(43 days)
No
The summary describes a bone graft substitute material and its physical properties and performance in in-vitro studies. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a bone void filler intended to facilitate bone healing, not to treat or diagnose specific diseases or conditions other than repairing structural defects.
No
Explanation: The provided text describes Vitoss Bioactive Foam as a bone graft substitute used for filling voids or gaps in bone. Its purpose is to facilitate bone healing, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical implant (resorbable, osteoconductive implant with a trabecular structure) and not a software product.
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 Bioactive Foam is a bone void filler for surgical and traumatic osseous defects. It is an implant placed directly into the body to aid in bone healing.
- Device Description: The description details a resorbable, osteoconductive implant with a trabecular structure. This describes a physical device intended for implantation.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. The in-vitro studies mentioned are for evaluating the material's properties (calcium phosphate growth) and are not a diagnostic test performed on a patient sample.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a therapeutic implant.
N/A
Intended Use / Indications for Use
Vitoss® Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use statement: Vitoss Bioactive Foam Bone Graft Substitute 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 Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
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, spine 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)
Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design r orrormative sond performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended. Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component. The osteostimulatory nature of Vitoss Bioactive Foam has not been correlated to human clinical experience.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032288, K052494, K060728, K062459
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.
0
K672/84
510(k) SUMMARY
SEP 1 8 2007
VITOSS® BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355
Phone: (610) 640-1775
Facsimile: (610) 640-1714
Contact Person: Gina M. Nagvajara, Ph.D. V.P., Regulatory Affairs
Date Prepared: August 3, 2007
Common or Usual Name - Vitoss® Bone Graft Substitute- Bioactive Foam Strip, Vitoss® BA Bone Graft Substitute- Bioactive Foam Strip, Bone Graft Substitute
Classification Name - Bone Void Filler
Product Code -MQV
Predicate Devices
-
Orthovita, Inc. - Vitoss Scaffold Foam Bone Graft Substitute (K032288)
-
NovaBone – NovaBone Bioactive Synthetic Graft (K052494)
-
NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728)
-
Nanotherapeutics - Origen DBM with Bioactive Glass (K062459)
Intended Use / Indications for Use
Vitoss® Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use statement:
1
Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void v thoss Dioactive I vann that are not intrinsic to the stability of the bony structure. ffiter for volus of gaps that area for use in the treatment of surgically created v tross Droactive Fount is marcants created from traumatic injury to the bone. osseous derects of own should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Technological Characteristics
Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
Performance Data
Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design r orrormative sond performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended.
Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component. The osteostimulatory nature of Vitoss Bioactive Foam has not been correlated to human clinical experience.
Substantial Equivalence
Vitoss Bioactive Foam is as safe and effective as its predicates. Vitoss Bioactive Foam has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences between Vitoss Bioactive Foam and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that Vitoss Bioactive Foam is as safe and effective as its predicate devices. Thus, Vitoss Bioactive Foam is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthovita, Inc. % Gina M. Nagvajara, Ph.D. V.P., Regulatory Affairs 45 Great Valley Parkway Malvern, PA 19355
SEP 1 8 2007
Re: K072184
Trade/Device Name: Vitoss® Bone Graft Substitute-Bioactive Foam Strip, Vitoss® BA Bone Graft Substitute- Bioactive Foam Strip, Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 3, 2007 Received: August 6, 2007
Dear Dr. Nagvajara:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Dr. Gina M. Nagvajara
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Soubave Pucum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Vitoss Bioactive Foam 510(k) Notification Orthovita, Inc.
510(k) Number (if known):
Device Name: Vitoss® Bioactive Foam Bone Graft Substitute
INDICATIONS FOR USE:
Vitoss Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use statement:
Vitoss Bioactive Foam Bone Graft Substitute 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 Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bonell
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072184