(24 days)
Not Found
No
The description focuses on the material composition and physical structure of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to fill bone voids and facilitate bone regeneration, directly treating osseous defects from surgical or traumatic injury.
No
The device is described as a bone void filler and a bone grafting construct, used for repair of bony defects, not for diagnosis.
No
The device description clearly states it is a physical bone void filler made from collagen and calcium salt, not software.
Based on the provided information, the Integra MOZAIK™ Osteoconductive Scaffold - Strip is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to fill bone voids and gaps in the skeletal system and treat osseous defects. This is a therapeutic and structural function within the body.
- Device Description: The device is a bone void filler made from collagen and calcium salt, designed to be implanted into the body to facilitate bone repair.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Integra MOZAIK™ Osteoconductive Scaffold - Strip does not perform this function. It is a material implanted into the body.
Therefore, the Integra MOZAIK™ Osteoconductive Scaffold - Strip is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / 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™ Osteoconductive Scaffold - 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 MOZAIKTM Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is a porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (8-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088).
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - 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 quickly imbibes fluids, making it easy to combine bone marrow aspirate.
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip guides bone regeneration across a critical defect site into which the products are implanted. New bone forms in apposition to the matrix surface when the grafts are placed in direct contact with viable host bone. Ultimately, the matrices are resorbed and remodeled into bone.
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system in the extremities, spine, and pelvis; osseous defects
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 tests were conducted to demonstrate equivalence between the 5cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip and to ensure that 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip meets specification. All test results were acceptable.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Integra LifeSciences Corporation Ms. Nicole C. Harlan Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K141841
Trade/Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 7, 2014 Received: July 8, 2014
Dear Ms. Harlan:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Nicole C. Harlan
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 vours.
Lori A. Wiggins
for 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): K141841
Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc)
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 extremittes, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK™ Osteoconductive Scaffold - 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 MOZAIKTM Osteoconductive Scaffold - 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)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K141841
Page 1 of 1
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510(K) SUMMARY
Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc)
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Nicole C. Harlan Specialist, Regulatory Affairs Telephone: 609.750.2836 Fax: 609.275.9445
Date Summary was prepared:
July 3, 2014
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:
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is indentical in formulation, function and intended use to the predicate device, 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip, detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K063124 | MQV | Integra MOZAIK™ | |
| Osteoconductive | |||
| Scaffold - Strip | Integra LifeSciences | ||
| Corporation |
Device Description:
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is a porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (8-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088).
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - 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 quickly imbibes fluids, making it easy to combine bone marrow aspirate.
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip guides bone regeneration across a critical defect site into which the products are implanted. New bone forms in apposition to the matrix surface when the grafts are placed in direct contact with viable host bone. Ultimately, the matrices are resorbed and remodeled into bone.
4
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.
Intended 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. The 5cc Integra MOZAIKTM Osteoconductive Scaffold - 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), 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.
Substantial Equivalence Comparison:
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same materials. design, performance, and indications for use as the commercially marketed devices, 10cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124). The only difference between products will be in the mass and dimensions, the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip being a smaller size offering.
Testing and Test Results:
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same materials, critical specifications and intended use as the 10cc and 15cc Integra MOZAIKTM Osteoconductive Scaffold - Strip.
Based on the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (June 2, 2003), the 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip biocompatibility and in vivo performance testing will be applied to the 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip.
Performance tests were conducted to demonstrate equivalence between the 5cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip and to ensure that 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip meets specification. All test results were acceptable.
Conclusion:
The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is substantially equivalent to the commercially marketed device, 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124).
The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness.