AESCULAP JET IRRIGATION SYSTEM

K971310 · Aesculap, Inc. · GEI · Jul 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971310
• Device Name: AESCULAP JET IRRIGATION SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R). The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.

Device Story

Aesculap Jet Irrigation System (GN090) functions as an accessory to Bipolar Coagulator (GN060) and Bipolar Irrigation Forceps (GK840R-GK847R). Device delivers controlled fluid irrigation to forceps tips; provides either measured drip irrigation or continuous jet stream. Drip mode prevents tissue overheating and adherence during coagulation; jet mode clears visual field. Operated by clinicians in surgical settings. System ensures precise fluid delivery to surgical site, enhancing bipolar coagulation safety and visualization.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

System comprises irrigation unit and bipolar forceps. Complies with UL requirements for medical/dental equipment and IEC 601-2-18 for endoscopic equipment safety. Manufactured per ISO and German DIN standards; manufacturer holds ISO 9001 certification. Mechanical fluid delivery system.

Indications for Use

Indicated for use with Aesculap Bipolar Coagulator and Bipolar Irrigation Forceps to provide drip irrigation for preventing tissue overheating/adherence during coagulation or continuous jet irrigation for visual field clearance.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Codman's Malis Irrigation System

Submission Summary (Full Text)

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JUL 18 1997
k971310

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Aesculap Jet Irrigation System

April 7, 1997

Submitted by: Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Mary Ellen Holden
Phone: [phone] x348
FAX: [phone]

Product: Aesculap Jet Irrigation System
Common Name: Irrigation System

## Intended Use

The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R). The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.

## Technological Characteristics

Aesculap's Jet Irrigation System is substantially equivalent to Codman's Malis Irrigation System in design features and technological characteristics.

Both the Jet Irrigation System and the Malis Irrigation System are designed to be used in conjunction with a Bipolar Coagulator. They provide delivery of precisely controlled irrigation to the tip of bipolar irrigation forceps.

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]
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## Performance Standards

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap’s Jet Irrigation Unit complies with the requirements of Underwriters Laboratories, Inc., for medical and dental equipment.

In addition, the Bipolar Irrigation Forceps meet the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.)

The Jet Irrigation System will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.

## Substantial Equivalence

Aesculap’s Jet Irrigation System shares similar features and function with corresponding devices distributed by Aesculap and Codman.

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

Ms. Mary Ellen Holden
Regulatory Compliance Associate
AESCULAP®, Inc.
1000 Gateway Boulevard
South San Francisco, California 94080-7030

JUL 18 1997

Re: K971310
Trade Name: Aesculap Jet Irrigation System
Regulatory Class: II
Product Code: GEI
Dated: July 3, 1997
Received: July 7, 1997

Dear Ms. Holden:

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 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

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Page 2 - Ms. Mary Ellen Holden

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,


Enclosure

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Page 1 of 1

# INDICATION FOR USE STATEMENT

510(k) Number (if known): N/A
k971310

## Device Name:
Aesculap Jet Irrigation System

## Indication for Use:
Aesculap's Jet Irrigation System is designed for use with Aesculap's Bipolar Coagulator. The Jet Irrigation System delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps. The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.

(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 General Restorative Devices
510(k) Number
R971310

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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