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.

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.

AI/ML Overview

The provided 510(k) summary for K071237, CopiOs™ Bone Void Filler, does not contain detailed acceptance criteria or a comprehensive study report with the requested information. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance
Biocompatibility	No explicit criteria mentioned, but assumed to meet ISO 10993 standards for medical devices.	"CopiOs™ Paste has undergone non-clinical testing, including biocompatibility..."
Migration Resistance	No explicit criteria mentioned.	"non-clinical testing, including... migration resistance"
pH	No explicit criteria mentioned.	"non-clinical testing, including... pH"
Hydration Characteristics	No explicit criteria mentioned.	"non-clinical testing, including... hydration"
Handling Characteristics	No explicit criteria mentioned, but likely relates to ease of mixing and packing.	"non-clinical testing, including... handling characteristics"
Safety and Effectiveness	Reasonable assurance of safety and effectiveness for intended use, as per substantial equivalence.	"Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device."

Missing Information:

Specific numerical or qualitative targets for each acceptance criterion (e.g., pH range, migration limits, specific mechanical properties related to handling).
Quantitative results or detailed qualitative descriptions of the device's performance against these criteria. The document only lists the types of tests performed, not the results.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "non-clinical testing" was performed but does not provide details on the number of samples used for each test (e.g., number of specimens for biocompatibility, number of paste samples for pH testing).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Non-clinical testing typically refers to laboratory-based evaluations, so it wouldn't be retrospective/prospective in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. This device is not an AI/diagnostic device that would require expert-established ground truth for a test set. The non-clinical testing for this bone void filler would involve laboratory analyses and physical/chemical characterization, not expert interpretation of results in the way a diagnostic algorithm does.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This device is a medical implant (bone void filler), not a diagnostic imaging or AI-assisted system that would typically undergo an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No, a standalone performance study was not done. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

This information is not applicable in the typical sense of AI/diagnostic devices. For non-clinical testing, "ground truth" would be established by validated analytical methods (e.g., pH meter readings, material composition analysis, cell culture assays for biocompatibility). The document does not specify the methods or "ground truth" for individual tests.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary of Device and Evidence:

The Kensey Nash Corporation's CopiOs™ Bone Void Filler (K071237) is a resorbable bone void filler made from calcium phosphate and Type I bovine dermal collagen, intended to fill bone voids in the skeletal system.

The company demonstrated substantial equivalence to its predicate device (K033679 - CopiOs™ Bone Void Filler (Sponge)) rather than conducting a standalone clinical effectiveness study with defined acceptance criteria for clinical outcomes. The justification for substantial equivalence relies on:

Non-Clinical Testing: The submission states that CopiOs™ Paste underwent non-clinical testing for:
- Biocompatibility
- Migration resistance
- pH
- Hydration characteristics
- Handling characteristics
Conclusion: This testing "provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device." The submission emphasizes that the new device (CopiOs™ Paste) is "substantially equivalent to the legally marketed predicate device, CopiOs™ Sponge with regard to materials, processing, intended use and fundamental scientific technology."

The provided documentation does not include specific, quantitative acceptance criteria or detailed results from the non-clinical tests. Instead, it relies on the broader concept of substantial equivalence, asserting that the new device performs comparably to a previously cleared predicate device, and the non-clinical tests confirmed its safety and basic functional properties.

Summary

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KO71237

2007

510(k) Summary

Submitted by:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341	JUN - 1
Contact Person:	Jennifer J. Bosley, MBA, RACRegulatory Affairs SpecialistPh: (484) 713-2100Fax: (484) 713-2903
Date Prepared:	May 2, 2007
Device Trade Name:Common/Usual Name:Proposed Classification:	CopiOs™ Bone Void FillerBone Void FillerResorbable Calcium Salt Bone Void Filler Device21CFR § 888.3045Class II MOV-87Orthopedics

Device Description:

Intended Use:

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

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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.

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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

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Indications For Use Statement

510(k) Number (if known):

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)

Division of General, Restorative, and Neurological Devices

510(k) Number 16011237

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.