(55 days)
DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
DB-EZ Bone Void Filler is a pre-mixed moldable and biocompatible putty/paste bone void filler. DB-EZ consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process.
The provided document is a 510(k) Premarket Notification for the DB-EZ Bone Void Filler. This type of submission establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical trials. Therefore, the information typically associated with acceptance criteria and a study proving device performance (like sensitivity, specificity, or AUC) for diagnostic AI/ML devices is not applicable here.
The device is a resorbable calcium salt bone void filler, which is a Class II medical device. The submission establishes substantial equivalence by demonstrating that the DB-EZ Bone Void Filler has the same intended use, technological characteristics, and performance characteristics as the predicate device, Skeletal Kinetics SKaffold NMX (K132211).
Instead of "acceptance criteria" related to diagnostic performance metrics, the document focuses on demonstrating equivalence through various physical, chemical, and biological tests.
Here's a breakdown of the information requested, tailored to the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implied by the predicate device's established performance and the demonstration that the subject device meets or is equivalent to those characteristics. The reported device performance is presented as being identical or substantially equivalent to the predicate.
| Characteristic | Predicate Device (SKaffold NMX - K132211) Performance | Subject Device (DB-EZ Bone Void Filler) Performance |
|---|---|---|
| Intended Use | Non-structural bone void filler for osseous defects | Non-structural bone void filler for osseous defects |
| Indications for Use | Same as Subject Device | Indicated to fill bony voids or gaps of the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process. |
| Target Population | Individuals with bony defects resulting from surgery, trauma or degeneration | Individuals with bony defects resulting from surgery, trauma or degeneration |
| Design | Self setting calcium phosphate bone void filler which hardens in aqueous environment at 37°C | Self setting calcium phosphate bone void filler which hardens in aqueous environment at 37°C |
| Components | Package contains one pre-formed putty paste | Package contains one pre-formed putty paste |
| Product Preparation | None | None |
| Chemical Composition | Calcium salt | Calcium salt |
| Starting Reactants | Alpha tricalcium phosphate, sodium phosphate monohydrate anhydrous, carboxymethyl cellulose with bioinert polyethylene glycol based polymer | Alpha tricalcium phosphate, sodium phosphate monohydrate anhydrous, carboxymethyl cellulose with bioinert polyethylene glycol based polymer |
| Crystal Structure (after hardening) | Hydroxyapatite | Hydroxyapatite |
| Calcium to Phosphate Ratio | 1.33 - 1.5 | 1.33 - 1.5 |
| Porosity | ~41.1% | ~41.1% |
| Density | 1.79 gm/cc | 1.79 gm/cc |
| Working Time | Approximately 15 minutes | Approximately 15 minutes |
| Setting Time | ~1.5 hours | ~1.5 hours |
| Total Curing Time | 24 hours | 24 hours |
| pH | Physiologic | Physiologic |
| Setting Reaction Temperature | Isothermic | Isothermic |
| Solubility and Dissolution | Similar to hydroxyapatite | Similar to hydroxyapatite |
| Pore Size | 0.04 microns | 0.04 microns |
| Bone Remodeling | New bone grows into the graft area via osteoconduction. The material is replaced by cell mediated remodeling tissue response. | New bone grows into the graft area via osteoconduction. The material is replaced by cell mediated remodeling tissue response. |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Sterility | Sterilized by e-beam, single use only | Sterilized by e-beam, single use only |
| Shelf Life | 12 months | 12 months |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | Biocompatible | Biocompatible |
| Dosage/Size | 5, 10 cc | 5, 10 cc |
2. Sample Size Used for the Test Set and Data Provenance
This is a materials science and engineering equivalence study, not a diagnostic performance study with a "test set" in the typical sense of a human-read or AI-analyzed dataset. The "testing" referred to in the document consists of various in-vitro and physical/chemical characterization tests.
- Sample Size: The document does not specify the exact number of samples used for each individual test (e.g., Working Time, Setting Time, FTIR, etc.). It refers to "test samples" without providing specific counts for each parameter.
- Data Provenance: The tests described were performed on the predicate device (K132211) and the results were provided in that earlier submission. For the subject device (DB-EZ Bone Void Filler), the submission states, "The following testing was performed on the predicate device and presented in the K132211 documentation." It further indicates that the subject device is composed of the same material and is manufactured and packaged by the same processes. New specific test results for the subject device are not independently presented for each parameter, but rather a claim of "identical" or "similar" performance based on the shared specifications and manufacturing process. The provenance of the original predicate testing data (K132211) is not detailed in this current submission. Given the nature of these tests, they would be lab-based, likely performed in a controlled environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this type of device is established through scientific and engineering principles, material characterization, and established standards (e.g., ASTM, USP), not through expert consensus on interpreting medical images or clinical outcomes in the same way as an AI diagnostic device. The performance is objectively measured by the tests listed.
4. Adjudication Method for the Test Set
This is not applicable. There is no "adjudication" in the sense of resolving discrepancies among experts for diagnostic interpretation. The tests are designed to yield objective, measurable results against predetermined specifications or comparisons to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The DB-EZ Bone Void Filler is a biomaterial device, not a diagnostic AI/ML device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. This question pertains to AI/ML algorithm performance. The DB-EZ Bone Void Filler is a physical biomaterial.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Material Science and Engineering Standards: Compliance with established physical, chemical, and mechanical properties (e.g., working time, setting time, solubility, crystal structure, porosity, density, pH, temperature profile) measured through validated test methods (e.g., ASTM F1185-03, USP<85>, USP<161>).
- Biocompatibility Standards: Demonstration of biocompatibility through compliance with relevant standards. The document states, "No new biocompatibility studies were needed... because no changes to the product were made from the identical predicate device."
- Sterility and Shelf-Life Testing: Verification against established sterilization (SAL 10-6) and shelf-life requirements.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm involved, and therefore no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for an AI/ML algorithm.
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September 22, 2021
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Dimensional Bioceramics, LLC. % Patsy J. Trisler, J.D., RAC Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K212353
Trade/Device Name: DB-EZ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 22, 2021 Received: July 29, 2021
Dear Ms. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (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 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,
Laura C. Rose -S
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K212353
Device Name
DB-EZ Bone Void Filler
Indications for Use (Describe)
DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
| 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) |
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Section 5
510(k) Summary
l. SUBMITTER
| Submitter Name | Dimensional Bioceramics, LLC |
|---|---|
| Submitter Address | 2161 Delaware Avenue, Suite ASanta Cruz, CA 95060 |
| Contact PersonPhone Number | Duran N. Yetkinler, M.D., Ph.D.408-757-6603 |
July 22, 2021
ll. DEVICE
| Trade Name | DB-EZ Bone Void Filler |
|---|---|
| Common Name | Bone Void Filler |
| Classification | Resorbable Calcium Salt Bone Void Filler Device |
| Name Number | 21 CFR 888.3045 |
| Product Code | MQV |
| Regulatory Class | Class 2 |
lll. PREDICATE DEVICE
Date Prepared
| Predicate Device | K132211, Skeletal Kinetics, SKaffold NMX BoneVoid Filler |
|---|---|
| Reference Device | K210193, Dimensional Bioceramics,DB-Composite Bone Void Filler |
INDICATIONS FOR USE IV.
This submission has identical indications for use as the predicate device, Skeletal Kinetics SKaffold NMX Bone Void Filler (K132211).
DB-EZ Bone Void Filler is Indicated to fill bony voids Indications For Use Statement or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
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V. DEVICE DESCRIPTION
| Device Identificationand TechnologicalCharacteristics | DB-EZ Bone Void Filler is a pre-mixed moldable andbiocompatible putty/paste bone void filler. DB-EZconsists of a mixture of calcium phosphate powderin a bioinert polyethylene glycol (PEG) basedpolymer that resorbs and is replaced with boneduring the healing process. |
|---|---|
| --------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Device Sizes and The 5 cc and 10 cc DB-EZ kits are provided sterile Sterility Information to SAL 10-6 and are for single use only.
VI. PERFORMANCE TESTING
Testing Summary: The following testing was performed on the predicate device and presented in the K132211 documentation.
| Test | Test Method Summary |
|---|---|
| Working Time InVitro | Ensures sufficient manipulation time is provided while alsoensuring setting times are met it the operative theater. |
| Setting Time | Measures the time for a bone void filler to set in simulatedphysiologic conditions. |
| Heavy MetalAnalysis | Samples are analyzed for trace heavy metal content usingICP-MS according to ASTM F1185-03. |
| pH Profile | Examines effects of the device on pH surrounding theimplanted device. pH is measured in physiologic buffersolution proximal to curing cement. |
| FTIR Analysis | This test identifies the chemical composition of subject andpredicate device following curing in simulated physiologicconditions. |
| CrystallographicAnalysis | XRD analysis is performed with samples set in simulatedphysiologic conditions for specified times and evaluated usingpowder x-ray diffraction and compared against knownmineralogic standards. |
| TemperatureProfile | Device samples are tested in simulated physiologic solutionto measure temperature of curing cement. |
| Solubility andDissolution | Test samples are cured and incubated at simulatedphysiological conditions for a specified time and measured forsolubility and dissolution. |
| Tensile Testing | Test samples were mixed and cured for 24 hours at simulatedphysiological conditions for a specified time and measured forsolubility and dissolution. |
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| Test | Test Method Summary |
|---|---|
| DimensionalStability | Dimensional stability is measured to establish that the bonevoid fillers maintain shape and do not dissolve in an untimelymanner. |
| Physical Form | Test samples were imaged by SEM to determinemicrostructure. Testing confirmed hydroxyapatite crystalformation. |
| Biocompatibility | No new biocompatibility studies were needed to confirmbiocompatibility and demonstrate substantial equivalence,because no changes to the product were made from theidentical predicate device. |
| Sterilization andShelf Life | The product is sterilized by E-beam to a SAL of $10^{-6}$ . Productis real time shelf life tested to one year. |
| BacterialEndotoxins | Testing, according to USP<85> and USP<161>, showed theproduct meets the acceptance limit of 20EU/device. |
| Animal Testing | No new animal studies were needed to demonstratesubstantial equivalence, since the subject device is identicalto the predicate device. |
| Clinical Testing | This product category does not require human clinical testing. |
VII. SUBSTANTIAL EQUIVALENCE COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Please refer to the SE Comparison Table below.
DB-EZ Bone Void Filler's intended use and critical specifications are substantially equivalent to the predicate device. Skeletal Kinetics SKaffold NMX (K132211). Further, this product is composed of the same material, and is manufactured and packaged by the same processes and core staff members as the predicate device. The only difference is the subject device is manufactured in a different facility than the predicate device.
There are no notable differences in comparison to the predicate device, therefore no questions related to safety and efficacy were raised.
CONCLUSIONS VIII.
Based on the comparisons provided and the information included in this 510(k), it can be concluded that DB-EZ Bone Void FIller is substantially equivalent to the predicate device Skeletal Kinetics SKaffold NMX (K132211).
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SUBSTANTIAL EQUIVALENCE COMPARISON
| Parameter | Predicate Device | Subject Device | ||
|---|---|---|---|---|
| Trade Name | SKaffold NMX | DB-EZ Bone Void Filler | ||
| 510(K) # | K132211 | K212353 | ||
| Common Name | Bone Void Filler | Bone Void Filler | ||
| Intended Use | A non-structural bone void filler forosseous defects | A non-structural bone void filler forosseous defects | ||
| Indications foruse | Indicated to fill bony voids or gapsof the skeletal system (i.e.extremities, and pelvis). Thesedefects may be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone. The device isindicated only for bony voids orgaps that are not intrinsic to thestability of the bony structure. Thedevice provides a bone void fillerthat resorbs and is replaced bybone during the healing process. | Indicated to fill bony voids or gapsof the skeletal system (i.e.extremities, and pelvis). Thesedefects may be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone. The device isindicated only for bony voids orgaps that are not intrinsic to thestability of the bony structure. Thedevice provides a bone void fillerthat resorbs and is replaced bybone during the healing process. | ||
| Target Population | Individuals with bony defectsresulting from surgery, trauma ordegeneration | Individuals with bony defectsresulting from surgery, trauma ordegeneration | ||
| Design | Self setting calcium phosphatebone void filler which hardens inaqueous environment at 37°C | Self setting calcium phosphatebone void filler which hardens inaqueous environment at 37°C | ||
| Components | Package contains one pre-formedputty paste | Package contains one pre-formedputty paste | ||
| ProductPreparation | None | None | ||
| Materials Characteristics | ||||
| ChemicalComposition | Calcium salt | Calcium salt | ||
| StartingReactants | A pre-formed putty/paste is madeby mixing Alpha tricalciumphosphate, sodium phosphatemonohydrate anhydrous,carboxymethyl cellulose withbioinert polyethylene glycol basedpolymer. | A pre-formed putty/paste is madeby mixing Alpha tricalciumphosphate, sodium phosphatemonohydrate anhydrous,carboxymethyl cellulose withbioinert polyethylene glycol basedpolymer. | ||
| Crystal structure,after hardening | Hydroxyapatite | Hydroxyapatite | ||
| Calcium tophosphate ratio | 1.33 - 1.5 | 1.33 - 1.5 | ||
| Physical properties | ||||
| Porosity | ~41.1% | ~41.1% | ||
| Density | 1.79 gm/cc | 1.79 gm/cc | ||
| Performance Characteristics | ||||
| Working time | Approximately 15 minutes | Approximately 15 minutes | ||
| Setting Time | ~1.5 hours | ~1.5 hours | ||
| Total Curing Time | 24 hours | 24 hours | ||
| pH | Physiologic | Physiologic | ||
| Setting reactiontemperature | Isothermic | Isothermic | ||
| Solubility andDissolution | Similar to hydroxyapatite | Similar to hydroxyapatite | ||
| Pore size | 0.04 microns | 0.04 microns | ||
| Bone Remodeling | New bone grows into the graft areavia osteoconduction. The materialis replaced by cell mediatedremodeling tissue response | New bone grows into the graft areavia osteoconduction. The materialis replaced by cell mediatedremodeling tissue response | ||
| Osteoconductivity | Osteoconductive | Osteoconductive | ||
| Sterility | Sterilized by e-beam, single useonly | Sterilized by e-beam, single useonly | ||
| Endotoxin | 12 months | 12 months | ||
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | ||
| Biocompatibility | Biocompatible | Biocompatible | ||
| Dosage /Size | 5, 10 сс | 5, 10 сс |
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§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.