KSEA N2O ENDOFLATOR

K980134 · KARL STORZ Endoscopy-America, Inc. · HIF · Apr 15, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980134
• Device Name: KSEA N2O ENDOFLATOR
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

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 N2O Endoflator is a gas insufflator delivering N2O gas to the abdominal cavity; facilitates use of endoscopes and surgical accessories during diagnostic laparoscopy and sterilization. Device used in clinical/surgical settings by qualified surgeons. Provides controlled insufflation to create pneumoperitoneum, allowing visualization and access for laparoscopic procedures. Benefits include improved surgical access and visualization for minimally invasive interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Gas insufflator for N2O delivery. Class II device (21 CFR 884.1730).

Indications for Use

Indicated for patients undergoing diagnostic laparoscopic procedures or 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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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white, with the words "STORZ" in large, bold letters at the top. Below that, in smaller letters, are the words "Karl Storz Endoscopy". The logo also includes a circular design with a white dot in the center.

K980134

APR 1 5 1998

## Pinl 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | <b>Common Name:</b><br>Gas Insufflator |

Trade Name: (optional) Karl Storz N2O Endoflator

The Karl Storz N2O Endoflator is designed for diagnostic laparoscopic and Indication: laparoscopic sterilization procedures.

Device Description: The Karl Storz No Endoflator is a gas insufflator designed to deliver NoO gas to the abdominal cavity to facilitate the use of endoscope and accessories.

Substantial Equivalence: The Karl Storz N2O Endoflator is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz N2O Endofiator 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 Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 1998

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

Re: K980134

KSEA N20 Endoflator (Laparoscopic Insufflator) Dated: January 13, 1998 Received: January 15, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 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 (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 (QS) 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 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/cdrb/dsmaldsmam.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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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in large, stylized letters above the words "Karl Storz Endoscopy" in a smaller font. The "O" in STORZ is represented by a target symbol with concentric circles. The logo is in white against a black background.

510(k) Number (if known): Not Yet Assigned

Device Name: KSEA N2O 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 D Ratting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981134

OR Over-The-Counter Use:

Prescription Use: سا (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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