(113 days)
Not Found
No
The description focuses on the material composition and physical properties of the bone graft material, with no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device is a bone void filler, which is an implantable material designed to fill voids or gaps in bone as part of bone repair, but it does not treat a disease.
No.
The "Intended Use" section states that OssiMend is "intended for use in filling bony voids or gaps of the skeletal system," indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states that OssiMend is a "collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation," indicating it is a physical material, not software.
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 use, not a diagnostic one.
- Device Description: The device is a collagen mineral composite matrix for surgical implantation. It is a physical material used to support bone growth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide information about a person's health or diagnose a condition.
IVD devices are specifically designed to perform tests in vitro (outside the body) to diagnose diseases or conditions. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
OssiMend, combined with autogenous bone marrow, is 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
MQV,MOV
Device Description
OssiMend™ Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation. The principle components of OssiMend are bovine type I collagen and anorganic bovine bone mieral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. OssiMend is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. OssiMend strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. OssiMend is fully resorbed during the natural process of bone formation and remodeling.
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
Not Found
Summary of Performance Studies
The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices. The characteristics of the OssiMend meet the design requirements for an effective bone grafting material, and an animal study confirmed the effectiveness of the product for use as a bone void filler. The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates.
Key Metrics
Not Found
Predicate Device(s)
K012751, K033679, K000122, K032288, K014289, K043034
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
$\mathbb{K}$
510(k) Summary of Safety and Effectiveness
JAN 2 5 2006
| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | December 21, 2005 |
| Device Common Name: | Bone Grafting Material
Bone Void Filler |
| Device Trade Name: | OssiMend™ Bone Graft Material |
| Device Classification Name:
Regulation Number:
Device Class:
Product Code: | Filler, Bone Void, Calcium Compound
888.3045
Class II
MQV |
| Predicate Device(s): | HEALOS® Bone Graft Material, K012751
CopiOs™ Bone Void Filler, K033679
Collagraft Strip Bone Graft Matrix, K000122
Vitoss® Scaffold Foam Bone Graft Material, K032288
ORTHOSS™ Resorbable Bone Void Filler, K014289
OsteoGuide® Anorganic Bone Mineral Products, K043034 |
Description of the Device
OssiMend™ Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation. The principle components of OssiMend are bovine type I collagen and anorganic bovine bone mieral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. OssiMend is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. OssiMend strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. OssiMend is fully resorbed during the natural process of bone formation and remodeling.
1
Intended Use
OssiMend, combined with autogenous bone marrow, is 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
OssiMend and its predicates have the same technological characteristics. In particular, OssiMend and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.
Safety
OssiMend has 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 OssiMend meet the design requirements for an effective bone grafting material, and an animal study confirmed the effectiveness of the product for use as a bone void filler.
Conclusion
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
JAN 2 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K052812/S1
Trade/Device Name: OssiMend™ Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: December 22, 2005 Received: December 23, 2005
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Peggy Hansen, RAC
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting 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): _ KO52812___________________________________________________________________________________________________________________________________________
Device Name: _ OssiMend TM Bone Graft Material
Indications for Use:
OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that arr 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 hone.
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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K052812