(30 days)
No
The device description and performance studies focus on the material properties and biological performance of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is intended to fill bony voids or gaps and is replaced by bone during the healing process, indicating a therapeutic effect on the skeletal system.
No
This device is a bone void filler, intended to fill bony voids or gaps in the skeletal system. It is a material used for treatment during surgery, not for diagnosing conditions.
No
The device description clearly states it is a moldable, injectable calcium phosphate bone void filler comprised of 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 phosphate, designed to be implanted into the body. IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information.
Therefore, DB-Orthopedics Bone Void Filler is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics 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-Orthopedics Bone Void Filler is a moldable, injectable and biocompatible calcium phosphate bone void filler. The DB-Orthopedics 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-Orthopedics Bone Void Filler kits are provided sterile to SAL of 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, 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)
- Working Time In Vitro: Ensures sufficient manipulation time is provided while also ensuring cement setting-times are met in the operative theater.
- Setting Time: This test measures the time for a bone void filler to set in simulated physiologic conditions.
- Ca to P Ratio: This test determines CA/P ratios via ICP-MS. DB-Orthopedics has a ratio of 1.5.
- 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 solutions surrounding curing cements.
- 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 solutions 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 temperature and pH. Tensile testing was performed using a mechanical tester and load at sample breakage was recorded and compared.
- 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 crystal formation.
- Biocompatibility: No biocompatibility studies were needed to demonstrate substantial equivalence. No changes to the product were made from the original submission.
- Pyrogenicity: Pyrogenicity (LAL) testing is routinely performed on the product.
- Sterilization and Shelf Life: The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Orthopedics Bone Void Filler will be labeled with a shelf life of 30 months.
- Animal Testing: No animal studies were needed to demonstration substantial equivalence.
- 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 Dr Indianapolis, Indiana 46250
Re: K200752
Trade/Device Name: DB-Orthopedics Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: March 17, 2020 Received: March 23, 2020
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 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
April 22, 2020
1
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,
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200752
Device Name
DB-Orthopedics
Indications for Use (Describe)
DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics 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) Summary – K200752
| I. SUBMITTER | ||
|---|---|---|
| Submitter Name: | Dimensional Bioceramics, LLC | |
| Submitter | ||
| Address: | 2161 Delaware Ave., Suite A | |
| Santa Cruz, CA 95060 | ||
| Contact Person: | ||
| Phone Number: | Duran N. Yetkinler, M.D., Ph.D. | |
| 408-757-6603 | ||
| Date Prepared: | March 17, 2020 | |
| II. DEVICE | ||
| Trade Name: | DB-Orthopedics Bone Void Filler | |
| Common Name | Bone Void Filler | |
| Classification | ||
| Name Number | ||
| Product Code | ||
| Regulatory | ||
| Class | Resorbable calcium salt bone void filler device | |
| 21 CFR 888.3045 | ||
| MQV | ||
| Class 2 | ||
| III. PREDICATE DEVICE | ||
| Primary | ||
| Predicate | ||
| Device: | K051123, Callos™ Bone Void Filler, Skeletal Kinetics | |
| Reference | ||
| Device: | K182742, DB-Cranial Bone Void Filler, Dimensional Bioceramics, LLC | |
| IV. INDICATIONS FOR USE | ||
| This submission expands the indications for use of the DB-Cranial 510(k) (Reference | ||
| Device K182742) clearance to orthopedics. | ||
| Indications for | ||
| Use Statement | DB-Orthopedics Bone Void Filler is indicated to fill bony voids or | |
| gaps of the skeletal system (i.e. extremities, spine, pelvis). These | ||
| defects may be surgically created osseous defects or osseous | ||
| defects created from traumatic injury to the bone. DB-Orthopedics | ||
| 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. | ||
| V. DEVICE DESCRIPTION | ||
| Device | ||
| Identification | DB-Orthopedics Bone Void Filler is a moldable, injectable and | |
| biocompatible calcium phosphate bone void filler. The DB- | ||
| Orthopedics 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. | ||
| Technological | ||
| Characteristics | The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits are | |
| provided sterile to SAL of 10-6 and are for single use only. | ||
| VI. PERFORMANCE TESTING | ||
| Test | Test Method Summary | |
| Working Time | ||
| In Vitro | Ensures sufficient manipulation time is provided while also ensuring | |
| cement setting-times are met in the operative theater. | ||
| Setting Time | This test measures the time for a bone void filler to set in simulated | |
| physiologic conditions. | ||
| Ca to P Ratio | This test determines CA/P ratios via ICP-MS. DB-Orthopedics has a | |
| ratio of 1.5. | ||
| 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 solutions surrounding | ||
| curing cements. | ||
| 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 solutions 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 | |
| temperature and pH. Tensile testing was performed using a | ||
| mechanical tester and load at sample breakage was recorded and | ||
| compared. | ||
| 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 crystal formation. | ||
| Biocompatibility | No biocompatibility studies were needed to demonstrate substantial | |
| equivalence. No changes to the product were made from the | ||
| original submission. | ||
| Pyrogenicity | Pyrogenicity (LAL) testing is routinely performed on the product. | |
| Sterilization and | ||
| Shelf Life | The sterilization method is gamma radiation. Sterilization validation | |
| is based on ISO 11137-2:2013 (VDMax25). | ||
| DB-Orthopedics Bone Void Filler will be labeled with a shelf life of 30 | ||
| months. | ||
| Animal Testing | No animal studies were needed to demonstration substantial equivalence. | |
| Clinical Testing | This product category does not require human clinical testing. |
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I
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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
DB-Orthopedics Bone Void Filler's intended use and critical specifications are identical to the predicate device, Skeletal Kinetics' Callos™ Bone Void Filler, K051123.
Further, this product is composed of the identical material, and is manufactured and packaged by the identical processes and in the identical facility, as the recently cleared Reference Device, K182742.
There are no notable differences in comparison to the predicate device, therefore, no questions related to safety and effectiveness were raised.
VIII. CONCLUSIONS
Based on the comparisons provided and the data submitted in this 510(k), it can be concluded the DB-Orthopedics is substantially equivalence to Callos™ predicate device.