(90 days)
Not Found
No
The device description and performance studies focus on mechanical and magnetic properties, with no mention of AI/ML algorithms or data processing for decision-making. The verification process is manual and requires radiographic confirmation.
Yes
The device is intended to shunt cerebrospinal fluid from the brain to the peritoneum to manage intracranial pressure, which is a therapeutic intervention.
No
Explanation: The device is a shunt system that diverts CSF; it does not diagnose a condition. While it has an accessory for verification and requires X-ray confirmation of its setting, these steps are for confirming the device's function and position, not for diagnosing a medical condition.
No
The device description clearly states it is a physical, implantable shunt system made of titanium with internal components and manual external accessories. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Miethke proSA Adjustable Shunt System is an implantable device designed to drain cerebrospinal fluid from the brain to the abdomen. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for shunting CSF, not for performing diagnostic tests on bodily fluids or tissues.
- Device Description: The description focuses on the mechanical components and how it functions as a shunt, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other elements typically associated with IVD devices.
While the device's setting is verified using an external instrument and confirmed by X-ray (an imaging modality), these are part of the device's operation and verification process, not diagnostic tests performed on biological samples.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
JXG
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 springs and ball, which are 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 verification 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiograph (X-ray)
Anatomical Site
lateral ventricles of the brain into the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062009 / K103003, K011030 / K110206
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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MAY 2 4 2012
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).
1
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 Device
Miethke Shunt System
proSA Valve | Predicate
Miethke Shunt System
proGAV Valve
K103003/K062009 | Predicte
Miethke Shunt System
(ShuntAssistant)
K103003/K011030 |
|----------------------------|---------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Adjustable | Yes | Yes | No |
| Valve Type | Adjustable Gravitational | Adjustable differential
pressure | 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 | Adjustable
0 - 40 cmH2O | Adjustable
0 - 20 cmH2O | Six pressure ranges
10 cmH2O
15 cmH2O
20 cmH2O
25 cmH2O
30 cmH2O
35 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.
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign.
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.
4
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:
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).
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
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