(29 days)
K033679-CopiOs™ Bone Void Filler (Sponge)
Not Found
No
The device description and intended use focus on the material composition and physical properties of a bone void filler, with no mention of AI or ML technologies.
No
This device is a bone void filler intended to physically fill gaps in bone and resorb during healing, not to directly treat a disease or condition for therapeutic benefit.
No
This device, CopiOs Bone Void Filler, is intended for filling bone voids or gaps in the skeletal system. Its function is to be gently packed into the void and resorb during healing, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical product (sponges or powder discs) made from calcium phosphate and collagen, intended for filling bone voids. It is a physical implant, 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 for "filling bone voids or gaps of the skeletal system." This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The description details a physical material (sponges or powder discs) used to fill a physical space in the body. This is consistent with a medical device used in surgery or treatment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (blood, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on biological samples.
Therefore, CopiOs™ Bone Void Filler is a medical device intended for surgical use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Product codes
MQV
Device Description
CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, pelvis, spine)
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)
Non-Clinical Testing: CopiOs™ Paste has undergone non-clinical testing, including biocompatibility, migration resistance, pH, hydration and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033679-CopiOs™ Bone Void Filler (Sponge)
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
KO71237
2007
510(k) Summary
| Submitted by: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 | JUN - 1 |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Jennifer J. Bosley, MBA, RAC
Regulatory Affairs Specialist
Ph: (484) 713-2100
Fax: (484) 713-2903 | |
| Date Prepared: | May 2, 2007 | |
| Device Trade Name:
Common/Usual Name:
Proposed Classification: | CopiOs™ Bone Void Filler
Bone Void Filler
Resorbable Calcium Salt Bone Void Filler Device
21CFR § 888.3045
Class II MOV-87Orthopedics | |
Device Description:
CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.
Intended Use:
CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Predicate Device:
K033679-CopiOs™ Bone Void Filler (Sponge), Kensey Nash Corp [Centerpulse Spine-Tech]
Substantial Equivalence:
CopiOs™ Paste is substantially equivalent to the legally marketed predicate device, CopiOs™ Sponge with regard to materials, processing, intended use and fundamental scientific technology.
Non-Clinical Testing:
CopiOs™ Paste has undergone non-clinical testing, including biocompatibility, migration resistance, pH, hydration and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device.
1-484-713-2100
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kensey Nash Corporation % Ms. Jennifer J. Bosley. MBA, RAC Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
JUN - 1 2007
Re: K071237
Trade/Device Name: CopiOs™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: May 2, 2007 Received: May3, 2007
Dear Ms. Bosley:
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.
2
Page 2 - Ms. Jennifer J. Bosley
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 yours, Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known):
Device Name:
CopiOs™ Bone Void Filler
Indications For Use:
CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Prescription Use X AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number 16011237
Page 1 of 1