(57 days)
Not Found
No
The summary describes a bone graft substitute material and its physical properties and intended use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for use as a bone void filler and guides the regeneration of bone, which indicates a therapeutic purpose in treating osseous defects.
No
The device is described as a "resorbable porous bone void filler for the repair of bony defects" and an "osteoconductive, porous implant." Its intended use is to fill voids or gaps in bone and guide bone regeneration. This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description clearly indicates it is a physical, resorbable porous bone void filler made of material with a trabecular structure, intended for implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is a resorbable porous bone void filler intended for surgical implantation to repair bony defects. It is a physical implant that interacts directly with the patient's body.
- Lack of Specimen Examination: The device does not involve the examination of specimens (like blood, urine, tissue samples) outside of the body.
Therefore, Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip falls under the category of a surgical implant or medical device used directly in the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) 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 process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 to 1000 um.
Vitoss BiModal Foam Strip guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BiModal Foam Strip is placed in direct contact with host bone, 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, pelvis and posterolateral spine)
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 BiModal Foam Strip is substantially equivalent to its predicate devices. The risk analysis determined that the predefined acceptance criteria was met for the following:
• Wettability and Fluid Retention Verification
• Porosity Verification
• Bioactivity Verification
• Clinical Handling Verification
• Product Stability throughout shelf-life
• Biocompatibility
• Design Validation
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.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other, forming a stylized representation of a person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Orthovita, Incorporated Ms. Meriam Gabera Senior Regulatory Affairs Specialist 59 Route 17 South Allendale, New Jersey 07401
Re: K153608
Trade/Device Name: Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 21, 2016 Received: January 22, 2016
Dear Ms. Gabera:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
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
510(k) Number (if known) K153608
Device Name
Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip
Indications for Use (Describe)
Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) 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 process.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Summary: Vitoss BiModal Foam Strip | |
|---|---|
| Submitter: | Stryker Orthobiologics |
| 74 East Swedesford Road | |
| Malvern, PA 19355 | |
| Contact Person | Meriam Gabera |
| Senior Regulatory Affairs Specialist | |
| Phone: 201-749-8043 | |
| Fax: 201-831-3000 | |
| Email: Meriam.Gabera@Stryker.com | |
| Date Prepared | December 16, 2015 |
| Trade Name | Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip |
| Common Name | Resorbable calcium salt bone void filler device |
| Proposed Class | Class II |
| Classification Name | |
| and Number | Filler, Bone Void, Calcium Compound |
| 888.3045 | |
| Product Code | MQV |
| Predicate Devices | Primary Predicate |
| Secondary Predicate | |
| Vitoss BA Foam Strip (K072184) | |
| Vitoss BiModal Foam Pack (K103173) | |
| Device Description | Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the |
| repair of bony defects. It is an osteoconductive, porous implant with a | |
| trabecular structure that resembles the multidirectional interconnected | |
| porosity of human cancellous bone. Pore diameters in the scaffold range | |
| from 1 to 1000 um. | |
| Vitoss BiModal Foam Strip guides the three-dimensional regeneration of | |
| bone in the defect site into which it is implanted. When Vitoss BiModal | |
| Foam Strip is placed in direct contact with host bone, 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. | |
| Intended Use | Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for | |
| use in the treatment of surgically created osseous defects or osseous defects | |
| created from traumatic injury to the bone. | |
| 510(k) Summary: Vitoss BiModal Foam Strip | |
| Vitoss BiModal Foam Strip is intended to be used for filling bony voids or | |
| gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral | |
| spine) 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 | As established in this submission, Vitoss BiModal Foam Strip was shown |
| to be substantially equivalent and has equivalent technological | |
| characteristics to its predicate device 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 BiModal Foam |
| Strip is substantially equivalent to its predicate devices. The risk analysis | |
| determined that the predefined acceptance criteria was met for the | |
| following: | |
| • Wettability and Fluid Retention Verification | |
| • Porosity Verification | |
| • Bioactivity Verification | |
| • Clinical Handling Verification | |
| • Product Stability throughout shelf-life | |
| • Biocompatibility | |
| • Design Validation | |
| Conclusion | The proposed Vitoss BiModal Foam Strip has identical 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 herein demonstrate the proposed device does not raise new | |
| questions of safety or effectiveness. Thus, the predicate devices (K072184 | |
| and K103173) and proposed device are considered substantially equivalent. |
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