(265 days)
DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.
The document provided is a 510(k) summary for the DB-Cranial device. It describes various performance tests conducted to demonstrate substantial equivalence to a predicate device, OsteoVation® Impact (K162864).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Important Note: This document does not describe a study that uses AI or machine learning. It is a submission for a medical device (a calcium phosphate bone void filler) that undergoes physical and chemical performance testing to demonstrate substantial equivalence. Therefore, many of the requested bullet points regarding AI/ML studies (e.g., sample size for test set, data provenance, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for DB-Cranial were established by comparing its performance to that of the predicate device, OsteoVation® Impact (K162864). The "Results" column essentially serves as the reported device performance and also confirms that the device meets the implied acceptance criteria of being substantially equivalent to the predicate.
| Test | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance and Substantial Equivalence |
|---|---|---|---|
| Working Time In-Vitro | Ensures sufficient manipulation time and setting strengths. Mixing, mold-ability, and setting strengths were measured. | Sufficient indentation loads to ensure targeted working time and setting strength. | Both subject and predicate device reached sufficient indentation loads to ensure targeted working time and setting strength. |
| Setting Time | Setting tests determined strength (Mean $\geq$ 450N and $\geq$ 700N) at specified time points post sterilization and post mixing. | Similar setting strengths to predicate at all time points. Strength values substantially equivalent. | Subject and predicate devices achieved similar setting strengths at all time points. Strength values of these two setting cements are substantially equivalent. |
| Ca to P Ratio | This test determines CA/P ratios via ICP-MS. | Ca/P ratio of 1.5, identical to the predicate device. | Both samples have a Ca/P ratio of 1.5. This test confirms both subject and predicate are composed of identical amounts of calcium and phosphate salts. |
| Kit Components | Kit ingredients are compared to determine substantial equivalence. | Consist of alpha-tricalcium phosphate (Powder) and sodium silicate-sodium phosphate solution (Liquid), identical to the predicate. | Both subject and predicate device consist of alpha-tricalcium phosphate (Powder) and sodium silicate-sodium phosphate solution (Liquid). |
| Heavy Metal Analysis | Samples are analyzed for trace heavy metal content using ICP-MS. | Trace metal limits below allowable limits. | Trace metal limits were below allowable limits in both subject and predicate. |
| pH Profile | Examines effects of the device on pH surrounding the implanted device. pH is measured in physiologic buffer solutions surrounding curing cements. | All pH readings remained within normal physiological range. | All pH readings remained within normal physiological range for both predicate and subject devices. |
| FTIR Analysis | Identifies the chemical composition following curing in simulated physiologic conditions. | Both subject and predicate device show the formation of hydroxyapatite. Substantially equivalent. | Both subject and predicate device both show the formation of hydroxyapatite. Subject and predicate device are substantially equivalent with regards to FTIR chemical analysis. |
| Crystallographic Analysis | XRD analysis with samples set in simulated physiologic conditions for 2 hours, 1 day, 3 days, and 7 days. Compared against known mineralogic standards. | Confirmed identical crystallographic analysis to predicate over several clinically relevant time points. | Both subject and predicate device are confirmed identical via crystallographic analysis. The same crystalline structure over several different clinically relevant time points is formed in both materials. |
| Temperature Profile | Device samples tested in simulated physiologic solutions to measure temperature of curing cement at 2-minute intervals over 20 minutes. | Set in an isothermic manner with minimal risk of thermal necrosis. Substantially equivalent. | Both subject and predicate device set in an isothermic manner as designed. This demonstrates a minimal risk of thermal necrosis of tissue surrounding the implantation site. In this respect, both subject and predicate device are substantially equivalent. |
| Solubility and Dissolution | Test samples cured and incubated at simulated physiological conditions for 4 days; fluid extracted and tested for Ca2+ concentration via ICP-AES. | Substantially equivalent solubility and dissolution to predicate. | Both subject and predicate device have substantially equivalent solubility and dissolution. |
| Tensile Testing | Test samples mixed and cured for 24 hours at simulated temperature and pH. Tensile testing performed using a mechanical tester. | Identical tensile strength at 24 hours to predicate. Substantially equivalent. | Subject and predicate device demonstrated identical tensile strength at 24 hours and are substantially equivalent in terms of tensile strength. |
| Dimensional Stability | Dimensional stability measured to establish that the bone void fillers maintain shape and do not dissolve in an untimely manner. | Dimensionally stable with no discernable differences from predicate. | Subject and predicate are dimensionally stable materials with no discernable differences in form. |
| Physical Form | Test samples imaged by SEM to determine microstructural similarities and differences. | Demonstrated hydroxyapatite crystal formation identical to predicate. | Both subject and predicate device demonstrated hydroxyapatite crystal formation. Subject and predicate device set to form hydroxyapatite in an identical manner. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify the exact number of samples used for each test (e.g., number of specimens for tensile testing, number of batches for chemical analysis). The tests are typically conducted on a sufficient number of samples to ensure statistically sound results for material characterization.
- Data Provenance: The data provenance is generally from laboratory bench testing (in vitro simulations). The country of origin of the data is not explicitly stated, but it would typically be where the manufacturer (Dimensional Bioceramics, LLC, Santa Cruz, CA) or their contracted laboratories are located. The testing is prospective for the device being submitted, although it involves comparison to an already marketed predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study involves physical and chemical property testing of a biomaterial, not subjective interpretation by medical experts. The "ground truth" for these tests comes from established scientific and engineering principles (e.g., ASTM/ISO standards for material testing, analytical chemistry techniques).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no subjective adjudication required for quantitative and qualitative material property tests.
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. This is not an AI/ML-driven diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests is derived from:
- Established material science and engineering principles.
- Quantitative measurements made by validated analytical equipment (e.g., ICP-MS, XRD, mechanical testers).
- Qualitative observations based on scientific methodologies (e.g., FTIR, SEM).
- The performance of the legally marketed predicate device, used as a benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
{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 logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
June 20, 2019
Dimensional Bioceramics, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave. #509 Chevy Chase, Maryland 20815
Re: K182742
Trade/Device Name: DB-Cranial Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: May 20, 2019 Received: May 21, 2019
Dear Patsy Trisler:
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
{1}------------------------------------------------
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 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 (QS) 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,
Matthew Krueger 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) K182742
Device Name DB-Cranial
Indications for Use (Describe)
DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
| 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 DB-Cranial
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Dimensional Bioceramics, LLC |
| Submitter Address: | 250 Natural Bridges DriveSanta Cruz, CA 95050 |
| Contact Person:Telephone #: | Duran N. Yetkinler, M.D., Ph.D.408-757-6603 |
| Date Prepared: | May 6, 2019 |
| II. DEVICE | |
| Device Trade Name: | DB-Cranial |
| Common or Usual Name: | Hydroxyapatite Cement |
| Regulatory Name(s): | Methyl Methacrylate For Cranioplasty |
| Classification #: | 21 CFR 882.5300 |
| Product Code: | GXP |
| III. PREDICATE DEVICE(s) | K162864, OsteoVation® ImpactSkeletalKinetics , LLC |
| IV. DEVICE DESCRIPTION | |
| Device Identification,Characteristics,Sterilization and Shelf life | DB-Cranial Bone Void Filler is a moldable andbiocompatible calcium phosphate bone void filler.DB-Cranial kit is comprised of two components: acalcium-phosphate powder and a mixing solutionin premeasured quantities, which will be mixedtogether prior to implantation. |
| The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Fillerkits are provided sterile to SAL of 10-6 and are forsingle use only. | |
| The sterilization method is gamma radiation.Sterilization validation is based on ISO 11137-2:2013 (VDMax25). | |
| DB-Cranial Bone Void Filler will be labeled with ashelf life of 30 months. | |
| V. INDICATIONS FOR USE | DB-Cranial is a calcium phosphate bone void fillerindicated for repair or filling of neurosurgical burrholes, other cranial bone defects and craniotomycuts with a surface area of no larger than 25cm².DB-Cranial may be used in the restoration oraugmentation of bony contours of the cranial boneskeleton. |
{4}------------------------------------------------
| VI. SUMMARY OF TESTING [PERFORMANCE DATA] | ||
|---|---|---|
| Performance Bench Testing | ||
| TEST | Test Method Summary | Results |
| Working TimeIn-Vitro | Ensures sufficient manipulationtime is provided while alsoensuring cement setting-timesare met in the operative theater.Mixing, mold-ability, and settingstrengths were measured | Both subject and predicate devicereached sufficient indentationloads to ensure targeted workingtime and setting strength |
| Setting Time | Setting tests determined strength(Mean $\geq$ 450N and $\geq$ 700N) atspecified time points poststerilization and post mixing. | Subject and predicate devicesachieved similar setting strengthsat all time points. Strength valuesof these two setting cements aresubstantially equivalent. |
| Ca to P Ratio | This test determines CA/P ratiosvia ICP-MS. | Both samples have a Ca/P ratio of1.5. This test confirms both subjectand predicate are composed ofidentical amounts of calcium andphosphate salts. |
| Kit Components | Kit ingredients are compared todetermine substantialequivalence. | Both subject and predicate deviceconsist of alpha-tricalciumphosphate (Powder) and sodiumsilicate-sodium phosphate solution(Liquid). |
| Heavy MetalAnalysis | Samples are analyzed for traceheavy metal content using ICP-MS. | Trace metal limits were belowallowable limits in both subjectand predicate. |
| pH Profile | Examines effects of the device onpH surrounding the implanteddevice. pH is measured inphysiologic buffer solutionssurrounding curing cements. | All pH readings remained withinnormal physiological range forboth predicate and subject devices. |
| FTIR Analysis | This test identifies the chemicalcomposition of subject andpredicate device following curingin simulated physiologicconditions for 24 hours then drycured at 37°C for 72 hours. | Both subject and predicate deviceboth show the formation ofhydroxyapatite. Subject andpredicate device are substantiallyequivalent with regards to FTIRchemical analysis. |
| CrystallographicAnalysis | XRD analysis is performed withsamples set in simulatedphysiologic conditions for 2hours, 1 day, 3 days, and 7 days.Samples are evaluated usingpowder x-ray diffraction andcompared against knownmineralogic standards. | Both subject and predicate deviceare confirmed identical viacrystallographic analysis. Thesame crystalline structure overseveral different clinically relevanttime points is formed in bothmaterials. |
| TemperatureProfile | Device samples are tested insimulated physiologic solutions tomeasure temperature of curingcement. Temperatures above, at,and below the level of the sampleare measured at 2 minuteintervals over 20 minutes. | Both subject and predicate deviceset in an isothermic manner asdesigned. This demonstrates aminimal risk of thermal necrosis oftissue surrounding theimplantation site. In this respect,both subject and predicate deviceare substantially equivalent. |
| Solubility andDissolution | Test samples are cured andincubated at simulatedphysiological conditions for 4days; fluid is extracted and testedfor Ca2+ concentration via ICP-AES. This experiment evaluatessolubility and dissolution. | Both subject and predicate devicehave substantially equivalentsolubility and dissolution. |
| Tensile Testing | Test samples were mixed andcured for 24 hours at simulatedtemperature and pH. Tensiletesting was performed using amechanical tester and load atsample breakage was recordedand compared. | Subject and predicate devicedemonstrated identical tensilestrength at 24 hours and aresubstantially equivalent in termsof tensile strength. |
| DimensionalStability | Dimensional stability is measuredto establish that the bone voidfillers maintain shape and do notdissolve in an untimely manner. | Subject and predicate aredimensionally stable materialswith no discernable differences inform. |
| Physical Form | Test samples were imaged bySEM to determinemicrostructural similarities anddifferences. | Both subject and predicate devicedemonstrated hydroxyapatitecrystal formation. Subject andpredicate device set to formhydroxyapatite in an identicalmanner. |
| BiocompatibilityTesting: | No biocompatibility studies were needed to demonstrate substantialequivalence. | |
| Animal Testing: | No animal studies were needed to demonstrate substantial equivalence. | |
| Clinical Testing: | This product type does not require clinical testing. | |
| VII. COMPARISON OFTECHNOLOGICAL CHARACTERISTICSWITH THE PREDICATE DEVICE | DB-Cranial intended use and critical specifications are substantially equivalent to the predicate device, OsteoVation Impact® (K162864), as shown by the comparative testing.There are no notable differences in comparison to the predicate device, therefore no new questions related to safety and effectiveness were raised. | |
| VII. CONCLUSIONS | Based on the comparison provided and the data submitted in the 510(k), it can be concluded the DB- Cranial is substantially equivalent to the predicate device, OsteoVation Impact® (K162864). |
{5}------------------------------------------------
{6}------------------------------------------------
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).