DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

DB-Composite Bone Void Filler is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3cc, 5cc, and 10cc DB-Composite Bone Void Filler Kits are provided sterile to SAL 10-6 and are for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called DB-Composite Bone Void Filler. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or meeting specific performance criteria through new clinical studies. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, AI performance, ground truth establishment) is not present here.

Instead, the submission focuses on comparing the new device's characteristics and performance to those of a predicate device (Skeletal Kinetics Callos ProModel Bone Void Filler). The "performance testing" section outlines a summary of tests performed on the predicate device (K112383) to demonstrate its safety and effectiveness, and the DB-Composite device is deemed substantially equivalent based on having identical materials, manufacturing processes, and indications for use.

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the DB-Composite device as part of a new study designed to prove its performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device whose performance has already been accepted by the FDA. The performance testing outlined was primarily conducted on the predicate device, and the DB-Composite is considered equivalent due to identical characteristics.

Test	Reported Performance (of Predicate Device, K112383)
Working Time In Vitro	Ensures sufficient manipulation time and setting times are met in the operative theater. (Specific values not provided for predicate or subject device)
Setting Time	Measures the time for a bone void filler to set in simulated physiologic conditions. (Specific values not provided for predicate or subject device)
Heavy Metal Analysis	Samples analyzed for trace heavy metal content using ICP-MS according to ASTM F1185-03. (Specific results not provided)
pH Profile	Examines effects of the device on pH surrounding the implanted device. pH measured in physiologic buffer solution proximal to curing cement. (Specific results not provided)
FTIR Analysis	Identifies chemical composition following curing in simulated physiologic conditions. (Confirmed chemical composition, specific details not provided)
Crystallographic Analysis	XRD analysis performed with samples set in simulated physiologic conditions. (Evaluated using powder x-ray diffraction and compared against known mineralogic standards, specific findings not provided)
Temperature Profile	Measures temperature of curing cement in simulated physiologic solution. (Specific results not provided)
Solubility and Dissolution	Test samples cured and incubated at simulated physiological conditions for specified time and measured for solubility and dissolution. (Specific results not provided)
Tensile Testing	Test samples mixed and cured for 24 hours at simulated physiological conditions for a specified time and measured for solubility and dissolution. (Specific results not provided)
Dimensional Stability	Measured to establish that bone void fillers maintain shape and do not dissolve in an untimely manner. (Specific results not provided)
Physical Form	Samples imaged by SEM to determine microstructure. (Testing confirmed hydroxyapatite and calcium sulfate dihydrate crystal formation)
Biocompatibility	No new studies needed; identical to predicate device.
Sterilization and Shelf Life	Sterilized by gamma radiation to SAL of 10-6, validated according to ANSI/AAMI/ISO 11137:1995.
Bacterial Endotoxins	Meets acceptance limit of 20 EU/device according to USP<85> and USP<161>.
Animal Testing	No new studies needed; identical to predicate device.
Clinical Testing	Not required for this product category.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the "test set" or information on data provenance. The performance testing section describes general test methods performed, primarily on the predicate device. It does not refer to a "test set" in the context of clinical or comparative studies on the DB-Composite device.

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)

No clinical "test set" requiring expert ground truth is described for the DB-Composite device within this 510(k) summary. The evaluation relies on substantial equivalence to the predicate device and non-clinical performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No clinical "test set" or adjudication method is described.

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

No MRMC study was performed or is relevant here, as this device is a bone void filler, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to AI performance, which is not applicable to this medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests mentioned (e.g., pH profile, FTIR Analysis, Bacterial Endotoxins, etc.), the "ground truth" would be established by the standardized methods and instrument readings defined by the test protocols (e.g., ASTM F1185-03, USP<85>, USP<161>, mineralogic standards). No clinical ground truth (like pathology or outcomes data from new studies) was used for the DB-Composite device, as no new clinical studies were conducted or required.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Dimensional Bioceramics, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K210193

Trade/Device Name: DB-Composite 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: January 19, 2021 Received: January 25, 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,

for

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) K210193

Device Name

DB-Composite

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
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Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Number: K210193 Dated: March 12, 2021

Submitter: Dimensional Bioceramics, LLC

DB-Composite Traditional 510(k)

K210193

Section 5 510(k) Summary

SUBMITTER l.

Submitter Name	Dimensional Bioceramics, LLC
Submitter Address	2161 Delaware Avenue, Suite ASanta Cruz, CA 95060
Contact Person	Duran N. Yetkinler, M.D., Ph.D.
Phone Number	408-757-6603
Date Prepared	March 12, 2021

II. DEVICE

Trade Name	DB-Composite 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

III. PREDICATE AND REFERENCE DEVICES

Predicate Device	K112383, Skeletal Kinetics, Callos ProModel BoneVoid Filler
Reference Device	K182742, Dimensional Bioceramics, DB-Cranial

IV. INDICATIONS FOR USE

This submission has identical indications for use as the predicate device.

Indications For Use DB-Composite Bone Void Filler is indicated to fill Statement bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

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V. DEVICE DESCRIPTION

DB-Composite Bone Void Filler is a moldable and Device Identification biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation.
The 3cc, 5cc, and 10cc DB-Composite Bone Void Technological Characteristics Filler Kits are provided sterile to SAL 10-6 and are for single use only.

VI. PERFORMANCE TESTING

Test Method Summary: The following testing was performed on the predicate device and presented in the documentation in K112383.

Test	Test Method Summary
Working Time InVitro	Ensures sufficient manipulation time is provided whilealso ensuring setting times are met it the operativetheater.
Setting Time	Measures the time for a bone void filler to set insimulated physiologic conditions.
Heavy MetalAnalysis	Samples are analyzed for trace heavy metal contentusing ICP-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 subjectand predicate device following curing in simulatedphysiologic conditions.
CrystallographicAnalysis	XRD analysis is performed with samples set in simulatedphysiologic conditions for specified times and evaluatedusing powder x-ray diffraction and compared againstknown mineralogic standards.
TemperatureProfile	Device samples are tested in simulated physiologicsolution to measure temperature of curing cement.
Solubility andDissolution	Test samples are cured and incubated at simulatedphysiological conditions for a specified time andmeasured for solubility and dissolution.

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Test	Test Method Summary
Tensile Testing	Test samples were mixed and cured for 24 hours atsimulated physiological conditions for a specified timeand measured for solubility and dissolution.
DimensionalStability	Dimensional stability is measured to establish that thebone void fillers maintain shape and do not dissolve inan untimely manner.
Physical Form	Test samples were imaged by SEM to determinemicrostructure. Testing confirmed hydroxyapatite andcalcium sulfate dihydrate crystal formation.
Biocompatibility	No new biocompatibility studies were needed todemonstrate substantial equivalence. No changes to theproduct were made from the identical predicate device.
Sterilization andShelf Life	The product is sterilized by gamma radiation to a SAL of10-6 and validated according to ANSI/AAMI/ISO11137:1995.
BacterialEndotoxins	Testing, according to USP<85> and USP<161>, showedthe product meets the acceptance limit of 20 EU/device.
Animal Testing	No new animal studies were needed to demonstratesubstantial equivalence, since the device is identical tothe predicate device.
Clinical Testing	This product category does not require human clinicaltesting.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

DB-Composite Bone Void Filler's intended use and critical specifications are substantially equivalent to the predicate device, Skeletal Kinetics Callos ProModel Bone Void Filler.

Further, this product is composed of the identical materials, 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; but the manufacturing location for the Reference device is the same as the subject, DB-Composite, device.

There are no notable differences in comparison to the predicate device, therefore no questions related to safety and efficacy were raised.

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VIII. CONCLUSIONS

Based on the comparisons shown and the information provided in this 510(k), it can be concluded that DB-Composite is substantially equivalent to the predicate device Skeletal Kinetics Callos ProModel.

Regulation Number and Section

§ 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.