HYSTERO CO2-PNEU 2221

K964136 · Richard Wolf Medical Instruments Corp. · HIG · Jan 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964136
• Device Name: HYSTERO CO2-PNEU 2221
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2

Intended Use

The Hystero CO₂-Pneu is designed for dilating the cavum uteri with CO₂ gas during diagnostic and operative hysteroscopy.

Device Story

Hystero CO₂-Pneu 2221 is an electronic insufflator for hysteroscopy. It receives CO₂ gas from cylinders or central supply; regulates gas pressure and flow rate via microprocessor control. Device allows user-preselection of intra-uterine pressure (10-150 mmHg) and flow rate (10-99 ml/min). Output includes gas delivery to the uterus and real-time display of pressure, flow, and gas consumption on video equipment. Features serial interface for printer data transmission and keyboard input for on-screen text. Used by clinicians in clinical settings to maintain uterine distension for visualization during procedures. Benefits include controlled, safe uterine dilation to facilitate diagnostic and operative hysteroscopic interventions.

Clinical Evidence

No clinical tests performed. Bench testing only; verified intrauterine pressure and flow rate output accuracy against preselected values within specified deviations.

Technological Characteristics

Microprocessor-controlled CO₂ insufflator. Pressure range: 0-150 mmHg (stepless 10-100 mmHg, 1 mmHg increments). Flow rate: 0-99 ml/min (1 ml/min increments). Features serial interface for printer connectivity and keyboard input for video overlay. Independent safety monitoring systems included.

Indications for Use

Indicated for patients undergoing diagnostic or operative hysteroscopy requiring uterine cavity dilation via CO₂ gas insufflation.

Regulatory Classification

Identification

A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

Predicate Devices

• Hysteroscopy-Insufflator 2020 (pre-enactment)
• Hysteroscope Autonom 4992 (K880314)
• HYS - Surgiflator (K924523)

Reference Devices

• Hamou-Micro-Hysteroflator (Karl Storz)
• Hystero-Insufflator Electronic (WISAP)

Submission Summary (Full Text)

{0}

JAN 10 1997
P192K964136

# 510(k) Summary of Safety and Effectiveness

| Submitter: | | | Date of Preparation: October 15, 1996 | |
| --- | --- | --- | --- | --- |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: Hystero CO₂-Pneu | | Model number: 2221 | | |
| Common name: Insufflator, Hysteroscopic | | Classification name: Insufflator, Hysteroscopic | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 pre enact. | 1 Hysteroscopy-Insufflator 2020 | | 1 Richard Wolf M.I.C. | |
| 2 K880314 | 2 Hysteroscope Autonom 4992 | | 2 Richard Wolf M.I.C. | |
| 3 K924523 | 3 HYS - Surgiflator | | 3 WOM GmbH, Germany | |
| 4 | 4 Hamou-Micro-Hysteroflator | | 4 Karl Storz | |
| 5 | 5 Hystero-Insufflator Electronic | | 5 WISAP | |
| 6 | 6 | | 6 | |

## 1.0 Description

They Hystero-CO₂-Pneu 2221 supplies CO₂ gas from cylinders or central gas supplies to dilate the cavum uteri by the CO₂ gas insufflation.

The gas pressure and flow rate are controlled according to the instructions by the device user.

## 2.0 Intended Use

The Hystero CO₂-Pneu is designed for dilating the cavum uteri with CO₂ gas during diagnostic and operative hysteroscopy.

## 3.0 Technological Characteristics

The pressure and flow values are checked by microprocessor control. A number of independent safety devices guarantee safe and problem-free insufflation.

The intra-uterine pressure can be steplessly preselected between 10 mmHg and 100 mmHg and reduced in steps (1 mmHg) to 0 mmHg or increased to 150 mmHg. The flow rate can also be preselected between 10 ml/min and 99 ml/min and reduced in steps (1 ml/min) to 0 ml/min.

11-1

{1}

K964136
p292

These values can be displayed on-screen in order to document the pressure, flow, and gas consumption values during intervention via video equipment. Additionally user defined text can be displayed on-screen by means of a separate keyboard.

All relevant measuring data can be transmitted to a printer by a serial interface.

## 4.0 Substantial Equivalence

The Hystero CO₂-Pneu 2221 is substantially equivalent to pre-enactment devices and 510(k) devices sold by Richard Wolf and to various existing hysteroscopic insufflators on the market. The differences do not affect safety or effectiveness of the device.

## 5.0 Performance Data

Bench data illustrating the intrauterine pressure at various output pressures and flow rates show that the preselected values are in accordance to the measured values within the specified deviations.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Data Conclusions

Hystero CO₂-Pneu 2221 is designed and tested to guarantee the safety and effectiveness during the expected life time, if the device is used according to the instruction manual.

By:
*Robert L. Casarsa*
Quality Assurance Manager
Date: Oct 10, 96

11-2