(154 days)
No
The device description focuses on mechanical components and pressure-dependent adjustments, with no mention of AI or ML.
Yes
The device is used for cerebrospinal fluid (CSF) shunting in the treatment of hydrocephalus, which directly treats a medical condition.
No
The device, the Miethke Shunt System, is described as being "used for cerebrospinal fluid (CSF) shunting" and "in the treatment of hydrocephalus." This indicates it is a therapeutic or treatment device designed to manage a condition, not to identify or diagnose a disease or condition.
No
The device description explicitly details physical components made of titanium (valves) and mentions accessories like catheters, connectors, deflectors, and reservoirs. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "cerebrospinal fluid (CSF) shunting" and treatment of "hydrocephalus." This is a therapeutic intervention performed in vivo (within the body) to manage a medical condition.
- Device Description: The description details a mechanical system (valves, catheters, connectors) designed to regulate fluid flow within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is clearly designed for direct implantation and function within the patient's body.
N/A
Intended Use / Indications for Use
The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.
Product codes
JXG
Device Description
The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.
The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following performance data is provided in support of the substantial equivalence determination. The below table summarizes the design verification activities. All samples met predefined acceptance criteria and the proposed devices passed design verification test activities. The test results demonstrate that the Aesculap Miethke GAV 2.0 valve and SA 2.0 valve of the Miethke Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2006 standard for shunt safety and performance including the identified stated clauses.
Test: Performance testing
Test Method Summary: 4.2 - Radiopacity, 4.3 - Biocompatibility, 4.5 - Control of the implanted shunt, 4.6 - Pressure flow characteristics, 4.7 - Identification of shunts in vivo, 4.8 - Ability to withstand overpressure, 4.9 - Dynamic breaking strength, 4.10 - Behavior under MR imaging, 4.11 - Bursting pressure, 5.1.1 - Reflux performance, 5.1.2 - Long term stability, 5.1.3 - Influence of the changed posture of the patient on the valve performance
Results: Pass
Results of the performance testing demonstrates that the device is substantially equivalent to the predicate device. The minor differences between the GAV 2.0 valve and SA 2.0 valve and the predicate devices raise no new issues of safety or effectiveness.
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
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K190174
Trade/Device Name: Miethke Shunt System GAV 2.0 and SA 2.0 Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: June 3, 2019 Received: June 3, 2019
Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190174
Device Name
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
Indications for Use (Describe) The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.
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 Shunt System
January 31, 2019
| 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@aesculapimplants.com |
| TRADE NAME: | Miethke Shunt System GAV 2.0 and SA 2.0 Valves |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
PRODUCT CODE: JXG
SUBSTANTIAL EQUIVALENCE
The Miethke Shunt System GAV 2.0 and SA 2.0 valves are substantially equivalent to the predicate, Aesculap Miethke Shunt System (K011030) and reference devices, Aesculap Miethke Shunt System (K110206/K031303)
DEVICE DESCRIPTION
The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.
The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
4
Page 2 of 5
The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
INDICATIONS FOR USE
The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke Shunt System GAV 2.0 and SA 2.0 valves are substantially equivalent to the predicate Aesculap Miethke Shunt System (K011030) and reference devices, Aesculap Miethke Shunt System (K110206/K031303). The GAV 2.0 valve is similar to the paediGAV, GAV and DualSwitch valves of the Miethke Shunt System (K031303/K011030). The SA 2.0 valve is similar to the paediSA, SA and DualSwitch valves of the Miethke Shunt System (K110206/K011030). 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 GAV 2.0 and SA 2.0 device characteristics are summarized below
| | New Device
Miethke Shunt System
GAV 2.0 and SA 2.0 Valves | Predicate
Miethke Shunt Systems
(K011030) | | | |
|---------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GAV 2.0 Valve:
Valve Type: | Combined gravitational unit
w/ ball-in-cone valve | | Combined gravitational unit
w/ ball-in-cone valve | | Same |
| Version: | ventriculo-peritoneal &
lumboperitoneal | | ventriculo-peritoneal
lumboperitoneal | | Same |
| Pressure level (cmH2O)
combinations: | Lying position
5
10 | Upright position
20, 25, 30, 35
25, 30 | Lying position
4
9
5
10 | Upright position
14, 19, 24
19, 24, 29
30, 35, 40
30, 40, 50 | Similar
The opening pressure level
combinations fall within the range
of the pressure levels of the
predicate device. The only
difference is three different
pressure range combinations,
which do not impact the
functionality or intended use
when compared to the predicate
device. |
| Materials:
Housing | Titanium Alloy Ti6Al4V | | Titanium Alloy Ti6Al4V | | Same |
| Ball
--ball-in-cone unit
--gravitational unit
Spring | Alpha Sapphire & Tantalum
Alpha Sapphire
Titanium | | Alpha Sapphire & Tantalum
Alpha Sapphire
Stainless Steel or Titanium Alloy | | Same
Same (Titanium Alloy Ti6Al4V) |
5
Page 3 of 5
| Spring Shape: | Micro spiral | Cylindrical coil | Similar
The subject device has a smaller and slightly different shape spring than the predicate device. Any differences are minor and and do not impact the functionality or intendied use when compared to the predicate device. |
|---------------------------------------|-----------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design: | Cylindrical tube and U shaped | Cylindrical tube | Similar
The subject device is offered in an additional U shape design, which does not impact the functionality or intended use when compared to the predicate device. |
| Dimensions: | | | |
| Height | 4.2 mm and 8.6 mm | 4.0 mm and 4.6 mm | Similar |
| Diameter | 4.2 mm | 4.0 mm and 4.6 mm | Similar |
| Length | 20.6 mm, 21.4 mm and 22.2 | 24.0 mm and 27.4 mm | Similar
The subject device has slightly different dimensions than those of the predicate device and any differences are minor and do not impact the functionality or intended use when compared to the predicate device. |
| SA 2.0 Valve: | | | |
| Valve Type: | Gravitational | Gravitational | Same |
| Version: | ventriculo-peritoneal & lumboperitoneal | ventriculo-peritoneal lumboperitoneal | Same |
| Pressure levels (cmH2O) combinations: | Lying position | Upright position | Same |
| | 0 | 10 | |
| | 0 | 15 | |
| | 0 | 20 | |
| | 0 | 25 | |
| | 0 | 30 | |
| | 0 | 35 | |
| Materials: | | | |
| Housing | Titanium Alloy Ti6Al4V | Titanium Alloy Ti6Al4V | Same |
| Ball | Alpha Sapphire & Tantalum | Alpha Sapphire & Tantalum | Same |
| Design: | Cylindrical tube and U shaped | Cylindrical tube | Similar
The subject device is offered in an additional U shape design, which does not impact the functionality or intended use when compared to the predicate device. |
6
Page 4 of 5
| Dimensions: | ||||
|---|---|---|---|---|
| Height | 4.2 m and 8.6 mm | 4.0 mm and 4.6 mm | Similar | The subject |
| device has | ||||
| Diameter | 4.2 mm | 4.0 mm and 4.6 mm | Similar | slightly |
| Length | 19.0 mm, 20.0 mm and 20.8 mm | 19.5 mm and 23.3mm | Similar | different |
| dimensions | ||||
| than those of | ||||
| the predicate | ||||
| devices and | ||||
| any differences | ||||
| are minor and | ||||
| do not impact | ||||
| the | ||||
| functionality or | ||||
| intended use | ||||
| when | ||||
| compared to | ||||
| the predicate | ||||
| device. | ||||
| GAV 2.0 & SA 2.0: | ||||
| MR labeling: | Added MR Conditional | |||
| information and MRI Safety | ||||
| Section | N/A | Added MR Conditional | ||
| information per ASTM F 2503 | ||||
| and MRI Safety Section to | ||||
| labeling per FDA Guidance | ||||
| Document "Establishing Safety | ||||
| and Compatibility of Passive | ||||
| Implants in the Magnetic | ||||
| Resonance (MR) Environment" to | ||||
| reflect MR testing | ||||
| Sterilization: | Steam | Steam | Same | |
| Packaging: | Double Peel Pouch | Double Peel Pouch | Same |
PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination. The below table summarizes the design verification activities. All samples met predefined acceptance criteria and the proposed devices passed design verification test activities. The test results demonstrate that the Aesculap Miethke GAV 2.0 valve and SA 2.0 valve of the Miethke Shunt System performs as intended and is substantially equivalent to the predicate device. Testing was conducted in accordance with ISO 7197:2006 standard for shunt safety and performance including the identified stated clauses.
| Test | Test Method Summary | Results |
|---|---|---|
| Performance testing | 4.2 - Radiopacity | |
| 4.3 - Biocompatibility | ||
| 4.5 - Control of the implanted shunt | ||
| 4.6 - Pressure flow characteristics | ||
| 4.7 - Identification of shunts in vivo | ||
| 4.8 - Ability to withstand overpressure | ||
| 4.9 - Dynamic breaking strength | ||
| 4.10 - Behavior under MR imaging | ||
| 4.11 - Bursting pressure | ||
| 5.1.1 - Reflux performance | ||
| 5.1.2 - Long term stability | ||
| 5.1.3 - Influence of the changed posture of the | ||
| patient on the valve performance | Pass |
7
Results of the performance testing demonstrates that the device is substantially equivalent to the predicate device. The minor differences between the GAV 2.0 valve and SA 2.0 valve and the predicate devices raise no new issues of safety or effectiveness
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.