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.

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for the Aesculap Jet Irrigation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a novel AI device would.

Therefore, many of the requested fields (AI-specific performance, ground truth, expert adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission for a medical device that is not an AI diagnostic tool.

Here's the information based on the provided text, with "N/A" (Not Applicable) for fields that don't fit this type of device and submission:

Acceptance Criteria and Device Performance Study

The submission does not detail specific quantitative acceptance criteria or a clinical study proving the device meets those criteria in the context of diagnostic accuracy or AI performance. Instead, it focuses on compliance with established standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety and Design	Substantially equivalent in design features and technological characteristics to Codman's Malis Irrigation System.	Shares similar features and function with corresponding devices distributed by Aesculap and Codman.
Electrical Safety	Compliance with Underwriters Laboratories, Inc. requirements for medical and dental equipment.	Unit complies with UL requirements.
Endoscopic Safety	Compliance with IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment) for Bipolar Irrigation Forceps.	Forceps meet IEC 601-2-18 requirements.
Manufacturing Quality	Manufacturing in accordance with ISO and German Din Standards.	Aesculap AG has received ISO 9001 certification.

Note: The "reported device performance" here describes compliance with standards and equivalence as claimed in the 510(k) summary, not a quantitative performance metric from a diagnostic study.

2. Sample size used for the test set and the data provenance:

Sample Size: N/A (No specific test set or patient data is mentioned for performance evaluation in the context of a diagnostic device.)
Data Provenance: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A (Ground truth generation by experts is not relevant for this type of device submission.)

4. Adjudication method for the test set:

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A (This device is not an AI diagnostic tool, so an MRMC study is not applicable.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A (This device is not an AI algorithm.)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

8. The sample size for the training set:

N/A (No training set is mentioned as this is not an AI/ML device.)

9. How the ground truth for the training set was established:

Summary

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JLAP

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 94080Contact: Mary Ellen HoldenPhone: (415) 876-7000 x348FAX: (415) 589-3007
	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.

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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

大971310

Device Name: Aesculap Jet Irrigation System

Indication for Use:

(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
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(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.