KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1

K080852 · KARL STORZ Endoscopy-America, Inc. · HIF · Mar 30, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K080852
• Device Name: KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Mar 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen for the diagnostic and/or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Device Story

KSEA Electronic CO2 ENDOFLATOR LC is an electronic insufflator used to create pneumoperitoneum for laparoscopic procedures. Device connects to a central CO2 gas supply; regulates gas delivery to achieve intra-abdominal pressures of 0-30 mmHg and flow rates of 0-30 L/min. Operated by clinicians in surgical settings to facilitate abdominal access for diagnostic or operative laparoscopy. Output is controlled gas flow; allows visualization and instrument maneuverability within the abdominal cavity. Benefits include stable abdominal distention during minimally invasive surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electronic CO2 gas insufflator. Pressure range: 0-30 mmHg. Flow rate: 0-30 L/min. Connects to central gas supply. Electronic control system.

Indications for Use

Indicated for patients undergoing diagnostic or operative laparoscopy requiring CO2 gas abdominal distention (pneumoperitoneum).

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

• KSEA CO2 ENDOFLATOR (K963423)
• Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863)

Submission Summary (Full Text)

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K08085z

mar 3 0 2009

Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is in large, bold, sans-serif font, with the "O" represented by a circle with a smaller circle inside. Below this, the words "KARL STORZ ENDOSCOPY" are printed in a smaller, sans-serif font. The logo is simple and professional, likely representing a medical or technological company.

# 510(k) SUMMARY

| Sponsor/Submitter: | Karl Storz Endoscopy-America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230-7600<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Specialist<br>Email: [e-mail] |
| Date of Submission: | March 25, 2008 |
| Device Trade Name: | KSEA Electronic CO2 ENDOFLATOR LC |
| Common Name: | Laparoscopic insufflator |
| Classification Name: | Laparoscopic insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Product Code: | HIF |
| Predicate Device(s): | KSEA CO2 ENDOFLATOR (K963423)<br>Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863) |
| Device Description: | The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device for<br>universal application in laparoscopic examinations and operations. |
| Indications for Use: | The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas<br>distention of the abdomen for the diagnostic and/or operative<br>laparoscopy. See the instruction manual for your laparoscope for special<br>indications for use. |
| Technological<br>Characteristics: | The KSEA Electronic CO2 ENDOFLATOR LC is an electronic CO2 gas<br>insufflator. The device is intended to be used with a central gas supply<br>line to achieve pressures from 0-30 mmHg and flow rates of 0-30 L/min. |
| Summary of<br>Substantial<br>Equivalence: | The KSEA Electronic CO2 ENDOFLATOR LC is substantially equivalent<br>to the predicate devices since the basic features, design, and intended<br>uses are similar. The minor differences between the KSEA Electronic<br>CO2 ENDOFLATOR LC and the predicate devices raise no new issues of<br>safety and effectiveness, as these design differences have no affect on<br>the performance, function, or intended use of the devices. For a<br>comparison between the KSEA Electronic CO2 ENDOFLATOR LC and<br>the predicate devices, refer to the attached substantial equivalence<br>chart |

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STORE STORZENDOSCOPY

# SUBSTANTIAL EQUIVALENCE TABLE FOR KSEA ELECTRONIC CO₂ ENDOFLATOR LC

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080852

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 3 0 2009

Ms. Crystal K. Dizol Regulatory Affairs Specialist KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

Re: K080852

Trade/Device Name: KSEA Electronic CO2 ENDOFLATOR LC Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: March 6, 2009 Received: March 9, 2009

Dear Ms. Dizol:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): K080852

Device Name:

KSEA Electronic CO2 ENDOFLATOR LC

Indications for Use:

The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Prescription Use: (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use:

(21 CFR 801 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.