(49 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical implant, with no mention of software, data processing, or AI/ML terms.
No
The device is described as a permanent implant that covers a bur hole and can support a lead, but it does not treat or cure a disease or condition. Its function is structural and supportive.
No
The device is a permanent implant designed to cover a bur hole in the cranium and support a lead, not to diagnose medical conditions.
No
The device description explicitly states, "The Burr Hole Cover does not include any software".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The NeuroPace® Burr Hole Cover is a physical implant designed to cover a surgical opening in the skull and support a lead. It is used within the body (in vivo) and does not perform any diagnostic tests on biological samples.
The description clearly outlines its function as a surgical implant and its purpose in supporting a lead, which are not activities associated with in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
GXR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Permanent implant in cranium (skull)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital / Healthcare Facility
Neurosurgeon
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)
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.
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).
0
| Category | Comments |
|---|---|
| Date Summary Prepared: | May 22, 2014 |
| Applicant: | NeuroPace Inc. |
| 455 N. Bernardo Avenue | |
| Mountain View, CA 94043 | |
| USA | |
| Tel: 650-237-2700 | |
| FAX: 815-352-0788 | |
| www.neuropace.com | |
| Applicant's Contact Information: | Isabella R. Abati |
| VP, Regulatory Affairs | |
| Device Trade/ Proprietary Name: | NeuroPace® Burr Hole Cover |
| model 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 Cover |
| model 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 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. | Same |
| Device Classification Name
and 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 and
Principal Operator | Hospital / Healthcare Facility
Neurosurgeon | Same |
| Target Population / principles
of operation | To be used following cranial surgery
in patients to cover a hole drilled into
the cranium and to support a lead
(electrode) | Same |
| Anatomical Site | Permanent implant in cranium (skull) | Same |
| Biocompatible? | Yes | Same |
| Method of Fixation to
Cranium | 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 double
Tyvek 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
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