(361 days)
The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures.
The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures. The Surgiflator-20 PIM described in this notification is similar in design and construction to the W.O.M. Surgiflator 20, K950035 and the Snowden-Pencer High Flow Insufflator, Model 89-8600 and Model SP 88-9700, distributed in the United States by Snowden-Pencer, Inc. The Surgiflator-20 PIM incorporates the same design features as the W.O.M. Surgiflator 20. The differences lie in the following features: Low pressure insufflation mode - fills the abdomen more gently; Fluid sensor: shows the user when the device is contaminated by backflow; Simultaneous pressure monitoring: monitoring of the pressure directly in the abdomen.
The provided text describes a medical device, the Surgiflator-20 PIM, which is a laparoscopic high-flow insufflator. However, the text does not contain the information requested in your bulleted list regarding acceptance criteria and the specifics of a study proving device performance.
Specifically, the document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed study results with acceptance criteria.
Here's a breakdown of why the information is missing from the provided text:
- Acceptance Criteria and Reported Device Performance: This information is entirely absent. The document states the device is "similar in design and construction" to predicate devices and highlights some differences, but it does not provide any quantitative or qualitative performance metrics, let alone specific acceptance criteria for those metrics.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set: All of these points relate to specific details of a clinical or performance study that are not included in this 510(k) summary. The document makes general statements about the utility and safety being "thoroughly reported in the literature" and refers to books on "Operative Laparoscopy" and "Minimal Invasive Surgery" as background information, but these are general references to the field, not specific studies on the Surgiflator-20 PIM with the requested data.
Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The text primarily focuses on establishing similarity to predicate devices and referencing general literature about laparoscopic techniques and insufflators.
§ 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.