(294 days)
Not Found
No
The device description and performance studies focus on mechanical and magnetic properties, with no mention of AI or ML algorithms for analysis, control, or decision-making. The "Compass" is described as a manual accessory for external use.
Yes.
The device is intended to shunt cerebrospinal fluid (CSF) from the brain, which directly treats a medical condition (hydrocephalus) by managing fluid pressure.
No
This device is an adjustable shunt system used to divert cerebrospinal fluid, and its setting is verified with an X-ray. It does not perform diagnostic functions.
No
The device description clearly states the device is a physical, adjustable differential pressure valve made of titanium with internal mechanical components. It also mentions manual accessories for external use. While a "Compass" is mentioned for verification, the core device is hardware.
Based on the provided information, the Miethke proGAV 2.0 Adjustable Shunt System is not an In Vitro Diagnostic (IVD) 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 in vivo (within the living body).
- Device Description: The device is an implantable valve designed to regulate fluid flow within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The proGAV 2.0 does not perform this function.
The device is a medical device, specifically an implantable shunt system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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. Adjustments of the proGAV 2.0 shunt can be verified by using the proGAV 2.0 Compass but must be confirmed by radiograph (X-ray).
Product codes
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. Once verified using the Compass the setting must be confirmed with an X-ray. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiograph (X-ray)
Anatomical Site
Brain (lateral ventricles), Peritoneum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (external use)
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 proGAV 2.0 Adjustable Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2009.
Tests Performed:
- Resistance to Leakage: 100 cm of air applied to the device submerged in water. No leakage allowed with a differential pressure from inside to outside of 100 cm water column within 5 mins.
- Results: No leakage detectable within 5 min under 100cm applied overpressure. Samples passed the acceptance criteria.
- Pressure-Flow: Tested between the flow range of 5 to 50 ml/h. Measured pressure must remain inside manufacturers declaration.
- Results: The pressure flow performance of each tested valve remains inside manufacturers declaration. Samples passed the acceptance criteria.
- Overpressure: Function and integrity of the device must withstand a positive pressure of 1 m water column applied to the open shunt.
- Results: Valve function/performance was verified due to an additional measurement of the pressure flow performance after applying the overpressure. Integrity was verified by passing the dynamic braking force. Samples passed the acceptance criteria.
- Dynamic Break Strength: Using a frequency of 1 Hz ±0.2, tension is applied in flow direction and should lead to an elongation of the device of 10% or a maximum force of 5 N. Testing carried out for 100,000 cycles.
- Results: No sample had a rupture or crack after applying 100 000 cycles. Samples passed the acceptance criteria.
- Bursting Pressure: Device must withstand a positive pressure of 2 m of water column inside the device without any change within a tolerance of ± 10% (no later than 2 hours after the burst pressure application).
- Results: No later than 2 hours after applying the positive pressure of 2m water column the valve pressure flow performance was inside manufacturers declaration. Samples passed the acceptance criteria.
- Reflux performance: To verify resistance a water bath was used for the 500 mm of water column against the flow direction of the device. A maximum flow of 0.04 ml/min is allowed to be drained back.
- Results: All tested items had a measured reflux lower that allowed. Samples passed the acceptance criteria.
- Long Term Stability: The device was immersed in distilled water and kept at 36°C ±5 while pumping distilled water at an average flow rate of 20 ml/h through the valve for 28 days. Flow rate was checked 3 times a day. Patient position was simulated (14 days/ horizontal and 14 days/vertical).
- Results: All items remained inside the manufacturers declaration over the period of 28 days. Samples passed the acceptance criteria.
- Valve adjustability/readability: Different materials with varying thicknesses were placed between the valve and the adjustment/verification tools to verify the adjustability/verification of the valve.
- Results: The adjustability and verification of all items remained inside the manufacturers declaration. Samples passed the acceptance criteria.
Results of the above testing demonstrates that the device is substantially equivalent to the predicate device.
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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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 an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Aesculap, Inc. Ms. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K141687
Trade/Device Name: Aesculap - Miethke ProGAV 2.0 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: March 5, 2015 Received: March 6, 2015
Dear Ms. Kathy 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 yours,
Carlos L. Pena -S 同公
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) K141687
Device Name
Aesculap Miethke proGAV 2.0 Adjustable Shunt System
Indications for Use (Describe)
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 proGAV 2.0 Compass but must be confirmed by radiograph (X-ray).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| -- | ------------------------------------------------- |
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 (as required by 21 CFR 807.92)
Miethke proGAV 2.0 Adjustable Shunt System
March 31, 2015
| 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 2.0 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
B.
SUBSTANTIAL EQUIVALENCE
Aesculap. Inc. believes that the Aesculap Miethke proGAV 2.0 Adjustable Shunt System is substantially equivalent to the Miethke proGAV Programmable Shunt System (K062009 / K103003). The proGAV 2.0 has some differences in technological features in comparison to the predicate device. There is no difference between the subject device and the predicate with respect to indications for use.
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. Once verified using the Compass the setting must be confirmed with an X-ray. 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.
4
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 proGAV 2.0 Compass but must be confirmed by radiograph (X-ray).
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke proGAV 2.0 Adjustable 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, intended use, and materials. The proGAV and proGAV 2.0 device characteristics are summarized below.
| | New Device
Miethke Shunt System
proGAV 2.0 Valve | Predicate
Miethke Shunt System
proGAV Valve
K103003/K062009 |
|-----------------------------|--------------------------------------------------------|----------------------------------------------------------------------|
| Adjustable: | Yes | Yes |
| Valve Type: | Adjustable differential pressure | Adjustable differential pressure |
| Pressure levels: | 0 - 20 cmH2O | 0 - 20 cmH2O |
| Materials: | Titanium Alloy Ti6Al4V | Yes |
| | Neodym Ferrite Boron | Yes |
| | Alpha Sapphire | Yes |
| Design: | Circular | Circular |
| Housing: | | |
| Inner | smooth | N/A |
| Outer | thin curved wave profile | smooth |
| Audible or tactile feedback | Yes | No |
| Dimensions: | | |
| Height | 4.5 mm | 4.4 mm |
| Diameter | 17 mm | 18 mm |
| # of Magnets | 4 | 2 |
| Sterilization: | Steam | Steam |
| Packaging: | Double Peel Pouch | Double Peel Pouch |
| Manual Instruments: | Yes | Yes |
| Tool settings and readings | 0 – 20 cmH2O | 0 - 20 cmH2O |
| Packaging: | PE case or wooden box (set) | PE case |
PERFORMANCE DATA
The below preclinical testing was performed to demonstrate that the Aesculap Miethke proGAV 2.0 Adjustable Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2009.
5
| Test | Test Method Summary | Results |
|---|---|---|
| Resistance to Leakage | 100 cm of air applied to the subject | |
| device submerged in water. No | ||
| leakage is allowed with a differential | ||
| pressure from the inside to outside | ||
| of 100 cm water column within 5 | ||
| min. | No leakage detectable within 5 min | |
| under 100cm applied overpressure. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Pressure-Flow | Pressure-flow-performance tested | |
| between the flow range of 5 to 50 | ||
| ml/h. The measured pressure has to | ||
| remain inside manufacturers | ||
| declaration. | The pressure flow performance of | |
| each tested valve remains inside | ||
| manufacturers declaration. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Overpressure | Function and integrity of the subject | |
| device shall withstand a positive | ||
| pressure of 1 m water column | ||
| applied to the open shunt. | Valve function/performance was | |
| verified due to an additional | ||
| measurement of the pressure flow | ||
| performance after applying the | ||
| overpressure. Integrity was verified | ||
| by passing the dynamic braking | ||
| force. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Dynamic Break Strength | Using a frequency of 1 Hz ±0.2, | |
| tension is applied in flow direction | ||
| and should lead to an elongation of | ||
| the subject device of 10% or a | ||
| maximum force of 5 N. Testing is | ||
| carried out for 100,000 cycles. | No sample had a rupture or crack | |
| after applying 100 000 cycles. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Bursting Pressure | Subject device must withstand a | |
| positive pressure of 2 m of water | ||
| column inside the subject device | ||
| without any change within a | ||
| tolerance of ± 10% (no later than 2 | ||
| hours after the burst pressure | ||
| application). | No later than 2 hours after applying | |
| the positive pressure of 2m water | ||
| column the valve pressure flow | ||
| performance was inside | ||
| manufacturers declaration. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Reflux performance | To verify resistance a water bath | |
| was used for the 500 mm of water | ||
| column against the flow direction of | ||
| the subject device. A maximum | ||
| flow of 0.04 ml/min is allowed to be | ||
| drained back. | All tested items had a measured | |
| reflux lower that allowed. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Long Term Stability | The subject device was immersed in | |
| distilled water and kept at 36°C ±5 | ||
| while pumping distilled water at an | ||
| average flow rate of 20 ml/h through | ||
| the valve for at 28 days. Flow rate | ||
| was check 3 times a day. Patient | ||
| position was simulated (14 days/ | ||
| horizontal and 14 days/ vertical) | All items remained inside the | |
| manufacturers declaration over the | ||
| period of 28 days. | ||
| Samples passed the acceptance | ||
| criteria | ||
| Valve adjustability/readability | Different materials with varying | |
| thicknesses were placed between the | ||
| valve and the adjustment/verification | ||
| tools to verify the | ||
| adjustability/verification of the valve | The adjustability and verification of | |
| all items remained inside the | ||
| manufacturers declaration. Samples | ||
| passed the acceptance criteria |
Results of the above testing demonstrates that the device is substantially equivalent to the predicate device.
6
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 device.