The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.

Device Description

The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.

Two different sizes are presented:

. FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
. FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.

The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Cranial COVER". This type of document is and does not feature studies in the traditional sense you're asking about (e.g., studies for AI algorithms). The document instead reports on mechanical and performance testing to demonstrate substantial equivalence to predicate devices, which is a common regulatory pathway for medical devices.

Therefore, many of the requested categories for AI/clinical studies are not applicable to this document. I will extract the information that is present regarding the device's acceptance criteria and the engineering tests performed.

No information is available regarding:

Sample sizes used for test set or data provenance in the context of an AI study.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
Standalone (algorithm only) performance.
Sample size for a training set.
How ground truth for a training set was established.

Acceptance Criteria and Device Performance (Mechanical and Performance Testing)

The "Cranial COVER" is a physical medical device (burr hole cover), not an AI algorithm. Therefore, the "acceptance criteria" discussed are design specifications and performance metrics related to mechanical function, biomechanics, and biocompatibility, as opposed to diagnostic performance metrics like sensitivity, specificity, or AUC.

Here's a table summarizing the acceptance criteria (stated as "Goal" or implied by standard adherence) and the reported device performance from the "Discussion of mechanical and performance testing" section:

Test	Acceptance Criteria / Goal	Reported Device Performance / Conclusion
A. Functional testing
A.1. Functionality of implantable parts (Breaking force of ratchet mechanism)	Determine the breaking force of the ratchet mechanism of the device's upper platform. (Implied: meeting breaking force specifications)	"All tested samples meet the specifications. Functionality of the devices is demonstrated. Results are comparable to the Cranial LOOP XL predicate device."
A.2. Functionality of the handle (Breaking force of ratchet mechanism)	Determine the breaking force of the ratchet mechanism between the handle and the lower platform (and cable ties). (Implied: meeting breaking force specifications)	Results not explicitly detailed in the table, but the overall conclusion for mechanical and performance testing states: "Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices."
B. Biomechanical testing
B.1. Push-in (Resistance to sinking under pressure)	Simulate patient's pressure on the device and determine the force required to sink the devices up to a maximum of 2 mm. (Implied: adequate resistance, not sinking beyond 2mm under specified force)	"All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. Results are better than those obtained with the Cranial LOOP XL predicate device. Both devices must be able to resist pull-out and push-in forces appropriately. However, the use of Cranial LOOP XL as a fixation element for the bone flap causes that these devices are subject to different force intensities. In general, it is reasonable to say that the Cranial COVER is subject to a less demanding situation than Cranial LOOP XL; the results obtained confirm this point."
B.2. Pull-out (Resistance to dislodgement)	Simulate pulling forces during implantation or caused by increased ICP, to determine the maximum force that 1) the device can withstand before sliding out from the burr hole, or 2) the handle can withstand before breaking. (Implied: retention under specified pull-out forces)	"All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. Results are better than those obtained with the Cranial LOOP XL predicate device. Both devices must be able to resist pull-out and push-in forces appropriately. ... In general, it is reasonable to say that the Cranial COVER is subject to a less demanding situation than Cranial LOOP XL; the results obtained confirm this point."
C. Cadaver testing
Evaluation of simulated implantation in a clinical environment	Evaluation of the devices when simulating their implantation on the skull of patients in a clinical environment, following the procedures described in the products' Instructions for Use. (Goal: demonstration of correct implantation, absence of danger, fast/instrument-free implantation, proper profiles, stability, complete covering, ease of removal)	"Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the Cranial COVER is equivalent, in terms of performance and safety and to the relevant extent, to the predicate device Cranial LOOP XL."
Overall Conclusion	Perform as intended and be substantially equivalent to predicate devices, particularly Cranial LOOP XL.	"All the setups applied in the tests simulate clinical service conditions and, in some cases, the worst case scenario. The results of the testing confirmed that both sizes of the Cranial COVER will perform as intended in the clinical setting, and that they are comparable to the predicate devices particularly to the Cranial LOOP XL (included in K132044)."

Additional Applicable Information from the Document:

The document states:

No clinical testing was deemed necessary to support substantial equivalence to predicate devices.
Biocompatibility: The implantable parts are made of PEEK, which is "well established as an implantable thermoplastic material." The non-implantable parts are made of "biocompatible polymers." This is a qualitative assessment of material suitability.
Sterility: The sterilization method is identical to the predicate device, Cranial LOOP XL, and the results are comparable. This implies meeting ISO 11137-1/2, ISO 11737-1/2 standards for sterilization.
Standards Applied: The device adheres to several ISO standards related to sterilization (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2006, ISO 11737-2:2009) and biological evaluation of medical devices (ISO 10993-1:2009). Adherence to these standards serves as a form of acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2016

Neos Surgery S.L. % Mr. Marcos Velez-Duran President M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York. New York 10018

Re: K160739

Trade/Device Name: Cranial COVER Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: March 16, 2016 Received: March 17, 2016

Dear Mr. Velez-Duran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -$ D/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160739

Device Name Cranial COVER

Indications for Use (Describe)

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

The following information is provided as required by 21 CFR § 807.87 for the Cranial COVER Cranial Burr Hole Cover System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 (08290) Cerdanyola del Vallès Barcelona, Spain
Contact: Marcos Velez-Duran M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 Ph: 703-562-9800 Ext 206 Fax: 702-562-9797 Email: MVelez-Duran@MSquaredAssociates,com

Date of Submission: March 16, 2016

Proprietary Name:	Cranial COVER, Cranial Burr Hole Cover System
Common Name:	Burr hole cover
Regulatory Class:	882.5250 Burr hole cover
Classification Panel:	Neurology
Product Codes:	GXR
Predicate Device(s):	Leibinger Burr Hole Covers – K983885

Neuropace Burr Hole Cover - K123163 Cranial LOOP XL - K132044

Device Description

The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It

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avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.

Two different sizes are presented:

. FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
. FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.

Indications for Use

Technological characteristics and comparison to predicate devices

The Cranial COVER is substantially equivalent in its indications for use and anatomical implantation site to the Leibinger Burr Hole Covers (K983885), the NeuroPace Burr Hole Cover (K123163) and the Cranial LOOP XL (included in K132044). More specifically:

· The Cranial COVER has the same indications for use as the primary indications for use of the Leibinger Burr Hole Covers and the NeuroPace Burr Hole Cover.
· A part of the indications for use of the Cranial LOOP XL is the same indications for use of the Cranial COVER (covering burr holes resulting from cranial surgery).

1 In burr holes made with perforators, epicranial and subcranial diameters are different. For instance, the 14/1 mm perforator generates burr holes with epicranial diameter 14 mm and subcranial diameter 11 mm.

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Additionally, Cranial COVER is substantially equivalent in its technology to the Cranial LOOP XL, as their design features and manner of implantation are the same: they are both clamp-like devices.

Finally, the material of the implanted parts of the Cranial COVER is the same as the material of the implanted part of the Cranial LOOP XL and the NeuroPace Burr Hole Cover (PEEK).

Device	Cranial COVER(FC050300 /FC050400)	Cranial LOOP XL(FC050200)	NeuroPace Burr HoleCover (model 8110)	Leibinger Burr HoleCovers
Company	Neos Surgery S.L.	Neos Surgery S.L.	NeuroPaceInc.	Howmedica, Inc.		covers the burr holelike a plug.	intended use by fixingthe bone flap to thecranial bone and bycovering the burr hole.
510(k) No.	Present submission	K132044	K123163	K983885	ApplierInstrument	Not necessary	Not necessary	Screwdriver(minimum)	Screwdriver(minimum)
Product Code	GXR - burr hole cover	GXR - burr hole cover	GXR - burr hole cover	GXR - burr hole cover	MaterialComposition	Platforms and ties(implantable parts) -PEEKHandle and applier-biocompatible polymer	Platforms and ties(implantable parts) -PEEKHandle and applier-biocompatible polymer	Synthetic polymer(PEEK according tothe IFUs) andsilicone.	Titanium
Indicationsfor Use	The Cranial COVER isintended for use tocover burr holesresulting from cranialsurgery. With theavailable sizes, burrholes with an epicranialdiameter between 10and 14 mm, made withstandard perforators orwith spherical drills,can be covered.	The Cranial LOOPCranial Bone FixationSystems: CranialLOOP, Cranial LOOP(L) and Cranial LOOP(XL), are long-termimplantable devicesindicated for post-craniotomy bone flapfixation.(...) The CranialLOOP (XL)(FC050200) is to beused for covering astandard 14 mmcranial burr hole only.	The NeuroPace®Burr Hole Cover isintended for usefollowing cranialsurgery to cover a 14mm burr hole.Secondarily, theNeuroPace Burr HoleCover also can be usedto support a 1.3 mmindwelling lead.	The Leibinger BurrHole Covers aredesigned to be usedwith fixation screws tocover burr holes ofvarious diameters inthe craniofacialskeleton in order toprovide good cosmeticresults and protectionof the underlying softtissues and brain. Thisdevice can also be usedto secure cranial boneflaps.	Sizes	- FC050300: for burrholes of diameter 14/11mm and 13/9 mm- FC050400: for burrholes of diameter from10 to 12 mm	FC050200, only sizeapplicable in burr holes.	One size (14 mm).	Four differentconfigurations.(According to theIntended Use: to coverburr holes of variousdiameters)
DeviceDesign	Two platforms linkedby two adjustable cableties, which are joined tothe lower platform andhave a locking systemthat allows movementof the upper platformtowards the lowerplatform but impedesbackward movements.The surgeon tightensthe upper platform tothe bone by gentlypressing with theapplier and pulling onthe handle. The deviceremains adjusted to thebone thickness and	Two platforms linkedby two adjustable cableties, which are joined tothe lower platform andhave a locking systemthat allows movementof the upper platformtowards the lowerplatform but impedesbackward movements.The surgeon tightensthe lower platform tothe bone and bone flapby gently pressing withthe applier and pullingon the handle. Thedevice remains adjustedto the bone thicknessand it achieves its	The NeuroPace® BurrHole Cover (model8110) includes a basethatis screwed to thecranium (skull) usingbone screws.The cap is an assemblycomprised of a cap anda gasket. The cap ispressed into the basecovering the opening inthe base and securing asingle 1.3 mm lead. TheBurr Hole Coverrequires three bonescrews (1.5 to 1.8 mm).	The Burr Hole Coverhas a segmented plate-like structure. TheseBurr Hole Covers are0.5 rnm thick and arecomprised of fourdifferent configurations	Implant life	Long-term implant	Long-term implant	Long-term implant	Long-term implant
Biocompa-tible	Yes	Yes	Yes	Yes
ProvidedSterile	Yes	Yes	Yes	No
MRICompatibility	MR Safe	MR Safe	MR compatible	MR compatible(although no data isavailable in the IFUs or510k summary).
Method ofFixation toCranium	Like a clamp	Like a clamp	Titanium Screws	Titanium Screws

A side-by-side comparison of the Cranial COVER to the predicate devices follows:

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Some differences exist in the diameters of the holes that the predicate devices are able to cover. Despite these differences, it is important to consider that burr holes made with a 14/11 mm standard perforator are the ones most commonly used in cranial surgery, and these burr holes can be covered with all the mentioned devices. Additionally, for both Cranial COVER and Leibinger Burr Hole Covers different sizes of the device are available, to cover different diameters.

Once implanted, and despite being based in essentially two basic designs to keep their position (clamp-like in the case of Cranial COVER and Cranial LOOP XL; screwed to the bone in the case of NeuroPace and Leibinger Burr Hole Covers), all these devices remain adjusted on the burr holes and cover them properly in the long-term.

Sterility

The sterilization method of the device does not differ from that of the Cranial LOOP XL predicate device (included in K132044). The sterilization process specification validation method and the bioburden limits are the same for this product and the predicate device Cranial LOOP XL. The results for the Cranial COVER are comparable to those obtained with Cranial LOOP XL.

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Biocompatibility

With respect to the materials used in their manufacturing, all devices are made of biocompatible materials. The Cranial COVER, as well as the predicate devices Cranial LOOP XL and NeuroPace Burr Hole Cover, are made of PEEK (this makes them radiolucent and prevents interference with CT scanning and MRI systems). The Leibinger Burr Hole Covers are made of titanium.

The implantable parts of the Cranial COVER are the upper and lower platforms, as well as the ties, all of which are made of PEEK. As already mentioned, this is the same material used in the same parts of the predicate device Cranial LOOP XL (K132044). PEEK is well established as an implantable thermoplastic material. The Cranial COVER handle and applier (the non-implantable parts of the device) are made of biocompatible polymers. Letters of Authorization to Masters Files for these polymers have been provided.

Discussion of mechanical and performance testing

Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices.

Performance testing has demonstrated that the technological characteristics of Cranial COVER do not raise any new safety or effectiveness issues. A summary of the tests performed, including a discussion of the relevance of their results to determine the substantial equivalence of Cranial COVER to the predicate devices, follows:

Test	Test Method Summary	Results and Conclusion
A. Functional testing
A.1. Functionalityof implantableparts	Goal: Determine the breaking force of theratchet mechanism of the device's upperplatform.	All tested samples meet thespecifications. Functionality ofthe devices is demonstrated.
	Method: Fully assembled devices were tested.A calibrated dynamometer was used to apply atraction force on the upper platform until itsratchets broke.	Results are comparable to theCranial LOOP XL predicatedevice.
A.2. Functionalityof the handle	Goal: Determine the breaking force of theratchet mechanism between the handle and thelower platform (and cable ties).
	Method: Fully assembled devices were tested.A calibrated dynamometer was used to apply atraction force on the handle until its ratchets
	broke.
B. Biomechanical testing
B.1. Push-in	Goal: Simulate patient's pressure on the deviceand determine the force required to sink thedevices up to a maximum of 2 mm.Method: Fully assembled devices were testedin holes equivalent to those in which they willbe implanted. The implanted devices wereplaced under a calibrated dynamometer and acylindrical tool used to apply force on theupper platform.	All tested samples meet thespecifications. The deviceshave an adequatebiomechanical behavior atpush-in and pull-out.Results are better than thoseobtained with the CranialLOOP XL predicate device.Both devices must be able toresist pull-out and push-inforces appropriately. However,the use of Cranial LOOP XLas a fixation element for thebone flap causes that thesedevices are subject to differentforce intensities. In general, itis reasonable to say that theCranial COVER is subject to aless demanding situation thanCranial LOOP XL; the resultsobtained confirm this point.
B.2. Pull-out	Goal: Simulate pulling forces duringimplantation or caused by increased ICP, todetermine the maximum force that 1) thedevice can withstand before sliding out fromthe burr hole, or 2) the handle can withstandbefore breaking.Method: Fully assembled devices were testedin holes equivalent to those in which they willbe implanted. A calibrated dynamometer wasused to apply a traction force on the handleuntil the lower platform slid out from the holeor the handle broke.
C. Cadaver testing	Goal: Evaluation of the devices whensimulating their implantation on the skull ofpatients in a clinical environment, followingthe procedures described in the products'Instructions for Use.Method: The test was performed on acadaveric specimen with fully assembleddevices. Some of the most relevant aspectsanalyzed include:- availability of space to place and position thedevice- absence of danger for the surgeon- fast and instrument-free implantation- epicranial and subcranial profiles- lateral and axial stability when the device ismoved- completeness of burr hole covering- ease of device removal	Correct implantation isverified in a simulated real-lifesituation. The devices showadequate performance andsafety.The results demonstrate thatthe Cranial COVER isequivalent, in terms ofperformance and safety and tothe relevant extent, to thepredicate device CranialLOOP XL.

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All the setups applied in the tests simulate clinical service conditions and, in some cases, the worst case scenario. The results of the testing confirmed that both sizes of the Cranial COVER will

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perform as intended in the clinical setting, and that they are comparable to the predicate devices particularly to the Cranial LOOP XL (included in K132044).

The following standards are applicable to the design and performance of the Cranial COVER:

· Recognition number 14-428: ISO 11137-1:2006, "Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]"
· Recognition number 14-409: ISO 11137-2:2013, "Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose"
· Recognition number 14-407: ISO 11737-1:2006, "Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]''
· Recognition number 14-327: ISO 11737-2:2009, "Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process"
· Recognition number 2-220: ISO 10993-1:2009, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]"

Discussion of clinical testing

No clinical testing was deemed necessary to support substantial equivalence to predicate devices.

Conclusion

Based on the design features, the use of established well-known biocompatible materials, technological characteristics comparison, indications for use, and results of the mechanical and performance testing, the subject device has demonstrated substantial equivalence to the identified legally marketed predicate devices.

Regulation Number and Section

§ 882.5250 Burr hole cover.

(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).