(98 days)
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.
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.
The provided text describes the 510(k) summary for the Integra MOZAIK™ Osteoconductive Scaffold - Strip. This is a medical device application for a bone void filler, and the performance data presented is in the context of demonstrating substantial equivalence to a predicate device, not typically a standalone AI algorithm performance study.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
For this bone graft device, the "acceptance criteria" are implicitly demonstrated through substantial equivalence to a legally marketed predicate device (VITOSS® Scaffold Foam Bone Graft Matrix). The performance is characterized by attributes that are compared directly to the predicate.
| Feature / Acceptance Criteria (Implied by Predicate) | Integra MOZAIK™ Osteoconductive Scaffold - Strip Performance | VITOSS® Scaffold Foam Bone Graft Material (Predicate) |
|---|---|---|
| Indications for Use: - Bone void filler - Skeletal system (extremities, spine, pelvis) - Non-intrinsic stability defects - Surgically treated/traumatic osseous defects - Resorption & replacement by bone | Matches predicate's intended use, including specific applications in extremities, spine, and pelvis for non-intrinsic defects, and for surgically treated/traumatic defects, with subsequent resorption and replacement by bone. | Intended as a bone void filler for voids/gaps not intrinsic to stability, for surgically created/traumatic osseous defects, and for filling bony voids/gaps in the skeletal system (extremities, spine, and pelvis), with resorption and replacement by bone |
| Pore Structure (range) | 12 - 350 microns | 12 - 700 microns |
| 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 |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site |
| Biocompatibility | Biocompatible | Biocompatible |
| Resorption & Bone Growth | Demonstrated to support bone growth, ultimately resorbed and replaced by remodeled bone (based on animal study). | (Implied by osteoconductivity and intended use) |
2. Sample size used for the test set and the data provenance
The document states, "Integra MOZAIK Strip has been demonstrated to support bone growth in an animal study."
- Sample size for test set: Not specified beyond "an animal study."
- Data provenance: Prospective animal study. The country of origin is not specified but generally, such studies for FDA submission are conducted under GLP guidelines, often in the US or accredited international facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. Ground truth for an animal study proving bone growth would typically involve histological analysis by veterinary pathologists or bone histologists, but the specifics are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide this information.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done. This device is a bone void filler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study demonstrating bone growth, the ground truth would typically be established through pathology/histological analysis of the bone defects and surrounding tissue over time.
8. The sample size for the training set
This is not applicable as this is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical device, not an AI algorithm requiring a training set.
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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.
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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.
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| Feature | Integra MOZAIK™Osteoconductive Scaffold - Strip | VITOSS® Foam StripBone Graft Material |
|---|---|---|
| Manufacturer | Integra LifeSciences Corp. | Orthovita, Inc., Malvern, PA |
| 510(k) | K063124 | K032288 |
| Classification | MQV | MQV |
| Indications for Use | Integra MOZAIK™ OsteoconductiveScaffold - Strip is intended for use asa bone void filler to fill voids or gapsof the skeletal system in theextremities, spine, and pelvis notintrinsic to the stability of the bonystructure. Integra MOZAIK Strip isalso indicated for use in the treatmentof surgically treated osseous defectsor osseous defects created fromtraumatic injury to the bone.Following placement in the bonyvoid or gap (defect), IntegraMOZAIK is resorbed and replacedwith bone during the healing process. | VITOSS Scaffold Foam Bone GraftMaterial is intended for use as a bonevoid filler for voids or gaps that are notintrinsic to the stability of the bonystructure. VITOSS Scaffold Foam isindicated for use in the treatment ofsurgically created osseous defects orosseous defects created from traumaticinjury to the bone. VITOSS ScaffoldFoam should not be used to treat largedefects that in the surgeon's opinionwould fail to heal spontaneously.VITOSS Scaffold Foam Bone GraftMaterial is intended to be used for fillingbony voids or gaps of the skeletal system(i.e., the extremities, spine and pelvis).Following placement in the bony void orgap, the scaffold resorbs and is replacedwith bone during the healing process. |
| Target population | Individuals with bony defectsresulting from surgery or trauma | Individuals with bony defects resultingfrom surgery or trauma |
| Design | ||
| • Physical structure | Trabecular structure similar tocancellous bone in strip form. | Trabecular structure similar tocancellous bone in strips, cylinder andshape forms. |
| • Pore Structure(range) | 12 - 350 microns | 12 - 700 microns |
| Materials | ||
| • Chemicalcomposition | Calcium salt with Type I bovinecollagen | Calcium salt with Type I bovinecollagen |
| • Mineral Phase | β-Tricalcium phosphate Ca3(PO4)2per ASTM F1088 | β-Tricalcium phosphate Ca3(PO4)2per ASTM F1088 |
| Performance | ||
| • Osteoconductivity | Osteoconductive | Osteoconductive |
| • MechanicalStrength | Does not impart mechanical strengthto surgical site | Does not impart mechanical strength tosurgical site |
| Sterility | Sterilized by 100% ethylene oxidegas, single use only | Sterilized by gamma irradiation, singleuse only |
| Biocompatibility | Biocompatible | Biocompatible |
| Anatomical location | Bony voids or gaps of the skeletalsystem i.e. the extremities, spine andpelvis | Bony voids or gaps of the skeletalsystem i.e. the extremities, spine andpelvis |
| 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
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.
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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.
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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
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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
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E - 005
§ 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.