedures. The submission is for a 510(k) premarket notification, claiming substantial equivalence to a predicate device, the GeniCon Pneumo-Needle (K993625).
The document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. The information provided relates to the substantial equivalence of a physical medical device (InsufflatOR Needle) to a predicate device, focusing on manufacturing specifications, sterilization methods, and basic performance tests relevant to its mechanical function.
Therefore, most of the requested information, which pertains to AI/ML device performance studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, adjudication methods, and MRMC studies, is not present in the provided text.
Based on the available text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document mentions that the InsufflatOR Needle was manufactured to the "same exact specifications as the predicate device by GeniCon." It also states, "All testing undertaken to demonstrate substantial equivalence of the requirements of its predetermined acceptance criteria and intended use." However, it does not explicitly list the specific acceptance criteria or the numerical performance results for most of these tests. It lists the types of tests performed.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Tip pull strength/resistance | Meets same exact specifications as predicate device |
| Switch operation functionality | Meets same exact specifications as predicate device |
| Spring obturator functionality | Meets same exact specifications as predicate device |
| Needle puncture force | Meets same exact specifications as predicate device |
| EtO sterilization validation according to ISO 11135-1:2007 | Testing conducted and demonstrated substantial equivalence |
| Ethylene Oxide Sterilisation Residuals according to ISO 10993-7:2008 | Testing conducted and demonstrated substantial equivalence |
| Packaging integrity after accelerated aging | Testing conducted and demonstrated substantial equivalence |
| Device functional performance after accelerated aging | Testing conducted and demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance:
Not applicable as this is a physical device, not an AI/ML algorithm requiring a data test set in the traditional sense. The "test set" described refers to physical devices undergoing functional and sterility testing. The sample size for these specific physical tests is not mentioned. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. The "ground truth" for this device would be its physical and functional specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of AI/ML. For this physical device, the "ground truth" implicitly refers to the established engineering specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO for sterilization).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.