K Number

Device Name

DB-CMF

Manufacturer

Dimensional Bioceramics, LLC

Date Cleared

2019-06-20

(265 days)

Product Code

GXP

Regulation Number

882.5300

Intended Use

DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.

Device Description

DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial 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-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.

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

K162864

Reference Devices

K162864

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a bone void filler material and its physical/chemical properties. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making component.

Therapeutic

No.
The device description indicates it is a calcium phosphate bone void filler for repairing cranial bone defects, acting as a structural filler rather than providing therapeutic treatment.

Diagnostic

Explanation: The device is a bone void filler intended for structural repair or augmentation of cranial bone, not for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a "moldable and biocompatible calcium phosphate bone void filler" comprised of a powder and a mixing solution, indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that DB-Cranial is a bone void filler for the repair or filling of cranial bone defects. This is a therapeutic and structural purpose, not a diagnostic one.
Device Description: The description details a moldable calcium phosphate material for implantation, not a reagent or instrument used to examine specimens from the human body.
Performance Studies: The performance studies focus on the physical and chemical properties of the material (working time, setting time, strength, etc.) and its equivalence to a predicate bone void filler. These are not studies related to diagnosing a condition or providing information about a patient's health status based on in vitro analysis.

IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. DB-Cranial is implanted into the body for structural repair.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GXP

Device Description

DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial 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-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only.
The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25).
DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial bone skeleton

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)

Performance Bench Testing was conducted including:

Working Time In-Vitro: Both subject and predicate device reached sufficient indentation loads to ensure targeted working time and setting strength.
Setting Time: Subject and predicate devices achieved similar setting strengths at all time points. Strength values of these two setting cements are substantially equivalent.
Ca to P Ratio: Both samples have a Ca/P ratio of 1.5. This test confirms both subject and predicate are composed of identical amounts of calcium and phosphate salts.
Kit Components: Both subject and predicate device consist of alpha-tricalcium phosphate (Powder) and sodium silicate-sodium phosphate solution (Liquid).
Heavy Metal Analysis: Trace metal limits were below allowable limits in both subject and predicate.
pH Profile: All pH readings remained within normal physiological range for both predicate and subject devices.
FTIR Analysis: Both subject and predicate device both show the formation of hydroxyapatite. Subject and predicate device are substantially equivalent with regards to FTIR chemical analysis.
Crystallographic Analysis: Both subject and predicate device are confirmed identical via crystallographic analysis. The same crystalline structure over several different clinically relevant time points is formed in both materials.
Temperature Profile: Both subject and predicate device set in an isothermic manner as designed. This demonstrates a minimal risk of thermal necrosis of tissue surrounding the implantation site. In this respect, both subject and predicate device are substantially equivalent.
Solubility and Dissolution: Both subject and predicate device have substantially equivalent solubility and dissolution.
Tensile Testing: Subject and predicate device demonstrated identical tensile strength at 24 hours and are substantially equivalent in terms of tensile strength.
Dimensional Stability: Subject and predicate are dimensionally stable materials with no discernable differences in form.
Physical Form: Both subject and predicate device demonstrated hydroxyapatite crystal formation. Subject and predicate device set to form hydroxyapatite in an identical manner.

Biocompatibility Testing: No biocompatibility studies were needed to demonstrate substantial equivalence.
Animal Testing: No animal studies were needed to demonstrate substantial equivalence.
Clinical Testing: This product type does not require clinical testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162864

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

June 20, 2019

Dimensional Bioceramics, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave. #509 Chevy Chase, Maryland 20815

Re: K182742

Trade/Device Name: DB-Cranial Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: May 20, 2019 Received: May 21, 2019

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 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,

Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K182742

Device Name DB-Cranial

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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510(k) Summary DB-Cranial

I. SUBMITTER
Submitter Name:	Dimensional Bioceramics, LLC
Submitter Address:	250 Natural Bridges Drive
Santa Cruz, CA 95050
Contact Person:
Telephone #:	Duran N. Yetkinler, M.D., Ph.D.
408-757-6603
Date Prepared:	May 6, 2019
II. DEVICE
Device Trade Name:	DB-Cranial
Common or Usual Name:	Hydroxyapatite Cement
Regulatory Name(s):	Methyl Methacrylate For Cranioplasty
Classification #:	21 CFR 882.5300
Product Code:	GXP
III. PREDICATE DEVICE(s)	K162864, OsteoVation® Impact
SkeletalKinetics , LLC
IV. DEVICE DESCRIPTION
Device Identification,
Characteristics,
Sterilization and Shelf life	DB-Cranial Bone Void Filler is a moldable and
biocompatible calcium phosphate bone void filler.
DB-Cranial 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-Cranial Bone Void Filler
kits are provided sterile to SAL of 10-6 and are for
single use only.
	The sterilization method is gamma radiation.
Sterilization validation is based on ISO 11137-
2:2013 (VDMax25).
	DB-Cranial Bone Void Filler will be labeled with a
shelf life of 30 months.
V. INDICATIONS FOR USE	DB-Cranial is a calcium phosphate bone void filler
indicated for repair or filling of neurosurgical burr
holes, other cranial bone defects and craniotomy
cuts with a surface area of no larger than 25cm².
DB-Cranial may be used in the restoration or
augmentation of bony contours of the cranial bone
skeleton.

VI. SUMMARY OF TESTING [PERFORMANCE DATA]
Performance Bench Testing
TEST	Test Method Summary	Results
Working Time
In-Vitro	Ensures sufficient manipulation
time is provided while also
ensuring cement setting-times
are met in the operative theater.
Mixing, mold-ability, and setting
strengths were measured	Both subject and predicate device
reached sufficient indentation
loads to ensure targeted working
time and setting strength
Setting Time	Setting tests determined strength
(Mean $\geq$ 450N and $\geq$ 700N) at
specified time points post
sterilization and post mixing.	Subject and predicate devices
achieved similar setting strengths
at all time points. Strength values
of these two setting cements are
substantially equivalent.
Ca to P Ratio	This test determines CA/P ratios
via ICP-MS.	Both samples have a Ca/P ratio of
1.5. This test confirms both subject
and predicate are composed of
identical amounts of calcium and
phosphate salts.
Kit Components	Kit ingredients are compared to
determine substantial
equivalence.	Both subject and predicate device
consist of alpha-tricalcium
phosphate (Powder) and sodium
silicate-sodium phosphate solution
(Liquid).
Heavy Metal
Analysis	Samples are analyzed for trace
heavy metal content using ICP-
MS.	Trace metal limits were below
allowable limits in both subject
and predicate.
pH Profile	Examines effects of the device on
pH surrounding the implanted
device. pH is measured in
physiologic buffer solutions
surrounding curing cements.	All pH readings remained within
normal physiological range for
both predicate and subject devices.
FTIR Analysis	This test identifies the chemical
composition of subject and
predicate device following curing
in simulated physiologic
conditions for 24 hours then dry
cured at 37°C for 72 hours.	Both subject and predicate device
both show the formation of
hydroxyapatite. Subject and
predicate device are substantially
equivalent with regards to FTIR
chemical analysis.
Crystallographic
Analysis	XRD analysis is performed with
samples set in simulated
physiologic conditions for 2
hours, 1 day, 3 days, and 7 days.
Samples are evaluated using
powder x-ray diffraction and
compared against known
mineralogic standards.	Both subject and predicate device
are confirmed identical via
crystallographic analysis. The
same crystalline structure over
several different clinically relevant
time points is formed in both
materials.
Temperature
Profile	Device samples are tested in
simulated physiologic solutions to
measure temperature of curing
cement. Temperatures above, at,
and below the level of the sample
are measured at 2 minute
intervals over 20 minutes.	Both subject and predicate device
set in an isothermic manner as
designed. This demonstrates a
minimal risk of thermal necrosis of
tissue surrounding the
implantation site. In this respect,
both subject and predicate device
are substantially equivalent.
Solubility and
Dissolution	Test samples are cured and
incubated at simulated
physiological conditions for 4
days; fluid is extracted and tested
for Ca2+ concentration via ICP-
AES. This experiment evaluates
solubility and dissolution.	Both subject and predicate device
have substantially equivalent
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.	Subject and predicate device
demonstrated identical tensile
strength at 24 hours and are
substantially equivalent in terms
of tensile strength.
Dimensional
Stability	Dimensional stability is measured
to establish that the bone void
fillers maintain shape and do not
dissolve in an untimely manner.	Subject and predicate are
dimensionally stable materials
with no discernable differences in
form.
Physical Form	Test samples were imaged by
SEM to determine
microstructural similarities and
differences.	Both subject and predicate device
demonstrated hydroxyapatite
crystal formation. Subject and
predicate device set to form
hydroxyapatite in an identical
manner.
Biocompatibility
Testing:	No biocompatibility studies were needed to demonstrate substantial
equivalence.
Animal Testing:	No animal studies were needed to demonstrate substantial equivalence.
Clinical Testing:	This product type does not require clinical testing.
VII. COMPARISON OF
TECHNOLOGICAL CHARACTERISTICS
WITH THE PREDICATE DEVICE	DB-Cranial intended use and critical specifications are substantially equivalent to the predicate device, OsteoVation Impact® (K162864), as shown by the comparative testing.

There are no notable differences in comparison to the predicate device, therefore no new questions related to safety and effectiveness were raised. | |
| VII. CONCLUSIONS | Based on the comparison provided and the data submitted in the 510(k), it can be concluded the DB- Cranial is substantially equivalent to the predicate device, OsteoVation Impact® (K162864). | |