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.

AI/ML Overview

The provided document describes the K192266 submission for the M.blue Adjustable Shunt System. This document focuses on the device's performance criteria and its substantial equivalence to a predicate device, rather than the performance of an AI/ML device or a medical imaging device. Therefore, many of the requested categories for AI/ML study descriptions are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M.blue Adjustable Shunt System are based on various performance tests demonstrating its safety and efficacy, often by showing it performs substantially equivalent to the predicate device.

Test	Acceptance Criteria	Reported Device Performance
Radiopacity	Shunt identifiable by radiographic pressure coding and flow direction via X-ray examination.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Resistance to Leakage	No leakage with a differential pressure of 100 cm water column within 5 min when 100 cm of air applied while submerged in water.	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	Measured pressure must remain within manufacturer's declaration for flow range of 5 to 50 ml/h.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Overpressure	Device function and integrity must withstand a positive pressure of 1 meter water column applied to the open shunt.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Dynamic Break Strength	Withstand 100,000 cycles with a frequency of 1 Hz ±0.2, tension applied in flow direction leading to 10% elongation or a maximum force of 5 N.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Bursting Pressure	Withstand a positive pressure of 2 meters water column inside the device without any change within ±10% tolerance (within 2 hours after burst pressure application).	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Reflux performance	Maximum flow of 0.04 ml/min allowed to be drained back when subjected to 500 mm of water column against flow direction.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Long Term Stability	Maintain performance over 28 days immersed in distilled water at 36°C ±5, pumping distilled water at 20 ml/h, with simulated patient position (14 days horizontal, 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	Valve characteristics should explicitly depend on patient posture and be cited in the Instructions for Use.	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	Equivalence between radiographic verification method and non-invasive method.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Effects of Exposure to MRI conditions	No effect on valve function and adjustability after MRI exposure.	Samples passed the acceptance criteria and therefore substantially equivalent to the predicate device.
Brake safety test evaluation	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	Meet standards for image artifacts (ASTM F2119), RF-induced heating (ASTM F2182), magnetically induced torque (ASTM F2213), and magnetically induced displacement force (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.
Biocompatibility (Cytotoxicity)	Cell culture treated with test sample exhibited no leachable substances in cytotoxic concentrations / no substances with cytotoxic potential released from the test item for the M.blue plus with Control reservoir and Peritoneal catheter, M.blue plus Compass scale ring, and M. blue Checkmate.	Non-Cytotoxic (for all components tested).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for each test listed. It generally refers to "samples" passing the acceptance criteria. The data provenance (country of origin, retrospective/prospective) is not mentioned, but these are likely laboratory or bench tests conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is a device performance and biocompatibility study, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical or chemical measurement against established standards.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication in these device performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth used for these tests are:

Established engineering standards and physical properties: e.g., pressure-flow characteristics, mechanical strength, resistance to leakage, bursting pressure, radiopacity.
Biological and chemical standards: e.g., cytotoxicity assays against ISO standards (ISO-10993).
MRI safety standards: as per ASTM guidelines.
Manufacturer's declarations: for certain performance characteristics mentioned in the Instructions for Use.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set."

Summary of Device and Study:

The K192266 submission describes the M.blue Adjustable Shunt System, a medical device for cerebrospinal fluid shunting. The core of the submission is to demonstrate its substantial equivalence to a legally marketed predicate device (Aesculap Miethke proSA Adjustable Shunt System K161853) and a reference device (Miethke Shunt System miniNAV Valve K110206).

The acceptance criteria are based on various physical and biological performance tests, as detailed in the table above. These tests cover aspects like radiopacity, resistance to leakage, pressure-flow performance, mechanical integrity (dynamic break strength, bursting pressure), long-term stability, and MRI compatibility. The device's components were also subjected to biocompatibility testing, specifically cytotoxicity, demonstrating the absence of cytotoxic potential.

The studies conducted are primarily bench testing (in vitro) and biocompatibility assessments. The document states that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities," concluding that the device "performs as intended and is substantially equivalent to the predicate device." The "performance data is provided in support of the substantial equivalence determination." This implies that the 'study' is a series of verification and validation tests aligned with relevant standards (e.g., EN ISO 7197:2009 for shunt safety and performance, and ISO-10993 for biocompatibility).

Summary

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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

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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 (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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (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

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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 DeviceAesculap MiethkeM.blue AdjustableShunt System	PredicateAesculap MiethkeproSA AdjustableShunt SystemK161853	Reference DeviceAesculap MiethkeShunt SystemminiNAV ValveK110206
Adjustable:Valve Type:	YesAdjustableGravitational withintegrated differentialpressure unit	YesAdjustableGravitational	NoDifferential pressure
Pressure levels:
--Gravitationalunit	Adjustable0 – 40 cmH2O	Adjustable0 – 40 cmH2O	No
--Differential unit	Four pressure ranges0 cmH2O5 cmH2O10 cmH2O15 cmH2O	N/A	Four pressure ranges0 cmH2O5 cmH2O10 cmH2O15 cmH2O
Materials:
Housing	Titanium AlloyTi6Al4V	Titanium AlloyTi6Al4V	Titanium AlloyTi6Al4V
Rotor	Titanium AlloyTi6Al4V	Titanium AlloyTi6Al4V	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 AlloyTi4Al6V	No	Stainless Steel
	New DeviceAesculap MiethkeM.blue AdjustableShunt System	PredicateAesculap MiethkeproSA AdjustableShunt SystemK161853	Reference DeviceAesculap MiethkeShunt SystemminiNAV ValveK110206
Design:	Circular	Circular	Cylindrical tube
Housing:
Inner	Smooth	Smooth	Smooth
Outer	Thin curved waveprofile	Smooth	Smooth
Audible and tactilefeedback	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:
CompassAdjustment RingAdjustmentAssistant	Manually wipe withan alcohol basecleaner (>75%alcohol). Maynot be sterilized.	Manually wipe withan alcohol basecleaner (>75%alcohol). Maynot be sterilized.	N/A
Checkmate	For use in a sterilesurgical field. Sterile,reusable, may be re-sterilized	For use in a sterilesurgical field. Sterile,reusable, may be re-sterilized	N/A
Instrument settingsand readings	0 - 40 cmH2O	0 - 40 cmH2O	N/A
InstrumentPackaging:
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 radiographicpressure coding system via X-rayexamination. Visual examination ofX-ray images detecting theradiographic pressure coding andflow direction.	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Resistance to Leakage	100 cm of air applied to the subjectdevice submerged in water. Noleakage is allowed with adifferential pressure from the insideto outside of 100 cm water columnwithin 5 min.	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Control of the Implanted Shunt	Functionality of the shunt and themethod of control	Functional characteristics andcontrol procedure are cited in theInstructions of Use and thereforesubstantially equivalent to thepredicate device.
Pressure-Flow	Pressure-flow-performance testedbetween the flow range of 5 to 50ml/h. The measured pressure has toremain inside manufacturer'sdeclaration.	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Overpressure	Function and integrity of the subjectdevice shall withstand a positivepressure of 1 m water columnapplied to the open shunt.	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Dynamic Break Strength	Using a frequency of 1 Hz ±0.2,tension is applied in flow directionand should lead to an elongation ofthe subject device of 10% or amaximum force of 5 N. Testing iscarried out for 100,000 cycles.	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Bursting Pressure	Subject device must withstand apositive pressure of 2 m of watercolumn inside the subject devicewithout any change within atolerance of ± 10% (no later than 2hours after the burst pressureapplication).	Samples passed the acceptancecriteria and therefore substantiallyequivalent to the predicate device.
Reflux performance	To verify resistance a water bathwas used for the 500 mm of watercolumn against the flow direction ofthe subject device. A maximumflow of 0.04 ml/min is allowed tobe drained back.	Samples passed the acceptancecriteria and therefore substantiallyequivalent 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 Methodand 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 Methodand 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 Methodand 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).

Regulation Number and Section

§ 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).