Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

K152342 · St Jude Medical · GXR · Jun 9, 2016 · Neurology

Device Facts

• Record ID: K152342
• Device Name: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
• Applicant: St Jude Medical
• Product Code: GXR · Neurology
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2

Intended Use

The Guardian™ Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter.

Device Story

Guardian Burr Hole Cover System is an implantable device used during cranial surgery to cover a 14 mm burr hole in the skull. It acts as a physical barrier to protect exposed brain tissue. The system includes a base, clip, and cover, with ancillary components (base holder, cranial screws, insertion tool, screwdriver) to assist placement. The device provides both temporary and permanent lead fixation for compatible 1.29 mm or 1.39 mm leads. The surgeon installs the base into the burr hole, uses the screwdriver to secure it to the skull, and uses the clip insertion tool to actuate the clip/insert for lead restraint. The device is a single-use, sterile implant.

Clinical Evidence

Bench testing only. No clinical data. Testing included preconditioning, accelerated aging, drop/shock testing, lead restraint performance, rotation testing, stylet/guide tube removal, multiple actuation, vibration testing, cover shear testing, and affixation checks. Biocompatibility testing followed ISO 10993 standards (cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, pyrogenicity, particulate load, and chemical characterization).

Technological Characteristics

Materials: PEEK (main cover), MP35N (springs), titanium alloy (pins), polycarbonate, silicone. Dimensions: 14 mm burr hole compatibility. Energy: None (mechanical). Connectivity: None. Sterilization: Ethylene oxide (ISO 11135). Software: None.

Indications for Use

Indicated for use during cranial surgery as an implantable 14 mm burr hole cover for the skull; also used to secure 1.29 mm or 1.39 mm diameter leads.

Regulatory Classification

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.

Predicate Devices

• NeuroPace, Inc. Burr Hole Cover (K123163)
• NeuroPace, Inc. Burr Hole Cover (K141368)

Submission Summary (Full Text)

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

June 9, 2016

St. Jude Medical Ms. Manasi Khare Senior Regulatory Affairs Specialist 6901 Preston Road Plano, Texas 75024

Re: K152342

Trade/Device Name: Guardian™ Burr Hole Cover System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: May 6, 2016 Received: May 9, 2016

Dear Ms. Khare:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carlos L. Pena -S

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) K152342

Device Name Guardian™ Burr Hole Cover System

Indications for Use (Describe)

The Guardian™ Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(K) SUMMARY

The 510(k) Summary of the Guardian™ Burr Hole Cover System, per 21 CFR 807.92, is provided on the following pages.

| 510(k) Summary | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K152342 |
| <b>Submitter Information:</b> | |
| Date Prepared: | August 17, 2015 |
| Submitter<br>Name &<br>Address: | St. Jude Medical<br>6901 Preston Road<br>Plano<br>TX 75024 USA |
| Contact Person: | Manasi Khare<br>Senior Regulatory Affairs Specialist<br>Phone [phone]<br>[e-mail] |
| <b>Device Information:</b> | |
| Trade Name: | GuardianTM Burr Hole Cover System |
| Common Name: | Cover, Burr Hole |
| Class | II |
| Classification Name: | 882.5250 Burr Hole Cover |
| Predicate Device: | NeuroPace, Inc. Burr Hole Cover (K123163) and (K141368) |
| Device Description: | The GuardianTM burr hole cover system consists of three main features: base, clip, and cover. The GuardianTM burr hole cover system is used to close a cranial burr hole and can be used to secure an implanted compatible lead (1.29mm and 1.39mm). The burr hole cover is mated with the burr hole that is drilled in the patient's skull during the cranial surgery. The burr hole cover acts as a physical barrier protecting the exposed brain by covering the burr hole. The burr hole cover can also be used to provide temporary and permanent lead fixation.<br>There are ancillary components of the system (base holder with cranial screws, clip, insertion tool and screw driver) that aid in the placement of the burr hole cover system. The base holder is intended to align the base with the burr hole and to maintain the cranial screws in place in the package and during installation.<br>A clip insertion tool is intended to actuate the clip/insert and place it in the base. A screw driver is used to install the screws to the skull. |
| Intended Use:<br>(Indications for Use) | The GuardianTM Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter. |

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| Comparison to<br>Predicate<br>Devices | The Guardian™ Burr Hole Cover System has substantially equivalent intended use and<br>fundamental scientific technology as the predicate device. The technological<br>characteristics of the Guardian™ Burr Hole Cover System are substantially equivalent<br>to the predicate device. | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The design comparison between the Guardian™ Burr Hole Cover System and the<br>predicate device indicate dimensional differences in the burr hole and lead<br>compatibility that does not affect the device intended use of covering a hole in the<br>cranium, as confirmed by the pre-clinical testing. The minor dimensional design<br>difference between the Guardian™ Burr Hole Cover System and the predicate device<br>is not imperative to establish the performance equivalence between the two systems. | | |
| | The Guardian™ Burr Hole Cover System includes an ancillary clip which can be used<br>for temporary restraint of the lead. The predicate device cover allows for both<br>temporary and permanent restraint of the lead, so this does not introduce new issues of<br>safety and effectiveness. | | |
| | Both use Polyaryletheretherketone (PEEK) as the main material for the Burr Hole<br>Cover. All the other additional materials do not affect the substantial equivalence and<br>intended use of the device due to contact type or duration. Both the devices are single<br>use and are sterilized using Ethylene oxide (EO). | | |
| | A table has been added to capture the comparison between the Guardian™ Burr Hole<br>Cover System and the predicate device: | | |
| | Attribute | NeuroPace, Inc. Burr Hole Cover<br>(K123163 and K141368) | Guardian™ Burr Hole Cover System<br>(this application) |
| | Indications for<br>Use | Intended to cover a 14 mm burr hole<br>following cranial surgery. Secondarily,<br>the NeuroPace Burr Hole Cover can be<br>used to support 1.3 mm indwelling<br>leads. | Intended for use during cranial surgery as<br>an implantable 14 mm burr hole cover for<br>the skull. It can also be used to secure a<br>lead with a 1.29 mm (0.051 in) or 1.39 mm<br>(0.055 in) diameter. |
| | Anatomical<br>Site | Permanent implant in cranium (skull) | |
| | Burr Hole<br>Compatibility | As produced by a 14 mm cranial burr. | As produced by a 14 mm cranial burr. |
| | Lead<br>Compatibility | Minimum depth 2.7 mm<br>$1.3 mm diameter \pm 0.05 mm$ | Minimum depth 3.7 mm<br>1.39 mm leads and 1.29 mm leads only |
| | Main<br>Components | Base, bone screws and cap | Base, clip, cover, and screws |
| | Sterility | Sterile, single use | |
| | Sterilization<br>method | Ethylene oxide (EO) | |
| | Labeled as<br>non-pyrogenic | Yes | |
| | Materials of<br>Construction | Polyaryletheretherketone (PEEK) and<br>silicone | Polyaryletheretherketone (PEEK);MP35N<br>(Springs in insert), and titanium alloy (pins<br>in insert); polycarbonate, silicone |
| | Biocompatible | Yes | Yes |
| | Shelf Life | 1 year | 2 years |
| | Based on the information in this premarket notification, the subject device has been<br>shown substantially equivalent to the predicate device. | | |

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| Summary on<br>Non-Clinical<br>Testing for the<br>Guardian ™<br>Burr Hole<br>Cover System | Performance bench testing and biocompatibility testing were performed to verify the<br>device met the pre-determined acceptance criteria and to confirm substantial<br>equivalence. The following performance bench tests were performed: | |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | | |
| Test | Testing Scope and Rationale | Results |
| Preconditioning<br>and<br>Accelerated<br>Aging | The SJM Burr Hole Cover (BHC) was preconditioned<br>prior to subsequent pre-clinical testing.<br><br>The NeuroPace Burr Hole Cover (BHC) was not<br>preconditioned because final finished sterilized<br>product was obtained from manufacturer and tested. | All SJM<br>devices<br>preconditioned |
| Hand-held Tool<br>Drop/Shock<br>Preconditioning | Only the SJM BHC was tested to confirm actuation of<br>temporary restraint (with the insert) when using the<br>handheld tool.<br><br>The NeuroPace BHC not tested because it doesn't<br>have handheld tool. | All SJM<br>devices passed |
| Insert Lead<br>Restraint Testing | Only the SJM BHC was tested to confirm that the lead<br>can be temporarily restrained by the insert.<br><br>The NeuroPace BHC was not tested because it doesn't<br>have an insert or temporary restraint mechanism. | All SJM<br>devices passed |
| Insert Rotation<br>Testing | Only SJM BHC was tested to confirm that the insert<br>does not rotate during temporary restraint.<br><br>The NeuroPace BHC was not tested because device<br>doesn't have an insert or temporary restraint<br>mechanism. | All SJM<br>devices passed |
| Stylet/Guide<br>Tube Removal | Only the SJM lead was tested to confirm the ability to<br>remove a stylet, cannula, or guide tube when the insert<br>(temporary restraint mechanism) is engaged.<br><br>The NeuroPace leads were not tested because device<br>doesn't have an insert or temporary restraint<br>mechanism. | All SJM<br>devices passed |
| Insert Multiple<br>Actuation Testing | Only the SJM BHC was tested to confirm that the<br>insert (temporary restraint mechanism) can be<br>actuated multiple times.<br><br>The NeuroPace BHC was not tested because it doesn't<br>have an insert or temporary restraint mechanism. | All SJM<br>devices passed |
| Cover Restraint<br>Testing (after<br>Worst Case<br>Vibration) | Both SJM and NeuroPace BHC were tested after<br>worst case vibration levels since they both have<br>permanent restraint mechanisms (i.e. a cover). | All SJM and<br>NeuroPace<br>devices<br>passed,<br>confirming<br>substantial<br>equivalence of<br>the devices |
| Lead Electrical<br>and Mechanical<br>Damage | Only SJM lead was tested to confirm there would be<br>no damage. The NeuroPace lead performance was not<br>evaluated. | All SJM<br>devices passed |
| Vibration Testing | Only SJM BHC was tested to confirm performance at<br>a pre-specified vibration level (separate from worst-<br>case testing). | All SJM<br>devices passed |

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| | | The NeuroPace BHC was only tested at the worst-case<br>vibration levels. | |
|--|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Cover Shear<br>Testing | Only the SJM BHC was tested to confirm<br>performance during an application of shear force.<br>The NeuroPace BHC was not tested because the<br>system does not have a cover that can be subjected to<br>shear forces. | All SJM<br>devices passed |
| | Insert/Base<br>Interaction<br>Testing | Only the SJM BHC was tested to confirm the<br>temporary restraint mechanism (the insert) is resistant<br>to removal once engaged.<br>The NeuroPace BHC was not tested because it doesn't<br>have an insert. | All SJM<br>devices passed |
| | Affixation Check<br>after Worst Case<br>Vibration | Both SJM and NeuroPace BHC were tested to confirm<br>the ability to permanently remain fixated to the<br>mounting surface after worst case vibration levels. | All SJM and<br>NeuroPace<br>devices<br>passed,<br>confirming<br>substantial<br>equivalence of<br>the devices |
| | Biocompatibility<br>Cytotoxicity | Only the SJM BHC system was assessed for potential<br>cytotoxic effects, based on using an in vitro<br>mammalian cell culture test. The study was conducted<br>following the guidelines of ISO 10993-5.<br>The NeuroPace device was not tested.<br>The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required. | The SJM BHC<br>system<br>demonstrated<br>compliance to<br>ISO 10993-5 |
| | Biocompatibility<br>Intracutaneous<br>Reactivity | Only the SJM BHC system was assessed for the<br>potential to cause irritation, based on intracutaneous<br>injection in rabbits. This study was conducted based<br>on ISO 10993-10.<br>The NeuroPace device was not tested.<br>The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required. | The SJM BHC<br>system<br>demonstrated<br>compliance to<br>ISO 10993-10 |
| | Biocompatibility<br>Sensitization | Only the SJM BHC system was assessed for the<br>potential to cause delayed contact dermal<br>sensitization, based on the guinea pig maximization<br>test. This study was conducted based on ISO 10993-<br>10.<br>The NeuroPace device was not tested. | The SJM BHC<br>system<br>demonstrated<br>compliance to<br>ISO 10993-10 |

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| | Biocompatibility<br>Acute Systemic<br>Toxicity | The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required.<br>Only the SJM BHC system was assessed for the<br>potential to cause acute systemic toxicity, based on the<br>mouse injection test. This study was conducted based<br>on ISO 10993-11.<br>The NeuroPace device was not tested. | The SJM BHC<br>system<br>demonstrated<br>compliance to<br>ISO 10993-11 |
|--|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Biocompatibility<br>Pyrogenicity | The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required.<br>Only the SJM BHC system was assessed for the<br>potential to cause a pyrogenic response, based on the<br>materials mediated rabbit pyrogen test. This study was<br>conducted based on ISO 10993-11.<br>The NeuroPace device was not tested. | The SJM<br>BHC system<br>demonstrated<br>compliance<br>to ISO<br>10993-11 |
| | Biocompatibility<br>Particulate | The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required.<br>Only the SJM BHC system was assessed for the<br>particulate load, based on the light obscuration<br>method. This study was conducted based on ISO<br>14708-3.particulate load.<br>The NeuroPace device was not tested. | The SJM<br>BHC system<br>demonstrated<br>compliance<br>to ISO<br>14708-3 |
| | Biocompatibility<br>Chemical<br>Characterization | The SJM BHC and the predicate device are classified<br>in the same device category based on body contact<br>and contact duration and were also assessed for<br>compliance to the same ISO standard; therefore<br>evaluation of the NeuroPace predicate is not required.<br>Only the SJM BHC system was assessed for chemical<br>characterization per ISO 10993-18 to demonstrate that<br>the leachables are toxicologically acceptable per ISO<br>10993-17.<br>The NeuroPace device was not tested. | The SJM<br>BHC system<br>demonstrated<br>compliance<br>to ISO<br>10993-18 and<br>ISO 10993-<br>17 |

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| | Sterilization and<br>Sterility | The SJM and Neuropace BHC are sterilized as per<br>ISO 11135:2007 (Sterilization of health care products<br>- Ethylene oxide - Part 1: Requirements for the<br>development, validation and routine control of a<br>sterilization process for medical devices) and the EO<br>residuals were evaluated as per ISO 10993-7:2008<br>(Biological evaluation of medical devices, Part 7:<br>Ethylene oxide sterilization residuals).<br><br>Since, both these devices have proved compliance to<br>these standards, further evaluation of the NeuroPace<br>BHC was not deemed necessary. | All SJM<br>devices<br>passed,<br>demonstrating<br>compliance to<br>the same ISO<br>standard and<br>confirming<br>substantial<br>equivalence of<br>the devices |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of<br>Equivalence | The GuardianTM Burr Hole Cover System has the same indications for use and<br>technological characteristics as the predicate device. Based on this and the data<br>provided in this pre-market notification, the subject device and predicate device has<br>been shown to be substantially equivalent. | | |