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

Device Description

The proGAV® is a "programmable" shunt that can be set for a range of pressures. The valve in the new proGAV® is a leaf spring and ball mechanism that is mechanically controlled by internal magnets. The outer case for the device is made of titanium. The shunt comes with a manual device to verify the pressure setting and another to set or re-set the pressure. These manual accessories are both for external use bu the physician. Once verified using the instrument the setting must be confirmed with an X-ray. Various Miethke shunt system accessories such as shunt assistants, connectors, deflectors and reservoirs are also offered with the proGAV®

AI/ML Overview

This submission pertains to the Miethke proGAV® Programmable Shunt System, a Class II medical device (Product Code JXG). This is a 510(k) submission for marketing clearance, asserting substantial equivalence to previously cleared devices.

Based on the provided text, the submission does not contain specific performance data, acceptance criteria, or a detailed study description for the device's efficacy or accuracy.

Here's a breakdown of what can be extracted or inferred, and what information is missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The submission does not detail any specific test set or clinical study to evaluate the device's performance against acceptance criteria.
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 information is not provided as no specific test set or study is described. The device's setting "must be confirmed by radiograph (X-ray)," implying expert interpretation of X-rays for ground truth in clinical use, but not for a performance study within this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as no specific test set or study is described.
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. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical shunt, not an algorithm. The text explicitly states that adjustments "must be confirmed by radiograph (X-ray)," indicating a human-in-the-loop process for clinical verification of the setting, not 'standalone' algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the clinical use of the device, the "ground truth" for verifying the shunt setting is an "X-ray." This implies expert radiological interpretation. However, for a device performance study, this information is not provided.
The sample size for the training set:
- Not applicable/Not provided. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission.
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an algorithm is involved.

Summary of Device and Evidence presented:

The document describes the Miethke proGAV® Programmable Shunt System, intended to shunt cerebrospinal fluid (CSF). Its key feature is programmability and its setting must be manually verified and "confirmed by radiograph (X-ray)."

The basis for this 510(k) submission is Substantial Equivalence to existing, legally marketed predicate devices, specifically:

Aesculap - Miethke Shunt System (K011030)
Sophy Polaris SPV Valve (K042481)
Medtronic's Strata II Adjustable Valve (K042465)
Hakim Programmable Valve System from Johnson & Johnson (K980778)

The submission states, "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device." This statement, coupled with the focus on substantial equivalence, indicates that the submission relies on the established safety and effectiveness of the predicate devices and the physical/operational similarities of the proGAV® shunt, rather than presenting new, specific performance data from a dedicated clinical or non-clinical study for this specific version of the device. Therefore, the detailed study information requested is not present in the provided text.

Summary

{0}------------------------------------------------

062009

Page 1 of 2

C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[in Accordance with SMDA of 1990]

Miethke proGAV® Shunt

12 January 2007

JAN 1 7 2007

COMPANY: Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 CONTACT: Matthew M. Hull, Regulatory Affairs Manager 800 258-1946 x 5072 (phone) 610 791-6882 (fax) Aesculap® - Miethke proGAV® Programmable Shunt System TRADE NAME: COMMON NAME: Hydrocephalus Shunt System DEVICE CLASS: Class II PRODUCT CODE: JXG CLASSIFICATION: 21 CFR Section 882.5550: Central Nervous System fluid shunt and components REVIEW PANEL: Neurology

INDICATIONS FOR USE

DEVICE DESCRIPTION

PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Miethke proGAV® Shunt.

PERFORMANCE DATA

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

{1}------------------------------------------------

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Aesculap® Miethke proGAV® Shunt is equivalent in materials and basic operational principles to the previously cleared Aesculap - Miethke Shunt System (K011030), the Sophy Polaris SPV Valve (K042481) by Sophysa S.A., Medtronic's Strata II Adjustable Valve (K042465), and the Hakim Programmable Valve System from Johnson & Johnson (K980778).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2007

Aesculap, Inc. % Mr. Matthew M. Hull, RAC Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K062009

Trade/Device Name: Miethke proGAV® Programmable Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: November 21, 2006 Received: November 22, 2006

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.

{3}------------------------------------------------

Page 2 - Mr. Matthew M. Hull, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Rolo

Mark N. Molkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

B. INDICATIONS FOR USE STATEMENT

510(k) Number:

KO6200

Miethke proGAV® Programmable Shunt System Device Name:

Indication for Use:

Prescription Use	X
or Over-the-Counter Use
(Per 21 CFR 801.109)

(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 General, Restorative,

and Neurological Devices

510(k) Number	L062009
---------------	---------

Page 1 of 1

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).