(537 days)
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
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.
The provided text describes the regulatory clearance of a medical device, the "Absorbable Cranial Flap Fixation System," by the FDA. It includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not contain information about an AI-based device or a study involving AI with human readers.
Therefore, I cannot provide details on:
- Acceptance criteria specific to AI device performance.
- Sample sizes for test sets or training sets related to AI.
- Data provenance for AI studies.
- Number and qualifications of experts for AI ground truth.
- Adjudication methods for AI test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies with AI.
- Standalone algorithm performance for AI.
- Type and establishment of ground truth for AI training sets.
The document entirely focuses on the mechanical and biological performance of a physical medical implant.
Here's the information that is available in the document regarding the non-AI device's acceptance criteria and related studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by "Pass" and "No statistical difference") | Reported Device Performance |
|---|---|---|
| Tripping Force | The device's locking function is comparable to the predicate device, meaning there is no statistical difference in the tension force required to release the upper disc. | Pass. No statistical difference between the predicate and subject device. |
| Compression Force | The maximum force required for the device to deform or crack meets pre-defined acceptance criteria and shows no statistical difference compared to the predicate device. | Pass. The acceptance criteria were met, and the results showed no statistical difference between the subject and predicate device. |
| Torque Force | The maximum force required for the connecting rod to break shows no statistical difference compared to the predicate device. | Pass. No statistical difference between the subject and predicate device. |
| Biocompatibility: | ||
| In Vitro Cytotoxicity (ISO 10993-5) | Percent cell viability ≥ 70%. | The percent cell viability of the subject device was 94.7% (>70%). Conclusion: Non-Cytotoxic |
| Skin Sensitization (ISO 10993-10) | No visible change observed in the test article groups when compared to controls, indicating no sensitization. | Under the conditions of the study, no visible change was observed in the test article groups. Conclusion: Non-Sensitizer |
| Intracutaneous Reactivity (ISO 10993-10) | Overall mean score difference between the test article and vehicle < 1.0, indicating no irritation. | Under the conditions of the study, the overall mean score difference between the test article and vehicle was 0.56, less than 1.0. Conclusion: Non-Irritant |
| Acute Systemic Test (ISO 10993-11) | No toxic response observed in the sample group. | Under the conditions of the study, no toxic response was observed in the sample group. Conclusion: Not Systemically Toxic |
| Material-Mediated Pyrogenicity (ISO 10993-11) | Body temperature of the three rabbits does not increase more than 0.5 °C. | The results showed that the body temperature of the three rabbits did not increase more than 0.5 °C. Conclusion: Not Pyrogenic |
| Bone Implantation Test (ISO 10993-6) | Histopathological response of the test article is similar to the control sample. | Under the conditions of the study, the histopathological response of the test article was similar with the control sample. Conclusion: Pass |
| Subchronic Systemic Toxicity (ISO 10993-11) | No toxic response observed. | Under the conditions of the study, no toxic response was observed. Conclusion: No evidence of systemic toxicity |
| Degradation Test (ISO 10993-13) | Results for blood lactate concentration, cerebrospinal fluid lactate concentration, pH, and histopathological are comparable to the control group, indicating proper degradation without toxicity. | Comparable results to the control group for blood lactate concentration, cerebrospinal fluid lactate concentration, pH, and histopathological. Conclusion: Degradable and no toxicity |
| Genotoxicity (ISO 10993-3) | Negative results for Ames test, no induction of chromosome aberrations, and no induction of gene mutation at TK locus. | - 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. Conclusion: Non-genotoxic |
| LAL Endotoxin Testing | Conforms to the required ≤ 2.15 EU/device. | The LAL endotoxin testing demonstrates that the sterile Absorbable Cranial Flap Fixation System conforms to the required ≤2.15 EU/device. |
Note: For the mechanical properties (Tripping, Compression, Torque Force), the acceptance criteria are largely implied by demonstrating "no statistical difference" when compared to the legally marketed predicate device (RapidFlap LS Cranial Fixation Flap System). The specific numerical thresholds for "Pass" are not detailed in this summary for these tests. For biocompatibility, the ISO standards define the acceptance criteria.
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each mechanical test (Tripping Force, Compression Force, Torque Force). It only states "The devices were fastened..." and "Apply pressure to the disk..." indicating testing was performed, likely on multiple samples to allow for statistical comparison, but the number is not provided.
- For biocompatibility tests, specific sample sizes (e.g., number of cells, number of animals) are not explicitly stated in this summary, but are typically defined by the referenced ISO standards (e.g., ISO 10993-5, 10, 11, 6, 3). For example, the pyrogenicity test mentions "three rabbits."
- Data Provenance: The tests were conducted by a Chinese company (Chengdu MedArt Medical Scientific Co., Ltd.) and were part of their submission to the U.S. FDA. The data provenance is internal testing performed by the manufacturer, likely in China. The data would be prospective for the purpose of demonstrating initial device performance to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The device is a physical medical implant, not an AI or diagnostic device that requires expert ground truth establishment for diagnostic interpretation. The "ground truth" for its performance is determined by direct mechanical and biological testing against engineering specifications and international standards, and comparison to a predicate device.
4. Adjudication method for the test set:
- Not applicable as this is a physical device and performance is assessed via objective tests (e.g., force measurements, biological reactions) rather than subjective interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable, as this is not an AI-based device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI-based device.
7. The type of ground truth used:
- For mechanical tests (Tripping Force, Compression Force, Torque Force): The "ground truth" for acceptable performance is established by comparison to the predicate device (RapidFlap LS Cranial Fixation Flap System) and adherence to internal engineering specifications (implied by "acceptance criteria were met").
- For biocompatibility tests: The "ground truth" is defined by the acceptance criteria specified in the referenced ISO 10993 series standards. These standards provide objective thresholds for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, performance in implantation models, degradation, and genotoxicity.
8. The sample size for the training set:
- Not applicable, as this is not an AI-based device and does not involve training sets.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI-based device and does not involve training sets.
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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"
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(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
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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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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-techIndustrial 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 |
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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 FlapFixation System (K221606) | Predicate Device:RapidFlap LS Cranial FixationFlap System (K130309) | Comments |
|---|---|---|---|
| Indication for Use | The Absorbable CranialFlap Fixation System isintended to be used forfixation of cranial boneflaps following craniotomy. | The RapidFlap LS CranialFixation Flap System is indicatedfor use in rigid fixation of acraniotomy in adult and pediatricpopulations. | Similar |
| Material | Poly-L-lactic acid | Polylactic/polyglycolic acidcopolymer | Similar |
| Material property | Resorbable | Resorbable | Same |
| Sterilization | Sterile by EO | Sterile by EO | Same |
6. Tabular Comparison of the Subject Device and Predicate Device
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| Specification/Characterization | Subject Device:Absorbable Cranial FlapFixation System (K221606) | Predicate Device:RapidFlap LS Cranial FixationFlap System (K130309) | Comments |
|---|---|---|---|
| Componentdescription | Lower disc and upper disc(each consisting of a circulardisk with a threaded hole)connected by a connectingrod | Inner and outer plates (eachconsisting of a circular disk with athreaded hole) connected by athreaded central post | Similar |
| Accessories | Battery operatedHeat/Contouring Pen withcutting heating head andsmoothing heating head | LactoSorb SE Heat Pen withcutting 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.1) The devices were fastened with the fixture of the tensile testing machine.2) Apply tension at the stretching speed of 20 mm/min until the upper disc is released and record the tension force3) Compared the test result of the subject and predicate device. | PassNo statistical difference between the predicate and subject device. |
| Compression Force | 1) Place the upper/lower disk on the flat test bench.2) 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 | PassThe acceptance criteria were met, and the results showed no statistical difference |
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| Test | Test method summary | Results |
|---|---|---|
| results with the predicate and ensure that theacceptance criteria is met. | between the subjectand predicatedevice. | |
| Torque Force | Clamp and fix both end of the connecting rod androtate the connecting plate at a fixed rotationalspeed until the connecting rod is damaged orstops rotating and record the maximum forcerequired for the connecting rod to break. | PassNo statisticaldifference betweenthe subject andpredicate 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 thesubject device was 94.7% (>70%). | PassNon - Cytotoxic |
| Skin Sensitization Test(ISO 10993-10:2010) | Under the conditions of the study novisible change was observed in thetest article groups. | PassNon - Sensitizer |
| IntracutaneousReactivity Test(ISO 10993-10:2010) | Under the conditions of the study theoverallmeanscoredifferencebetween the test article and vehiclewas 0.56, less than 1.0. | PassNon - Irritant |
| Acute Systemic Test(ISO 10993-11:2017) | Under the conditions of the study theno toxic response was observed inthe sample group. | PassNot SystemicallyToxic |
| Material-MediatedPyrogenicity(ISO 10993-11:2017) | The results showed that the bodytemperature of the three rabbits didnot increase more than 0.5 °C. | PassNot Pyrogenic |
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| Test | Results | Conclusion |
|---|---|---|
| Bone Implantation Test(ISO 10993-6:2016) | Under the conditions of the study thehistopathological response of the testarticle was similar with the controlsample. | Pass |
| Subchronic SystemicToxicity(ISO 10993-11:2017) | Under the conditions of the study notoxic response was observed. | PassNo evidence ofsystemictoxicity |
| Degradation Test(ISO 10993-13:2010) | Comparable results to the controlgroup for blood lactate concentration,cerebrospinal fluid lactateconcentration, pH, andhistopathological. | Degradable and notoxicity |
| Genotoxicity(ISO 10993-3:2014) | - The result of Ames test for the testarticle was negative.- The results indicated that the testsample could not inducechromosome aberrations.- The results showed that the testarticle did not induce gene mutationat TK locus. | PassNon - 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.
§ 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).