(361 days)
K950035, Model 89-8600, Model SP 88-9700
No
The document describes a standard insufflator with added features like low-pressure mode, fluid sensor, and simultaneous pressure monitoring. There is no mention of AI, ML, or any related concepts in the description, intended use, or performance studies.
No.
The device is an insufflator used to fill the abdominal cavity with CO2 to enable laparoscopic procedures, which is a supportive role for the procedure rather than providing a direct therapeutic effect.
No
The device is an insufflator intended to fill the abdominal cavity with CO2 for laparoscopic procedures, which is a therapeutic rather than a diagnostic function.
No
The device is described as a laparoscopic high flow insufflator, which is a physical medical device used to fill the abdominal cavity with CO2. The description details hardware features like low pressure insufflation mode, fluid sensor, and simultaneous pressure monitoring, indicating it is not software-only.
Based on the provided information, the Surgiflator-20 PIM is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "fill the abdominal cavity with CO2 to enable laparoscopic procedures." This is a direct intervention on the patient's body during a surgical procedure.
- Device Description: The description confirms its function as a laparoscopic insufflator, which is a surgical instrument used to create space within the body for surgical access.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Surgiflator-20 PIM does not perform any such analysis of biological specimens.
Therefore, the Surgiflator-20 PIM is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures.
Product codes
Not Found
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K950035, Model 89-8600, Model SP 88-9700
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.