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

Device Description

proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf spring and ball mechanism. The pressure setting is magnetically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure. These manual accessories are for external use by the physician. Once verified using the verification instrument the setting must be confirmed with an X-ray. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

AI/ML Overview

I'm sorry, but this document does not contain the detailed information needed to fill out all the sections of your request. This 510(k) summary provides a declaration of substantial equivalence for a medical device (a shunt system), focusing on its design, intended use, and performance testing against established standards.

Here's what can be extracted and what is missing:

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

The document lists the types of performance tests conducted and states that "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 devices." It also states "Preclinical testing was performed to demonstrate that the Aesculap Miethke proSA Adjustable Shunt System performs as intended and is safe and effective."

However, it does not provide specific numerical acceptance criteria or the reported device performance values for these tests (e.g., minimum burst pressure, specific flow rates, or MR artifact sizes). It only lists the types of tests performed.

Acceptance Criteria	Reported Device Performance
Not specified (e.g., specific thresholds for leak, pressure-flow, overpressure, etc.)	Device performs "as intended" and is "safe and effective."
MRI compatibility according to ASTM F 2503	Device is "MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Preclinical testing was performed..." but does not specify the sample sizes used for any of the tests. It also does not mention the data provenance (country of origin, retrospective/prospective). This is typical for 510(k) summaries which often summarize the testing rather than provide full study details.

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)

This entire section is not applicable or not provided in the document. The testing described is primarily in vitro and physical performance testing of the device itself, not image interpretation or diagnostic accuracy where expert ground truth would be established.

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

This is not applicable or not provided. Adjudication methods are typically relevant for studies involving human interpretation of data, which is not the nature of the preclinical performance testing described here.

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. This document describes a physical medical device (a shunt system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not have been performed.

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

This is not applicable. As stated above, this is not an AI-powered device.

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

For the performance testing mentioned (Leak, Pressure-Flow, Overpressure, Dynamic Break Strength, Bursting Pressure, Reflux performance, Long Term Stability, Angle dependence, and MRI compatibility), the "ground truth" would be established by engineering standards and physical measurements based on the specified test protocols (e.g., ISO 7197:2006, ASTM F2119, F2182, F2213, F2052, F2503). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is 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

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

Summary

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MAY 2 4 2012

K120559

Page 1 of 3

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

Miethke proSA Adjustable Shunt System May 23, 2012

COMPANY:

ਾ ਦ

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

CONTACT:

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

TRADE NAME:

Aesculap Meithke proSA Adjustable Shunt System

Hydrocephalus Shunt System COMMON NAME:

CLASSIFICATION NAME: Shunt, Central Nervous System and Components

REGULATION NUMBER: 882.5550

PRODUCT CODE: JXG

SUBSTANTIAL EQUIVALENCE

Aesculap, Inc. believes that the Aesculap Miethke proSA Adjustable Shunt System is Acountially to Miethke proGAV Programmable Shunt System (K062009 / K103003) and Aesculap Miethke Shunt System (K011030 / K110206).

DEVICE DESCRIPTION

DEVICE DESCHIP TION
proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf proOH valve is comphood of a titanian notically controlled by internal magnets. Several sphilig and bail moonaliant in to verify the pressure setting and to set or re-set the manual devices are available to Trilly are manual accessories are for external use by pressure pre and postopenantsing the verification instrument the setting must be the physician: Onoo vehica asing will be distributed by itself or in combination with Commined with an - X ray. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

INDICATIONS FOR USE

INDICATIONS I ON OSE
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospite of the The Mietnike proch Adjactubis of the brain into the peritoneum. Adjustments of the (CSF) from the lateral ventholo of the brain instrument but must be confirmed by radiograph (X-ray).

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TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke proSA Adjustable Shunt System is substantially equivalent to the predicate Aesculap Meithke Shunt System and Meithke proGAV Programmable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate devices through comparison in design, principles of operation, intended use, and materials. The ShuntAssistant, proGAV and proSA device characteristics are summarized below.

	New DeviceMiethke Shunt SystemproSA Valve	PredicateMiethke Shunt SystemproGAV ValveK103003/K062009	PredicteMiethke Shunt System(ShuntAssistant)K103003/K011030
Adjustable	Yes	Yes	No
Valve Type	Adjustable Gravitational	Adjustable differentialpressure	Gravitational
Materials
Titanium Alloy Ti4Al6V	Yes	Yes	Yes
Neodym Ferrite Boron	Yes	Yes	No
Alpha Sapphire	Yes	Yes	Yes
Tantalum	Yes	No	Yes
Design	Circular	Circular	Cylindrical tube
Magnet	Yes	Yes	No
Pressure levels	Adjustable0 - 40 cmH2O	Adjustable0 - 20 cmH2O	Six pressure ranges10 cmH2O15 cmH2O20 cmH2O25 cmH2O30 cmH2O35 cmH2O
Manual Instruments	Yes	Yes	No
Tool settings and readings	0-40 cmH2O	0-20 cmH2O	N/A

PERFORMANCE DATA

Preclinical testing was performed to demonstrate that the Aesculap Miethke proSA Adjustable Shunt System performs as intended and is safe and effective. Testing was conducted in accordance with ISO 7197:2006 and included Leak, Pressure-Flow, Overpressure, Dynamic Break Strength, Bursting Pressure, Reflux performance, and Long Term Stability. Angle dependence testing was also performed.

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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 devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

MAY 2 4 2012

Re: K120559

Trade/Device Name: Miethke Adjustable proSA Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system shunt and components Regulatory Class: Class II Product Code: JXG Dated: February 23, 2012 Received: February 24, 2012

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 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.

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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 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Signature

Malvina B. Eydelman, 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

510(k) Number (if known): K120559

Device Name: Meithke proSA Adjustable Shunt System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

JOE HUTTER

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

510(k) Number

માં ૨૦૬૬૧

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).