The Miethke Shunt System miniNAV Valve is used in the treatment of hydrocephalus. The miniNAV Valve is a small cylindrical tube with inlet and outlet connections at opposite ends. A ball-in-cone valve is integrated in the inlet of the device. A spiral spring maintains the opening pressure of the ball-in-cone valve. A sapphire ball ensures the precise closure of the valve. The housing of the miniNAV Valve is manufactured from titanium. The miniNAV Valve is available as a single device as well as in combination as shunt assistants, catheters, connectors, deflectors and reservoirs.

The McLanahan reservoir is a flushing reservoir. It has an integrated occlusion mechanism while flushing in both the proximal and distal directions. The McLanahan reservoir is manufactured of silicone elastomer and titanium.

AI/ML Overview

The provided document is a 510(k) summary for the Miethke Shunt System miniNAV Valve, which is a medical device and not an AI/ML powered device. As such, the typical acceptance criteria and study designs involving AI performance metrics (like those listed in the prompt, e.g., MRMC studies, standalone performance, ground truth establishment by experts, training/test set sizes) are not applicable to this submission.

The document describes performance data related to the device's physical properties and safety in a specific environment (MRI).

Here's a summary of the performance data presented, formatted to align with the prompt's request where applicable, and noting where typical AI/ML criteria do not apply:

Acceptance Criteria and Device Performance Study for Miethke Shunt System miniNAV Valve

The provided 510(k) summary (K110206) focuses on demonstrating the substantial equivalence of the Miethke Shunt System miniNAV Valve to predicate devices, primarily through engineering and safety testing, particularly regarding MRI compatibility. It does not involve AI/ML performance evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Material/Design/Operation	Similar to predicate devices: Paedi-GAV Valve and MonoStep Valve of the Miethke Shunt System, and Strata II Valve.	Materials, design, principle of operation, and intended use are described as equivalent to previously cleared devices. Only differences noted are the size of the valve and a lower pressure opening.
Intended Use	Shunting cerebrospinal fluid (CSF) from lateral ventricles to the peritoneum.	Device is stated to have the same intended use as previously cleared devices.
MRI Compatibility	Adherence to ISO and ASTM MRI standards (ISO 7197:2000, ISO/TS 10974:2009, ASTM F2119, ASTM F2115, ASTM F2052, ASTM F2213).	The device is MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503. Results were found to be similar to the predicate devices.

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

Sample Size: Not specified in terms of number of devices or clinical cases. The testing appears to be primarily bench testing (engineering and MRI compatibility), rather than clinical studies with human subjects that would typically involve a "test set" in the context of AI/ML evaluation.
Data Provenance: The document does not specify the origin of any "data provenance" as would be relevant for clinical data (e.g., country of origin, retrospective/prospective). The data pertains to laboratory and engineering tests of the device itself.

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

This is not applicable as the evaluation is not based on expert-established ground truth for diagnostic or prognostic performance, but rather on objective engineering and MRI compatibility testing according to international standards.

4. Adjudication method for the test set

This is not applicable. The testing involves adherence to engineering and safety standards, not interpretation by multiple human readers requiring an adjudication method.

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

This is not applicable. The device is a physical shunt system, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical medical implant; there is no "algorithm only" performance to evaluate.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established by international and national standards for medical devices (ISO 7197:2000, ISO/TS 10974:2009, ASTM F2119, ASTM F2115, ASTM F2052, ASTM F2213, ASTM F 2503) related to material properties, function, and compatibility (specifically MRI safety). It is not expert consensus, pathology, or outcomes data in the typical sense of AI/ML validation.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML product, so there is no training set in the context of machine learning.

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

This is not applicable as there is no training set for an AI/ML algorithm.

Summary

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K110206

510(k) SUMMARY (as required by 21 CFR 807.92)

Miethke Shunt System miniNAV Valve September 22, 2011

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714

Kathy A. Racosky CONTACT: 610-984-9291 (phone) 610-791-6882 (fax) kathy.racosky@aesculap.com

Hydrocephalus Shunt System COMMON NAME:

CLASSIFICATION NAME: Aesculap Miethke Shunt System

REGULATION NUMBER: 882.5550

JXG PRODUCT CODE:

DEVICE DESCRIPTION

: "

DEVICE DESCRIP IION
The Miethke Shunt System miniNAV Valve is used in the treatment of hylot sepposition The Milline Shum System milling N Valvo lo chamber with inlet and outlet connection The mininNAV Valve is a shiall offinancer tabe" is integrated in the inlet of the device. A ports at opposite ends. A ball-in oone valve 10 linegris-cone valve and a sapphire
spiral spring maintains the opening pressure of the ball-in-cone valve in in MAV Value is Spiral Spinig maintains the opening prosoure of the housing of the miniNAV Valve is ball ensures the precise closure of the YAV V. ve is available as a single device as well manufactured from thanian. "The ministration as shunt assistants, catheters, connectors, deflectors and reservoirs.

The McLanahan reservoir is a flushing reservoir. It has an integrated occlusion The MoLananan 1000Wolf is a hasin the proximal and distal directions. The mechanism while hashing in Don The McLanahan reservoir is manufactured of silicone elastomer and titanium.

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110206

INDICATIONS FOR USE

NDICATIONS FOR DSE lateral ventricles of the brain into the peritoneum.

SUBSTANTIAL EQUIVALENCE

SUBSTANTHAL EQONALE: " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " Aesculap ', Inc. believes that the minin's . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Miethke Shunt System are Substantially System (K011030) and Medical
MonoStep Valve of the Miethke Shunt System (K011030) and Medical MonoStep Valve of the Miethke Shunt Oyunlike (K042465). The new
Strata II Valve and Shunt Assembies with and without BioGlide (K042465). The new
Strata II Valve and Shunt A Strata if Valve is similar to the current Paedi-GAV Valve and MonoStep Valve. The miniNAV Valve is similar to the current i acal Clower pressure opening. The materials,
only differences are the size of the valve and a lower pressure opening to cleared only differences are the size of the vare and intended use is a seviously cleared
design, principle of operation and intended use is equivalent to the previously design, principle of operation and intended as one of the Miethke Shunt System. The previously
Paedi-GAV Valve and MonoStep Valve of the Miethke Shunt System. The same valv Paedi-GAV Valve and MonoStep Valve of the Michael and which has the same valve
cleared system also included the Shuntassistant component which has an integrated cleared system also included the Shans reservoir has an integrated
pressure level range as the miniNAV. The McLanahan reservoir has an integrated occlusion mechanism similar to the Strata II Valve.

PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the new miniNAV The parpose for this on reservoir of the Miethke Shunt System.

PERFORMANCE DATA

PERFORMANCE DATA
Testing of the Aesculap Miethke Shunt System miniNAV Valve was performed in Testing of the Aesculap Miernic Onant System results were found to be similar to the accordance with 150 71972000 and 100ans 160 is performed according to the following MRI standards:

ASTM F2119 Evaluation of MR Image Artifacts .
ASTM F2115 Evaluation of Mr. Rimage Induced Heating During ● Magnetic Resonance Imaging
Magnetic Hoofnance Measurement of Magnetically Induced Torque in . the Magnetic Resonance Environment
the Magnetic Floorham at of Magnetically Induced Displacement Force on . the in the Magnetic Resonance Environment

The results and evaluation conclude that the device is MR Conditional in 3-Tesla The results and overlakion on (MRI) systems according to ASTM F 2503 and is substantially equivalent to the predicate devices.

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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 depiction of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 7 2011

Aesculap, Inc. c/o Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

Re: K110206

Trade/Device Name: Aesculap Miethke Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: October 04, 2011 Received: October 05, 2011

Dear Ms. Racosky:

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 identions 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, Dr to 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maslering.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric Riemenschneider

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K110206

Device Name: Miethke Shunt System

Indications for Use:

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

Prescription Use _______________________ and/or _ Over-the-Counter Use _ (Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110206

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).