(28 days)
Not Found
No
The summary describes a resorbable bone void filler made of calcium phosphate and collagen. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device is a passive material intended to fill voids and resorb.
No
The device is a bone void filler, which is a material used to fill gaps in bone, not a therapeutic device designed to treat a disease or condition through active intervention.
No
This device is a bone void filler intended for filling gaps in the skeletal system, not for diagnosing medical conditions.
No
The device description clearly states that the device is a resorbable sponge or paste manufactured from calcium phosphate and Type I bovine dermal collagen, which are physical materials, 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 bone voids or gaps in the skeletal system. This is a therapeutic or surgical intervention, not a diagnostic test performed on in vitro samples (like blood, urine, or tissue).
- Device Description: The device is a resorbable sponge or paste made from calcium phosphate and collagen. This is a material intended for implantation or filling, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) 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 sponges or paste (hydrated powder discs), which are manufactured from calcium phosphate and Type I bovine dermal collagen. 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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware)
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® Bone Void Filler Sponge & Paste have previously undergone non-clinical testing, including animal study, biocompatibility, migration resistance, pH, hydration and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
SEP 2 1 2007 Submitted by: Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341 Contact Person: Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist Ph: (484) 713-2100 Fax: (484) 713-2903 Date Prepared: September 21, 2007 K072384 510(k) #: Device Trade Name: CopiOs Bone Void Filler Sponge & Paste Bone Void Filler Common/Usual Name: Proposed Classification: Resorbable Calcium Salt Bone Void Filler Device 21CFR $ 888.3045 Class II, MQV-87Orthopedics
Device Description:
CopiOs® Bone Void Fillers are resorbable sponges or paste (hydrated powder discs), which are manufactured from calcium phosphate and Type I bovine dermal collagen. 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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) 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:
K071237--- CopiOs * Bone Void Filler Sponge & Paste (Kensey Nash Corporation) K033679-CopiOs™ Bone Void Filler (Centerpulse Spine Tech)
Substantial Equivalence:
CopiOs® Bone Void Filler Sponge & Paste is substantially equivalent to the legally marketed predicate device. CopiOs® Bone Void Filler Sponge & Paste (K071237) having identical device designs, materials, processing, intended use and fundamental scientific technology.
Non-Clinical Testing:
CopiOs® Bone Void Filler Sponge & Paste have previously undergone non-clinical testing, including animal study, biocompatibility, migration resistance, pH, hydration and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use.
座谈:24年30元 (10)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2007
Kensey Nash Corporation % Ms. Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, PA 19341
Re: K072384
Trade/Device Name: CopiOs® Bone Void Filler Sponge & Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Codes: MQV Dated: August 23, 2007 Received: August 24, 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.T
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Page 2 - Ms. Jennifer J. Bosley, MBA, 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 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 toll-free number (800) 63-2011 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Mark A. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devicesd Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known): K072384
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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) 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)
Mark A. Milliken
(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices K072389
510(k) Number
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