(282 days)
Not Found
No
The summary describes a mechanical bone fixation system and burr hole cover. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and functional testing.
No.
The device is a bone fixation system for post-craniotomy bone flap and burr hole covers, which are structural components used for repair, not for treating a disease or condition for therapeutic purpose.
No
The device is described as a "Cranial Bone Fixation System" intended for "post-craniotomy bone flap fixation and burr hole cover." This indicates a therapeutic or surgical function, not a diagnostic one. The performance studies also focus on functional, biomechanical, and cadaver testing to demonstrate mechanical equivalence and safety, not diagnostic accuracy.
No
The device description explicitly states it is a "biocompatible, postoperative cranial bone fixation system" and mentions physical components like "Flap Fixator" and "Burr Hole Cover" made for specific cranial thicknesses and burr hole diameters. The performance studies also include "Functional testing, Biomechanical testing, Cadaver testing," which are indicative of hardware evaluation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole." This describes a surgical implant used to physically fix bone and cover a surgical opening.
- Device Description: The description details a "biocompatible, postoperative cranial bone fixation system" and a "Burr Hole Cover." It discusses physical characteristics like size and material.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are typically used to test samples like blood, urine, or tissue to provide diagnostic information. This device is a surgical implant used for structural support and closure.
N/A
Intended Use / Indications for Use
CirFIX® Cranial bone fixation system: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
Product codes
GXR
Device Description
The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery.
The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by standard perforators or with spherical drills, can be covered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Burr hole
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
A. Functional testing:
A.1. Functionality of the implantable parts:
Goal: Verification the available sizes for cranial: (A) Burr hole diameter (B) Bone thickness
Method: Fully assembled devices were tested. Simulated surgery to each size of burr hole diameter and bone thickness.
Result: All tested samples meet the functionality acceptance criteria and relevancy the test result has demonstrated that the technological characteristics of CirFIX® Cranial bone fixation system is substantially equivalent to the predicate devices do not raise any new safety or effectiveness issues.
A.2. Functionality of the implantable parts and the driver:
Goal: Determine the maximum torque force (breaking force) of the threads mechanism of the driver and upper platforms (Screw).
Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a torque force on the driver until platforms or bolt broke.
B. Biomechanical testing:
B.1. Strength to bone flap compression (Push-in):
Goal: Simulate strength to bone flap compression (Push-in) and determine the force required to sink the bone flap up to a maximum of 2 mm.
Method: A push load was applied to model which simulates the cranium and bone flap with three Flap Fixators representing clinical use.
Result: All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. The relevancy of the test results in determining the substantial equivalence of the proposed device.
B.2. 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.
B.3. Pull-out:
Goal: Simulate pulling forces caused by increased ICP, to determine the maximum force that the device can withstand before sliding out from the burr bole
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 button of lower platform until the lower platform slid out from the hole.
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 two cadaveric specimens with fully assembled devices. Four different craniotomies were tested:
- Frontal-Parietal (Right side)
- Parietal-Temporal (Left side)
- Frontal-Parietal-Temporal (Right side)
- Frontal-Parietal-Sphenoid wing (Left side)
Some of the most relevant aspects analyzed include:
- Sufficient space for device placement.
- No danger for the surgeon during device application.
- Correct positioning of the device.
- Rapid and simple application of the device with minimum instruments.
- Absence of damage to the dura mater: the tissue will be examined after removal of the device to detect any possible incidence.
- Easy removal of the system: after implantation.
- Lateral and axial stability when the device is moved.
- Low epicranial and subcranial platform profiles.
- Adaptation to different cranium curvatures.
- Adaptation to different cranium thicknesses.
- No artifacts on neuroimaging.
- Fast and no special tools are required.
Result: Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the CirFIX® Cranial bone fixation system is equivalent, in terms of performance and safety and to the relevant extent, to the predicate devices.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
June 3, 2020
Ossaware Biotech Co., Ltd. Meng Huang General Manager No. 51, Xinggong Rd. Shenkang Hsiang, 50971 Tw
Re: K192310
Trade/Device Name: CirFIX Cranial Bone Fixation System: Flap Fixator and Burr Hole Cover Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: May 1, 2020 Received: May 1, 2020
Dear Meng Huang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192310
Device Name
CirFIX Cranial Bone Fixation System: Flap Fixator and Burr Hole Cover
Indications for Use (Describe)
CirFIX Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 84 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the CirFIX® Cranial bone fixation system Submission.
Date: June 3, 2020
| Submitted by | OSSAWARE BIOTECH CO., LTD.
No. 51, Xinggong Rd., Shenkang Hsiang,
Changhua(50971), Taiwan |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Meng Feng Huang
General Manager
Phone: +886-4-7980819
E-mail: FDA@CUSMED.COM |
| Trade Name | CirFIX® Cranial bone fixation system: Flap Fixator and
Burr Hole Cover |
| Common Name | Burr hole cover |
| Proposed Class | Class II |
| Classification Name and
Reference | 882.5250 Burr hole cover |
| Device Product Code,
Device Panel | GXR, Neurology |
| Predicate Device | Legally marketed predicate devices to which substantial
equivalence is claimed:
● Cranial Loop, Cranial Loop L And Cranial Loop XI And
Cranial Bone Fixation System_K132044
● Cranial Cover_K160739 |
| | |
| Device Description | The CirFIX® Cranial bone fixation system: Flap Fixator is a
biocompatible, postoperative cranial bone fixation
system that fixes the bone flap to the skull after
craniotomy and Burr Hole Cover which is for covering a
single burr hole resulting from cranial surgery.
The CirFIX® Cranial bone fixation system is provided in
sterile, for a single use. With available sizes for cranial
thickness ranging from 3 mm to 14 mm and burr holes
with an epicranial diameter from 10 to 15 mm, made by
standard perforators or with spherical drills, can be
covered. |
| Intended Use and
Indications for Use | The CirFIX® Cranial bone fixation system: Flap Fixator is
intended for use to post-craniotomy bone flap fixation
and the Burr Hole Cover is to be used for covering a
single burr hole. |
| Summary of the Technological
Characteristics | The subject CirFIX® Cranial bone fixation system: Flap
Fixator and Burr Hole Cover and the predicates are
identical in indications for use, surgical technique and
anatomical implantation site. The subject CirFIX® Cranial
bone fixation system and the predicates share similar
design features:
• Method of fixation like a clamp.
• Comparable size, material. |
| Summary of Non-Clinical Testing | Mechanical and performance testing confirms the
CirFIX® Cranial bone fixation system: Flap Fixator and
Burr Hole Cover performs as intended and substantially
equivalent to the predicate device. |
| Conclusion | Based on the design features, the use of established well
known materials, feature comparisons, indications for
use, and results of the mechanical testing, the CirFIX®
Cranial bone fixation system has demonstrated
substantial equivalence to the identified predicate
devices. |
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5
Technological characteristics and comparison to predicate devices
Documentation was provided to demonstrate that the CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover is substantially equivalent to the legally marketed predicates. The CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover is substantially equivalent to the predicate devices in indications for use, anatomical implantation site, materials, design features, mechanical performances, and operating principles. Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices.
| Device | Gap analysis | CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover | Cranial Loop, Cranial Loop L And Cranial Loop XI And Cranial Bone Fixation System | Cranial Cover | |
|---|---|---|---|---|---|
| Company | - | OssAware Biotech Co., Ltd. | Neos Surgery S.L. | Neos Surgery S.L. | |
| 510(k) No. | - | K192310 | K132044 | K160739 | |
| Product Code | Same | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | |
| Device Description | Same | The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery. | |||
| The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by 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 postcraniotomy bone flap fixation. In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP L (FC50100) are for use with the calvarial gap while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only. | The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With then available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered. | |||
| Anatomical site | Same | Burr hole | Cutting line or Burr hole | Burr hole | |
| Device Design | Same | Two platforms linked | Two platforms linked by | Two platforms linked by | |
| by a bolt, joined with | |||||
| lower platform | |||||
| allowing movement of | |||||
| the upper platform | |||||
| towards the lower | |||||
| platform. The surgeon | |||||
| tightens the upper | |||||
| platform to the bone | |||||
| by gently rotate the | |||||
| driver to covers the | |||||
| burr hole like a plug. | 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. | 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. | |||||
| Applier | |||||
| Instrument | Same | Not necessary | Not necessary | Not necessary | |
| Material | |||||
| Composition | Same | Platforms (Implantable parts)-PEEK | Platforms and ties | ||
| (implantable parts) – | |||||
| PEEK | Platforms and ties | ||||
| (implantable parts) – | |||||
| PEEK | |||||
| Sizes | Same | Various sizes for the | |||
| system, that available for | |||||
| burr hole of diameter | |||||
| 11/7, 11/8, 13/9, 14/11, | |||||
| 15/12 mm made with | |||||
| standard perforators or | |||||
| 10, 11, 12 mm with | |||||
| spherical drills, can be | |||||
| covered. | |||||
| They can fix skull | |||||
| thicknesses ranging from | |||||
| 3mm to 14mm. | FC050000 and FC050100 | ||||
| applicable in osteotomy | |||||
| line for bone flap | |||||
| fixation. |
FC050200, only size
applicable in burr holes
cover.
They can fix cranical
thicknesses ranging from
4mm to 24mm. | - FC050300: for burr
holes of diameter 14/11
mm and 13/9 mm
- FC050400: for burr
holes of diameter from
10 to 12 mm | |
| Implant life | Same | Long-term implant | Long-term implant | Long-term implant | |
| Biocompatible | Same | Yes | Yes | Yes | |
| Provided
Sterile | Same | Yes | Yes | Yes | |
| Sterile
Method | Same | Irradiation | Irradiation | Irradiation | |
| MRI
Compatibility | Same | MR Safe | MR Safe | MR Safe | |
| Method of
Fixation to
Cranium | Same | Like a clamp | Like a clamp | Like a clamp | |
A side-by-side comparison of the CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover to the predicate devices as following:
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7
| Discussion of mechanical and performance testing | ||
|---|---|---|
| Test | Test Method Summary | Result |
| A. Functional testing | ||
| A.1.Functionality of the implantable parts | Goal :Verification the available sizes for cranial: | |
| (A) Burr hole diameter | ||
| (B) Bone thickness |
Method: Fully assembled devices were tested. Simulated surgery to each size of burr hole diameter and bone thickness. | All tested samples meet the functionality acceptance criteria and relevancy the test result has demonstrated that the technological characteristics of CirFIX® Cranial bone fixation system is substantially equivalent to the predicate devices do not raise any new safety or effectiveness issues. |
| A.2. Functionality of the implantable parts and the driver | Goal: Determine the maximum torque force (breaking force) of the threads mechanism of the driver and upper platforms (Screw).
Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a torque force on the driver until platforms or bolt broke. | |
| B. Biomechanical testing | | |
| B.1.
Strength to bone flap compression (Push-in) | Goal: Simulate strength to bone flap compression (Push-in) and determine the force required to sink the bone flap up to a maximum of 2 mm.
Method: A push load was applied to model which simulates the cranium and bone flap with three Flap Fixators representing clinical use. | All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out.
The relevancy of the test results in determining the substantial equivalence of the proposed device. |
| B.2.
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. | |
| B.3.
Pull-out | Goal: Simulate pulling forces caused by increased ICP, to determine the maximum force that the device can withstand before sliding out from the burr bole | |
| | | |
| | 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 button of lower platform until | |
| | the lower platform slid out from the hole. | |
| C. Cadaver testing | Goal: Evaluation of the devices when | Correct implantation is |
| | simulating their implantation on the skull | verified in a simulated real-life |
| | of patients in a clinical environment, | situation. The devices show |
| | following the procedures described in the | adequate performance and |
| | products' Instructions for Use. | safety. |
| | | |
| | Method: The test was performed on two | The results demonstrate that |
| | cadaveric specimens with fully assembled | the CirFIX® Cranial bone fixation |
| | devices. Four different craniotomies were | system is equivalent, in terms of |
| | tested: | performance and safety and to |
| | ● Frontal-Parietal(Right side) | the relevant extent, to the |
| | ● Parietal-Temporal (Left side) | predicate devices. |
| | ● Frontal-Parietal-Temporal(Right side) | |
| | ● Frontal-Parietal-Sphenoid wing(Left | |
| | side) | |
| | Some of the most relevant aspects | |
| | analyzed include: | |
| | 1. Sufficient space for device placement. | |
| | 2. No danger for the surgeon during | |
| | device application. | |
| | 3. Correct positioning of the device. | |
| | 4. Rapid and simple application of the | |
| | device with minimum instruments. | |
| | 5. Absence of damage to the dura mater: | |
| | the tissue will be examined after | |
| | removal of the device to detect any | |
| | possible incidence. | |
| | 6. Easy removal of the system: after | |
| | implantation. | |
| | 7. Lateral and axial stability when the | |
| | device is moved. | |
| | 8. Low epicranial and subcranial platform | |
| | profiles. | |
| | 9. Adaptation to different cranium | |
| | curvatures. | |
| | 10.Adaptation to different cranium | |
| | thicknesses. | |
| | 11.No artifacts on neuroimaging. | |
| | 12.Fast and no special tools are required. | |
Discussion of mechanical and performance testing
8