(196 days)
Not Found
No
The device description and summary of performance studies focus on the material composition and biological properties of the bone graft material, with no mention of AI or ML technology.
Yes.
The device is intended for use in filling bony voids or gaps of the skeletal system, which directly addresses and treats a medical condition.
No.
This device is described as a bone graft material intended for filling bony voids, which is a therapeutic rather than a diagnostic function.
No
The device is a physical bone graft material, not software. The description details its composition and form (granules or blocks).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The device is a bone graft material, designed to be implanted into the body to aid in bone repair. IVDs are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples, detect markers, or provide diagnostic information.
The device is clearly intended for surgical implantation and bone regeneration, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MOV
Device Description
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the products is physically and chemically comparable to the mineralized matrix of human bone. The composition of the Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. Anorganic Bone Mineral Collagen and Anorganic Bone Mineral Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skeletal system (i.e., 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
An animal study was performed to verify substantial equivalence and effectiveness of the product.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and animal study, show that Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are safe and substantially equivalent to its predicates.
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.
ORTHOSST™ Resorbable Bone Void Filler, K014289, VITOSS® Scaffold Synthetic Cancellous Bone Void Filler, K032409, OsteoGuide® Anorganic Bone Mineral Products, K043034
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
K06 2200
510(k) Summary of Safety and Effectiveness
FEB 1 3 2007
| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Sr. Director, Clinical, Regulatory, and QA
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | July 28, 2006 |
| Device Common Name: | Bone Grafting Material
Bone Void Filler |
| Device Trade Name: | Collagen Matrix Anorganic Bone Mineral Bone Graft
Materials |
| Device Classification Name:
Regulation Number:
Device Class:
Product Code: | Filler, Bone Void, Calcium Compound
888.3045
Class II
MQV |
| Predicate Device(s): | ORTHOSST™ Resorbable Bone Void Filler, K014289
VITOSS® Scaffold Synthetic Cancellous Bone Void
Filler, K032409
OsteoGuide® Anorganic Bone Mineral Products, K043034 |
Description of the Device
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the products is physically and chemically comparable to the mineralized matrix of human bone. The composition of the Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. Anorganic Bone Mineral Collagen and Anorganic Bone Mineral Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.
1
....
Intended Use
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
Summary/Comparison of Technical Characteristics
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials and their predicates have the same technological characteristics. In particular, Collagen Matrix Anorganic Bone Mineral Bone Graft Materials and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.
Safety
Collagen Matrix Anorganic Bone Mineral Bone Graft Materials have been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Effectiveness
The characteristics of the Collagen Matrix Anorganic Bone Mineral Bone Graft Materials meet the design requirements for an effective bone grafting material. An animal study was performed to verify substantial equivalence and effectiveness of the product.
Conclusion
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and animal study, show that Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are safe and substantially equivalent to its predicates.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2007
Collagen Matrix, Inc. c/o Ms. Peggy Hansen, RAC Sr. Director, Clinical, Regulatory, and Quality Assurance 509 Commerce St. Franklin Lakes, NJ 07417
Re: K062200 -
Device Name: Collagen Matrix Anorganic Bone Mineral Bone Graft Materials Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 16, 2006 Received: November 17, 2006
Dear Ms. Hansen:
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
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Page 2 - Ms. Peggy Hansen, RAC
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 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 vours.
Barbara Buchins
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: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Anorganic Bone Mineral Bone Graft Materials are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrjwic to the stability of the bony structure. These defects may be surgically created osseous. defects or osseous defects resulting from traumatic injury to the bone.
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)
Barbere Brechun
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _1
510(k) Number Kole 2200