(158 days)
Not Found
No
The summary describes a bone graft substitute material and its physical and chemical properties, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device is a bone void filler intended to facilitate bone healing and regeneration, which qualifies it as a therapeutic device.
No
This device is a bone graft substitute intended to fill bone voids and gaps, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "Bone Void Filler Kit" containing "medical grade calcium sulfate powder and mixing solution," which are physical components, 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 as a bone graft substitute for filling bone voids and gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a material (calcium sulfate) that is implanted into the body to aid in bone healing. It does not analyze samples taken from the body to provide diagnostic information.
- Performance Studies: The performance studies focus on material properties (chemistry, crystallinity, etc.), biocompatibility, pyrogenicity, sterilization, shelf-life, and animal studies evaluating bone healing. These are all relevant to an implantable medical device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
In summary, the device is a therapeutic medical device used for bone repair, not a diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.
Product codes
MOV
Device Description
Dimensional Bioceramics (DB) Calcium Sulfate Device (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile for single patient use. The Kit contains medical grade calcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterile mixing bowl, the resultant paste may be injected, digitally implanted, or applied to a mold to produce pellets. DB-CSD resorbs and is replaced with bone during the healing process. DB-CSD is a moldable, biocompatible, biodegradable, and resorbable calcium sulfate material that is to be applied directly to the intended sites. It may be used within an infected site. The critical specifications are chemistry, crystallinity, physical form, porosity, and solubility.
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
- Laboratory Testing: Critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) of DB-CSD were compared with those of the predicate device. Chemistry was determined by Fourier Transformed Infrared Spectroscopy (FTIR) and X-ray Diffraction (XRD) techniques. Crystallinity was determined by X-ray Diffraction. Physical form was determined by Scanning Electron Microscopy. Porosity was determined by Mercury Intrusion Porosimetry. Solubility was measured in vitro dissolution method measuring Ca2+ ion concentration in solution using Inductively Coupled Plasma - Atomic Emission Spectroscopy.
- Biocompatibility Testing: Biocompatibility tests, according to ISO 10993-1 were performed and are provided in the 510(k) documentation. They demonstrated DB-CSD met the requirements of the ISO standards.
- Pyrogenicity Testing: ISO Materials Mediated Rabbit Pyrogen testing was performed and provided in the 510(k). The results of the testing indicate the DB-CSD is non-pyrogenic.
- Sterilization and Shelf-Life Testing: DB-CSD will be provided as a single use, sterile medical device. The radiation dose of 25k Gy-40 kGy has been validated in accordance with ISO 11137-2006, Sterilization of Health Care Products - Radiation to Sterility Assurance Level (SAL) 10-6.
- Animal Testing: An animal study was performed to analyze the biocompatibility, implant resorption, bone formation, and surgical handling properties following metaphyseal implantation in an ovine, critical size, cancellous bone defect model. No abnormal acute hematologic and major organ toxicity was observed in both subject and predicate devices. Histological and radiographic data demonstrated that both materials appeared to be biocompatible, and complete resorption of the implanted regions, followed by normal bone healing occurred for both subject and predicate devices by 12 weeks.
- Clinical Testing: N/A: This product type does not require clinical testing.
- Key Results: Performance test results demonstrated that DB-CSD has substantially equivalent critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) as the predicate device, Stimulan Bone Void Filler.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Dimensional Bioceramics™ LLC % Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase, Maryland 20815
September 25, 2017
Re: K171161
Trade/Device Name: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: August 14, 2017 Received: August 17, 2017
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171161
Device Name Dimensional Bioceramics Calcium Sulfate Device (DB - CSD)
Indications for Use (Describe)
Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and may be used in an infected site.
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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K171161 510(k) SUMMARY DB-CSD
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Dimensional Bioceramics™ LLC |
| Submitter Address: | 163 McKenzie Creek Road |
| Scotts Valley, CA 95066 | |
| Contact Person: | |
| Telephone #: | David Delaney, Director |
| 831.234.4892 | |
| Date Prepared: | August 14, 2017 |
| II. DEVICE | |
| Device Trade Name: | Dimensional Bioceramics Calcium Sulfate Device |
| (DB-CSD) | |
| Regulatory Name(s): | Resorbable Calcium Sulfate Bone Void Filler |
| Classification #: | 21 CFR 888.3045 |
| Product Code: | MQV |
| III. PREDICATE DEVICE(s) | K141830, Stimulan Rapid Cure, Biocomposites, Ltd. |
| IV. DEVICE DESCRIPTION | |
| Device Identification, | |
| Characteristics, | |
| Mechanism of Action: | Dimensional Bioceramics (DB) Calcium Sulfate Device |
| (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile | |
| for single patient use. The Kit contains medical grade | |
| calcium sulfate powder and mixing solution in pre- | |
| measured quantities. When mixed together in a sterile | |
| mixing bowl, the resultant paste may be injected, digitally | |
| implanted, or applied to a mold to produce pellets. |
DB-CSD resorbs and is replaced with bone during the
healing process.
DB-CSD is a moldable, biocompatible, biodegradable,
and resorbable calcium sulfate material that is to be
applied directly to the intended sites. It may be used
within an infected site.
The critical specifications are chemistry, crystallinity,
physical form, porosity, and solubility. |
| V. INDICATIONS FOR USE | Dimensional Bioceramics™ (DB) Calcium Sulfate Device
(CSD) is a bone graft substitute that is intended for use
as a bone void filler for voids and gaps and pelvis that
are not intrinsic to the stability of the bony structure.
These osseous defects may be surgically created or
created from a traumatic injury to the bone. DB-CSD is
intended to be gently packed into bony voids or gaps of
the skeletal system (i.e., extremities and pelvis). DB-
CSD is a bone graft substitute that resorbs and replaced
with bone during the healing process. DB-CSD is
biodegradable and biocompatible and may be used in an
infected site. |
| VI. SUMMARY OF TESTING
[PERFORMANCE DATA] | Performance, Safety and Biocompatibility test data are
provided in the 510(k) application. They include the
following: |
| Laboratory Testing | Critical specifications (chemistry, crystallinity, physical
form, porosity, and solubility) of DB-CSD were compared
with those of the predicate device. Chemistry was
determined by Fourier Transformed Infrared
Spectroscopy (FTIR) and X-ray Diffraction (XRD)
techniques. Crystallinity was determined by X-ray
Diffraction. Physical form was determined by Scanning
Electron Microscopy. Porosity was determined by
Mercury Intrusion Porosimetry. Solubility was measured
in vitro dissolution method measuring Ca2+ ion
concentration in solution using Inductively Coupled
Plasma - Atomic Emission Spectroscopy. |
| Biocompatibility Testing: | Biocompatibility tests, according to ISO 10993-1 were
performed and are provided in the 510(k)
documentation. They demonstrated DB-CSD met the
requirements of the ISO standards. |
| Pyrogenicity Testing: | ISO Materials Mediated Rabbit Pyrogen testing was
performed and provided in the 510(k). The results of the
testing indicate the DB-CSD is non-pyrogenic. |
| Sterilization and Shelf-Life
Testing | DB-CSD will be provided as a single use, sterile medical
device. The radiation dose of 25k Gy-40 kGy has been
validated in accordance with ISO 11137-2006,
Sterilization of Health Care Products - Radiation to
Sterility Assurance Level (SAL) 10-6. |
| Animal Testing: | An animal study was performed to analyze the
biocompatibility, implant resorption, bone formation, and
surgical handling properties following metaphyseal
implantation in an ovine, critical size, cancellous bone
defect model. No abnormal acute hematologic and
major organ toxicity was observed in both subject and
predicate devices. Histological and radiographic data
demonstrated that both materials appeared to be |
| | biocompatible, and complete resorption of the implanted
regions, followed by normal bone healing occurred for
both subject and predicate devices by 12 weeks. |
| Clinical Testing: | N/A: This product type does not require clinical testing. |
| VII. COMPARISON OF
TECHNOLOGICAL
CHARACTERISTICS WITH
THE PREDICATE DEVICE | DB-CSD intended use and critical specifications are
substantially equivalent to the predicate device, Stimulan
Rapid Cure of Biocomposites Ltd (K141830). |
| | Both medical devices are composed of a hydrated
calcium sulfate salt that is implanted following mixing
with a solution component that yields 5, 10, or 20 cc. |
| | Performance test results demonstrated that DB-CSD has
substantially equivalent critical specifications (chemistry,
crystallinity, physical form, porosity, and solubility) as the
predicate device, Stimulan Bone Void Filler. |
| VIII. CONCLUSIONS | Based on the comparison provided and the data
submitted in the 510(k), it can be concluded the DB-CSD
is substantially equivalent to the predicate device,
Stimulan - Rapid Cure Bone Void Filler (K141830). |
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