(295 days)
Not Found
No
The device description and performance studies focus on mechanical and biocompatibility testing of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is a burr hole cover for the skull and can secure a lead. It acts as a physical barrier to protect the exposed brain and provides lead fixation, but it does not directly treat or diagnose a disease or condition itself.
No
The device is a burr hole cover system intended for use during cranial surgery as an implantable cover for the skull and to secure leads. Its function is to provide a physical barrier and lead fixation, not to diagnose medical conditions.
No
The device description clearly outlines physical components (base, clip, cover, base holder, cranial screws, clip insertion tool, screw driver) that are implanted or used in a surgical procedure, indicating it is a hardware medical device.
Based on the provided information, the Guardian™ Burr Hole Cover System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for cranial surgery as an implantable burr hole cover and to secure a lead. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical implant and tools for its placement. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The Guardian™ Burr Hole Cover System is a surgical implant used to physically cover a burr hole in the skull and secure a lead. Its function is mechanical and structural, not diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GXR
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.
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
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)
Performance bench testing and biocompatibility testing were performed to verify the device met the pre-determined acceptance criteria and to confirm substantial equivalence. The following performance bench tests were performed:
- Preconditioning and Accelerated Aging: The SJM Burr Hole Cover (BHC) was preconditioned prior to subsequent pre-clinical testing. All SJM devices preconditioned.
- Hand-held Tool Drop/Shock Preconditioning: Only the SJM BHC was tested to confirm actuation of temporary restraint (with the insert) when using the handheld tool. All SJM devices passed.
- Insert Lead Restraint Testing: Only the SJM BHC was tested to confirm that the lead can be temporarily restrained by the insert. All SJM devices passed.
- Insert Rotation Testing: Only SJM BHC was tested to confirm that the insert does not rotate during temporary restraint. All SJM devices passed.
- Stylet/Guide Tube Removal: Only the SJM lead was tested to confirm the ability to remove a stylet, cannula, or guide tube when the insert (temporary restraint mechanism) is engaged. All SJM devices passed.
- Insert Multiple Actuation Testing: Only the SJM BHC was tested to confirm that the insert (temporary restraint mechanism) can be actuated multiple times. All SJM devices passed.
- Cover Restraint Testing (after Worst Case Vibration): Both SJM and NeuroPace BHC were tested after worst case vibration levels since they both have permanent restraint mechanisms (i.e. a cover). All SJM and NeuroPace devices passed, confirming substantial equivalence of the devices.
- Lead Electrical and Mechanical Damage: Only SJM lead was tested to confirm there would be no damage. All SJM devices passed.
- Vibration Testing: Only SJM BHC was tested to confirm performance at a pre-specified vibration level (separate from worst-case testing). All SJM devices passed.
- Cover Shear Testing: Only the SJM BHC was tested to confirm performance during an application of shear force. All SJM devices passed.
- Insert/Base Interaction Testing: Only the SJM BHC was tested to confirm the temporary restraint mechanism (the insert) is resistant to removal once engaged. All SJM devices passed.
- Affixation Check after Worst Case Vibration: Both SJM and NeuroPace BHC were tested to confirm the ability to permanently remain fixated to the mounting surface after worst case vibration levels. All SJM and NeuroPace devices passed, confirming substantial equivalence of the devices.
Biocompatibility tests were performed for the SJM BHC system:
- Cytotoxicity: Assessed for potential cytotoxic effects using an in vitro mammalian cell culture test following ISO 10993-5. The SJM BHC system demonstrated compliance to ISO 10993-5.
- Intracutaneous Reactivity: Assessed for potential to cause irritation using intracutaneous injection in rabbits based on ISO 10993-10. The SJM BHC system demonstrated compliance to ISO 10993-10.
- Sensitization: Assessed for potential to cause delayed contact dermal sensitization using the guinea pig maximization test based on ISO 10993-10. The SJM BHC system demonstrated compliance to ISO 10993-10.
- Acute Systemic Toxicity: Assessed for potential to cause acute systemic toxicity based on the mouse injection test following ISO 10993-11. The SJM BHC system demonstrated compliance to ISO 10993-11.
- Pyrogenicity: Assessed for potential to cause a pyrogenic response based on the materials mediated rabbit pyrogen test following ISO 10993-11. The SJM BHC system demonstrated compliance to ISO 10993-11.
- Particulate: Assessed for particulate load based on the light obscuration method following ISO 14708-3. The SJM BHC system demonstrated compliance to ISO 14708-3.
- Chemical Characterization: Assessed for chemical characterization per ISO 10993-18 to demonstrate that the leachables are toxicologically acceptable per ISO 10993-17. The SJM BHC system demonstrated compliance to ISO 10993-18 and ISO 10993-17.
Sterilization and Sterility: The SJM and Neuropace BHC are sterilized as per ISO 11135:2007 and EO residuals were evaluated as per ISO 10993-7:2008. All SJM devices passed, demonstrating compliance to the same ISO standard and confirming substantial equivalence of the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
2
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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3
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 |
| Submitter | |
| Name & | |
| Address: | St. Jude Medical |
| 6901 Preston Road | |
| Plano | |
| TX 75024 USA | |
| Contact Person: | Manasi Khare |
| Senior Regulatory Affairs Specialist | |
| Phone (818) 493-2085 | |
| MKhare@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. |
4
| Comparison to
Predicate
Devices | The Guardian™ Burr Hole Cover System has substantially equivalent intended use and
fundamental scientific technology as the predicate device. The technological
characteristics of the Guardian™ Burr Hole Cover System are substantially equivalent
to the predicate device. | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The design comparison between the Guardian™ Burr Hole Cover System and the
predicate device indicate dimensional differences in the burr hole and lead
compatibility that does not affect the device intended use of covering a hole in the
cranium, as confirmed by the pre-clinical testing. The minor dimensional design
difference between the Guardian™ Burr Hole Cover System and the predicate device
is not imperative to establish the performance equivalence between the two systems. | | |
| | The Guardian™ Burr Hole Cover System includes an ancillary clip which can be used
for temporary restraint of the lead. The predicate device cover allows for both
temporary and permanent restraint of the lead, so this does not introduce new issues of
safety and effectiveness. | | |
| | Both use Polyaryletheretherketone (PEEK) as the main material for the Burr Hole
Cover. All the other additional materials do not affect the substantial equivalence and
intended use of the device due to contact type or duration. Both the devices are single
use and are sterilized using Ethylene oxide (EO). | | |
| | A table has been added to capture the comparison between the Guardian™ Burr Hole
Cover System and the predicate device: | | |
| | Attribute | NeuroPace, Inc. Burr Hole Cover
(K123163 and K141368) | Guardian™ Burr Hole Cover System
(this application) |
| | Indications for
Use | Intended to cover a 14 mm burr hole
following cranial surgery. Secondarily,
the NeuroPace Burr Hole Cover can be
used to support 1.3 mm indwelling
leads. | 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. |
| | Anatomical
Site | Permanent implant in cranium (skull) | |
| | Burr Hole
Compatibility | As produced by a 14 mm cranial burr. | As produced by a 14 mm cranial burr. |
| | Lead
Compatibility | Minimum depth 2.7 mm
$1.3 mm diameter \pm 0.05 mm$ | Minimum depth 3.7 mm
1.39 mm leads and 1.29 mm leads only |
| | Main
Components | Base, bone screws and cap | Base, clip, cover, and screws |
| | Sterility | Sterile, single use | |
| | Sterilization
method | Ethylene oxide (EO) | |
| | Labeled as
non-pyrogenic | Yes | |
| | Materials of
Construction | Polyaryletheretherketone (PEEK) and
silicone | Polyaryletheretherketone (PEEK);MP35N
(Springs in insert), and titanium alloy (pins
in insert); polycarbonate, silicone |
| | Biocompatible | Yes | Yes |
| | Shelf Life | 1 year | 2 years |
| | Based on the information in this premarket notification, the subject device has been
shown substantially equivalent to the predicate device. | | |
5
| Summary on
Non-Clinical
Testing for the
Guardian ™
Burr Hole
Cover System | Performance bench testing and biocompatibility testing were performed to verify the
device met the pre-determined acceptance criteria and to confirm substantial
equivalence. The following performance bench tests were performed: | |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | | |
| Test | Testing Scope and Rationale | Results |
| Preconditioning
and
Accelerated
Aging | The SJM Burr Hole Cover (BHC) was preconditioned
prior to subsequent pre-clinical testing.
The NeuroPace Burr Hole Cover (BHC) was not
preconditioned because final finished sterilized
product was obtained from manufacturer and tested. | All SJM
devices
preconditioned |
| Hand-held Tool
Drop/Shock
Preconditioning | Only the SJM BHC was tested to confirm actuation of
temporary restraint (with the insert) when using the
handheld tool.
The NeuroPace BHC not tested because it doesn't
have handheld tool. | All SJM
devices passed |
| Insert Lead
Restraint Testing | Only the SJM BHC was tested to confirm that the lead
can be temporarily restrained by the insert.
The NeuroPace BHC was not tested because it doesn't
have an insert or temporary restraint mechanism. | All SJM
devices passed |
| Insert Rotation
Testing | Only SJM BHC was tested to confirm that the insert
does not rotate during temporary restraint.
The NeuroPace BHC was not tested because device
doesn't have an insert or temporary restraint
mechanism. | All SJM
devices passed |
| Stylet/Guide
Tube Removal | Only the SJM lead was tested to confirm the ability to
remove a stylet, cannula, or guide tube when the insert
(temporary restraint mechanism) is engaged.
The NeuroPace leads were not tested because device
doesn't have an insert or temporary restraint
mechanism. | All SJM
devices passed |
| Insert Multiple
Actuation Testing | Only the SJM BHC was tested to confirm that the
insert (temporary restraint mechanism) can be
actuated multiple times.
The NeuroPace BHC was not tested because it doesn't
have an insert or temporary restraint mechanism. | All SJM
devices passed |
| Cover Restraint
Testing (after
Worst Case
Vibration) | Both SJM and NeuroPace BHC were tested after
worst case vibration levels since they both have
permanent restraint mechanisms (i.e. a cover). | All SJM and
NeuroPace
devices
passed,
confirming
substantial
equivalence of
the devices |
| Lead Electrical
and Mechanical
Damage | Only SJM lead was tested to confirm there would be
no damage. The NeuroPace lead performance was not
evaluated. | All SJM
devices passed |
| Vibration Testing | Only SJM BHC was tested to confirm performance at
a pre-specified vibration level (separate from worst-
case testing). | All SJM
devices passed |
6
| | | The NeuroPace BHC was only tested at the worst-case
vibration levels. | |
|--|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Cover Shear
Testing | Only the SJM BHC was tested to confirm
performance during an application of shear force.
The NeuroPace BHC was not tested because the
system does not have a cover that can be subjected to
shear forces. | All SJM
devices passed |
| | Insert/Base
Interaction
Testing | Only the SJM BHC was tested to confirm the
temporary restraint mechanism (the insert) is resistant
to removal once engaged.
The NeuroPace BHC was not tested because it doesn't
have an insert. | All SJM
devices passed |
| | Affixation Check
after Worst Case
Vibration | Both SJM and NeuroPace BHC were tested to confirm
the ability to permanently remain fixated to the
mounting surface after worst case vibration levels. | All SJM and
NeuroPace
devices
passed,
confirming
substantial
equivalence of
the devices |
| | Biocompatibility
Cytotoxicity | Only the SJM BHC system was assessed for potential
cytotoxic effects, based on using an in vitro
mammalian cell culture test. The study was conducted
following the guidelines of ISO 10993-5.
The NeuroPace device was not tested.
The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required. | The SJM BHC
system
demonstrated
compliance to
ISO 10993-5 |
| | Biocompatibility
Intracutaneous
Reactivity | Only the SJM BHC system was assessed for the
potential to cause irritation, based on intracutaneous
injection in rabbits. This study was conducted based
on ISO 10993-10.
The NeuroPace device was not tested.
The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required. | The SJM BHC
system
demonstrated
compliance to
ISO 10993-10 |
| | Biocompatibility
Sensitization | Only the SJM BHC system was assessed for the
potential to cause delayed contact dermal
sensitization, based on the guinea pig maximization
test. This study was conducted based on ISO 10993-
10.
The NeuroPace device was not tested. | The SJM BHC
system
demonstrated
compliance to
ISO 10993-10 |
7
| | Biocompatibility
Acute Systemic
Toxicity | The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required.
Only the SJM BHC system was assessed for the
potential to cause acute systemic toxicity, based on the
mouse injection test. This study was conducted based
on ISO 10993-11.
The NeuroPace device was not tested. | The SJM BHC
system
demonstrated
compliance to
ISO 10993-11 |
|--|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Biocompatibility
Pyrogenicity | The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required.
Only the SJM BHC system was assessed for the
potential to cause a pyrogenic response, based on the
materials mediated rabbit pyrogen test. This study was
conducted based on ISO 10993-11.
The NeuroPace device was not tested. | The SJM
BHC system
demonstrated
compliance
to ISO
10993-11 |
| | Biocompatibility
Particulate | The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required.
Only the SJM BHC system was assessed for the
particulate load, based on the light obscuration
method. This study was conducted based on ISO
14708-3.particulate load.
The NeuroPace device was not tested. | The SJM
BHC system
demonstrated
compliance
to ISO
14708-3 |
| | Biocompatibility
Chemical
Characterization | The SJM BHC and the predicate device are classified
in the same device category based on body contact
and contact duration and were also assessed for
compliance to the same ISO standard; therefore
evaluation of the NeuroPace predicate is not required.
Only the SJM BHC system was assessed for chemical
characterization per ISO 10993-18 to demonstrate that
the leachables are toxicologically acceptable per ISO
10993-17.
The NeuroPace device was not tested. | The SJM
BHC system
demonstrated
compliance
to ISO
10993-18 and
ISO 10993-
17 |
8
| | Sterilization and
Sterility | The SJM and Neuropace BHC are sterilized as per
ISO 11135:2007 (Sterilization of health care products
- Ethylene oxide - Part 1: Requirements for the
development, validation and routine control of a
sterilization process for medical devices) and the EO
residuals 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 to
these standards, further evaluation of the NeuroPace
BHC was not deemed necessary. | All SJM
devices
passed,
demonstrating
compliance to
the same ISO
standard and
confirming
substantial
equivalence of
the devices |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
Equivalence | The GuardianTM Burr Hole Cover System has the same indications for use and
technological characteristics as the predicate device. Based on this and the data
provided in this pre-market notification, the subject device and predicate device has
been shown to be substantially equivalent. | | |