(87 days)
No
The summary describes a device that controls gas pressure and flow rate based on user input, with no mention of AI or ML algorithms for decision-making, analysis, or control.
Yes
The device is used to dilate the cavum uteri with CO2 gas during diagnostic and operative hysteroscopy, which is a therapeutic intervention.
No
The device is designed for dilating the uterus with CO2 gas during diagnostic and operative hysteroscopy, which is a procedural function, not a diagnostic one. While it can display values related to the insufflation process, it does not analyze patient data or provide diagnostic information.
No
The device description explicitly states it "supplies CO2 gas from cylinders or central gas supplies to dilate the cavum uteri by the CO2 gas insufflation," indicating it is a hardware device that controls gas flow and pressure. While it has a display for values, its primary function is hardware-based gas delivery.
Based on the provided information, the Hystero CO2-Pneu is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate the cavum uteri with CO2 gas during hysteroscopy. This is a procedure performed in vivo (within the living body) to visualize and potentially operate on the uterus.
- Device Description: The device supplies CO2 gas for insufflation into the uterus. This is a physical action performed on the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Hystero CO2-Pneu's function is to facilitate a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The Hystero CO2-Pneu is designed for dilating the cavum uteri with CO2 gas during diagnostic and operative hysteroscopy.
Product codes
Not Found
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cavum uteri
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
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. No clinical tests performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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