(49 days)
No
The summary describes a bone void filler material and its physical and chemical properties, with no mention of AI or ML technology.
Yes
The device is indicated to fill bony voids or gaps of the skeletal system to aid in the healing process, clearly serving a therapeutic purpose.
No
Explanation: The device is a bone void filler used for structural support, not for diagnosing medical conditions.
No
The device description clearly states it is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler provided as a kit with powder and mixing solution, indicating it is a physical material, 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 to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is a bone void filler made of calcium sulfate/calcium phosphate. It is implanted into the body. IVDs are typically used to examine specimens from the body (like blood, urine, tissue) to diagnose conditions.
- Performance Studies: The performance studies focus on the physical and biological properties of the material itself (working time, setting time, pH, solubility, biocompatibility, etc.) and its interaction with the body, not on its ability to detect or measure substances in a biological sample for diagnostic purposes.
In summary, the device is an implantable medical device used for structural support and bone regeneration, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, posterolateral spine, pelvis)
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)
Test Method Summary: The following testing was performed on the predicate device and presented in the documentation in K112383.
Working Time In Vitro: Ensures sufficient manipulation time is provided while also ensuring setting times are met it the operative theater.
Setting Time: Measures the time for a bone void filler to set in simulated physiologic conditions.
Heavy Metal Analysis: Samples are analyzed for trace heavy metal content using ICP-MS according to ASTM F1185-03.
pH Profile: Examines effects of the device on pH surrounding the implanted device. pH is measured in physiologic buffer solution proximal to curing cement.
FTIR Analysis: This test identifies the chemical composition of subject and predicate device following curing in simulated physiologic conditions.
Crystallographic Analysis: XRD analysis is performed with samples set in simulated physiologic conditions for specified times and evaluated using powder x-ray diffraction and compared against known mineralogic standards.
Temperature Profile: Device samples are tested in simulated physiologic solution to measure temperature of curing cement.
Solubility and Dissolution: Test samples are cured and incubated at simulated physiological conditions for a specified time and measured for solubility and dissolution.
Tensile Testing: Test samples were mixed and cured for 24 hours at simulated physiological conditions for a specified time and measured for solubility and dissolution.
Dimensional Stability: Dimensional stability is measured to establish that the bone void fillers maintain shape and do not dissolve in an untimely manner.
Physical Form: Test samples were imaged by SEM to determine microstructure. Testing confirmed hydroxyapatite and calcium sulfate dihydrate crystal formation.
Biocompatibility: No new biocompatibility studies were needed to demonstrate substantial equivalence. No changes to the product were made from the identical predicate device.
Sterilization and Shelf Life: The product is sterilized by gamma radiation to a SAL of 10-6 and validated according to ANSI/AAMI/ISO 11137:1995.
Bacterial Endotoxins: Testing, according to USP and USP, showed the product meets the acceptance limit of 20 EU/device.
Animal Testing: No new animal studies were needed to demonstrate substantial equivalence, since the device is identical to the predicate device.
Clinical Testing: This product category does not require human clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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)
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.
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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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 A |
| Santa 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 Bone
Void 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 In | |
| Vitro | Ensures sufficient manipulation time is provided while |
| also ensuring setting times are met it the operative | |
| theater. | |
| Setting Time | Measures the time for a bone void filler to set in |
| simulated physiologic conditions. | |
| Heavy Metal | |
| Analysis | Samples are analyzed for trace heavy metal content |
| using ICP-MS according to ASTM F1185-03. | |
| pH Profile | Examines effects of the device on pH surrounding the |
| implanted device. pH is measured in physiologic buffer | |
| solution proximal to curing cement. | |
| FTIR Analysis | This test identifies the chemical composition of subject |
| and predicate device following curing in simulated | |
| physiologic conditions. | |
| Crystallographic | |
| Analysis | XRD analysis is performed with samples set in simulated |
| physiologic conditions for specified times and evaluated | |
| using powder x-ray diffraction and compared against | |
| known mineralogic standards. | |
| Temperature | |
| Profile | Device samples are tested in simulated physiologic |
| solution to measure temperature of curing cement. | |
| Solubility and | |
| Dissolution | Test samples are cured and incubated at simulated |
| physiological conditions for a specified time and | |
| measured for solubility and dissolution. |
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| Test | Test Method Summary |
|---|---|
| Tensile Testing | Test samples were mixed and cured for 24 hours at |
| simulated physiological conditions for a specified time | |
| and measured for solubility and dissolution. | |
| Dimensional | |
| Stability | Dimensional stability is measured to establish that the |
| bone void fillers maintain shape and do not dissolve in | |
| an untimely manner. | |
| Physical Form | Test samples were imaged by SEM to determine |
| microstructure. Testing confirmed hydroxyapatite and | |
| calcium sulfate dihydrate crystal formation. | |
| Biocompatibility | No new biocompatibility studies were needed to |
| demonstrate substantial equivalence. No changes to the | |
| product were made from the identical predicate device. | |
| Sterilization and | |
| Shelf Life | The product is sterilized by gamma radiation to a SAL of |
| 10-6 and validated according to ANSI/AAMI/ISO | |
| 11137:1995. | |
| Bacterial | |
| Endotoxins | Testing, according to USP and USP, showed |
| the product meets the acceptance limit of 20 EU/device. | |
| Animal Testing | No new animal studies were needed to demonstrate |
| substantial equivalence, since the device is identical to | |
| the predicate device. | |
| Clinical Testing | This product category does not require human clinical |
| testing. |
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.