(131 days)
Not Found
No
The summary describes a synthetic bone graft substitute and its physical properties and performance testing, with no mention of AI or ML.
Yes
The device is described as a "bone void filler" used for "treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone," indicating its use in therapy (healing/repair of defects).
No
Explanation: The device is intended for use as a bone void filler and is applied to existing defects, as opposed to diagnosing conditions or diseases.
No
The device is a physical bone graft substitute made from materials like beta tricalcium phosphate and bioactive glass, provided in a syringe for injection. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Vitoss BA Injectable is a "bone void filler" for surgically created or traumatic osseous defects. This describes a device used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a synthetic resorbable porous bone void filler that is injected into the body and resorbs over time as bone grows. This is consistent with an implantable or surgically applied device, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples (like blood, urine, or tissue) to diagnose a disease or condition. Its function is to physically fill a void in bone.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Vitoss BA Injectable does not fit this description.
N/A
Intended Use / Indications for Use
Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, FMF
Device Description
Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone void filler for the repair of bony defects made from a combination of beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin and sodium carboxymethyl cellulose. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a specified volume of hydration fluid is combined with the dry component of the device. Mixing is facilitated by a syringe to syringe mixing system. The resulting material can be administered to the treatment site by injection through a cannula or by manual application. After injection or insertion into the defect site new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the 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)
Risk analysis was performed to demonstrate that Vitoss BA Injectable is substantially equivalent to its predicate devices. The risk analysis determined that the predefined acceptance criteria was met for the following:
• Comparative animal performance testing in a rabbit model
• Bioactivity testing included in-vitro studies in which calcium phosphate growth was induced on the surface of Vitoss Bioactive Injectable in the presence of simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component. The bioactivity has not been evaluated in human clinical trials.
• Permeability testing
• Irrigation testing
• Usability testing
• Extrusion testing
• Packaging and shelf life validations
• Sterilization validation
• Biocompatibility
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.
K081439, K103173, K141600, K132868
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2017
Orthovita, Inc. % John Rossman Regulatory Affairs Project Manager Stryker Corporation Stryker Spine 59 Route 17 South Allendale, New Jersey 07401
Re: K163621
Trade/Device Name: Vitoss Bioactive (BA) Injectable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 13, 2017 Received: March 17, 2017
Dear Mr. Rossman:
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 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
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the quality systems (OS) 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 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 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,
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163621
Device Name Vitoss Bioactive (BA) Injectable
Indications for Use (Describe)
Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with 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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Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is centered and takes up most of the image.
| 510(k) Summary: | Vitoss BA Injectable Bone Graft Substitute |
|---|---|
| Submitter: | Stryker Orthobiologics |
| 74 East Swedesford Road | |
| Malvern, PA 19355 | |
| Contact Person : | Name: John Rossman |
| Phone: (201) 749-8193 | |
| Fax: (201) 831-3000 | |
| Email: john.rossman@stryker.com | |
| Date Prepared: | 04/24/2017 |
| Trade Name: | Vitoss Bioactive (BA) Injectable |
| Common Name: | Resorbable calcium salt bone void filler device |
| Proposed Class: | Class II |
| Classification Name: | Filler, Bone Void, Calcium Compound (21 CFR 888.3045) |
| Syringe, Piston (21 CFR 880.5860) | |
| Product Code: | MQV |
| FMF | |
| Predicate Devices: | Primary Predicate: |
| Vitoss BA Foam Pack (K081439) |
Additional Predicates:
Vitoss BA BiModal (K103173)
NanOss Bioactive Loaded (K141600)
Carricell (K132868) |
| Device Description: | Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous
bone void filler for the repair of bony defects made from a combination of
beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin
and sodium carboxymethyl cellulose. It is an osteoconductive porous implant
with a trabecular structure that resembles the multidirectional
interconnected porosity of human cancellous bone.
Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a
specified volume of hydration fluid is combined with the dry component of
the device. Mixing is facilitated by a syringe to syringe mixing system. The
resulting material can be administered to the treatment site by injection
through a cannula or by manual application. After injection or insertion into
the defect site new bone grows in apposition to the surfaces of the implant. As
the implant resorbs, bone and other connective tissues grow into the space
previously occupied by the scaffold. |
| 510(k) Summary: Vitoss BA Injectable Bone Graft Substitute | |
| Intended Use: | Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps
that are not intrinsic to the stability of the bony structure. Vitoss BA
Injectable is indicated for use in the treatment of surgically created osseous
defects or osseous defects created from traumatic injury to the bone.
Vitoss BA Injectable is intended to be used for filling bony voids and gaps of
the skeletal system (i.e. the extremities and pelvis), and may be combined
with saline, autogenous blood, and/or bone marrow. Following placement in
the bony void or gap, the scaffold resorbs and is replaced with bone during
the healing process. |
| Summary of the
Technological
Characteristics | Vitoss BA Injectable was shown to be substantially equivalent and has
equivalent technological characteristics to its predicate devices through
comparison in areas including intended use, material composition,
principles of operation and design. |
| Summary of the
Performance Data | Risk analysis was performed to demonstrate that Vitoss BA Injectable is
substantially equivalent to its predicate devices. The risk analysis
determined that the predefined acceptance criteria was met for the following:
• Comparative animal performance testing in a rabbit model
• Bioactivity testing included in-vitro studies in which calcium phosphate
growth was induced on the surface of Vitoss Bioactive Injectable in the
presence of simulated body fluid. This phenomenon was not observed in
control samples in which there was no bioactive glass component. The
bioactivity has not been evaluated in human clinical trials.
• Permeability testing
• Irrigation testing
• Usability testing
• Extrusion testing
• Packaging and shelf life validations
• Sterilization validation
• Biocompatibility |
| Conclusion | The proposed Vitoss BA Injectable has equivalent indications, technological
characteristics, and principles of operation as its predicates. The risk
analysis performed demonstrates that any minor differences do not impact
device performance as compared to the predicates. The design verifications
and validations performed as a result of the risk analysis and presented in the
submission demonstrate the proposed device does not raise new questions of
safety or effectiveness. Thus, the aforementioned predicate devices and
subject device are considered substantially equivalent. |
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