(236 days)
Not Found
No
The device description and performance studies focus on mechanical and manual adjustment mechanisms, with no mention of AI or ML.
Yes
The device is intended to shunt cerebrospinal fluid (CSF) from the brain, which directly impacts a physiological function to treat a medical condition.
No
This device is a therapeutic device (a shunt system) intended to drain cerebrospinal fluid, not to diagnose a condition. While it has accessories for verifying pressure settings, these are for managing the therapeutic function of the shunt, not for diagnosing a patient's medical condition.
No
The device description clearly outlines physical components made of titanium and tantalum, as well as manual accessories for external use, indicating it is a hardware device with mechanical mechanisms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum." This is a surgical procedure involving the direct manipulation of bodily fluids within the body, not the examination of specimens in vitro (outside the body).
- Device Description: The device is a shunt system designed for implantation. It describes mechanical components and external tools for adjusting the implanted device. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Collecting or preparing biological specimens (blood, urine, tissue, etc.).
- Performing tests or assays on biological specimens.
- Providing diagnostic information based on the analysis of biological specimens.
The device is clearly an implantable medical device used for a therapeutic purpose (managing CSF flow), not for diagnostic testing of biological samples.
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.
The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Product codes (comma separated list FDA assigned to the subject device)
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. Various Miethke shunt system accessories such as shunt assistants, catheters, connectors, deflectors and reservoirs are also offered with the proGAV.
proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
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 that is mechanically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the miniNAV valve or proGAV valve. 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
Not Found
Anatomical Site
lateral ventricles of the brain
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)
Bench testing on the proposed device, proGAV Programmable Shunt System, included the following:
- Verification testing assessing the measurement agreement between X-ray confirmation. and the proGAV Verification Tool when used with the proGAV Programmable Shunt System
- . Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV Programmable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV Verification Tool and proGAV Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV Programmable Shunt System is substantially equivalent to the predicate proGAV Programmable Shunt System.
Bench testing on the proposed device, proGAV 2.0 Adjustable Shunt System, included the following:
- Verification testing assessing the measurement agreement between X-ray confirmation. and the proGAV 2.0 Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV Verification Tool when used with the proGAV 2.0 Adjustable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV 2.0 Compass, proGAV Verification Compass and proGAV Verification Tool. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate proGAV 2.0 Adjustable Shunt System.
Bench testing on the proposed device, proSA Adjustable Shunt System, included the following:
- Verification testing assessing the measurement between X-ray confirmation ● and the proSA Verification Tool when used with the proSA Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proSA Verification Compass when used with the proSA Adjustable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proSA Verification Tool and proSA Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proSA Adjustable Shunt System is substantially equivalent to the predicate proSA Adjustable Shunt System.
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, K141687, K120559
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a cascading manner, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Aesculap, Inc. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K161853
Trade/Device Name: Miethke proGAV Programmable Shunt System, Miethke proGAV 2.0 Adjustable Shunt System, Miethke proSA Adjustable 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: January 20, 2017 Received: January 23, 2017
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena-S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161853
Device Name
Miethke proGAV Programmable Shunt System Miethke proGAV 2.0 Adjustable Shunt System Miethke proSA Adjustable Shunt System
Indications for Use (Describe)
The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| | Miethke proGAV Programmable Shunt System
February 15, 2017 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| COMPANY: | 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 Miethke proGAV Programmable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| | CLASSIFICATION NAME: Shunt, Central Nervous System and Components |
| 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. Various Miethke shunt system accessories such as shunt assistants, catheters, connectors, deflectors and reservoirs are also offered with the proGAV .
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.
SUBSTANTIAL EQUIVALENCE
Comparative information presented in the 510(k) supports the substantial equivalence of the subject proGAV Programmable Shunt System to the predicate proGAV Programmable Shunt System (K062009 / K103003). The proGAV Programmable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the
4
predicate is the removal of the required radiographic verification stated in the indications for use and labeling.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke proGAV Programmable Shunt System is substantially equivalent to the predicate Miethke proGAV Programmable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proGAV device characteristics are summarized below.
| | Miethke proGAV
Programmable Shunt System
K161853 | Miethke proGAV
Programmable Shunt System
K103003/K062009 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proGAV
Programmable Shunt System is
intended to shunt cerebrospinal
fluid (CSF) from the lateral
ventricles of the brain into the
peritoneum. | 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). |
| Adjustable | Same | Yes |
| ValveType | Same | Adjustable differential pressure |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 2 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 5.3 mm3 |
| Pressure levels: | Same | Adjustable
0 - 20 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |
5
| | Miethke proGAV
Programmable Shunt System
K161853 | Miethke proGAV
Programmable Shunt System
K103003/K062009 |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Tools: | | |
| Verification tool
Masterdisc
Verification Compass
Adjustment tool
Adjustment disc | Same | Manually wipe with an alcohol
base cleaner (>75% alcohol). May
not be re-sterilized. |
| Check-mate | Same | For use in a sterile surgical field.
Sterile, reusable, may be re-
sterilized |
| Tool settings and
readings: | Same | 0 - 20 cmH2O |
PERFORMANCE DATA
Bench testing on the proposed device, proGAV Programmable Shunt System, included the following:
- Verification testing assessing the measurement agreement between X-ray confirmation . and the proGAV Verification Tool when used with the proGAV Programmable Shunt System
- . Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV Programmable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV Verification Tool and proGAV Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV Programmable Shunt System is substantially equivalent to the predicate proGAV Programmable Shunt System.
6
Page 1 of 3
510(k) SUMMARY
| Miethke proGAV 2.0 Adjustable Shunt System | |
|---|---|
| February 15, 2017 | |
| COMPANY: | 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 proGAV 2.0 Programmable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | JXG |
DEVICE DESCRIPTION
proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
INDICATIONS FOR USE
The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
SUBSTANTIAL EQUIVALENCE
Comparative information presented in the 510(k) supports the substantial equivalence of the subject proGAV 2.0 Adjustable Shunt System to the predicate proGAV 2.0 Adjustable Shunt
7
System (K141687). The proGAV 2.0 Adjustable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the predicate is the removal of the required radiographic verification stated in the indications for use and labeling.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate Miethke proGAV 2.0 Adjustable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proGAV 2.0 device characteristics are summarized below.
| | Miethke proGAV 2.0 Adjustable
Shunt System
K161853 | Miethke proGAV 2.0 Adjustable
Shunt System
K141687 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proGAV 2.0
Adjustable Shunt System is
intended to shunt cerebrospinal
fluid (CSF) from the lateral
ventricles of the brain into the
peritoneum. | The Miethke proGAV 2.0
Adjustable Shunt System is
intended to shunt cerebrospinal
fluid (CSF) from the lateral
ventricles of the brain into the
peritoneum. Adjustments of the
proGAV 2.0 shunt can be verified
by using the verification
instrument but must be confirmed
by radiograph (X-ray). |
| Adjustable | Same | Yes |
| ValveType: | Same | Adjustable differential pressure |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 4 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 10.6 mm3 |
| Pressure levels: | Same | Adjustable |
| | Same | 0 - 20 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |
8
| | Miethke proGAV 2.0 Adjustable
Shunt System | Miethke proGAV 2.0 Adjustable
Shunt System |
|----------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | K161853 | K141687 |
| proGAV 2.0 Tools: | | |
| Compass | Same | Manually wipe with an alcohol |
| Adjustment tool | Same | base cleaner (>75% alcohol).
May not be re-sterilized. |
| Compatible w/
proGAV Tools: | | |
| | Same | Verification tool, Verification
compass, Master disk, Adjustment
tool, Adjustment disk, Check-
mate |
| Tool settings and
readings: | Same | 0 – 20 cmH2O |
PERFORMANCE DATA
Bench testing on the proposed device, proGAV 2.0 Adjustable Shunt System, included the following:
- Verification testing assessing the measurement agreement between X-ray confirmation . and the proGAV 2.0 Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV Verification Tool when used with the proGAV 2.0 Adjustable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV 2.0 Compass, proGAV Verification Compass and proGAV Verification Tool. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate proGAV 2.0 Adjustable Shunt System.
9
510(k) SUMMARY
| Miethke proSA Adjustable Shunt System | |
|---|---|
| February 15, 2017 | |
| COMPANY: | 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 Miethke proSA Adjustable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | 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 spring and ball mechanism that is mechanically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the miniNAV valve or proGAV valve. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
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.
SUBSTANTIAL EQUIVALENCE
Comparative information presented in the 510(k) supports the substantial equivalence of the subject proSA Adjustable Shunt System to the predicate proSA Adjustable Shunt System
10
(K120559). The proSA Adjustable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the predicate is the removal of the required radiographic verification stated in the indications for use and labeling.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke proSA Adjustable Shunt System is substantially equivalent to the predicate Miethke proSA Adjustable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proSA device characteristics are summarized below.
| | Miethke proSA Adjustable
Shunt System
K161853 | Miethke proSA Adjustable
Shunt System
K120559 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proSA Adjustable
Shunt System is intended to shunt
cerebrospinal fluid (CSF) from
the lateral ventricles of the brain
into the peritoneum. | 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). |
| Adjustable | Same | Yes |
| ValveType | Same | Adjustable Gravitational valve |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Weight | Same | Tantalum |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 2 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 5.3 mm3 |
| Pressure levels: | Same | Adjustable |
| | | |
| | Same | 0 - 40 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |
11
| | Miethke proSA Adjustable
Shunt System | Miethke proSA Adjustable
Shunt System |
|-----------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------|
| | K161853 | K120559 |
| Tools: | | |
| Verification tool
Masterdisc
Verification Compass
Adjustment tool
Adjustment disc | Same | Manually wipe with an alcohol
base cleaner (>75% alcohol). May
not be re-sterilized. |
| Check-mate | Same | For use in a sterile surgical field.
Sterile, reusable, may be re-
sterilized |
| Tool settings and
readings: | Same | 0 - 40 cmH2O |
PERFORMANCE DATA
Bench testing on the proposed device, proSA Adjustable Shunt System, included the following:
- Verification testing assessing the measurement between X-ray confirmation ● and the proSA Verification Tool when used with the proSA Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proSA Verification Compass when used with the proSA Adjustable Shunt System
Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proSA Verification Tool and proSA Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proSA Adjustable Shunt System is substantially equivalent to the predicate proSA Adjustable Shunt System.