(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.
{0}------------------------------------------------
Summary of Safety and Effectiveness - 510(k) Summary G.
W.O.M. GmbH DEC 1 7 1996 Pascalstr. 11 D-10587 Berlin Germany.
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 utility and safety of laparoscopic techniques using modern electronic high flow insufflators is thoroughly reported in the literature with the advantages and risks well articulated.
- A comprehensive discussion of the use of insufflation methods is presented in the book "Operative Laparoscopy" (1): 9-15, by M .- A. Bruhat, 1992, which observes that Laparoscopy, along with the entire concept of minimally invasive surgery through endoscopically guided intra-abdominal surgery, has become a mainstay in gynecologic surgery. The review of instrumentation in this field includes comments on the use of modern high flow insufflators, the establishment of the pneumoperitoneum, use of instrumentation and use of CO2-laser.
- Background information and experiences with the use of laparoscopic techniques including videoendoscopy are presented in the book "Minimal Invasive Surgery" (3): 57ff, 216-218, 291-295 by John G. Hunter, M.D. and Jonathan M. Sackier, M.D., McGraw-Hill, Inc., 3-6 and 216, 291. New technologies are discussed as well as advantages and disadvantages of minimally invasive surgery. The importance of effective, well-maintained instrumentation, i.e. insufflators and other instrumentation like light sources, television screens, and energy sources, is discussed.
{1}------------------------------------------------
REFERENCES
-
Maurice-Antoine Bruhat. "Operative Laparoscopy". New York: McGraw-Hill, 1992, 226 pages.
-
John G. Hunter. "Minimally Invasive Surgery". New York: McGraw Hill, 1 993, 358 pages.
§ 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.