(56 days)
The GuardianTM burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) 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 is used to close a cranial burr hole and secure an implanted, compatible lead, when applicable. The burr hole cover system is nonpyrogenic and has three main features: base, clip, and cover. The base is intended for burr holes with a 14-mm (0.55-in) diameter. It contains two grooved slots to hold a lead in place. The clip fits into the base to hold the lead. The locking mechanism temporarily holds a lead in place before the burr hole cover is secured. The cover snaps onto the base, closing the burr hole and locking a lead in place.
The document describes a 510(k) premarket notification for a modification to the Guardian™ Burr Hole Cover System to include an "MR Conditional" statement in the labeling. The acceptance criteria and the study that proves the device meets them are related to this MR Conditional status.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to MR Conditional Status) | Reported Device Performance (Guardian™ Burr Hole Cover System) |
|---|---|
| Device establishes "MR Conditional" status (as per FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment") | Demonstrated to be "MR Conditional" |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a "test set" in the context of medical imaging or diagnostic device performance evaluation. Instead, the testing was for the "MR Conditional" status. This typically involves physical testing of the device itself according to specific MR safety standards. Therefore, the "sample size" would refer to the number of physical devices tested to assess their behavior in an MR environment. The document does not specify the exact number of units tested.
- Data Provenance: The testing was conducted "following the FDA Guidance, 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment'." This implies a laboratory or testing facility setting, rather than clinical patient data. The country of origin of the data is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not directly applicable to this type of submission. Establishing "MR Conditional" status for a passive implant primarily involves engineering and physics expertise for conducting MR safety tests and interpreting their results according to established international standards (e.g., ASTM F2052, F2119, F2182). It does not typically involve a panel of medical experts establishing "ground truth" on patient images or outcomes. The "ground truth" in this context is the objective measurement of MR-related effects (e.g., heating, artifact, force).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. MR safety testing data is typically objective and quantitative, and does not require adjudication by medical experts in the way clinical diagnostic study results might.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a burr hole cover system (a passive implant), not a diagnostic imaging AI algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's inherent physical properties and behavior in an MR environment.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for determining MR Conditional status is based on objective, quantifiable measurements from MR safety testing protocols defined in recognized standards (e.g., SAR measurements, temperature rise, displacement force, torque, image artifact assessment). This is not derived from expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
July 20, 2018
St Jude Medical Rebecca Brunson Regulatory Affairs Specialist 6901 Preston Road Plano, Texas 75024
Re: K181382
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 23, 2018 Received: May 25, 2018
Dear Ms. Brunson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K181382
Device Name Guardian Burr Hole Cover System
Indications for Use (Describe)
The Guardian burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.5-in) 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 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| 510(k) Summary | |
|---|---|
| 510(k) Number | K181382 |
| Submitter Information: | |
| Date Prepared: | May 23, 2018 |
| Submitter Name &Address: | St. Jude Medical6901 Preston RoadPlano, TX 75024USA |
| Contact Person: | Rebecca BrunsonRegulatory Affairs SpecialistPhone (972) 526-4658Fax (855) 902-0767Becky.Brunson@abbott.com |
| Device Information: | |
| Name of Device | GuardianTM Burr Hole Cover System |
| Common Name: | Cover, Burr Hole |
| Regulatory Class | II |
| Classification Name: | 882.5250 Burr Hole Cover |
| Predicate Device: | K152342: GuardianTM Burr Hole Cover System |
| Purpose of Submission | This Abbreviated 510(k) premarket notification is submitted toobtain clearance for the modification to the device labeling forthe Guardian Burr Hole Cover System to include the “MRConditional” statement in accordance with the FDA Guidance,“Establishing Safety and Compatibility of Passive Implants inthe Magnetic Resonance (MR) Environment”. |
| Device Description: | The GuardianTM burr hole cover system is used to close acranial burr hole and secure an implanted, compatible lead,when applicable. The burr hole cover system is nonpyrogenicand has three main features: base, clip, and cover. The base isintended for burr holes with a 14-mm (0.55-in) diameter. Itcontains two grooved slots to hold a lead in place. The clip fitsinto the base to hold the lead. The locking mechanismtemporarily holds a lead in place before the burr hole cover issecured. The cover snaps onto the base, closing the burr holeand locking a lead in place. |
| Intended Use:(Indications for Use) | The GuardianTM burr hole cover system is intended for usefollowing cranial surgery as an implantable 14-mm (0.55-in)burr hole cover for the 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 |
| Summary on Non-Clinical Testing | Non-clinical testing following the FDA Guidance,"Establishing Safety and Compatibility of Passive Implants inthe Magnetic Resonance (MR) Environment", demonstratedthat the GuardianTM Burr Hole Cover System is “MRConditional”. |
| Statement of Equivalence | The GuardianTM Burr Hole Cover System is substantiallyequivalent to the predicate device in which the basic designfeatures and intended uses are the same. The difference, theMR Conditional labeling, is supported by performance data.Based on the indications for use, technological characteristics,and the summary of data submitted, St. Jude Medical hasdetermined that the proposed device is substantially equivalentto the currently marketed predicate device. |
{4}------------------------------------------------
§ 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).