(295 days)
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.
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.
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.
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.
The provided text is a 510(k) summary for the Guardian™ Burr Hole Cover System, which is a medical device. This document details non-clinical bench testing and biocompatibility testing to establish substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets the acceptance criteria in the context of AI, multi-reader, or standalone algorithm performance.
However, I can extract the acceptance criteria and results for the non-clinical performance and biocompatibility testing of the Guardian™ Burr Hole Cover System.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing & Biocompatibility)
The document primarily focuses on verifying the device meets "pre-determined acceptance criteria" through a series of non-clinical tests. The "Testing Scope and Rationale" column often implies the acceptance criteria (e.g., "confirm actuation," "confirm does not rotate," "confirm no damage," "confirm ability to permanently remain fixated," "demonstrated compliance to ISO standards"). The "Results" column indicates whether these criteria were met.
| Acceptance Criteria (Implied from "Testing Scope and Rationale") | Reported Device Performance |
|---|---|
| Bench Testing | |
| Preconditioning prior to subsequent preclinical testing. | All SJM devices preconditioned. |
| Confirm actuation of temporary restraint (with the insert) when using the handheld tool. | All SJM devices passed. |
| Confirm that the lead can be temporarily restrained by the insert. | All SJM devices passed. |
| Confirm that the insert does not rotate during temporary restraint. | All SJM devices passed. |
| Confirm the ability to remove a stylet, cannula, or guide tube when the insert is engaged. | All SJM devices passed. |
| Confirm that the insert (temporary restraint mechanism) can be actuated multiple times. | All SJM devices passed. |
| Confirm permanent restraint mechanism (cover) functions after worst-case vibration levels. | All SJM and NeuroPace devices passed. |
| Confirm no damage to lead electrical and mechanical components. | All SJM devices passed. |
| Confirm performance at a pre-specified vibration level. | All SJM devices passed. |
| Confirm performance during an application of shear force. | All SJM devices passed. |
| Confirm the temporary restraint mechanism (the insert) is resistant to removal once engaged. | All SJM devices passed. |
| Confirm the ability to permanently remain fixated to the mounting surface after worst-case vibration levels. | All SJM and NeuroPace devices passed. |
| Biocompatibility Testing | |
| Assess for potential cytotoxic effects (following ISO 10993-5). | The SJM BHC system demonstrated compliance to ISO 10993-5. |
| Assess for the potential to cause irritation (following ISO 10993-10). | The SJM BHC system demonstrated compliance to ISO 10993-10. |
| Assess for the potential to cause delayed contact dermal sensitization (following ISO 10993-10). | The SJM BHC system demonstrated compliance to ISO 10993-10. |
| Assess for the potential to cause acute systemic toxicity (following ISO 10993-11). | The SJM BHC system demonstrated compliance to ISO 10993-11. |
| Assess for the potential to cause a pyrogenic response (following ISO 10993-11). | The SJM BHC system demonstrated compliance to ISO 10993-11. |
| Assess for particulate load (following ISO 14708-3). | The SJM BHC system demonstrated compliance to ISO 14708-3. |
| Assess chemical characterization to demonstrate leachables are toxicologically acceptable (following ISO 10993-18 and ISO 10993-17). | The SJM BHC system demonstrated compliance to ISO 10993-18 and ISO 10993-17. |
| Sterilization and EO residuals evaluated (following ISO 11135:2007 and ISO 10993-7:2008). | All SJM devices passed, demonstrating compliance. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document repeatedly uses the phrase "All SJM devices passed" or "All SJM and NeuroPace devices passed" for the performance bench tests. Biocompatibility tests also refer to "the SJM BHC system" being assessed. However, specific numerical sample sizes for each test are not provided in this document.
- Data Provenance: The nature of these tests (bench testing, in vitro, and in vivo animal biocompatibility studies) indicates the data provenance is from laboratory and animal studies, not human clinical data. There is no information regarding country of origin, or whether it's retrospective or prospective in the sense of human subject studies. These are pre-market device tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this document. The tests described are objective, non-clinical performance and biocompatibility assessments, not studies requiring expert interpretation of results or ground truth establishment in the context of diagnoses or clinical assessments. Compliance with established ASTM, ISO, or internal St. Jude Medical test protocols would be the "ground truth."
4. Adjudication Method for the Test Set
- This information is not applicable to this document, as the tests are objective mechanical and biological assessments, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable to this document. The device is a physical medical implant (burr hole cover system), not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this information is not applicable to this document. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- For Performance Bench Testing: The "ground truth" is defined by the pre-determined acceptance criteria and established engineering/physical principles applied in the test protocols (e.g., proper actuation, no rotation, no damage, consistent fixation, etc.).
- For Biocompatibility Testing: The "ground truth" is defined by compliance with internationally recognized standards, specifically referenced ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 14708-3, ISO 10993-18, ISO 10993-17, ISO 11135:2007, ISO 10993-7:2008).
8. The Sample Size for the Training Set
- This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. Since there is no training set, there is no ground truth to be established for it.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
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 (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 -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)
| 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 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 |
| Submitter Information: | |
| Date Prepared: | August 17, 2015 |
| SubmitterName &Address: | St. Jude Medical6901 Preston RoadPlanoTX 75024 USA |
| Contact Person: | Manasi KhareSenior Regulatory Affairs SpecialistPhone (818) 493-2085MKhare@sjm.com |
| Device Information: | |
| 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.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.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:(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 toPredicateDevices | The Guardian™ Burr Hole Cover System has substantially equivalent intended use andfundamental scientific technology as the predicate device. The technologicalcharacteristics of the Guardian™ Burr Hole Cover System are substantially equivalentto the predicate device. | ||
|---|---|---|---|
| The design comparison between the Guardian™ Burr Hole Cover System and thepredicate device indicate dimensional differences in the burr hole and leadcompatibility that does not affect the device intended use of covering a hole in thecranium, as confirmed by the pre-clinical testing. The minor dimensional designdifference between the Guardian™ Burr Hole Cover System and the predicate deviceis not imperative to establish the performance equivalence between the two systems. | |||
| The Guardian™ Burr Hole Cover System includes an ancillary clip which can be usedfor temporary restraint of the lead. The predicate device cover allows for bothtemporary and permanent restraint of the lead, so this does not introduce new issues ofsafety and effectiveness. | |||
| Both use Polyaryletheretherketone (PEEK) as the main material for the Burr HoleCover. All the other additional materials do not affect the substantial equivalence andintended use of the device due to contact type or duration. Both the devices are singleuse and are sterilized using Ethylene oxide (EO). | |||
| A table has been added to capture the comparison between the Guardian™ Burr HoleCover System and the predicate device: | |||
| Attribute | NeuroPace, Inc. Burr Hole Cover(K123163 and K141368) | Guardian™ Burr Hole Cover System(this application) | |
| Indications forUse | Intended to cover a 14 mm burr holefollowing cranial surgery. Secondarily,the NeuroPace Burr Hole Cover can beused to support 1.3 mm indwellingleads. | Intended for use during cranial surgery asan implantable 14 mm burr hole cover forthe skull. It can also be used to secure alead with a 1.29 mm (0.051 in) or 1.39 mm(0.055 in) diameter. | |
| AnatomicalSite | Permanent implant in cranium (skull) | ||
| Burr HoleCompatibility | As produced by a 14 mm cranial burr. | As produced by a 14 mm cranial burr. | |
| LeadCompatibility | Minimum depth 2.7 mm$1.3 mm diameter \pm 0.05 mm$ | Minimum depth 3.7 mm1.39 mm leads and 1.29 mm leads only | |
| MainComponents | Base, bone screws and cap | Base, clip, cover, and screws | |
| Sterility | Sterile, single use | ||
| Sterilizationmethod | Ethylene oxide (EO) | ||
| Labeled asnon-pyrogenic | Yes | ||
| Materials ofConstruction | Polyaryletheretherketone (PEEK) andsilicone | Polyaryletheretherketone (PEEK);MP35N(Springs in insert), and titanium alloy (pinsin insert); polycarbonate, silicone | |
| Biocompatible | Yes | Yes | |
| Shelf Life | 1 year | 2 years | |
| Based on the information in this premarket notification, the subject device has beenshown substantially equivalent to the predicate device. |
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| Summary onNon-ClinicalTesting for theGuardian ™Burr HoleCover System | Performance bench testing and biocompatibility testing were performed to verify thedevice met the pre-determined acceptance criteria and to confirm substantialequivalence. The following performance bench tests were performed: | |
|---|---|---|
| Test | Testing Scope and Rationale | Results |
| PreconditioningandAcceleratedAging | The SJM Burr Hole Cover (BHC) was preconditionedprior to subsequent pre-clinical testing.The NeuroPace Burr Hole Cover (BHC) was notpreconditioned because final finished sterilizedproduct was obtained from manufacturer and tested. | All SJMdevicespreconditioned |
| Hand-held ToolDrop/ShockPreconditioning | Only the SJM BHC was tested to confirm actuation oftemporary restraint (with the insert) when using thehandheld tool.The NeuroPace BHC not tested because it doesn'thave handheld tool. | All SJMdevices passed |
| Insert LeadRestraint Testing | Only the SJM BHC was tested to confirm that the leadcan be temporarily restrained by the insert.The NeuroPace BHC was not tested because it doesn'thave an insert or temporary restraint mechanism. | All SJMdevices passed |
| Insert RotationTesting | Only SJM BHC was tested to confirm that the insertdoes not rotate during temporary restraint.The NeuroPace BHC was not tested because devicedoesn't have an insert or temporary restraintmechanism. | All SJMdevices passed |
| Stylet/GuideTube Removal | Only the SJM lead was tested to confirm the ability toremove a stylet, cannula, or guide tube when the insert(temporary restraint mechanism) is engaged.The NeuroPace leads were not tested because devicedoesn't have an insert or temporary restraintmechanism. | All SJMdevices passed |
| Insert MultipleActuation Testing | Only the SJM BHC was tested to confirm that theinsert (temporary restraint mechanism) can beactuated multiple times.The NeuroPace BHC was not tested because it doesn'thave an insert or temporary restraint mechanism. | All SJMdevices passed |
| Cover RestraintTesting (afterWorst CaseVibration) | Both SJM and NeuroPace BHC were tested afterworst case vibration levels since they both havepermanent restraint mechanisms (i.e. a cover). | All SJM andNeuroPacedevicespassed,confirmingsubstantialequivalence ofthe devices |
| Lead Electricaland MechanicalDamage | Only SJM lead was tested to confirm there would beno damage. The NeuroPace lead performance was notevaluated. | All SJMdevices passed |
| Vibration Testing | Only SJM BHC was tested to confirm performance ata pre-specified vibration level (separate from worst-case testing). | All SJMdevices passed |
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| The NeuroPace BHC was only tested at the worst-casevibration levels. | |||
|---|---|---|---|
| Cover ShearTesting | Only the SJM BHC was tested to confirmperformance during an application of shear force.The NeuroPace BHC was not tested because thesystem does not have a cover that can be subjected toshear forces. | All SJMdevices passed | |
| Insert/BaseInteractionTesting | Only the SJM BHC was tested to confirm thetemporary restraint mechanism (the insert) is resistantto removal once engaged.The NeuroPace BHC was not tested because it doesn'thave an insert. | All SJMdevices passed | |
| Affixation Checkafter Worst CaseVibration | Both SJM and NeuroPace BHC were tested to confirmthe ability to permanently remain fixated to themounting surface after worst case vibration levels. | All SJM andNeuroPacedevicespassed,confirmingsubstantialequivalence ofthe devices | |
| BiocompatibilityCytotoxicity | Only the SJM BHC system was assessed for potentialcytotoxic effects, based on using an in vitromammalian cell culture test. The study was conductedfollowing the guidelines of ISO 10993-5.The NeuroPace device was not tested.The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required. | The SJM BHCsystemdemonstratedcompliance toISO 10993-5 | |
| BiocompatibilityIntracutaneousReactivity | Only the SJM BHC system was assessed for thepotential to cause irritation, based on intracutaneousinjection in rabbits. This study was conducted basedon ISO 10993-10.The NeuroPace device was not tested.The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required. | The SJM BHCsystemdemonstratedcompliance toISO 10993-10 | |
| BiocompatibilitySensitization | Only the SJM BHC system was assessed for thepotential to cause delayed contact dermalsensitization, based on the guinea pig maximizationtest. This study was conducted based on ISO 10993-10.The NeuroPace device was not tested. | The SJM BHCsystemdemonstratedcompliance toISO 10993-10 |
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| BiocompatibilityAcute SystemicToxicity | The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required.Only the SJM BHC system was assessed for thepotential to cause acute systemic toxicity, based on themouse injection test. This study was conducted basedon ISO 10993-11.The NeuroPace device was not tested. | The SJM BHCsystemdemonstratedcompliance toISO 10993-11 | |
|---|---|---|---|
| BiocompatibilityPyrogenicity | The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required.Only the SJM BHC system was assessed for thepotential to cause a pyrogenic response, based on thematerials mediated rabbit pyrogen test. This study wasconducted based on ISO 10993-11.The NeuroPace device was not tested. | The SJMBHC systemdemonstratedcomplianceto ISO10993-11 | |
| BiocompatibilityParticulate | The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required.Only the SJM BHC system was assessed for theparticulate load, based on the light obscurationmethod. This study was conducted based on ISO14708-3.particulate load.The NeuroPace device was not tested. | The SJMBHC systemdemonstratedcomplianceto ISO14708-3 | |
| BiocompatibilityChemicalCharacterization | The SJM BHC and the predicate device are classifiedin the same device category based on body contactand contact duration and were also assessed forcompliance to the same ISO standard; thereforeevaluation of the NeuroPace predicate is not required.Only the SJM BHC system was assessed for chemicalcharacterization per ISO 10993-18 to demonstrate thatthe leachables are toxicologically acceptable per ISO10993-17.The NeuroPace device was not tested. | The SJMBHC systemdemonstratedcomplianceto ISO10993-18 andISO 10993-17 |
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| Sterilization andSterility | The SJM and Neuropace BHC are sterilized as perISO 11135:2007 (Sterilization of health care products- Ethylene oxide - Part 1: Requirements for thedevelopment, validation and routine control of asterilization process for medical devices) and the EOresiduals were evaluated as per ISO 10993-7:2008(Biological evaluation of medical devices, Part 7:Ethylene oxide sterilization residuals).Since, both these devices have proved compliance tothese standards, further evaluation of the NeuroPaceBHC was not deemed necessary. | All SJMdevicespassed,demonstratingcompliance tothe same ISOstandard andconfirmingsubstantialequivalence ofthe devices | |
|---|---|---|---|
| Statement ofEquivalence | The GuardianTM Burr Hole Cover System has the same indications for use andtechnological characteristics as the predicate device. Based on this and the dataprovided in this pre-market notification, the subject device and predicate device hasbeen shown to be substantially equivalent. |
§ 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).