(214 days)
Not Found
No
The summary describes a bone void filler material and its physical properties and intended use, with no mention of AI or ML technology.
Yes
The device is described as a bone void filler intended for use in the treatment of osseous defects and to guide bone regeneration, which are therapeutic applications.
No
The device is described as a "bone void filler" and a "resorbable bone void filler" intended to "facilitate the repair of bony defects" and "guide the regeneration of bone," not to diagnose conditions.
No
The device description clearly states it is a resorbable bone void filler made from a porous collagen matrix with B-TCP granules and cubes, which are physical components, 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 gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the physical composition and function of the device as a scaffold for bone regeneration. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to provide information about a patient's health status, disease, or condition.
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 implanted in vivo (inside the body) to facilitate bone healing.
N/A
Intended Use / Indications for Use
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MQV
Device Description
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbable bone void fillers made from a porous highly purified collagen matrix that has high purity beta tricalcium phosphate (B-TCP) granules and cubes dispersed throughout. The implant is provided sterile, non-pyrogenic, for single use in double peel packages.
The Integra Mozaik Moldable Morsels and Integra Moldable Morsels bone grafting construct are designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels quickly imbibe fluids, making it easy to combine with bone marrow aspirate.
Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels guide the regeneration of bone across the defect site into which the Moldable Morsels are 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
skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use, and are, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
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
XO9/302
DEC - 4 2009
Special 510(k) Premarket Notification Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Integra LifeSciences Corporation
510(K) SUMMARY
Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels
Submitter's name and address: Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Marilyn Konicky Director, Regulatory Affairs (609) 936-5563
Date: November 30, 2009
Name of the device:
| Proprietary Name: | Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Bone Void Filler |
|---|---|
| Common Name: | Filler, Bone Void, Calcium Compound, Product Code MQV |
| Classification Name: | Class II Regulation Number 888.3045 Orthopedic |
Classification Panel:
Substantial Equivalence:
Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are substantially equivalent in function and intended use to the currently marketed Integra MOZAIK Ostecondcutive Scaffold -Putty (K062353).
Intended Use:
Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.
1
Device Description:
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbable bone void fillers made from a porous highly purified collagen matrix that has high purity beta tricalcium phosphate (B-TCP) granules and cubes dispersed throughout. The implant is provided sterile, non-pyrogenic, for single use in double peel packages.
The Integra Mozaik Moldable Morsels and Integra Moldable Morsels bone grafting construct are designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels quickly imbibe fluids, making it easy to combine with bone marrow aspirate.
Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels guide the regeneration of bone across the defect site into which the Moldable Morsels are 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.
Conclusion:
Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use, and are, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with the head, torso, and legs represented by flowing lines. The figure is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Peter Allan Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536
DEC = 4 2009
Re: K091302
Trade/Device Name: Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 05, 2009 Received: November 06, 2009
Dear Mr. Allan:
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 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
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Page 2 - Mr. Peter Allan
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K091302
Device Name: Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels
Indications for Use:
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Moldable Morsels and Integra OS Moldable Morsels are 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)
FOR M. MELKERSON
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091302