The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.

The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

AI/ML Overview

This document is a 510(k) summary for the Miethke Shunt System GAV 2.0 and SA 2.0 Valves, which is a cerebrospinal fluid (CSF) shunting device. This type of device regulates the flow of CSF to treat hydrocephalus.

Based on the provided information, the device is a shunt system, not an AI/ML powered device. As such, concepts like "acceptance criteria for an AI/ML powered device," "sample sized used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable in this context.

The acceptance criteria and study that proves the device meets the acceptance criteria are related to the physical performance and safety of the shunt system.

Here's the information extracted from the document regarding the acceptance criteria and performance of the device:

1. A table of acceptance criteria and the reported device performance:

The document summarizes that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." It does not provide a specific table of quantitative acceptance criteria values for each test, but rather lists the types of tests performed and attests to a "Pass" result for all of them.

Test	Test Method Summary	Acceptance Criteria (Implicit: Predefined)	Reported Device Performance
Radiopacity	ISO 7197:2006, Clause 4.2	(Predefined Acceptance Criteria Met)	Pass
Biocompatibility	ISO 7197:2006, Clause 4.3	(Predefined Acceptance Criteria Met)	Pass
Control of the implanted shunt	ISO 7197:2006, Clause 4.5	(Predefined Acceptance Criteria Met)	Pass
Pressure flow characteristics	ISO 7197:2006, Clause 4.6	(Predefined Acceptance Criteria Met)	Pass
Identification of shunts in vivo	ISO 7197:2006, Clause 4.7	(Predefined Acceptance Criteria Met)	Pass
Ability to withstand overpressure	ISO 7197:2006, Clause 4.8	(Predefined Acceptance Criteria Met)	Pass
Dynamic breaking strength	ISO 7197:2006, Clause 4.9	(Predefined Acceptance Criteria Met)	Pass
Behavior under MR imaging	ISO 7197:2006, Clause 4.10	(Predefined Acceptance Criteria Met)	Pass
Bursting pressure	ISO 7197:2006, Clause 4.11	(Predefined Acceptance Criteria Met)	Pass
Reflux performance	ISO 7197:2006, Clause 5.1.1	(Predefined Acceptance Criteria Met)	Pass
Long term stability	ISO 7197:2006, Clause 5.1.2	(Predefined Acceptance Criteria Met)	Pass
Influence of the changed posture of the patient on the valve performance	ISO 7197:2006, Clause 5.1.3	(Predefined Acceptance Criteria Met)	Pass
MRI Safety Testing
Evaluation of MR Image Artifacts	ASTM F2119	MR Conditional in 3-Tesla MRI systems	Pass
Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging	ASTM F2182	MR Conditional in 3-Tesla MRI systems	Pass
Qualitative Measurement of Magnetically Induced Torque in the Magnetic Resonance Environment	ASTM F2213	MR Conditional in 3-Tesla MRI systems	Pass
Measurement of Magnetically Induced Displacement Force on the in the Magnetic Resonance Environment	ASTM F2052	MR Conditional in 3-Tesla MRI systems	Pass

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

The document states, "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." However, it does not specify the sample size used for these performance tests. The data provenance (e.g., country of origin, retrospective or prospective) is not stated, but given it's a device manufactured by Aesculap, Inc. in Center Valley, Pennsylvania, the testing was likely conducted in a controlled lab environment, not on patient data directly.

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

This concept is not applicable for a physical device performance test. The "ground truth" for a medical device like a shunt is its compliance with established engineering standards and its physical performance characteristics, measured in controlled laboratory settings, not established by human experts in the way an AI algorithm's output might be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a term used in validating expert assessments for AI/ML models. For a physical device, the "adjudication" is typically adherence to predefined test protocols and measurement verification.

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:

Not applicable. This is relevant to AI/ML software. This document is for a physical medical device.

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

Not applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in mechanical terms, meaning it functions without human intervention once implanted, but its pre-market testing is bench testing.

7. The type of ground truth used:

The ground truth for the device's performance is established by physical measurements and adherence to international and national standards for medical device safety and performance, specifically ISO 7197:2006 and various ASTM F standards for MRI compatibility.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K190174

Trade/Device Name: Miethke Shunt System GAV 2.0 and SA 2.0 Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: June 3, 2019 Received: June 3, 2019

Dear Kathy 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190174

Device Name

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

Indications for Use (Describe) The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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

Miethke Shunt System

January 31, 2019

COMPANY:	Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculapimplants.com
TRADE NAME:	Miethke Shunt System GAV 2.0 and SA 2.0 Valves
COMMON NAME:	Hydrocephalus Shunt System
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Shunt, Central Nervous System and Components
REGULATION NUMBER:	882.5550

PRODUCT CODE: JXG

SUBSTANTIAL EQUIVALENCE

The Miethke Shunt System GAV 2.0 and SA 2.0 valves are substantially equivalent to the predicate, Aesculap Miethke Shunt System (K011030) and reference devices, Aesculap Miethke Shunt System (K110206/K031303)

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke Shunt System GAV 2.0 and SA 2.0 valves are substantially equivalent to the predicate Aesculap Miethke Shunt System (K011030) and reference devices, Aesculap Miethke Shunt System (K110206/K031303). The GAV 2.0 valve is similar to the paediGAV, GAV and DualSwitch valves of the Miethke Shunt System (K031303/K011030). The SA 2.0 valve is similar to the paediSA, SA and DualSwitch valves of the Miethke Shunt System (K110206/K011030). The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, intended use, and materials. The GAV 2.0 and SA 2.0 device characteristics are summarized below

	New DeviceMiethke Shunt SystemGAV 2.0 and SA 2.0 Valves	PredicateMiethke Shunt Systems(K011030)
GAV 2.0 Valve:Valve Type:	Combined gravitational unitw/ ball-in-cone valve		Combined gravitational unitw/ ball-in-cone valve		Same
Version:	ventriculo-peritoneal &lumboperitoneal		ventriculo-peritoneallumboperitoneal		Same
Pressure level (cmH2O)combinations:	Lying position510	Upright position20, 25, 30, 3525, 30	Lying position49510	Upright position14, 19, 2419, 24, 2930, 35, 4030, 40, 50	SimilarThe opening pressure levelcombinations fall within the rangeof the pressure levels of thepredicate device. The onlydifference is three differentpressure range combinations,which do not impact thefunctionality or intended usewhen compared to the predicatedevice.
Materials:Housing	Titanium Alloy Ti6Al4V		Titanium Alloy Ti6Al4V		Same
Ball--ball-in-cone unit--gravitational unitSpring	Alpha Sapphire & TantalumAlpha SapphireTitanium		Alpha Sapphire & TantalumAlpha SapphireStainless Steel or Titanium Alloy		SameSame (Titanium Alloy Ti6Al4V)

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Spring Shape:	Micro spiral	Cylindrical coil	SimilarThe subject device has a smaller and slightly different shape spring than the predicate device. Any differences are minor and and do not impact the functionality or intendied use when compared to the predicate device.
Design:	Cylindrical tube and U shaped	Cylindrical tube	SimilarThe subject device is offered in an additional U shape design, which does not impact the functionality or intended use when compared to the predicate device.
Dimensions:
Height	4.2 mm and 8.6 mm	4.0 mm and 4.6 mm	Similar
Diameter	4.2 mm	4.0 mm and 4.6 mm	Similar
Length	20.6 mm, 21.4 mm and 22.2	24.0 mm and 27.4 mm	SimilarThe subject device has slightly different dimensions than those of the predicate device and any differences are minor and do not impact the functionality or intended use when compared to the predicate device.
SA 2.0 Valve:
Valve Type:	Gravitational	Gravitational	Same
Version:	ventriculo-peritoneal & lumboperitoneal	ventriculo-peritoneal lumboperitoneal	Same
Pressure levels (cmH2O) combinations:	Lying position	Upright position	Same
	0	10
	0	15
	0	20
	0	25
	0	30
	0	35
Materials:
Housing	Titanium Alloy Ti6Al4V	Titanium Alloy Ti6Al4V	Same
Ball	Alpha Sapphire & Tantalum	Alpha Sapphire & Tantalum	Same
Design:	Cylindrical tube and U shaped	Cylindrical tube	SimilarThe subject device is offered in an additional U shape design, which does not impact the functionality or intended use when compared to the predicate device.

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Dimensions:
Height	4.2 m and 8.6 mm	4.0 mm and 4.6 mm	Similar	The subjectdevice has
Diameter	4.2 mm	4.0 mm and 4.6 mm	Similar	slightly
Length	19.0 mm, 20.0 mm and 20.8 mm	19.5 mm and 23.3mm	Similar	differentdimensionsthan those ofthe predicatedevices andany differencesare minor anddo not impactthefunctionality orintended usewhencompared tothe predicatedevice.
GAV 2.0 & SA 2.0:
MR labeling:	Added MR Conditionalinformation and MRI SafetySection	N/A	Added MR Conditionalinformation per ASTM F 2503and MRI Safety Section tolabeling per FDA GuidanceDocument "Establishing Safetyand Compatibility of PassiveImplants in the MagneticResonance (MR) Environment" toreflect MR testing
Sterilization:	Steam	Steam	Same
Packaging:	Double Peel Pouch	Double Peel Pouch	Same

PERFORMANCE DATA

The following performance data is provided in support of the substantial equivalence determination. The below table summarizes the design verification activities. All samples met predefined acceptance criteria and the proposed devices passed design verification test activities. The test results demonstrate that the Aesculap Miethke GAV 2.0 valve and SA 2.0 valve of the Miethke Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2006 standard for shunt safety and performance including the identified stated clauses.

Test	Test Method Summary	Results
Performance testing	4.2 - Radiopacity4.3 - Biocompatibility4.5 - Control of the implanted shunt4.6 - Pressure flow characteristics4.7 - Identification of shunts in vivo4.8 - Ability to withstand overpressure4.9 - Dynamic breaking strength4.10 - Behavior under MR imaging4.11 - Bursting pressure5.1.1 - Reflux performance5.1.2 - Long term stability5.1.3 - Influence of the changed posture of thepatient on the valve performance	Pass

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Results of the performance testing demonstrates that the device is substantially equivalent to the predicate device. The minor differences between the GAV 2.0 valve and SA 2.0 valve and the predicate devices raise no new issues of safety or effectiveness

In addition testing was performed according to the following MRI standards:

ASTM F2119 Evaluation of MR Image Artifacts
ASTM F2182 Measurement of Radio Frequency Induced Heating During Magnetic ● Resonance Imaging
ASTM F2213 Qualitative Measurement of Magnetically Induced Torque in the . Magnetic Resonance Environment
ASTM F2052 Measurement 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 Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 and is substantially equivalent to the predicate device.

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).