(537 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI/ML or data processing.
No.
The device is used for fixation of cranial bone flaps, which is a structural and mechanical function, rather than an active therapeutic effect involving treatment or alleviation of a disease or condition.
No.
The device is used for fixation of cranial bone flaps after surgery, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's medical condition.
No
The device description clearly outlines physical components (lower disc, upper disc, connecting rod, rotating lock) made from poly-L-lactic acid, and an accessory device (Heat/Contouring Pen) which is a handheld, battery-powered device. These are hardware components, 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 "fixation of cranial bone flaps following craniotomy." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant used to secure bone.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. This device is used in vivo (inside the body) for a surgical fixation purpose.
N/A
Intended Use / Indications for Use
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
Product codes (comma separated list FDA assigned to the subject device)
GXR
Device Description
The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone.
The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use.
The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone flaps
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)
The subject device was tested for Tripping Force, Compression Force, and Torque Force. Results showed no statistical difference between the subject device and the predicate device for all three tests, indicating comparable mechanical performance.
Biocompatibility testing included:
- In Vitro Cytotoxicity Test: 94.7% cell viability (Pass, Non-Cytotoxic)
- Skin Sensitization Test: No visible change (Pass, Non-Sensitizer)
- Intracutaneous Reactivity Test: Mean score difference 0.56 (
§ 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
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Chendu MedArt Medical Scientific Co., Ltd. % Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K221606
Trade/Device Name: Absorbable Cranial Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: October 20, 2023 Received: October 23, 2023
Dear Joyce Yang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Image /page/1/Picture/8 description: The image shows the name "Adam D. Pierce -S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce -S" is present. Below this, the date "2023.11.21" and time "09:27:14-05'00'" are listed.
Adam D. Pierce. Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221606
Device Name Absorbable Cranial Flap Fixation System
Indications for Use (Describe)
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Date prepared: November 15, 2023
1. Submitter
| 1. Submitter | |
|---|---|
| Applicant Name | Chengdu MedArt Medical Scientific Co., Ltd. |
| Address | No.102, Tianying Road, Chengdu High-tech |
| Industrial Development Zone, 611731 Sichuan, | |
| China | |
| Contact person | Huaping Ran |
| Phone | 086-28-87958626 |
| yangm@biomedart.cn | |
| 2. Device Identification | |
| Trade Name | Absorbable Cranial Flap Fixation System |
| Regulation Number | 21 CFR § 882.5250 |
| Device Class | II |
| Regulation Description | Burr hole cover |
| Product Code | GXR |
| 3. Predicate Device | |
| Trade Name | RapidFlap LS Cranial Fixation Flap System |
| Submission Number | K130309 |
| Regulation Number | 21 CFR § 882.5250 |
| Device Class | II |
| Regulation Description | Burr hole cover |
| Product Code | GXR |
| Manufacturer | Biomet Microfixation |
5
4. Device Description
The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone.
The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use.
The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.
5. Indications for Use
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
| Specification/
Characterization | Subject Device:
Absorbable Cranial Flap
Fixation System (K221606) | Predicate Device:
RapidFlap LS Cranial Fixation
Flap System (K130309) | Comments |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indication for Use | The Absorbable Cranial
Flap Fixation System is
intended to be used for
fixation of cranial bone
flaps following craniotomy. | The RapidFlap LS Cranial
Fixation Flap System is indicated
for use in rigid fixation of a
craniotomy in adult and pediatric
populations. | Similar |
| Material | Poly-L-lactic acid | Polylactic/polyglycolic acid
copolymer | Similar |
| Material property | Resorbable | Resorbable | Same |
| Sterilization | Sterile by EO | Sterile by EO | Same |
6. Tabular Comparison of the Subject Device and Predicate Device
6
| Specification/
Characterization | Subject Device:
Absorbable Cranial Flap
Fixation System (K221606) | Predicate Device:
RapidFlap LS Cranial Fixation
Flap System (K130309) | Comments |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------|
| Component
description | Lower disc and upper disc
(each consisting of a circular
disk with a threaded hole)
connected by a connecting
rod | Inner and outer plates (each
consisting of a circular disk with a
threaded hole) connected by a
threaded central post | Similar |
| Accessories | Battery operated
Heat/Contouring Pen with
cutting heating head and
smoothing heating head | LactoSorb SE Heat Pen with
cutting tip and contouring tip | Different |
7. Summary of Non-clinical Testing
The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid.
The main performance of the product is tripping force, compression force and torque force and the test results showed no statistical difference between the subject device and predicate device.
| Test | Test method summary | Results |
|---|---|---|
| Tripping Force | The purpose of this test is to determine the locking function of the device is comparable to the predicate device. |
-
The devices were fastened with the fixture of the tensile testing machine.
-
Apply tension at the stretching speed of 20 mm/min until the upper disc is released and record the tension force
-
Compared the test result of the subject and predicate device. | Pass
No statistical difference between the predicate and subject device. |
| Compression Force | 1) Place the upper/lower disk on the flat test bench. -
Apply pressure to the disk with the microcomputer control electronic universal tester and record the maximum force required for the device to deform or crack. Compare the | Pass
The acceptance criteria were met, and the results showed no statistical difference |
7
| Test | Test method summary | Results |
|---|---|---|
| results with the predicate and ensure that the | ||
| acceptance criteria is met. | between the subject | |
| and predicate | ||
| device. | ||
| Torque Force | Clamp and fix both end of the connecting rod and | |
| rotate the connecting plate at a fixed rotational | ||
| speed until the connecting rod is damaged or | ||
| stops rotating and record the maximum force | ||
| required for the connecting rod to break. | Pass | |
| No statistical | ||
| difference between | ||
| the subject and | ||
| predicate device. |
The biocompatibility evaluation for the Absorbable Cranial Flap Fixation System was conducted in accordance with the FDA guidance document "Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"".
| Test | Results | Conclusion |
|---|---|---|
| In Vitro Cytotoxicity Test | ||
| (ISO 10993-5:2009) | The percent cell viability of the | |
| subject device was 94.7% (>70%). | Pass | |
| Non - Cytotoxic | ||
| Skin Sensitization Test | ||
| (ISO 10993-10:2010) | Under the conditions of the study no | |
| visible change was observed in the | ||
| test article groups. | Pass | |
| Non - Sensitizer | ||
| Intracutaneous | ||
| Reactivity Test | ||
| (ISO 10993-10:2010) | Under the conditions of the study the | |
| overall | ||
| mean | ||
| score | ||
| difference | ||
| between the test article and vehicle | ||
| was 0.56, less than 1.0. | Pass | |
| Non - Irritant | ||
| Acute Systemic Test | ||
| (ISO 10993-11:2017) | Under the conditions of the study the | |
| no toxic response was observed in | ||
| the sample group. | Pass | |
| Not Systemically | ||
| Toxic | ||
| Material-Mediated | ||
| Pyrogenicity | ||
| (ISO 10993-11:2017) | The results showed that the body | |
| temperature of the three rabbits did | ||
| not increase more than 0.5 °C. | Pass | |
| Not Pyrogenic |
8
| Test | Results | Conclusion |
|---|---|---|
| Bone Implantation Test | ||
| (ISO 10993-6:2016) | Under the conditions of the study the | |
| histopathological response of the test | ||
| article was similar with the control | ||
| sample. | Pass | |
| Subchronic Systemic | ||
| Toxicity | ||
| (ISO 10993-11:2017) | Under the conditions of the study no | |
| toxic response was observed. | Pass | |
| No evidence of | ||
| systemic | ||
| toxicity | ||
| Degradation Test | ||
| (ISO 10993-13:2010) | Comparable results to the control | |
| group for blood lactate concentration, | ||
| cerebrospinal fluid lactate | ||
| concentration, pH, and | ||
| histopathological. | Degradable and no | |
| toxicity | ||
| Genotoxicity | ||
| (ISO 10993-3:2014) | - The result of Ames test for the test | |
| article was negative. |
- The results indicated that the test
sample could not induce
chromosome aberrations. - The results showed that the test
article did not induce gene mutation
at TK locus. | Pass
Non - genotoxic |
The LAL endotoxin testing demonstrates that the sterile Absorbable Cranial Flap Fixation System conforms to the required ≤2.15 EU/device.
8. Conclusion
The subject device, Absorbable Cranial Flap Fixation System, has the same intended use, design, function, and is composed of a similar material to the predicate device, RapidFlap LS Cranial Fixation Flap System. Based on the comparison of the technological and functions characteristics, intended use and performance data, the Absorbable Cranial Flap Fixation System is substantially equivalent to the predicate device, RapidFlap LS Cranial Fixation Flap System.