(28 days)
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).
The proGAV is a "programmable" shunt that can be set for a range of pressures. The valve in the 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 by 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, catheters, connectors, deflectors and reservoirs are also offered with the proGAV . The proposed modification is to the internal magnet.
Acceptance Criteria and Study for Miethke proGAV Shunt (K103003)
This 510(k) pertains to a modification of the Miethke proGAV Shunt, specifically to its internal magnet. The submission claims substantial equivalence to the previously cleared proGAV Shunt (K062009) and focuses on ensuring the modified device maintains the same safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of numerical acceptance criteria or performance metrics for the proGAV shunt. Instead, it lists the types of tests conducted to demonstrate safety and effectiveness, particularly concerning MRI compatibility, which is a critical aspect for devices with internal magnets.
| Acceptance Criteria Category | Test Performed | Reported Device Performance (Implied) |
|---|---|---|
| MRI Safety - Image Artifacts | ASTM F2119: Evaluation of MR Image Artifacts | The device passed this test, implying that it does not produce unacceptable MR image artifacts that would hinder diagnostic imaging or compromise patient safety during MRI procedures. |
| MRI Safety - RF Induced Heating | ASTM F2182: Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging | The device passed this test, indicating that it does not undergo significant or unsafe temperature increases when exposed to radiofrequency fields during MRI. This prevents the risk of thermal injury to the patient. |
| MRI Safety - Magnetically Induced Torque | ASTM F2213: Qualitative Measurement of Magnetically Induced Torque in the Magnetic Resonance Environment | The device passed this test, suggesting that it does not experience dangerous levels of torque when exposed to the strong static magnetic fields of an MRI scanner. This ensures the device remains in its intended location and does not cause internal damage. |
| MRI Safety - Magnetically Induced Displacement Force | ASTM F2052: Measurement of Magnetically Induced Displacement Force on the in the Magnetic Resonance Environment | The device passed this test, implying that it does not experience significant displacement forces that would cause it to move or migrate within the body when exposed to the magnetic fields of an MRI. This is crucial for avoiding internal injury or compromising the shunt's intended function. |
| Functional Equivalence | Not explicitly detailed in the performance data section | Implicitly, the modified internal magnet is assumed to maintain the same functional characteristics (e.g., pressure adjustment range, accuracy) as the predicate device (K062009). The statement "The materials, design, principle of operation and intended use is equivalent to the previously cleared proGAV Shunt" supports this. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size for the mechanical/biophysical tests conducted (ASTM F2119, F2182, F2213, F2052). These are typically bench tests performed on a defined number of device units rather than human patient data.
The data provenance is retrospective in the sense that it relies on demonstrating equivalence to an already cleared device and likely leverages existing knowledge about its performance. The tests themselves are laboratory/bench studies and do not involve human or animal subjects in this specific submission. Therefore, country of origin of data is not applicable in the context of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are objective, standardized engineering/biophysical tests (ASTM standards) that do not require expert consensus or qualitative interpretation to establish ground truth. The 'ground truth' for these tests is the physical measurement itself, compared against predetermined engineering specifications and safety thresholds outlined in the ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are objective physical tests, not clinical evaluations requiring adjudication.
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 device is a medical implant (shunt), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance data (MRI compatibility tests) is the physical measurements and observations derived from standardized ASTM test methods. These methods provide objective, quantifiable data that are compared against predefined safety limits and performance characteristics.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for this type of device development involves engineering design, material selection, and manufacturing processes, culminating in verification and validation testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8. The "ground truth" during the development and manufacturing of such a device would be established through a rigorous quality management system, engineering specifications, design controls, and adherence to relevant standards, ensuring the device consistently meets its intended performance and safety requirements.
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510(k) SUMMARY (as required by 21 CFR 807.92) B.
Miethke proGAV Shunt November 9, 2010
NOV - 9 2010
| 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 |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION NAME: | Aesculap Miethke proGAV Programmable Shunt System |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | JXG |
DEVICE DESCRIPTION
The proGAV is a "programmable" shunt that can be set for a range of pressures. The valve in the 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 by 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, catheters, connectors, deflectors and reservoirs are also offered with the proGAV . The proposed modification is to the internal magnet.
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-rav).
SUBSTANTIAL EQUIVALENCE
Aesculab®, Inc. believes that the modified proGAV Shunt is substantially equivalent to the proGAV Shunt of the Miethke proGAV Programmable Shunt System (K062009). The modified shunt is similar to the current proGAV Shunt. The only difference is the internal magnets. The materials, design, principle of operation and intended use is equivalent to the previously cleared proGAV Shunt.
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the new Miethke proGAV Shunt.
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PERFORMANCE DATA
1
The following tests demonstrated the proGAV shunt is safe and effective.
- 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
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Inc. c/o Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
NOV - 9 2010
Re: K103003
Trade/Device Name: Aesculap Miethke proGAV Programmable 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: October 11, 2010 Received: October 12, 2010
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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Page 2 - Ms. Kathy A. Racosky
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 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Qun. L. Qum. for
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
NOV - 9 2010
510(k) Number: K103003
Device Name: Miethke proGAV Programmable Shunt System
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).
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)
JOE HUTTER
Page I of 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
§ 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).