(92 days)
No
The device description focuses on mechanical components and manual adjustment by a healthcare provider. There is no mention of AI, ML, or any computational processing of data for decision-making or control.
Yes.
The device is used for cerebrospinal fluid (CSF) shunting, which is a therapeutic intervention to treat conditions like hydrocephalus.
No
This device is a therapeutic device (a shunt system) used for cerebrospinal fluid shunting, not a diagnostic device. It treats a condition rather than diagnosing it.
No
The device description clearly details a physical, implantable valve made of titanium, tantalum, and sapphire, along with manual accessories for external use. This is a hardware medical device, not software-only.
Based on the provided information, the M.blue Adjustable Shunt System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "cerebrospinal fluid (CSF) shunting." This is a therapeutic procedure to manage excess CSF in the brain, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a mechanical valve designed to regulate fluid flow within the body. It does not describe reagents, calibrators, controls, or other components typically associated with in vitro diagnostic tests.
- Input Imaging Modality: While it mentions "Radiographic pressure coding system via X-ray examination," this is used to verify the setting of the implanted device, not to analyze a biological sample for diagnostic purposes.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the shunt system (pressure-flow, leakage, stability, etc.) and its interaction with the body (MRI safety), not on the accuracy of measuring analytes in a biological sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The M.blue Adjustable Shunt System is an implanted medical device used for treatment.
N/A
Intended Use / Indications for Use
The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.
Product codes
JXG
Device Description
M.blue is an adjustable valve that combines an adjustable gravitational unit and a fixed differential pressure unit. The M.blue valve can be set for a range of pressures and is offered in four pressure level settings. The M.blue valve is comprised of a titanium housing enclosed by a thin titanium membrane with a curved wave profile design. The gravitational unit of the M.blue valve contains a tantalum weight, leaf spring and ball mechanically controlled by internal magnets. The differential pressure unit (ball-in-cone) of the M.blue valve contains a sapphire ball and titanium spring.
Manual devices are available to locate, verify the pressure setting and to set or change the pressure pre and postoperatively. These manual accessories are for external use by the Healthcare provider.
The M.blue valve will be distributed by itself or in combination with the proGAV 2.0 valve. The M.blue 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare provider
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 M.blue valve of the Miethke Shunt System performs as intended and is substantially equivalent to the predicate device.
Performance testing was conducted in accordance with EN ISO 7197:2009 standard for shunt safety and performance including the identified stated clauses.
| Test | Test Summary | Results |
|---|---|---|
| Radiopacity | Shunt identifiable by radiographic pressure coding system via X-ray examination. Visual examination of X-ray images detecting the radiographic pressure coding and flow direction. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| 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. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Control of the Implanted Shunt | Functionality of the shunt and the method of control | Functional characteristics and control procedure are cited in the Instructions of Use and therefore substantially equivalent to the predicate device. |
| Pressure-Flow | Pressure-flow-performance tested between the flow range of 5 to 50 ml/h. The measured pressure has to remain inside manufacturer's declaration. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Overpressure | Function and integrity of the subject device shall withstand a positive pressure of 1 m water column applied to the open shunt. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| 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. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| 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). | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| 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. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| 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) | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Influence of the changed posture of the patient on the valve performance | The characteristics of the valve depend on the posture of the patient. | The performance characteristics are cited in the Instructions for Use and therefore substantially equivalent to the predicate device. |
| Accuracy of the M.blue plus Compass | To verify the equivalence between a radiographic verification method and the non-invasive method. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Effects of Exposure to MRI conditions | To verify that the MRI exposure had no effect on the valve function and adjustability. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Brake safety test evaluation | To verify that the Active-Lock mechanism protects against inadvertent re-adjustment by external magnetic fields. | There was no change in pressure setting and therefore substantially equivalent to the predicate device. |
| MRI safety testing | Image artifacts testing per ASTM F2119 Radio frequency induced heating testing per ASTM F2182 Magnetically induced torque testing per ASTM F2213 Magnetically induced displacement force testing per ASTM E2052 | The results demonstrate 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. |
The performance testing demonstrates that the device is safe, as effective, and performs as well as or better than the predicate.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2019
Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K192266
Trade/Device Name: M.blue 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: August 22, 2019 Received: August 23, 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
1
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) 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 (OS) 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 mediation-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,
Xiaolin Zheng, Ph.D. Director (Acting) 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) K192266
Device Name M.blue Adjustable Shunt System
Indications for Use (Describe)
The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Page 1 of 6
510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Miethke M.blue Adjustable Shunt System
October 25, 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@aesculap.com |
| TRADE NAME: | M.blue 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 |
SUBSTANTIAL EQUIVALENCE
Aesculap, Inc. believes that the Aesculap Miethke M.blue Adjustable Shunt System is substantially equivalent to the predicate, Aesculap Miethke proSA Adjustable Shunt System (K161853) and reference device, Miethke Shunt System miniNAV Valve (K110206).
DEVICE DESCRIPTION
M.blue is an adjustable valve that combines an adjustable gravitational unit and a fixed differential pressure unit. The M.blue valve can be set for a range of pressures and is offered in four pressure level settings. The M.blue valve is comprised of a titanium housing enclosed by a thin titanium membrane with a curved wave profile design. The gravitational unit of the M.blue valve contains a tantalum weight, leaf spring and ball mechanically controlled by internal magnets. The differential pressure unit (ball-in-cone) of the M.blue valve contains a sapphire ball and titanium spring.
Manual devices are available to locate, verify the pressure setting and to set or change the pressure pre and postoperatively. These manual accessories are for external use by the Healthcare provider.
4
The M.blue valve will be distributed by itself or in combination with the proGAV 2.0 valve. The M.blue valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
INDICATIONS FOR USE
The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Miethke M.blue Adjustable Shunt System is substantially equivalent to the predicate, Aesculap Miethke proSA Adjustable Shunt System (K161853) and reference device, Miethke Shunt System miniNAV Valve (K110206). The M.blue has some differences in technological features in comparison to the predicate device. The subject device has the same intended use, design principles, operational principles and materials. The M.blue valve is also similar to the reference device. The M.blue device characteristics are summarized below.
| | New Device
Aesculap Miethke
M.blue Adjustable
Shunt System | Predicate
Aesculap Miethke
proSA Adjustable
Shunt System
K161853 | Reference Device
Aesculap Miethke
Shunt System
miniNAV Valve
K110206 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Adjustable:
Valve Type: | Yes
Adjustable
Gravitational with
integrated differential
pressure unit | Yes
Adjustable
Gravitational | No
Differential pressure |
| Pressure levels: | | | |
| --Gravitational
unit | Adjustable
0 – 40 cmH2O | Adjustable
0 – 40 cmH2O | No |
| --Differential unit | Four pressure ranges
0 cmH2O
5 cmH2O
10 cmH2O
15 cmH2O | N/A | Four pressure ranges
0 cmH2O
5 cmH2O
10 cmH2O
15 cmH2O |
| Materials: | | | |
| Housing | Titanium Alloy
Ti6Al4V | Titanium Alloy
Ti6Al4V | Titanium Alloy
Ti6Al4V |
| Rotor | Titanium Alloy
Ti6Al4V | Titanium Alloy
Ti6Al4V | No |
| Magnet | Neodym Ferrite Boron | Neodym Ferrite Boron | No |
| Ball | Alpha Sapphire | Alpha Sapphire | Alpha Sapphire |
| Weight | Tantalum | Tantalum | No |
| Micro spring | Titanium | No | No |
| Spring | Titanium Alloy
Ti4Al6V | No | Stainless Steel |
| | New Device
Aesculap Miethke
M.blue Adjustable
Shunt System | Predicate
Aesculap Miethke
proSA Adjustable
Shunt System
K161853 | Reference Device
Aesculap Miethke
Shunt System
miniNAV Valve
K110206 |
| Design: | Circular | Circular | Cylindrical tube |
| Housing: | | | |
| Inner | Smooth | Smooth | Smooth |
| Outer | Thin curved wave
profile | Smooth | Smooth |
| Audible and tactile
feedback | Yes | No | No |
| Dimensions: | | | |
| Height | 4.2 mm | 4.5 mm | N/A |
| Diameter | 16.6 mm | 18 mm | 2.8 mm |
| Length | 25.0 mm | 27.1 mm | 14.7 mm |
| # of Magnets | 4 | 2 | No |
| Sterilization: | Steam | Steam | Steam |
| Packaging: | Double Peel Pouch | Double Peel Pouch | Double Peel Pouch |
| Instruments: | | | |
| Compass
Adjustment Ring
Adjustment
Assistant | Manually wipe with
an alcohol base
cleaner (>75%
alcohol). May
not be sterilized. | Manually wipe with
an alcohol base
cleaner (>75%
alcohol). May
not be sterilized. | N/A |
| Checkmate | For use in a sterile
surgical field. Sterile,
reusable, may be re-
sterilized | For use in a sterile
surgical field. Sterile,
reusable, may be re-
sterilized | N/A |
| Instrument settings
and readings | 0 - 40 cmH2O | 0 - 40 cmH2O | N/A |
| Instrument
Packaging: | | | |
| Instrument set | Leather case | Metal case | N/A |
| Single Instrument | PE case | PE case | N/A |
5
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 M.blue valve of the Miethke Shunt System performs as intended and is substantially equivalent to the predicate device.
6
Performance testing was conducted in accordance with EN ISO 7197:2009 standard for shunt safety and performance including the identified stated clauses.
| Test | Test Summary | Results |
|---|---|---|
| Radiopacity | Shunt identifiable by radiographic | |
| pressure coding system via X-ray | ||
| examination. Visual examination of | ||
| X-ray images detecting the | ||
| radiographic pressure coding and | ||
| flow direction. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| 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. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| Control of the Implanted Shunt | Functionality of the shunt and the | |
| method of control | Functional characteristics and | |
| control procedure are cited in the | ||
| Instructions of Use and therefore | ||
| substantially equivalent to the | ||
| predicate device. | ||
| Pressure-Flow | Pressure-flow-performance tested | |
| between the flow range of 5 to 50 | ||
| ml/h. The measured pressure has to | ||
| remain inside manufacturer's | ||
| declaration. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| Overpressure | Function and integrity of the subject | |
| device shall withstand a positive | ||
| pressure of 1 m water column | ||
| applied to the open shunt. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| 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. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| 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). | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| 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. | Samples passed the acceptance | |
| criteria and therefore substantially | ||
| equivalent to the predicate device. | ||
| 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) | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Influence of the changed posture of the patient on the valve performance | The characteristics of the valve depend on the posture of the patient. | The performance characteristics are cited in the Instructions for Use and therefore substantially equivalent to the predicate device. |
| Accuracy of the M.blue plus Compass | To verify the equivalence between a radiographic verification method and the non-invasive method. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Effects of Exposure to MRI conditions | To verify that the MRI exposure had no effect on the valve function and adjustability. | Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device. |
| Brake safety test evaluation | To verify that the Active-Lock mechanism protects against inadvertent re-adjustment by external magnetic fields. | There was no change in pressure setting and therefore substantially equivalent to the predicate device. |
| MRI safety testing | Image artifacts testing per ASTM F2119 Radio frequency induced heating testing per ASTM F2182 Magnetically induced torque testing per ASTM F2213 Magnetically induced displacement force testing per ASTM E2052 | The results demonstrate 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. |
7
The performance testing demonstrates that the device is safe, as effective, and performs as well as or better than the predicate. The minor differences between the M.blue Adjustable Shunt System and the predicate device raise no new issues of safety or effectiveness.
BIOCOMPATIBILITY:
Biocompatibility evaluations were conducted according to International Standard ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -1 Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff.
Cytotoxicity testing and biological risk assessments were conducted. The materials of the M.blue Adjustable Shunt System are the same as previously cleared Miethke Shunt System submissions (K120559/K161853).
8
The following biocompatibility testing was submitted in support of substantial equivalence.
| M.blue plus with Control reservoir and Peritoneal catheter | ||
|---|---|---|
| Test | Test Summary | Conclusions |
| Cytotoxicity - Extraction Method | ||
| and XTT Dye | Cell culture treated with test sample exhibited no leachable substances in cytotoxic concentrations released from the test item | Non-Cytotoxic |
| M.blue plus Compass scale ring | ||
|---|---|---|
| Test | Test Summary | Conclusions |
| Cytotoxicity – Extraction Method | ||
| and XTT Dye | Cell culture treated with test sample exhibited no substances with cytotoxic potential released from the test item. | Non-Cytotoxic |
| M. blue Checkmate | ||
|---|---|---|
| Test | Test Summary | Conclusions |
| Cytotoxicity – Extraction Method | ||
| and XTT Dye | Cell culture treated with test sample exhibited no substances with cytotoxic potential released from the test item. | Non-Cytotoxic |
The cytotoxicity testing and biological risk assessments demonstrated that the M. blue valve and M.blue plus Instruments do not pose a risk and are safe for their intended use.
CONCLUSION:
Based on the indications for use, design, materials, function, comparison to the predicate device, and performance testing performed, it can be concluded that the Aesculap Miethke M.blue Adjustable Shunt System is substantially equivalent to the Aesculap Miethke proSA Adjustable Shunt System (K161853).