(186 days)
The Laparo CO2-Pneu automatic insufflator generates and maintains pneumoperitoneum under CO2 gas and can be used in diagnostic and operative laparoscopy.
The Laparo CO2-Pneu 2232 supplies CO2 gas from cylinders or central gas supplies to dilate the abdomen by the CO2 gas insufflation. The gas pressure and the flow rate are adjusted by the user and electronically controlled.
The provided 510(k) summary for the Richard Wolf Medical Instruments Corp. Laparo CO2-Pneu (K991906) indicates that no performance data or clinical tests were performed as part of this submission. Therefore, it is not possible to describe acceptance criteria and associated study details from this document.
The submission explicitly states:
- "5.0 Performance Data No performance data generated."
- "6.0 Clinical Tests No clinical tests performed."
The basis for market clearance was an assertion of substantial equivalence to existing 510(k) devices (K981334 and K955073), meaning the manufacturer demonstrated that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness.
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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
NOV 23 1999
트
| RICHARD WOLF |
|---|
| -------------- |
MEDICAL INSTRUMENTS CORPORATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Image /page/0/Picture/5 description: The image contains a black and white symbol that resembles a stylized letter or character. The symbol is composed of angular lines and curves, creating a unique and abstract design. The symbol is set against a white background, which provides contrast and makes the symbol stand out. The symbol is small and compact, and it appears to be a part of a larger text or design.
510(k) Summary of Safety and Effectiveness
| Date of Preparation | May 14, 1999 |
|---|---|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
| FDA establishment regulation number: | 14 184 79 |
| Division name (if applicable): | N.A. |
| Phone number (include area code): | (847) 913-1113 |
| Street address: | 353 Corporate Woods Parkway |
| FAX number (include area code). | (847) 913-0924 |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Trade name: | Laparo CO₂-Pneu |
| Model number: | 2232.621, 631 |
| Common name: | Automated Laparoscopic CO₂ Insufflator |
| Classification Name: | Laparoscopic Insufflator |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K981334 | Laparo CO₂ Pneu 2232 (20 L) | Richard Wolf |
| 2 | K955073 | Thermoflator 264320 20 | Karl Storz |
| 3 | |||
| 4 |
1.0 Description
The Laparo CO2-Pneu 2232 supplies CO2 gas from cylinders or central gas supplies to dilate the abdomen by the CO2 gas insufflation. The gas pressure and the flow rate are adjusted by the user and electronically controlled.
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2.0 Intended Use
The Laparo CO2-Pneu automatic insufflator generates and maintains pneumoperitoneum under CO2 gas and can be used in diagnostic and operative laparoscopy.
3.0 Technological Characteristics
The pressure and flow values are checked by microprocessor control. A number of independent safety devices provide safe and problem-free insufflation.
The intra-abdominal pressure between 5 mmHg and 25 mmHg can be preselected. The pressure is reduced if the intra-abdominal pressure is higher than the preselected. THC
The flow rate can be preselected between 1 L/minute and 30 L/minute at a pace of 1 V/min.
The measured values can be displayed on-screen in order to document the pressure, flow, and gas consumption values during intervention via video equipment.
An electronic circuit, integrated into the insufflation tube, warms the gas to body temperature.
4.0 Substantial Equivalence
The Laparo CO2-Pneu is substantially equivalent to existing 510(k) devices sold by Richard Wolf and Karl Storz.
- 5.0 Performance Data No performance data generated.
- 6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
Laparo CO2-Pneu 2232 was designed and tested to guarantee the safety and effectiveness during the expected life time of the device when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: May 18, 1999
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird, with its wings spread and head facing to the left. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K991906 Laparo CO2 Pneu 2232 Automatic Insufflator Dated: September 1, 1999 Received: September 2, 1999 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K991906
Device Name: _
Intended Use:
The Laparo CO2-Pneu automatic insufflator generates and maintains pneumoperitoneum under CO2 gas and can be used in diagnostic and operative laparoscopy.
Contraindications:
The use of this device is contraindicated if laparoscopy is contraindicated.
Warning: The device has a high flow rate. The device is not suitable for hysteroscopy. Do not use this device to inflate the cavum uteri.
Contractindications for the patient resulting from the general findings, which are described in the relevant literature must be observed.
Possible Combinations:
Important! In addition to the product instruction manual, be sure to observe the instruction manuals of the products used in combination with this product.
Electromagnetic interference or other influences which may occur between the product and other products may lead to defects or malfunctions.
Warning! Danger of potentially fatal gas or air embolism. Purge the connection tubes thoroughly with CO, before every use. The use of devices using additional gaseous media in combination with the Laparo CO-Pncu automatic insufflator lies exclusively in the responsibility of the user.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991906 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over- |
|---|---|---|
| ------------------ | ------------------------------------------ | ------- |
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Warning! There is danger of intra-abdominal pressure when a second gas source is used.
When argon plasma coagulations are used, it is vital for the user to also have additional visual or manual pressure monitoring available, as there is a potential risk that the breasure monitoring or ventilation of the Laparo CO2-Pneu is deactivated, e.g. by a kinked insufflation tube or a closed instrument port (stopcock). The preselected gas flow rate of argon plasma coagulations should not excecd 2 Vmin. Activate the argon plasma coagulator only for shot periods of time.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K991906
Prescription Use X
Per 21 CRF 801.109
OR
§ 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.