M. Blue Adjustable Shunt System

K192266 · Aesculap, Inc. · JXG · Nov 21, 2019 · Neurology

Device Facts

• Record ID: K192266
• Device Name: M. Blue Adjustable Shunt System
• Applicant: Aesculap, Inc.
• Product Code: JXG · Neurology
• Decision Date: Nov 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.

Device Story

M.blue Adjustable Shunt System is an implantable device for CSF shunting; combines adjustable gravitational unit and fixed differential pressure unit. Gravitational unit uses tantalum weight, leaf spring, and ball controlled by internal magnets; differential pressure unit uses sapphire ball and titanium spring. Valve pressure settings are adjustable pre- and post-operatively using external manual accessories (Compass, Adjustment Ring, Adjustment Assistant) operated by healthcare providers. Device provides audible and tactile feedback during adjustment. Titanium housing features curved wave profile. Used in clinical settings to manage CSF pressure; helps prevent complications associated with hydrocephalus. External instruments allow clinicians to verify and change pressure settings non-invasively. MR Conditional in 3-Tesla systems.

Clinical Evidence

Bench testing only. Performance verified per EN ISO 7197:2009, including radiopacity, leakage resistance, pressure-flow performance, overpressure, dynamic break strength, bursting pressure, reflux performance, long-term stability, and MRI safety (ASTM F2119, F2182, F2213, E2052). Biocompatibility testing (cytotoxicity per ISO 10993) confirmed non-cytotoxic materials. No clinical data presented.

Technological Characteristics

Titanium alloy (Ti6Al4V) housing, tantalum weight, alpha sapphire ball, Neodym Ferrite Boron magnets, titanium springs. Gravitational unit (0-40 cmH2O) and differential pressure unit (four ranges: 0, 5, 10, 15 cmH2O). Dimensions: 16.6mm diameter, 4.2mm height, 25.0mm length. Steam sterilized. Mechanical adjustment via external magnetic instruments. MR Conditional (3-Tesla).

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting for hydrocephalus management.

Regulatory Classification

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.

Predicate Devices

• Aesculap Miethke proSA Adjustable Shunt System (K161853)

Reference Devices

• Miethke Shunt System miniNAV Valve (K110206)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) SUMMARY (as required by 21 CFR 807.92)

#### Aesculap Miethke M.blue Adjustable Shunt System

October 25, 2019

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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.

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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<br>Aesculap Miethke<br>M.blue Adjustable<br>Shunt System | Predicate<br>Aesculap Miethke<br>proSA Adjustable<br>Shunt System<br>K161853 | Reference Device<br>Aesculap Miethke<br>Shunt System<br>miniNAV Valve<br>K110206 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Adjustable:<br>Valve Type: | Yes<br>Adjustable<br>Gravitational with<br>integrated differential<br>pressure unit | Yes<br>Adjustable<br>Gravitational | No<br>Differential pressure |
| Pressure levels: | | | |
| --Gravitational<br>unit | Adjustable<br>0 – 40 cmH2O | Adjustable<br>0 – 40 cmH2O | No |
| --Differential unit | Four pressure ranges<br>0 cmH2O<br>5 cmH2O<br>10 cmH2O<br>15 cmH2O | N/A | Four pressure ranges<br>0 cmH2O<br>5 cmH2O<br>10 cmH2O<br>15 cmH2O |
| Materials: | | | |
| Housing | Titanium Alloy<br>Ti6Al4V | Titanium Alloy<br>Ti6Al4V | Titanium Alloy<br>Ti6Al4V |
| Rotor | Titanium Alloy<br>Ti6Al4V | Titanium Alloy<br>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<br>Ti4Al6V | No | Stainless Steel |
| | New Device<br>Aesculap Miethke<br>M.blue Adjustable<br>Shunt System | Predicate<br>Aesculap Miethke<br>proSA Adjustable<br>Shunt System<br>K161853 | Reference Device<br>Aesculap Miethke<br>Shunt System<br>miniNAV Valve<br>K110206 |
| Design: | Circular | Circular | Cylindrical tube |
| Housing: | | | |
| Inner | Smooth | Smooth | Smooth |
| Outer | Thin curved wave<br>profile | Smooth | Smooth |
| Audible and tactile<br>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<br>Adjustment Ring<br>Adjustment<br>Assistant | Manually wipe with<br>an alcohol base<br>cleaner (>75%<br>alcohol). May<br>not be sterilized. | Manually wipe with<br>an alcohol base<br>cleaner (>75%<br>alcohol). May<br>not be sterilized. | N/A |
| Checkmate | For use in a sterile<br>surgical field. Sterile,<br>reusable, may be re-<br>sterilized | For use in a sterile<br>surgical field. Sterile,<br>reusable, may be re-<br>sterilized | N/A |
| Instrument settings<br>and readings | 0 - 40 cmH2O | 0 - 40 cmH2O | N/A |
| Instrument<br>Packaging: | | | |
| Instrument set | Leather case | Metal case | N/A |
| Single Instrument | PE case | PE case | N/A |

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## 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.

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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<br>pressure coding system via X-ray<br>examination. Visual examination of<br>X-ray images detecting the<br>radiographic pressure coding and<br>flow direction. | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Resistance to Leakage | 100 cm of air applied to the subject<br>device submerged in water. No<br>leakage is allowed with a<br>differential pressure from the inside<br>to outside of 100 cm water column<br>within 5 min. | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Control of the Implanted Shunt | Functionality of the shunt and the<br>method of control | Functional characteristics and<br>control procedure are cited in the<br>Instructions of Use and therefore<br>substantially equivalent to the<br>predicate device. |
| Pressure-Flow | Pressure-flow-performance tested<br>between the flow range of 5 to 50<br>ml/h. The measured pressure has to<br>remain inside manufacturer's<br>declaration. | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Overpressure | Function and integrity of the subject<br>device shall withstand a positive<br>pressure of 1 m water column<br>applied to the open shunt. | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Dynamic Break Strength | Using a frequency of 1 Hz ±0.2,<br>tension is applied in flow direction<br>and should lead to an elongation of<br>the subject device of 10% or a<br>maximum force of 5 N. Testing is<br>carried out for 100,000 cycles. | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Bursting Pressure | Subject device must withstand a<br>positive pressure of 2 m of water<br>column inside the subject device<br>without any change within a<br>tolerance of ± 10% (no later than 2<br>hours after the burst pressure<br>application). | Samples passed the acceptance<br>criteria and therefore substantially<br>equivalent to the predicate device. |
| Reflux performance | To verify resistance a water bath<br>was used for the 500 mm of water<br>column against the flow direction of<br>the subject device. A maximum<br>flow of 0.04 ml/min is allowed to<br>be drained back. | Samples passed the acceptance<br>criteria and therefore substantially<br>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. |

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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).

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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<br>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<br>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<br>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).