(87 days)
The Hystero CO2-Pneu is designed for dilating the cavum uteri with CO2 gas during diagnostic and operative hysteroscopy.
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.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Intrauterine pressure adjustable between 0 mmHg and 150 mmHg. | Preselected values are in accordance with measured values within specified deviations. |
| Flow rate adjustable between 0 ml/min and 99 ml/min. | Preselected values are in accordance with measured values within specified deviations. |
| Pressure and flow values checked by microprocessor control. | Verified through microprocessor control. |
| Independent safety devices to guarantee safe insufflation. | Present and functioning as described. |
| Ability to display pressure, flow, and gas consumption on-screen. | Data can be displayed on-screen. |
| Ability to display user-defined text on-screen. | User-defined text can be displayed. |
| Ability to transmit measuring data to a printer via a serial interface. | Relevant measuring data can be transmitted to a printer. |
2. Sample Size and Data Provenance
According to the provided text, no clinical tests were performed. The "bench data" refers to measurements performed on the device itself. Therefore, a sample size for a test set in the traditional sense (e.g., patient data) is not applicable, nor is the concept of data provenance in terms of country of origin or retrospective/prospective for patient data. The "bench data" would have been generated from the device in a laboratory setting.
3. Number of Experts and Qualifications
Not applicable. No clinical tests were performed, and the evaluation was based on "bench data." Therefore, no experts were used to establish ground truth from patient data.
4. Adjudication Method
Not applicable. No clinical tests were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device's evaluation was based on bench data, not human interpretation of medical images or data.
6. Standalone (Algorithm Only) Performance
Not applicable in the context of an algorithm. This device is a medical instrument (insufflator), not an AI algorithm. The performance described is its inherent mechanical and electronic functionality.
7. Type of Ground Truth Used
The ground truth for the device's performance was established through direct measurement of the device's output (pressure and flow rates) against its preselected settings in a laboratory or bench setting. This is a form of empirical measurement against design specifications.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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JAN 1 0 1997
P192 K964136
510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | October 15, 1996 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| 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 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.
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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.
Substantial Equivalence 4.0
The Hystero CO-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.
Clinical Tests 6.0
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 J. Casares
Robert L. Casarsa Quality Assurance Manager
Date: Oct 10, 96
11 964136
p 2012
§ 884.1700 Hysteroscopic insufflator.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. 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.