SURGIFLATOR-20 ECU

K981859 · W.O.M. World of Medicine GmbH · HIF · Jun 26, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981859
• Device Name: SURGIFLATOR-20 ECU
• Applicant: W.O.M. World of Medicine GmbH
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Indications for Use

intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

Device Story

Surgiflator-20 ECU is a laparoscopic high flow insufflator; fills peritoneal cavity with CO2 gas to distend abdomen for laparoscopic visualization. Device is a modified version of Surgiflator-20 PIM; adds serial interface for integration with HERMES Operating Room Control Center. Allows surgeon to select device settings via voice-activation control through HERMES system. Used in operating room environment by surgeons. Benefits include facilitated laparoscopic access and visualization during minimally invasive surgery.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by literature references regarding laparoscopic techniques and high flow insufflators.

Technological Characteristics

High flow CO2 insufflator; includes serial interface for external control integration. Operates via electronic control. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring abdominal distention via intraperitoneal high flow CO2 gas insufflation.

Regulatory Classification

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

• Surgiflator 20-PIM (K955791)

Reference Devices

• HERMES Operating Room Control Center (K980787)

Submission Summary (Full Text)

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# JUN 26 1998

### J.

## Summary of Safety and Effectiveness - 510(k) Summary

K98F859

P192

W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.

SURGIFLATOR-20 ECU Proprietary Name: Laparoscopic Insufflator Common Name:

The Surgiflator-20 ECU is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH.

The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

- · The utility and safety of laparoscopic techniques using modern electronic high flow insufflators is thoroughly reported in the literature with the advantages and the 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 edoscopically guided intraabdominal 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 CO2-lasers.
- · A detailed description of the use of different insufflator types is given in the book "Laparoscopy in gynecology, surgery and pediatrics," by H. Frongenheim. Requirements for insufflation apparatus and for the sterilization of instruments are described (2): 8-26, 39-A3

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 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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#### Summary of Safety and Effectiveness - 510(k) Summary J.

K981859
p292

W.O.M. GmbH Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.

Page -2- / -2-

### REFERENCES

- Maurice-Antoine Bruhat. "Operative Laparoscopy". New York: McGraw-Hill, 1992, 1. 226 pages.
- H. Frongenheim. "Laparoscopy in Gynecology, Surgery and Pediatry" Stuttgart: Georg 2. Thieme Verlag, 1977, 214 pages.
- John G., Hunter. "Minimally Invasive Surgery". New York: McGraw Hill, 1993, 3. 358 pages.

Signed:

M. McDaid

Michael McGrail Manager, Regulatory Affairs

13 May 1998
Date:

Date:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 26 1998

W.O.M. GmbH c/o Mr. Robert P. Reznick Hughes, Hubbard and Reed, L.L.P. 1775 I Street. N.W. Washington, D.C. 20006-2041

Re: K981859

SURGIFLATOR-20 ECU, Laparoscopic Insufflator, for (optional) use with the Hermes Operating Room Control Center Dated: May 26, 1998 Received: May 27, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Reznick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the I vice is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 (OS) for Medical Devices: General regulation (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 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.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaln.html".

Sincerely yours.

Lillian Yin, Ph.D.

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): K981859

Device Name: SURGIFLATOR-20 ECU, Laparoscopic Insufflator, for use with the HERMES Operating Room Control Center

Indications For Use:

intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Rottinghaus

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)