The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proGAV 2.0 shunt can be verified by using the proGAV 2.0 Compass but must be confirmed by radiograph (X-ray).

Device Description

proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. Once verified using the Compass the setting must be confirmed with an X-ray. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

AI/ML Overview

The provided text is related to the Aesculap Miethke proGAV 2.0 Adjustable Shunt System, a medical device. This document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device through preclinical testing, rather than a clinical study involving human patients or detailed AI performance metrics. Therefore, many of the requested sections about AI-related performance, human reader studies, and training set details are not applicable or cannot be extracted from this specific document.

Here's the information that can be extracted and a note on what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Resistance to Leakage	No leakage detectable within 5 min under 100cm applied overpressure.	No leakage detectable within 5 min under 100cm applied overpressure. Samples passed the acceptance criteria.
Pressure-Flow	The measured pressure has to remain inside manufacturers declaration between the flow range of 5 to 50 ml/h.	The pressure flow performance of each tested valve remains inside manufacturers declaration. Samples passed the acceptance criteria.
Overpressure	Valve function/performance verified by an additional measurement of the pressure flow performance after applying overpressure. Integrity verified by passing the dynamic breaking force. Device shall withstand a positive pressure of 1 m water column applied to the open shunt.	Valve function/performance was verified due to an additional measurement of the pressure flow performance after applying the overpressure. Integrity was verified by passing the dynamic breaking force. Samples passed the acceptance criteria.
Dynamic Break Strength	No rupture or crack after applying 100,000 cycles with a frequency of 1 Hz ±0.2, tension applied in flow direction, leading to an elongation of 10% or a maximum force of 5 N.	No sample had a rupture or crack after applying 100,000 cycles. Samples passed the acceptance criteria.
Bursting Pressure	Device must withstand a positive pressure of 2 m of water column inside the device without any change within a tolerance of ± 10% (no later than 2 hours after application).	No later than 2 hours after applying the positive pressure of 2m water column the valve pressure flow performance was inside manufacturers declaration. Samples passed the acceptance criteria.
Reflux performance	A maximum flow of 0.04 ml/min is allowed to be drained back using a water bath for 500 mm of water column against the flow direction.	All tested items had a measured reflux lower than allowed. Samples passed the acceptance criteria.
Long Term Stability	All items remained inside the manufacturers declaration over the period of 28 days (immersed in distilled water at 36°C ±5, pumping at 20 ml/h, patient position simulated for 14 days/horizontal and 14 days/vertical).	All items remained inside the manufacturers declaration over the period of 28 days. Samples passed the acceptance criteria.
Valve adjustability/readability	The adjustability and verification of all items remained inside the manufacturers declaration when tested with different materials/thicknesses between the valve and tools.	The adjustability and verification of all items remained inside the manufacturers declaration. Samples passed the acceptance criteria.
MRI Compatibility	MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 (based on evaluation of MR Image Artifacts, RF Induced Heating, Magnetically Induced Torque, and Magnetically Induced Displacement Force).	The device is MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503.

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

The document does not explicitly state the sample size (number of devices) used for each preclinical test. It consistently refers to "Samples" or "All tested items" without specifying the quantity.
Data Provenance: The data is from preclinical bench testing performed by the manufacturer, Aesculap, Inc., to demonstrate the device's performance and substantial equivalence to a predicate device in accordance with ISO 7197:2009 standards and ASTM standards for MRI compatibility. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not Applicable. This document describes preclinical bench testing of a medical device, not a study involving diagnostic images or clinical data requiring expert human interpretation or ground truth establishment.

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

Not Applicable. As above, this is preclinical bench testing and does not involve adjudication of expert opinions.

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 document is not about an AI device. It's about a physical medical device (a shunt system).

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

Not Applicable. This document is not about an algorithm or AI device.

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

The "ground truth" for this device's performance is established by the predefined physical and engineering specifications and performance criteria for the shunt system, as outlined in relevant international standards (ISO 7197:2009) and internal manufacturer declarations. The tests directly measure physical properties and functionality.

8. The sample size for the training set:

Not Applicable. This document describes preclinical testing, not the development or training of an AI model.

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

Not Applicable. As above, this document is not about an AI model.

Summary

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

April 2, 2015

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

Re: K141687

Trade/Device Name: Aesculap - Miethke ProGAV 2.0 Adjustable Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: March 5, 2015 Received: March 6, 2015

Dear Ms. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141687

Device Name

Aesculap Miethke proGAV 2.0 Adjustable Shunt System

Indications for Use (Describe)

	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 proGAV 2.0 Adjustable Shunt System

March 31, 2015

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@aesculap.com
TRADE NAME:	Aesculap Miethke proGAV 2.0 Adjustable Shunt System
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

Aesculap. Inc. believes that the Aesculap Miethke proGAV 2.0 Adjustable Shunt System is substantially equivalent to the Miethke proGAV Programmable Shunt System (K062009 / K103003). The proGAV 2.0 has some differences in technological features in comparison to the predicate device. There is no difference between the subject device and the predicate with respect to indications for use.

DEVICE DESCRIPTION

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TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate Miethke proGAV Programmable Shunt System. 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 proGAV and proGAV 2.0 device characteristics are summarized below.

	New DeviceMiethke Shunt SystemproGAV 2.0 Valve	PredicateMiethke Shunt SystemproGAV ValveK103003/K062009
Adjustable:	Yes	Yes
Valve Type:	Adjustable differential pressure	Adjustable differential pressure
Pressure levels:	0 - 20 cmH2O	0 - 20 cmH2O
Materials:	Titanium Alloy Ti6Al4V	Yes
	Neodym Ferrite Boron	Yes
	Alpha Sapphire	Yes
Design:	Circular	Circular
Housing:
Inner	smooth	N/A
Outer	thin curved wave profile	smooth
Audible or tactile feedback	Yes	No
Dimensions:
Height	4.5 mm	4.4 mm
Diameter	17 mm	18 mm
# of Magnets	4	2
Sterilization:	Steam	Steam
Packaging:	Double Peel Pouch	Double Peel Pouch
Manual Instruments:	Yes	Yes
Tool settings and readings	0 – 20 cmH2O	0 - 20 cmH2O
Packaging:	PE case or wooden box (set)	PE case

PERFORMANCE DATA

The below preclinical testing was performed to demonstrate that the Aesculap Miethke proGAV 2.0 Adjustable Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2009.

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Test	Test Method Summary	Results
Resistance to Leakage	100 cm of air applied to the subjectdevice submerged in water. Noleakage is allowed with a differentialpressure from the inside to outsideof 100 cm water column within 5min.	No leakage detectable within 5 minunder 100cm applied overpressure.Samples passed the acceptancecriteria
Pressure-Flow	Pressure-flow-performance testedbetween the flow range of 5 to 50ml/h. The measured pressure has toremain inside manufacturersdeclaration.	The pressure flow performance ofeach tested valve remains insidemanufacturers declaration.Samples passed the acceptancecriteria
Overpressure	Function and integrity of the subjectdevice shall withstand a positivepressure of 1 m water columnapplied to the open shunt.	Valve function/performance wasverified due to an additionalmeasurement of the pressure flowperformance after applying theoverpressure. Integrity was verifiedby passing the dynamic brakingforce.Samples passed the acceptancecriteria
Dynamic Break Strength	Using a frequency of 1 Hz ±0.2,tension is applied in flow directionand should lead to an elongation ofthe subject device of 10% or amaximum force of 5 N. Testing iscarried out for 100,000 cycles.	No sample had a rupture or crackafter applying 100 000 cycles.Samples passed the acceptancecriteria
Bursting Pressure	Subject device must withstand apositive pressure of 2 m of watercolumn inside the subject devicewithout any change within atolerance of ± 10% (no later than 2hours after the burst pressureapplication).	No later than 2 hours after applyingthe positive pressure of 2m watercolumn the valve pressure flowperformance was insidemanufacturers declaration.Samples passed the acceptancecriteria
Reflux performance	To verify resistance a water bathwas used for the 500 mm of watercolumn against the flow direction ofthe subject device. A maximumflow of 0.04 ml/min is allowed to bedrained back.	All tested items had a measuredreflux lower that allowed.Samples passed the acceptancecriteria
Long Term Stability	The subject device was immersed indistilled water and kept at 36°C ±5while pumping distilled water at anaverage flow rate of 20 ml/h throughthe valve for at 28 days. Flow ratewas check 3 times a day. Patientposition was simulated (14 days/horizontal and 14 days/ vertical)	All items remained inside themanufacturers declaration over theperiod of 28 days.Samples passed the acceptancecriteria
Valve adjustability/readability	Different materials with varyingthicknesses were placed between thevalve and the adjustment/verificationtools to verify theadjustability/verification of the valve	The adjustability and verification ofall items remained inside themanufacturers declaration. Samplespassed the acceptance criteria

Results of the above testing demonstrates that the device is substantially equivalent to the predicate device.

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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).