(49 days)
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm bur hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling Jead.
The NeuroPace® Burr Hole Cover (model 8110) includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm). The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic. The NeuroPace® Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant. The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The base is made from a synthetic polymer and the cap is made from silicone. The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO). The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.
The provided document, K141368, is a 510(k) premarket notification for the NeuroPace® Burr Hole Cover, Model 8110. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data or detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the information regarding acceptance criteria, specific study design elements (like sample sizes, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), is not explicitly present in this summary document. The document primarily relies on non-clinical testing and comparison to the predicate device to establish substantial equivalence.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is not available:
Acceptance Criteria and Device Performance
The document doesn't explicitly list numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/software device evaluation. Instead, it states that the modified device was subjected to various non-clinical tests to demonstrate functional equivalence and safety.
| Category of Testing | Reported Device Performance/Conclusion |
|---|---|
| Dimensional / Geometry | Successfully performed, indicating the device meets its design specifications. |
| Functionality at Operation | Successfully performed, indicating the device functions as intended during use. |
| Lead Compatibility | Successfully performed, confirming compatibility with the 1.3 mm indwelling lead. |
| Lead Movement | Successfully performed, indicating appropriate control or restriction of lead movement. |
| Retention | Successfully performed, indicating the device maintains its position. |
| Cranial Rigidity | Successfully performed, indicating the device provides adequate structural support to the cranium. |
| Biocompatibility | Materials are biocompatible and are the same as used in the predicate device. |
| Sterility | Evaluations confirmed non-pyrogenicity and product sterility, and that bioburden and residual levels demonstrated compliance with recognized performance standards. (Sterile (SAL 1 x 10^-6)). |
| MR/CT Compatibility | Yes. |
| Shelf Life | 1 year. |
| Substantial Equivalence | The modified NeuroPace® Burr Hole Cover is substantially equivalent to the legally marketed predicate NeuroPace® Burr Hole Cover (K123163). No new issues of safety or effectiveness are raised. |
Study Details (Not Applicable/Available for this submission type)
Since this is a 510(k) submission for a physical medical device (burr hole cover) and not a software or AI/ML-based device, most of the requested details related to performance evaluation against ground truth, expert consensus, and sample sizes for diagnostic accuracy are not applicable or not provided in this type of regulatory document. The focus is on non-clinical testing demonstrating physical and material properties, and functionality consistent with its intended use and predicate device.
- Sample size used for the test set and the data provenance: Not applicable in the context of a diagnostic dataset. The "test set" here refers to physical devices undergoing engineering and material testing. No specific sample sizes for these tests are detailed in this summary, nor is data provenance in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/ML diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be established engineering specifications and material properties, against which the physical device is tested.
- The sample size for the training set: Not applicable, as no algorithm is being "trained."
- How the ground truth for the training set was established: Not applicable.
In summary, the K141368 document demonstrates substantial equivalence through non-clinical testing of the physical, material, and functional characteristics of the NeuroPace® Burr Hole Cover, Model 8110, compared to its predicate device. It does not involve AI/ML components, clinical studies for diagnostic accuracy, or associated performance metrics and ground truth evaluations often seen in software as a medical device (SaMD) submissions.
{0}------------------------------------------------
| Category | Comments |
|---|---|
| Date Summary Prepared: | May 22, 2014 |
| Applicant: | NeuroPace Inc.455 N. Bernardo AvenueMountain View, CA 94043USATel: 650-237-2700FAX: 815-352-0788www.neuropace.com |
| Applicant's Contact Information: | Isabella R. AbatiVP, Regulatory Affairs |
| Device Trade/ Proprietary Name: | NeuroPace® Burr Hole Covermodel 8110 |
| Device Common Name: | Cover, Burr Hole |
| Device Classification: | II |
| Device Classification Name: | Burr Hole Cover (21 CFR 882.5250,Product Code GXR) |
JUL 1-1-2014 Premarket Notification [510(k)] Summary
Substantial Equivalence Device Information
| Predicate Device(s): | NeuroPace® Burr Hole Cover |
|---|---|
| 510(k) Number: | K123163 |
| Device Trade/ Proprietary Name: | NeuroPace® Burr Hole Covermodel 8110 |
| Predicate Device Common Name: | Cover, Burr Hole |
| Device Classification: | II |
| Predicate Device Classification Name & Citation: | Burr Hole Cover (21 CFR 882.5250, Product Code GXR) |
510(k) Summary - Predicate Device Information
Description of the Device
The NeuroPace® Burr Hole Cover (model 8110) (also referred to as "the predicate device") includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm).
The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic.
{1}------------------------------------------------
Device Characteristics
The NeuroPace® Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant.
The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The base is made from a synthetic polymer and the cap is made from silicone.
The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO).
The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.
Indications for Use / Intended Uses
The intended use of the NeuroPace® Burr Hole Cover, as described in its labeling, has not changed as a result of the modifications to the device.
The indication for use/ intended uses are as follows:
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm burr hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling lead.
Summary of Technological Characteristics
The modified Burr Hole Cover (subject device) is substantially equivalent to NeuroPace's Burr Hole Cover (predicate device, FDA 510(k) K123163). Modifications were made to the predicate device to both the cap assembly and the base (or retainer) of the cleared Burr Hole Cover. The modifications do not affect the intended use and do not constitute a significant change compared to the predicate device in terms of the design, the materials. the fundamental scientific technology, the target population, or the anatomical site.
A side-by-side comparison of the modified device and the predicate device is provided in the following table.
| Description | Modified Device:NeuroPace® Burr Hole Cover | Predicate Device:NeuroPace® Burr Hole Cover(K123163) |
|---|---|---|
| Intended Use | For use following cranial surgery tocover a 14 mm burr hole.Secondarily, the NeuroPace® BurrHole Cover also can be used tosupport a 1.3 mm indwelling lead. | Same |
| Device Classification Nameand Product Code | Burr Hole Cover (21 CFR 882.5250,Product Code GXR) | Same |
| Materials | Synthetic Polymer and Silicone | Same |
510(k) Summary - Device Comparison
{2}------------------------------------------------
| Description | Modified Device:NeuroPace® Burr Hole Cover | Predicate Device:NeuroPace® Burr Hole Cover(K123163) |
|---|---|---|
| Environment of Use andPrincipal Operator | Hospital / Healthcare FacilityNeurosurgeon | Same |
| Target Population / principlesof operation | To be used following cranial surgeryin patients to cover a hole drilled intothe cranium and to support a lead(electrode) | Same |
| Anatomical Site | Permanent implant in cranium (skull) | Same |
| Biocompatible? | Yes | Same |
| Method of Fixation toCranium | Titanium Screws | Same |
| Lead (Electrode) Support? | Yes | Same |
| MR/CT Compatible? | Yes | Same |
| Method of Sterilization | EtO (Ethylene Oxide) | Same |
| Packaging materials | Device packaged within doubleTyvek pouch | Same |
| How Supplied? | Sterile (SAL 1 x 10-6) | Same |
| Labeled as non-pyrogenic? | Yes | Same |
| Single Use? | Yes | Same |
| Shelf Life | 1 year | Same |
510(k) Summary - Device Comparison
Summary of Supporting Data
The results of testing conducted on the modified Burr Hole Cover demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following evaluations were successfully performed on the proposed device such as: dimensional / geometry, functionality at operature, lead compatibility, lead movement, retention and cranial rigidity. Materials used in the modified device are biocompatible and are the same as used in the predicate device. Sterility evaluations were performed on the modified device confirming non-pyrogenicity and product sterility, and that bioburden and residual levels demonstrated compliance with recognized performance standards. The modified Burr Hole Cover does not require clinical or animal testing to support substantial equivalence. The clearance of the predicate device also did not require these types of testing.
Conclusions
The modified NeuroPace® Burr Hole Cover is substantially equivalent to the legally marketed predicate NeuroPace® Burr Hole Cover (as shown in 510(k) Summary - Device Comparison). The successful completion of performance evaluations further supports that the modified device is substantially equivalent to the predicate device (K123163). No new issues of safety or effectiveness are raised by the modifications made to the predicate device.
{3}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
NeuroPace, Inc. Ms. Isabella R. Abati Vice President, Regulatory Affairs 455 N. Bernardo Avenue Mountain View, CA 94043
Re: K141368
Trade/Device Name: NeuroPace® Burr Hole Cover, Model 8110 Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: June 9, 2014 Received: June 11, 2014
Dear Ms. Abati:
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
{4}------------------------------------------------
Page 2 - Ms. Isabella R. Abati
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
hun://www.fda.gov/MedicalDevices/Safetw/ReportalProblem/default.hum 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/Resourcesfor You/Industry/default.htm.
Sincercly yours.
Carlos L. Pëña -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
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510/k) Number (if known) K141368
Device Name
NeuroPace® Burr Hole Cover, Model 8110
Indications for Use (Describe)
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm bur hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling Jead.
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)
. |
·
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
. .
Carlos L. Pena -S
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."
§ 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).