K Number

Device Name

DB-EZ Bone Void Filler

Manufacturer

Dimensional Bioceramics, LLC.

Date Cleared

2021-09-22

(55 days)

Product Code

MQV

Regulation Number

888.3045

Intended Use

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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K132211

Reference Devices

K210193

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone void filler material and its physical and chemical properties. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is described as a "bone void filler" that "resorbs and is replaced by bone during the healing process" to fill "bony voids or gaps" in the skeletal system. This indicates it directly facilitates the healing and restoration of bone tissue, qualifying it as a therapeutic device.

Diagnostic

No
Explanation: The device is a bone void filler intended to fill bony defects. It is a therapeutic device, not a diagnostic one, as it does not diagnose, identify, or monitor medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "pre-mixed moldable and biocompatible putty/paste bone void filler" consisting of "calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer". This describes a physical material, not software. The performance studies also focus on material properties and biological interactions, not software functionality.

IVD (In Vitro Diagnostic)

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 and a polymer. It is designed to be implanted and resorb, being replaced by bone. This is an implantable medical device, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide information about a patient's health status, which is the core function of an IVD.
Testing Summary: The testing performed focuses on the physical properties, biocompatibility, and performance of the material as a bone void filler (working time, setting time, strength, dissolution, etc.). These are relevant tests for an implantable device, not an IVD.

In summary, the DB-EZ Bone Void Filler is a medical device intended for surgical implantation to aid in bone healing, not a device used to perform diagnostic tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

MQV

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system (i.e. extremities and 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)

The following testing was performed on the predicate device and presented in the K132211 documentation:

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 crystal formation.
Biocompatibility: No new biocompatibility studies were needed to confirm biocompatibility and demonstrate substantial equivalence, because no changes to the product were made from the identical predicate device.
Sterilization and Shelf Life: The product is sterilized by E-beam to a SAL of 10^-6. Product is real time shelf life tested to one year.
Bacterial Endotoxins: Testing, according to USP and USP, showed the product meets the acceptance limit of 20EU/device.
Animal Testing: No new animal studies were needed to demonstrate substantial equivalence, since the subject 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)

K132211

Reference Device(s)

K210193

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

September 22, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized depiction of a human figure. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

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

Indications for Use

510(k) Number (if known) K212353

Device Name

DB-EZ Bone Void Filler

Indications for Use (Describe)

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 A
Santa Cruz, CA 95060
Contact Person
Phone 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 Bone
Void 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.

V. DEVICE DESCRIPTION

| Device Identification
and Technological
Characteristics | 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. |

---------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 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.

Test	Test Method Summary
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 new biocompatibility studies were needed to confirm
biocompatibility and demonstrate substantial equivalence,
because no changes to the product were made from the
identical predicate device.
Sterilization and
Shelf Life	The product is sterilized by E-beam to a SAL of $10^{-6}$ . Product
is real time shelf life tested to one year.
Bacterial
Endotoxins	Testing, according to USP and USP, showed the
product meets the acceptance limit of 20EU/device.
Animal Testing	No new animal studies were needed to demonstrate
substantial equivalence, since the subject device is identical
to 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).

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 for
osseous defects	A non-structural bone void filler for
osseous defects
Indications for
use	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.	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.
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
Materials Characteristics
Chemical
Composition	Calcium salt	Calcium salt
Starting
Reactants	A pre-formed putty/paste is made
by mixing Alpha tricalcium
phosphate, sodium phosphate
monohydrate anhydrous,
carboxymethyl cellulose with
bioinert polyethylene glycol based
polymer.	A pre-formed putty/paste is made
by mixing 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
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 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
Endotoxin	12 months	12 months
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Biocompatibility	Biocompatible	Biocompatible
Dosage /Size	5, 10 сс	5, 10 сс