(87 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a physical implant for covering burr holes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and intended use state that it covers burr holes resulting from cranial surgery to avoid anti-cosmetic postoperative skin concavities. It does not treat or diagnose a disease or condition, which is a characteristic of a therapeutic device.
No
Explanation: The device is a burr hole cover system intended to cover burr holes resulting from cranial surgery. It is a post-operative implant, not a diagnostic tool.
No
The device description clearly indicates it is a physical, implantable medical device made of biocompatible materials, designed to cover burr holes. The performance studies involve functional, biomechanical, and cadaver testing of the physical device's mechanical properties and implantation. There is no mention of software as a component or function of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover burr holes resulting from cranial surgery. This is a surgical implant/device used directly on the patient's body.
- Device Description: The description details a physical implantable device designed to fit into burr holes.
- Performance Studies: The performance studies focus on the mechanical and functional properties of the device in a surgical context (push-in, pull-out, cadaver testing).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.
Product codes (comma separated list FDA assigned to the subject device)
GXR
Device Description
The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.
Two different sizes are presented:
- . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
- . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.
The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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)
Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices.
A. Functional testing
A.1. Functionality of implantable parts:
Goal: Determine the breaking force of the ratchet mechanism of the device's upper platform.
Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a traction force on the upper platform until its ratchets broke.
Results and Conclusion: All tested samples meet the specifications. Functionality of the devices is demonstrated. Results are comparable to the Cranial LOOP XL predicate device.
A.2. Functionality of the handle:
Goal: Determine the breaking force of the ratchet mechanism between the handle and the lower platform (and cable ties).
Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a traction force on the handle until its ratchets broke.
B. Biomechanical testing
B.1. Push-in:
Goal: Simulate patient's pressure on the device and determine the force required to sink the devices up to a maximum of 2 mm.
Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. The implanted devices were placed under a calibrated dynamometer and a cylindrical tool used to apply force on the upper platform.
Results and Conclusion: All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. Results are better than those obtained with the Cranial LOOP XL predicate device. Both devices must be able to resist pull-out and push-in forces appropriately.
B.2. Pull-out:
Goal: Simulate pulling forces during implantation or caused by increased ICP, to determine the maximum force that 1) the device can withstand before sliding out from the burr hole, or 2) the handle can withstand before breaking.
Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. A calibrated dynamometer was used to apply a traction force on the handle until the lower platform slid out from the hole or the handle broke.
C. Cadaver testing:
Goal: Evaluation of the devices when simulating their implantation on the skull of patients in a clinical environment, following the procedures described in the products' Instructions for Use.
Method: The test was performed on a cadaveric specimen with fully assembled devices. Some of the most relevant aspects analyzed include:
- availability of space to place and position the device
- absence of danger for the surgeon
- fast and instrument-free implantation
- epicranial and subcranial profiles
- lateral and axial stability when the device is moved
- completeness of burr hole covering
- ease of device removal
Results and Conclusion: Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the Cranial COVER is equivalent, in terms of performance and safety and to the relevant extent, to the predicate device Cranial LOOP XL.
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.
Leibinger Burr Hole Covers – K983885, NeuroPace Burr Hole Cover - K123163, Cranial LOOP XL - K132044
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 shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2016
Neos Surgery S.L. % Mr. Marcos Velez-Duran President M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York. New York 10018
Re: K160739
Trade/Device Name: Cranial COVER Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: March 16, 2016 Received: March 17, 2016
Dear Mr. Velez-Duran:
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
1
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" (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 -$ D/A
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) K160739
Device Name Cranial COVER
Indications for Use (Describe)
The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.
| 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)
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
The following information is provided as required by 21 CFR § 807.87 for the Cranial COVER Cranial Burr Hole Cover System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 (08290) Cerdanyola del Vallès Barcelona, Spain
- Contact: Marcos Velez-Duran M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 Ph: 703-562-9800 Ext 206 Fax: 702-562-9797 Email: MVelez-Duran@MSquaredAssociates,com
Date of Submission: March 16, 2016
| Proprietary Name: | Cranial COVER, Cranial Burr Hole Cover System |
|---|---|
| Common Name: | Burr hole cover |
| Regulatory Class: | 882.5250 Burr hole cover |
| Classification Panel: | Neurology |
| Product Codes: | GXR |
| Predicate Device(s): | Leibinger Burr Hole Covers – K983885 |
Neuropace Burr Hole Cover - K123163 Cranial LOOP XL - K132044
Device Description
The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It
4
avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.
Two different sizes are presented:
- . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
- . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.
The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.
Indications for Use
The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.
Technological characteristics and comparison to predicate devices
The Cranial COVER is substantially equivalent in its indications for use and anatomical implantation site to the Leibinger Burr Hole Covers (K983885), the NeuroPace Burr Hole Cover (K123163) and the Cranial LOOP XL (included in K132044). More specifically:
- · The Cranial COVER has the same indications for use as the primary indications for use of the Leibinger Burr Hole Covers and the NeuroPace Burr Hole Cover.
- · A part of the indications for use of the Cranial LOOP XL is the same indications for use of the Cranial COVER (covering burr holes resulting from cranial surgery).
1 In burr holes made with perforators, epicranial and subcranial diameters are different. For instance, the 14/1 mm perforator generates burr holes with epicranial diameter 14 mm and subcranial diameter 11 mm.
5
Additionally, Cranial COVER is substantially equivalent in its technology to the Cranial LOOP XL, as their design features and manner of implantation are the same: they are both clamp-like devices.
Finally, the material of the implanted parts of the Cranial COVER is the same as the material of the implanted part of the Cranial LOOP XL and the NeuroPace Burr Hole Cover (PEEK).
| Device | Cranial COVER
(FC050300 /
FC050400) | Cranial LOOP XL
(FC050200) | NeuroPace Burr Hole
Cover (model 8110) | Leibinger Burr Hole
Covers | | | | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Company | Neos Surgery S.L. | Neos Surgery S.L. | NeuroPace
Inc. | Howmedica, Inc. | | covers the burr hole
like a plug. | intended use by fixing
the bone flap to the
cranial bone and by
covering the burr hole. | | |
| 510(k) No. | Present submission | K132044 | K123163 | K983885 | Applier
Instrument | Not necessary | Not necessary | Screwdriver
(minimum) | Screwdriver
(minimum) |
| Product Code | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | Material
Composition | Platforms and ties
(implantable parts) -
PEEK
Handle and applier-
biocompatible polymer | Platforms and ties
(implantable parts) -
PEEK
Handle and applier-
biocompatible polymer | Synthetic polymer
(PEEK according to
the IFUs) and
silicone. | Titanium |
| Indications
for Use | The Cranial COVER is
intended for use to
cover burr holes
resulting from cranial
surgery. With the
available sizes, burr
holes with an epicranial
diameter between 10
and 14 mm, made with
standard perforators or
with spherical drills,
can be covered. | The Cranial LOOP
Cranial Bone Fixation
Systems: Cranial
LOOP, Cranial LOOP
(L) and Cranial LOOP
(XL), are long-term
implantable devices
indicated for post-
craniotomy bone flap
fixation.
(...) The Cranial
LOOP (XL)
(FC050200) is to be
used for covering a
standard 14 mm
cranial burr hole only. | 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. | The Leibinger Burr
Hole Covers are
designed to be used
with fixation screws to
cover burr holes of
various diameters in
the craniofacial
skeleton in order to
provide good cosmetic
results and protection
of the underlying soft
tissues and brain. This
device can also be used
to secure cranial bone
flaps. | Sizes | - FC050300: for burr
holes of diameter 14/11
mm and 13/9 mm
- FC050400: for burr
holes of diameter from
10 to 12 mm | FC050200, only size
applicable in burr holes. | One size (14 mm). | Four different
configurations.
(According to the
Intended Use: to cover
burr holes of various
diameters) |
| Device
Design | Two platforms linked
by two adjustable cable
ties, which are joined to
the lower platform and
have a locking system
that allows movement
of the upper platform
towards the lower
platform but impedes
backward movements.
The surgeon tightens
the upper platform to
the bone by gently
pressing with the
applier and pulling on
the handle. The device
remains adjusted to the
bone thickness and | Two platforms linked
by two adjustable cable
ties, which are joined to
the lower platform and
have a locking system
that allows movement
of the upper platform
towards the lower
platform but impedes
backward movements.
The surgeon tightens
the lower platform to
the bone and bone flap
by gently pressing with
the applier and pulling
on the handle. The
device remains adjusted
to the bone thickness
and it achieves its | The NeuroPace® Burr
Hole Cover (model
- includes a base
that
is screwed to the
cranium (skull) using
bone screws.
The cap is an assembly
comprised of a cap and
a gasket. 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 Burr Hole Cover
has a segmented plate-
like structure. These
Burr Hole Covers are
0.5 rnm thick and are
comprised of four
different configurations | Implant life | Long-term implant | Long-term implant | Long-term implant | Long-term implant |
| Biocompa-
tible | Yes | Yes | Yes | Yes | | | | | |
| Provided
Sterile | Yes | Yes | Yes | No | | | | | |
| MRI
Compatibility | MR Safe | MR Safe | MR compatible | MR compatible
(although no data is
available in the IFUs or
510k summary). | | | | | |
| Method of
Fixation to
Cranium | Like a clamp | Like a clamp | Titanium Screws | Titanium Screws | | | | | |
A side-by-side comparison of the Cranial COVER to the predicate devices follows:
6
Some differences exist in the diameters of the holes that the predicate devices are able to cover. Despite these differences, it is important to consider that burr holes made with a 14/11 mm standard perforator are the ones most commonly used in cranial surgery, and these burr holes can be covered with all the mentioned devices. Additionally, for both Cranial COVER and Leibinger Burr Hole Covers different sizes of the device are available, to cover different diameters.
Once implanted, and despite being based in essentially two basic designs to keep their position (clamp-like in the case of Cranial COVER and Cranial LOOP XL; screwed to the bone in the case of NeuroPace and Leibinger Burr Hole Covers), all these devices remain adjusted on the burr holes and cover them properly in the long-term.
Sterility
The sterilization method of the device does not differ from that of the Cranial LOOP XL predicate device (included in K132044). The sterilization process specification validation method and the bioburden limits are the same for this product and the predicate device Cranial LOOP XL. The results for the Cranial COVER are comparable to those obtained with Cranial LOOP XL.
7
Biocompatibility
With respect to the materials used in their manufacturing, all devices are made of biocompatible materials. The Cranial COVER, as well as the predicate devices Cranial LOOP XL and NeuroPace Burr Hole Cover, are made of PEEK (this makes them radiolucent and prevents interference with CT scanning and MRI systems). The Leibinger Burr Hole Covers are made of titanium.
The implantable parts of the Cranial COVER are the upper and lower platforms, as well as the ties, all of which are made of PEEK. As already mentioned, this is the same material used in the same parts of the predicate device Cranial LOOP XL (K132044). PEEK is well established as an implantable thermoplastic material. The Cranial COVER handle and applier (the non-implantable parts of the device) are made of biocompatible polymers. Letters of Authorization to Masters Files for these polymers have been provided.
Discussion of mechanical and performance testing
Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices.
Performance testing has demonstrated that the technological characteristics of Cranial COVER do not raise any new safety or effectiveness issues. A summary of the tests performed, including a discussion of the relevance of their results to determine the substantial equivalence of Cranial COVER to the predicate devices, follows:
| Test | Test Method Summary | Results and Conclusion |
|---|---|---|
| A. Functional testing | ||
| A.1. Functionality | ||
| of implantable | ||
| parts | Goal: Determine the breaking force of the | |
| ratchet mechanism of the device's upper | ||
| platform. | All tested samples meet the | |
| specifications. Functionality of | ||
| the devices is demonstrated. | ||
| Method: Fully assembled devices were tested. | ||
| A calibrated dynamometer was used to apply a | ||
| traction force on the upper platform until its | ||
| ratchets broke. | Results are comparable to the | |
| Cranial LOOP XL predicate | ||
| device. | ||
| A.2. Functionality | ||
| of the handle | Goal: Determine the breaking force of the | |
| ratchet mechanism between the handle and the | ||
| lower platform (and cable ties). | ||
| Method: Fully assembled devices were tested. | ||
| A calibrated dynamometer was used to apply a | ||
| traction force on the handle until its ratchets | ||
| broke. | ||
| B. Biomechanical testing | ||
| B.1. Push-in | Goal: Simulate patient's pressure on the device | |
| and determine the force required to sink the | ||
| devices up to a maximum of 2 mm. | ||
| Method: Fully assembled devices were tested | ||
| in holes equivalent to those in which they will | ||
| be implanted. The implanted devices were | ||
| placed under a calibrated dynamometer and a | ||
| cylindrical tool used to apply force on the | ||
| upper platform. | All tested samples meet the | |
| specifications. The devices | ||
| have an adequate | ||
| biomechanical behavior at | ||
| push-in and pull-out. | ||
| Results are better than those | ||
| obtained with the Cranial | ||
| LOOP XL predicate device. | ||
| Both devices must be able to | ||
| resist pull-out and push-in | ||
| forces appropriately. However, | ||
| the use of Cranial LOOP XL | ||
| as a fixation element for the | ||
| bone flap causes that these | ||
| devices are subject to different | ||
| force intensities. In general, it | ||
| is reasonable to say that the | ||
| Cranial COVER is subject to a | ||
| less demanding situation than | ||
| Cranial LOOP XL; the results | ||
| obtained confirm this point. | ||
| B.2. Pull-out | Goal: Simulate pulling forces during | |
| implantation or caused by increased ICP, to | ||
| determine the maximum force that 1) the | ||
| device can withstand before sliding out from | ||
| the burr hole, or 2) the handle can withstand | ||
| before breaking. | ||
| Method: Fully assembled devices were tested | ||
| in holes equivalent to those in which they will | ||
| be implanted. A calibrated dynamometer was | ||
| used to apply a traction force on the handle | ||
| until the lower platform slid out from the hole | ||
| or the handle broke. | ||
| C. Cadaver testing | Goal: Evaluation of the devices when | |
| simulating their implantation on the skull of | ||
| patients in a clinical environment, following | ||
| the procedures described in the products' | ||
| Instructions for Use. | ||
| Method: The test was performed on a | ||
| cadaveric specimen with fully assembled | ||
| devices. Some of the most relevant aspects | ||
| analyzed include: |
- availability of space to place and position the
device - absence of danger for the surgeon
- fast and instrument-free implantation
- epicranial and subcranial profiles
- lateral and axial stability when the device is
moved - completeness of burr hole covering
- ease of device removal | Correct implantation is
verified in a simulated real-life
situation. The devices show
adequate performance and
safety.
The results demonstrate that
the Cranial COVER is
equivalent, in terms of
performance and safety and to
the relevant extent, to the
predicate device Cranial
LOOP XL. |
8
All the setups applied in the tests simulate clinical service conditions and, in some cases, the worst case scenario. The results of the testing confirmed that both sizes of the Cranial COVER will
9
perform as intended in the clinical setting, and that they are comparable to the predicate devices particularly to the Cranial LOOP XL (included in K132044).
The following standards are applicable to the design and performance of the Cranial COVER:
- · Recognition number 14-428: ISO 11137-1:2006, "Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]"
- · Recognition number 14-409: ISO 11137-2:2013, "Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose"
- · Recognition number 14-407: ISO 11737-1:2006, "Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]''
- · Recognition number 14-327: ISO 11737-2:2009, "Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process"
- · Recognition number 2-220: ISO 10993-1:2009, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]"
Discussion of clinical testing
No clinical testing was deemed necessary to support substantial equivalence to predicate devices.
Conclusion
Based on the design features, the use of established well-known biocompatible materials, technological characteristics comparison, indications for use, and results of the mechanical and performance testing, the subject device has demonstrated substantial equivalence to the identified legally marketed predicate devices.