(89 days)
No
The device description focuses on the material properties and physical characteristics of a collagen sheet for bone healing, with no mention of software, algorithms, or data processing.
Yes
The device is intended to maintain the relative position of weak bony tissue, acting as a supportive and protective material for bone healing, which aligns with the definition of a therapeutic intervention.
No
The device is described as a product intended for maintaining the position of bone tissue or graft materials during orthopedic procedures, not for detecting, diagnosing, or monitoring a medical condition.
No
The device description clearly describes a physical, resorbable membrane matrix made from collagen, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Collagen Bone Healing Protective Sheet is a physical implantable device made of collagen. Its intended use is to maintain the position of bone tissue and restrict cement during surgical procedures. It is applied directly to the bone during surgery.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and structural within the body.
Therefore, the Collagen Bone Healing Protective Sheet falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:
- Long bones .
- Flat bones
- Short bones
- Irregular bones .
- Appendicular skeleton
- Thorax .
When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:
- Tumor resections where bone strength has not been compromised .
- Iliac crest harvests .
This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.
Product codes
HRS, FTM, LZN
Device Description
The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The Collagen Bone Healing Protective Sheet can be cut with scissors to the desired shape and size. The Collagen Bone Healing Protective Sheet is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. The Collagen Bone Healing Protective Sheet can be used cither alone or in conjunction with internal bonc fixation devices such as plates and screws, which also can scrve to further stabilize the anatomical region.
The Collagen Bone Healing Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The thickness of the Collagen Bone Healing Protective Shect ranges from 0.5 mm to 2.0 mm according to the orthopedic region to be treated. The Collagen Bone Healing Protective Sheet consists of micropores
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Dean Lab
0C1 25 2005
510(k) Summary of Safety and Effectiveness
| 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: | October 25, 2005 | | |
| Device Common Name: | Collagen Bone Healing Protective Sheet | | |
| Device Trade Name: | To be determined | | |
| Device Classification Name: | Plate, Fixation, Bone
Class II
888.3030
HRS | Mesh, Surgical
Class II
878.3300
FTM | Cement Obturator
Class II
878.3300
LZN |
| Predicate Device(s): | Collagen Dental Membrane, K011695
BioGide®, K960724
EBI LactoSorb® Graft Containment System, K033918
MacroPoreOS Protective Sheet, K994158 | | |
Description of the Device
The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The Collagen Bone Healing Protective Sheet can be cut with scissors to the desired shape and size. The Collagen Bone Healing Protective Sheet is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. The Collagen Bone Healing Protective Sheet can be used cither alone or in conjunction with internal bonc fixation devices such as plates and screws, which also can scrve to further stabilize the anatomical region.
The Collagen Bone Healing Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The thickness of the Collagen Bone Healing Protective Shect ranges from 0.5 mm to 2.0 mm according to the orthopedic region to be treated. The Collagen Bone Healing Protective Sheet consists of micropores