The components of the Miethke Shunt System can include the NPH-DualSwitch® -Valve, a proximal diaphraqm valve. The modified NPH-DualSwitch® - Valve consists of two chambers and is offers a new low pressure setting (5 cmH2O) for patients in the lying position.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, specifically a cerebrospinal fluid (CSF) shunt system. For such a device, the focus is on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance criteria demonstrated through clinical studies in the same way an AI/ML device would.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth for training data) are not applicable in this context. The review is based on direct comparison to an existing device and engineering testing, not algorithms or AI.

Here's an analysis based on the provided text, highlighting what can be extracted and what is not relevant for this type of submission:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

The document explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system."

Instead of acceptance criteria based on performance metrics, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device. The key claims for equivalence are:

The Miethke Shunt System with NPH-DualSwitch® – Valve is substantially equivalent to Aesculap®, Inc.'s currently marketed Miethke Shunt System with DualSwitch® - Valve.
The new low pressure setting (5 cmH2O) for patients in the lying position is also equivalent to the setting on the Codman Hakim Micro Precision Valve.

The document implies that the "design input for the new features" (the NPH-DualSwitch® - Valve and the new low pressure setting) were "verified by engineering testing," but no specific results or methods of this testing are provided in this summary.

Study Details (Not Applicable for AI/ML device, but can infer for Substantial Equivalence)

Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the sense of a dataset for an AI/ML model. The evaluation is likely based on bench testing of device components and comparison of device specifications to predicates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not a concept here.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a shunt system, not an imaging interpretation or diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used: Not applicable in the context of AI/ML. For a physical device, "ground truth" would relate to measured physical properties and performance characteristics (e.g., flow rates, pressure settings, durability), which are assumed to be validated through engineering testing.
The sample size for the training set: Not applicable. No AI/ML model involved.
How the ground truth for the training set was established: Not applicable. No AI/ML model involved.

Summary

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MAR 2 0 2003

K050698

Page 1 of 1

C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)

AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Matthew M. Hull800-258-1946 x 5072 (phone)610-791-6882 (fax)
TRADE NAME:	Aesculap - Miethke Shunt System
COMMON NAME:	Hydrocephalus Shunt System
DEVICE CLASS:	Class II
PRODUCT CODE:	84 JXG
CLASSIFICATION:	882.5550 - Central Nervous System fluid shunt andcomponents.
REVIEW PANEL:	Neurology

INDICATIONS FOR USE

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

DEVICE DESCRIPTION

PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Miethke Shunt System with NPH-DualSwitch® – Valve is substantially equivalent to our currently marketed Miethke Shunt System with DualSwitch® - Valve. The low pressure setting is also equivalent to the setting on the Codman Hakim Micro Precision Valve.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is rendered in black and white.

MAR 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew M. Hull Senior Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K030698

Trade/Device Name: Aesculap - Meithke Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: March 5, 2003 Received: March 6, 2003

Dear Mr. Hull:

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.

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.

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Page 2 - Mr. Matthew M. Hull

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark n Melbern

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

Enclosure

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INDICATIONS FOR USE STATEMENT B.

510(k) Number: K030698

Device Name: Aesculap - Miethke Shunt System

Indication for Use:

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ or Over-the-Counter Use _
(per 21 CFR 801.109)

for Mark N Millenn
Division Sign-Off
Division of General, Restorative
and Neurological Devices

K030698
Number __

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).