(98 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
The device is a bone void filler intended to facilitate the repair and regeneration of bone in skeletal defects, which directly addresses a medical condition or aims to restore physiological function.
No
This device is a bone void filler intended for use in the skeletal system to facilitate bone repair and regeneration, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made from collagen and tricalcium phosphate, intended for surgical implantation as a bone void filler. It is a hardware device, 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 the device is a "bone void filler" used to "fill voids or gaps of the skeletal system" and is "resorbed and replaced with bone during the healing process." This describes a device that is implanted into the body to facilitate bone repair.
- Device Description: The description details a "resorbable bone void filler made from a porous highly purified collagen matrix" with "tricalcium phosphate (TCP) granules." It explains how it "guides the regeneration of bone" and is "implanted." This further reinforces its function as an implantable medical device for bone repair.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples, analysis of biological markers, or diagnostic purposes.
Therefore, the Integra MOZAIK Osteoconductive Scaffold - Strip is a medical device intended for surgical implantation to aid in bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integra MOZAIK Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.
Product codes
MQV
Device Description
The Integra MOZAIK™ Osteoconductive Scaffold – Strip is a resorbable bone void filler made from a porous highly purified collagen matrix that high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Integra MOZAIK Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure of the Integra MOZAIK Strip quickly imbibes fluids, making it easy to mx with bone marrow aspirate or blood.
Integra MOZAIK Strip guides the regeneration of bone across a critical defect site into which the strip is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Integra MOZAIK Strip has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone. These results, in conjunction with in vitro product characterization studies, performance testing and biocompatibility data demonstrate that Integra MOZAIK Osteoconductive Scaffold -Strip is as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
510(K) SUMMARY
Integra MOZAIK™ Osteoconductive Scaffold
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
JAN | 9 2007
Contact person and telephone number:
Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:
Date Summary was prepared:
December 11, 2006
Name of the device:
| Proprietary Name: | Integra MOZAIK™ Osteoconductive Scaffold – Strip |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name: | Filler, Bone Void, Calcium Compound |
| Product Code: | MQV |
Substantial Equivalence:
Integra MOZAIK Osteoconductive Scaffold - Strip is substantially equivalent in function and intended use to VITOSS® Scaffold Foam Bone Graft Matrix which has been cleared to market under Premarket Notification 510(k) K032288.
Device Description:
The Integra MOZAIK™ Osteoconductive Scaffold – Strip is a resorbable bone void filler made from a porous highly purified collagen matrix that high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Integra MOZAIK Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure of the Integra MOZAIK Strip quickly imbibes fluids, making it easy to mx with bone marrow aspirate or blood.
Integra MOZAIK Strip guides the regeneration of bone across a critical defect site into which the strip is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Intended Use:
The Integra MOZAIK Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.
1
Performance Data:
.
Integra MOZAIK Strip has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone. These results, in conjunction with in vitro product characterization studies, performance testing and biocompatibility data demonstrate that Integra MOZAIK Osteoconductive Scaffold -Strip is as safe and effective as its predicate device.
2
| Feature | Integra MOZAIK™
Osteoconductive Scaffold - Strip | VITOSS® Foam Strip
Bone Graft Material |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Integra LifeSciences Corp. | Orthovita, Inc., Malvern, PA |
| 510(k) | K063124 | K032288 |
| Classification | MQV | MQV |
| Indications for Use | Integra MOZAIK™ Osteoconductive
Scaffold - Strip is intended for use as
a bone void filler to fill voids or gaps
of the skeletal system in the
extremities, spine, and pelvis not
intrinsic to the stability of the bony
structure. Integra MOZAIK Strip is
also indicated for use in the treatment
of surgically treated osseous defects
or osseous defects created from
traumatic injury to the bone.
Following placement in the bony
void or gap (defect), Integra
MOZAIK is resorbed and replaced
with bone during the healing process. | VITOSS Scaffold Foam Bone Graft
Material 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 Scaffold Foam is
indicated for use in the treatment of
surgically created osseous defects or
osseous defects created from traumatic
injury to the bone. VITOSS Scaffold
Foam should not be used to treat large
defects that in the surgeon's opinion
would fail to heal spontaneously.
VITOSS Scaffold Foam Bone Graft
Material 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. |
| Target population | Individuals with bony defects
resulting from surgery or trauma | Individuals with bony defects resulting
from surgery or trauma |
| Design | | |
| • Physical structure | Trabecular structure similar to
cancellous bone in strip form. | Trabecular structure similar to
cancellous bone in strips, cylinder and
shape forms. |
| • Pore Structure
(range) | 12 - 350 microns | 12 - 700 microns |
| Materials | | |
| • Chemical
composition | Calcium salt with Type I bovine
collagen | Calcium salt with Type I bovine
collagen |
| • Mineral Phase | β-Tricalcium phosphate Ca3(PO4)2
per ASTM F1088 | β-Tricalcium phosphate Ca3(PO4)2
per ASTM F1088 |
| Performance | | |
| • Osteoconductivity | Osteoconductive | Osteoconductive |
| • Mechanical
Strength | Does not impart mechanical strength
to surgical site | Does not impart mechanical strength to
surgical site |
| Sterility | Sterilized by 100% ethylene oxide
gas, single use only | Sterilized by gamma irradiation, single
use only |
| Biocompatibility | Biocompatible | Biocompatible |
| Anatomical location | Bony voids or gaps of the skeletal
system i.e. the extremities, spine and
pelvis | Bony voids or gaps of the skeletal
system i.e. the extremities, spine and
pelvis |
| Dosage Form(s) | 15 cc (25 x 100 x 6mm) | 25 x 50 x 4mm (5cc)
25 x 100 x 8mm (20cc)
25 x 100 x 4mm (10cc)
75 x 100 x 4mm (30cc) |
Substantial Equivalence Comparison Chart
.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integra LifeSciences Corporation % Ms. Diana Bordon Manager, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
JAN 1 9 2007
Re: K063124
Trade/Device Name: MOZAIK™ Osteoconductive Scaffold - Strips -Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 12, 2006 Received: December 14, 2006
Dear Ms. Bordon:
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.
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 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.
4
Page 2 – Ms. Diana Bordon
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
barbara Bruckm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip
Indications For Use: The Integra MOZAIK Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehrig for mxm
(Division Sign-off)
Division of General, Restorative, and Neurological Devices
510(k) Number K063124
Page 1 of 1
E - 005