SURGIFLATOR-30

K973432 · W.O.M. World of Medicine GmbH · HIF · Dec 9, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K973432
• Device Name: SURGIFLATOR-30
• Applicant: W.O.M. World of Medicine GmbH
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Device Story

Surgiflator-30 is a high-flow laparoscopic insufflator; fills peritoneal cavity with gas to distend abdomen for laparoscopic surgery. Device provides max flow rate of 30 L/min (or 25 L/min version). Used in clinical/surgical settings by physicians to enable minimally invasive access. Device design is based on W.O.M. Surgiflator 20-PIM; provides necessary pneumoperitoneum for endoscopic visualization and instrumentation. Benefits include facilitating minimally invasive surgical techniques.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by literature references regarding the utility and safety of high-flow insufflators in laparoscopic surgery, including texts by Bruhat (1992), Frongenheim (1977), and Hunter & Sackier (1993).

Technological Characteristics

High-flow laparoscopic insufflator; max flow rate 30 L/min or 25 L/min. Electronic control system. Standalone device. No simultaneous pressure monitoring feature.

Indications for Use

Indicated for use in patients undergoing laparoscopic procedures to distend the peritoneal cavity with gas to facilitate the use of a laparoscope.

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

• W.O.M. Surgiflator 20-PIM (K955791)
• KSEA Thermoflator, Model 26 4320 20

Submission Summary (Full Text)

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K973432

PI92

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

W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Pascalstr. 11 D-10587 Berlin Germany.

DEC - 9 1997

Proprietary Name: SURGIFLATOR 30 Common Name: Laparoscopic Insufflator

The Surgiflator-30 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-30 described in this notification is substantially equivalent to the W.O.M. Surgiflator 20-PIM. K 955791, and the `KSEA Thermoflator`, Model 26 4320 20, by Kan Storz Endoscopy - America, Inc.

- · The Surgifiator-30 incorporates the same design features as the W.O.M. Surgifiator 20-PIM. The only differences lie in the following:
Surgiflator-30 offers an increased flow rate of max. 30 Vmin. The device will also be available as a 25 Vmin version.

The Surgifiator-30 does not offer optional simultaneous pressure monitoring.

- · 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 intra-abdominal surgerv. 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

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## K973432 12022

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

W.O.M. GmbH Pascalstr. 11 D-10587 Berlin Germany.

Page -2- / -2-

Background information and experiences with the use of laparoscopic techniques including video endoscopy 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 and disadvantages 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.

## REFERENCES

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

Signed:

03 September 1987 Michael McGrail

Manager, Regulatory Affairs

M. McOuil

Date:

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure.

DEC - 9 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W.O.M. GmbH c/o Robert P. Reznick Hughes Hubbard & Reed 1300 I Street, N.W. Suite 900 West Washington, D.C. 20005-3306 Re: K973432 Surgiflator-30 Dated: September 9, 1997 Received: September 10, 1997 Regulatory Class: II 21 CFR §884.1730/Product Code: 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 device 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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 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 predication 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 vito 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 respensibilities 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/cdrh/dsmamain.html".

Sincerely yours,

William Yin

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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| Name: | Surgiflator-30 |

CONFIDENTIAL

Indications For Use:

510(k)

Device

:

To facilitate the use of the laparoscope by filling To factitate the abo on one and and it. .

(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 K973432

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)