(56 days)
Not Found
No
The description focuses on the mechanical function of a burr hole cover and lead securing system, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is used to cover a burr hole and secure a lead after cranial surgery; it does not treat a condition.
No
The device is a burr hole cover system intended for use after cranial surgery to cover burr holes and secure leads, which are treatment-oriented functions rather than diagnostic ones.
No
The device description clearly outlines physical components (base, clip, cover) intended for implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation to cover a burr hole in the skull and potentially secure a lead. This is a surgical device used in vivo (within the body).
- Device Description: The description details a physical implantable system (base, clip, cover) for closing a burr hole and securing a lead. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
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
Product codes
GXR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing following the FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that the GuardianTM Burr Hole Cover System is “MR Conditional”.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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);
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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
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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) |
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510(k) Summary
| 510(k) Summary | |
|---|---|
| 510(k) Number | K181382 |
| Submitter Information: | |
| Date Prepared: | May 23, 2018 |
| Submitter Name & | |
| Address: | St. Jude Medical |
| 6901 Preston Road | |
| Plano, TX 75024 | |
| USA | |
| Contact Person: | Rebecca Brunson |
| Regulatory Affairs Specialist | |
| Phone (972) 526-4658 | |
| Fax (855) 902-0767 | |
| Becky.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 to |
| obtain clearance for the modification to the device labeling for | |
| the Guardian Burr Hole Cover System to include the “MR | |
| Conditional” statement in accordance with the FDA Guidance, | |
| “Establishing Safety and Compatibility of Passive Implants in | |
| the Magnetic Resonance (MR) Environment”. | |
| Device Description: | 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. | |
| Intended Use: | |
| (Indications for Use) | 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 | |
| Summary on Non- | |
| Clinical Testing | Non-clinical testing following the FDA Guidance, |
| "Establishing Safety and Compatibility of Passive Implants in | |
| the Magnetic Resonance (MR) Environment", demonstrated | |
| that the GuardianTM Burr Hole Cover System is “MR | |
| Conditional”. | |
| Statement of Equivalence | The GuardianTM Burr Hole Cover System is substantially |
| equivalent to the predicate device in which the basic design | |
| features and intended uses are the same. The difference, the | |
| MR Conditional labeling, is supported by performance data. | |
| Based on the indications for use, technological characteristics, | |
| and the summary of data submitted, St. Jude Medical has | |
| determined that the proposed device is substantially equivalent | |
| to the currently marketed predicate device. |
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