(184 days)
Not Found
No
The description focuses on a mechanical, programmable shunt system with manual adjustment and verification tools. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to shunt cerebrospinal fluid from the brain to alleviate a medical condition.
No
The device is a programmable shunt system for cerebrospinal fluid (CSF) management. Its function is therapeutic (shunting CSF), and while it has a verification instrument, the setting must be confirmed by X-ray, which is a diagnostic tool, but the device itself is not.
No
The device description clearly states it is a "programmable" shunt with a physical valve mechanism, outer case made of titanium, and manual accessories for setting and verifying pressure. This indicates a hardware-based medical device.
Based on the provided information, the Miethke proGAV® Programmable Shunt System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to shunt cerebrospinal fluid (CSF) from the brain to the peritoneum. This is a surgical procedure performed on a living patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The device is an implantable shunt system with external adjustment tools. It is designed to manage fluid flow within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to diagnose a condition, analyze a sample, or provide information about a patient's health status based on testing a biological specimen.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases, monitor health, or screen for conditions. The proGAV® system is a therapeutic device used to treat a condition (hydrocephalus, which causes excess CSF).
N/A
Intended Use / Indications for Use
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).
Product codes
JXG
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®
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
lateral ventricles of the brain, peritoneum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device.
Key Metrics
Not Found
Predicate Device(s)
K011030, K042481, K042465, K980778
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
062009
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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
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®
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.
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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:
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).
| 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 |
|---|---|
| --------------- | --------- |
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