(226 days)
Not Found
No
The device description focuses on the material composition and physical properties of a synthetic bone graft material. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a synthetic bone graft material intended to fill bone voids and resorb during healing, which directly contributes to the restoration of anatomical structure, rather than actively treating a condition through physiological, pharmacological, or immunological means beyond structural support for healing.
No
This device, CopiOs™ BVF, is described as a synthetic bone graft material intended for "filling bone voids or gaps of the skeletal system". Its purpose is to facilitate healing by providing a scaffold for bone growth, not to diagnose a condition.
No
The device description clearly states that CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen formed into three-dimensional pads for surgical implantation. This describes a physical implantable device, 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 and structural application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a synthetic bone graft material for surgical implantation. This aligns with a medical device used for treatment or repair, not for analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (ie, 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™ BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Product codes (comma separated list FDA assigned to the subject device)
89MQV, MQV
Device Description
CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into three-dimensional pads of various sizes for surgical implantation.
The CopiOs™ BVF product sponge consists of dehydrothermally (DHT) cross-linked bovine dermal collagen mixed with calcium phosphate salt. The pads are approximately 67% mineral by weight. The fibrous collagen mixed with the calcium phosphate salt is cast into sponges as described in this application. The average porosity of the product was determined to be 93.39%, which allows for favorable conditions for cell migration and adherence to the collagenous matrix. Further, the calcium phosphate provides the mineral required for osteogenesis and the specific CopiOs™ BVF formulation provides a pH environment conducive for osteoinduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (ie, 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)
The results from the tests conducted as described in this submission support the substantial equivalence of CopiOs™ BVF 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.
K012751, K00122, K994337, K980817, K990131, K0000515, K974399
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
Centerpulse Spine-Tech, Inc.
K033679
510(K) SUMMARY 7.0
| Name of 510(k) Sponsor: | Centerpulse Spine-Tech, Inc. |
|---|---|
| Sponsor Address: | 7375 Bush Lake Road |
| Minneapolis, Minnesota 55439 | |
| Telephone Number: (952) 830-6284 | |
| Fax Number: (952) 832-5620 | |
| Sponsor Contact: | Tim Miller |
| Director Clinical and Regulatory Affairs | |
| Proprietary Name of Device: | CopiOs™ Bone Void Filler (BVF) |
| Generic/Classification Name: | Resorbable Calcium Salt Bone Void Filler |
| Classification Number: | Class II |
| Product Code: | 89MQV |
| Legally Marketed | |
| Predicate Devices: | HEALOS Bone Graft Material (K012751); |
| Collagraft Strip Bone Graft Matrix (K00122); | |
| Vitoss Scaffold Synthetic | |
| Cancellous Bone Void Filler (K994337); | |
| Pro Osteon Implant 500R | |
| Resorbable Bone Graft Filler/Bone Graft Material; 200R | |
| Resorbable Bone Graft Material (K980817, K990131, | |
| K0000515); | |
| Bio-Oss Collagen (K974399) |
Device Description:
CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into three-dimensional pads of various sizes for surgical implantation.
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1
The CopiOs™ BVF product sponge consists of dehydrothermally (DHT) cross-linked bovine dermal collagen mixed with calcium phosphate salt. The pads are approximately 67% mineral by weight. The fibrous collagen mixed with the calcium phosphate salt is cast into sponges as described in this application. The average porosity of the product was determined to be 93.39%, which allows for favorable conditions for cell migration and adherence to the collagenous matrix. Further, the calcium phosphate provides the mineral required for osteogenesis and the specific CopiOs™ BVF formulation provides a pH environment conducive for osteoinduction.
Intended Use:
CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (ie, 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™ BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Technological Characteristics:
The intended use, composition, physical structure, and target population of CopiOs™ BVF are substantially equivalent to the FDA cleared and legally marketed predicate device, HEALOS.
- CopiOsTM BVF and the predicate device HEALOS are intended for the . same use and target populations.
- CopiOs™ BVF and the predicate device HEALOS are sterile and provide . a favorable environment for cell migration and adherence to the collagenous matrix.
- Both CopiOs™ BVF and the predicate device HEALOS are supplied as . lyophilized products.
- Like HEALOS, the predicate device, CopiOs™ BVF contains . approximately 33% type 1 bovine collagen while HEALOS contains 70%. Additionally. CopiOs™ BVF contains 67% calcium phosphate salt while HEALOS contains approximately 30% non-ceramic hydroxyappatite.
- CopiOs™ BVF and the predicate device HEALOS are resorbed following . surgical implantation. The resorption rate between CopiOsTM BVF and HEALOS are similar as evidenced in the comparative rabbit radial defect study.
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2
- CopiOs™ BVF and the predicate device HEALOS both promote bone . regeneration and are remodeled into new bone at equivalent rates as demonstrated in the comparative rabbit radial defect study.
Conclusions:
The results from the tests conducted as described in this submission support the substantial equivalence of CopiOs™ BVF to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Ms. Kimberly Tokach Senior Regulatory Affairs Specialist Zimmer Spine 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K033679
Trade Name: CopiOs™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 28, 2004 Received: May 4, 2004
Dear Ms. Tokach:
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.
4
Page 2 – Ms. Kimberly Tokach
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 n you attire of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K033679
Device Name: CopiOs™ BVF
Indications for Use:
CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling OplOS - BVT, in oornismation system (i.e., extremities, pelvis, spine) that are not intrinsic to bone volute of the bone structure. These voids may be a result of trauma or creation by the stablity of the bene care cantly packed into the void or gap and will resorb during the course of the healing process.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K093677