KSEA CO2 ENDOFLATOR

K963423 · Karl Storz Endoscopy · HIF · May 27, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K963423
• Device Name: KSEA CO2 ENDOFLATOR
• Applicant: Karl Storz Endoscopy
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments are intended for use by qualified surgeons and provide gas insufflation designed for diagnostic laparoscopic procedures, and laparoscopic sterilization procedures.

Device Story

Karl Storz CO₂ Endoflator delivers CO₂ gas to abdominal cavity to facilitate use of endoscope and accessories during laparoscopic surgical and diagnostic procedures. Device used in OR by qualified surgeons. Provides controlled insufflation to create pneumoperitoneum, allowing visualization and access for laparoscopic instruments. Benefits include improved surgical access and visualization for minimally invasive procedures.

Technological Characteristics

Gas insufflator for CO₂ delivery. Class II device (21 CFR 884.1730, Product code 85 HIF).

Indications for Use

Indicated for patients undergoing diagnostic laparoscopic procedures and laparoscopic sterilization procedures. Intended for use by qualified surgeons.

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.

Submission Summary (Full Text)

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STORZ
Karl Storz Endoscopy
K963423

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 27 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA’s knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

## Contact:

Kevin Kennan
Regulatory Affairs Specialist

## Device Identification:

Common Name:
Gas Insufflator

Trade Name: (optional)
Karl Storz CO₂ Endoflator

## Indication:

The Karl Storz CO₂ Endoflator is designed for Ob/Gyn laparoscopic surgical and diagnostic procedures.

## Device Description:

The Karl Storz CO₂ Endoflator is a gas insufflator designed to deliver CO₂ gas to the abdominal cavity to facilitate the use of endoscope and accessories.

## Substantial Equivalence:

The Karl Storz CO₂ Endoflator is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz CO₂ Endoflator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:
Kevin Kennan
Regulatory Affairs Specialist

000073

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# MAY 27 1997

Mr. Kevin A. Kennan
Regulatory Affairs Specialist
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600

Re: K963423
KSEA CO₂ Endoflator
Dated: April 22, 1997
Received: April 23, 1997
Regulatory class: II
21 CFR §884.1730/Product code: 85 HIF

Dear Mr. Kennan:

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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

If 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 [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/cdrh/dsmamain.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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STORZ
Karl Storz Endoscopy

10(k) Number (if known): 963423

Device Name: KSEA CO₂ Endoflator

Indications for Use: These instruments are intended for use by qualified surgeons and provide gas insufflation designed for

* diagnostic laparoscopic procedures, and
* laparoscopic sterilization procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sillig
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963423

Prescription Use: ☑ OR Over-The-Counter Use: