← Product Code [HIF](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF) · K955791

# SURGIFLATOR-20 PIM (K955791)

_W.O.M. World of Medicine GmbH · HIF · Dec 17, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K955791

## Device Facts

- **Applicant:** W.O.M. World of Medicine GmbH
- **Product Code:** [HIF](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF.md)
- **Decision Date:** Dec 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1730
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## 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.

## Device Story

Laparoscopic high flow insufflator; fills abdominal cavity with CO2 to create pneumoperitoneum for minimally invasive surgery. Input: CO2 gas source. Operation: electronic flow control; features low-pressure insufflation mode for gentle filling; fluid sensor detects backflow contamination; simultaneous pressure monitoring via direct abdominal measurement. Output: regulated CO2 flow and pressure data. Used in OR by surgeons/staff. Provides stable pneumoperitoneum for visualization and instrument access during gynecologic and other laparoscopic surgeries.

## Clinical Evidence

No clinical data. Safety and utility of high-flow insufflators for laparoscopic techniques are established in referenced medical literature (Bruhat, 1992; Hunter & Sackier, 1993).

## Technological Characteristics

Electronic high-flow insufflator; CO2 gas source; integrated fluid sensor for backflow detection; pressure monitoring system. Design incorporates electronic flow regulation and pressure sensing circuitry.

## Regulatory 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.

## Predicate Devices

- W.O.M. Surgiflator 20 ([K950035](/device/K950035.md))
- Snowden-Pencer High Flow Insufflator Model 89-8600
- Snowden-Pencer High Flow Insufflator Model SP 88-9700

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# G. Summary of Safety and Effectiveness - 510(k) Summary

W.O.M. GmbH
Pascalstr. 11
D-10587 Berlin
Germany.

DEC 17 1996

The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with $\mathrm{CO}_{2}$ 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 $\mathrm{CO}_{2}$-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.

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# REFERENCES

1. Maurice-Antoine Bruhat. "Operative Laparoscopy". New York: McGraw-Hill, 1992, 226 pages.
2. John G. Hunter. "Minimally Invasive Surgery". New York: McGraw Hill, 1993, 358 pages.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K955791](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K955791)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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