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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the CopiOs® Bone Void Filler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as might be seen for a new drug or a novel device with a very different mechanism of action.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or data provenance.
Number and qualifications of experts for ground truth.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Instead, the submission states:

Acceptance Criteria/Study Information:

Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The document explicitly states:
- "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."
- The predicate devices mentioned are K071237 (CopiOs Bone Void Filler Sponge & Paste) and K033679 (CopiOs™ Bone Void Filler).
Non-Clinical Testing:
- The document mentions that "CopiOs® Bone Void Filler Sponge & Paste have previously undergone non-clinical testing, including animal study, biocompatibility, migration resistance, pH, hydration and handling characteristics."
- This testing "provides reasonable assurance of safety and effectiveness for its intended use."

In summary, the 510(k) process for this device did not involve the types of studies typically associated with "acceptance criteria" for performance metrics in the way a diagnostic algorithm or a novel therapeutic might. Instead, the focus was on demonstrating that the new device is as safe and effective as a previously cleared device through substantial equivalence and supporting non-clinical data.

Summary

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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:

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)

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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

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Indications For Use Statement

510(k) Number (if known): K072384

Device Name:

CopiOs® Bone Void Filler

Indications For Use:

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

Page 1 of 1

Regulation Number and Section

§ 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.