Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process.

Device Description

Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.

AI/ML Overview

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Cerasorb Ortho Foam device:

This document is a 510(k) premarket notification for a medical device called Cerasorb Ortho Foam. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" and "study" described here are focused on demonstrating substantial equivalence to a predicate, not necessarily meeting a specific performance metric in a standalone sense.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Criteria	Predicate Device (Vitoss Scaffold Foam Bone Graft Material) Performance	Proposed Device (Cerasorb Ortho Foam) Performance (Claimed)	Rationale for Equivalence
Intended Use	Bone void filler for skeletal system (extremities, spine, pelvis)	Bone void filler for skeletal system (extremities, pelvis)	Substantially equivalent (minor difference in explicitly listed anatomical locations, but overall 'bone void filler' function is same).
Target Population	Individual with bony defect resulting from surgery or trauma	Individual with bony defect resulting from surgery or trauma	Identical
Anatomical Locations	Bony voids/gaps of extremities, spine, and pelvis	Bony voids/gaps of extremities and pelvis	Substantially equivalent (exclusion of 'spine' for proposed device not deemed significant, implies similar general application).
Labeling	Contains comparable intended use, warnings, and precautions	Contains comparable intended use, warnings, and precautions	Substantially equivalent
Chemical Composition	Calcium salt with Type I bovine collagen	Calcium salt with Type I and Type III porcine collagen	Equivalent, with rationale for porcine collagen for safety.
Mineral Phases	ß-Tricalcium phosphate Ca3(PO4)2	ß-Tricalcium phosphate Ca3(PO4)2	Identical
Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone	Identical
Pore Size (range)	1-1000 µm	0.1-500 µm	Within same general range, with statement "No significant functional implications are expected."
Osteoconductivity	Osteoconductive	Osteoconductive	Identical
Mechanical Strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site	Identical
Sterility	Sterilized by gamma irradiation, single use only	Sterilized by gamma irradiation, single use only	Identical
Biocompatibility	Established	Established	Established, implying performance is comparable.
Dosage Form(s)	Cylinders (Blocks), Strips, Packs, Flow, Shapes	Strips, Packs (Mouldable Foam and Flexible Foam Strip)	Different specific forms, but both offer forms for filling voids.
New Bone Formation (Animal Study)	Not explicitly quantified, but implied successful performance	Performed at least as well as the predicate device	Demonstrated non-inferiority to predicate in animal model.
Fibrosis and Inflammation (Animal Study)	Not explicitly quantified, but implied successful performance	Occurrence evaluated	Implied comparable or acceptable levels.

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

Test Set (Animal Study): The document states "A comparative study in sheep using the critical size defect model was performed." It does not specify the exact number of sheep used (sample size) or the number of defects created/treated.
Data Provenance: The study was "in sheep," which indicates animal data. The location of the study (country of origin) is not explicitly stated in this document but implied to be part of the manufacturer's (curasan AG, Germany) activities. It is a prospective animal study designed for comparison.

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

The document does not mention the number of experts used or their qualifications for establishing ground truth in the animal study. The evaluation focused on "amount and quality of newly formed bone" and "occurrence of fibrosis and inflammation," which would typically involve histological analysis and potentially expert pathology assessment, but specifics are omitted.

4. Adjudication Method for the Test Set:

The document does not provide details on an adjudication method. It simply states that bone formation, fibrosis, and inflammation were "evaluated." This suggests standard scientific evaluation by the researchers involved in the study, but no formal adjudication process with independent experts is described.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) evaluating medical images or cases with and without AI assistance to measure improvement in diagnostic performance. The Cerasorb Ortho Foam is a physical bone void filler, not an AI software device.

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

This question is not applicable. Cerasorb Ortho Foam is a physical medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the animal study (test set): The ground truth was established through histological evaluation of the amount and quality of newly formed bone, and the occurrence of fibrosis and inflammation at the surgical site in the sheep. This is a form of direct biological/pathological assessment.

8. The Sample Size for the Training Set:

This question is not applicable. Cerasorb Ortho Foam is a physical medical device. It does not involve a "training set" in the context of machine learning or AI. The product's development would have involved various material science and biological compatibility tests, but not a dataset for training an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

Curasan AG % Dr. Karin Lübbers Managing Director YES Medical Device Services GmbH Bahnstrasse 42-46 Friedrichsdorf, Hesse 61381 Germany

Re: K160566

Trade/Device Name: Cerasorb Ortho Foam Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 28, 2016 Received: October 31, 2016

Dear Dr. Lübbers:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160566

Device Name Cerasorb Ortho Foam

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

1. Submitter

This 510(k) application was created in January 2016

The 510(k) owner for this application is:

Company	curasan AG
Address	Lindigstr. 463801 KleinostheimGermany
Phone:	+49-6027-40900-0
Fax:	+49-6027-40900-29
Email:	info@curasan.de
Establishment registration number:	3003771570

Contact person:

Name:	Dr. Wolf-Dietrich Hübner
Position:	Medical Director

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510(k) Application

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2. Device Name and Classification

Proprietary / Trade Name: Common Name: Classification Name: Classification: Product Code Panel

Cerasorb Ortho Foam Bone Void Filler Filler, Bone Void, Calcium Compound Class II per 21 CFR § 888.3045 MQV Orthopedic

3. Predicate Device

This application claims that Cerasorb Ortho Foam is substantially equivalent to the following predicate device:

510(k) number	K 032288
Proprietary / Trade Name:	Vitoss Scaffold Foam Bone Graft Material
Common Name:	Bone Void Filler
Classification Name:	Filler, Bone Void, Calcium Compound
Classification:	Class II per 21 CFR § 888.3045
Product Code	MQV
Panel	Orthopedic
Manufacturer	Orthovita, Inc., 45 Great Valley Parkway, Malvern, PA 19355

4. Description

Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.

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Image /page/5/Picture/2 description: The image shows the word "curasan" in red, lowercase letters. The letters are slightly tilted to the right, giving the word a dynamic appearance. The font is bold and sans-serif, contributing to the modern and clean look of the logo. The background is plain white, which makes the red letters stand out.

Cerasorb Ortho Foam

Available sizes:
Product name
Cerasorb Ortho Mouldable Foam
Cerasorb Ortho Mouldable Foam
Cerasorb Ortho Mouldable Foam
Cerasorb Ortho Flexible Foam Strip
Cerasorb Ortho Flexible Foam Strip

Dimensions LxWxH [mm] 25x25x4 25x50x4 25x100x4 25x50x4 25x100x4

5. Intended Use

6. Substantial Equivalence

Cerasorb Ortho Foam is substantially equivalent to the predicate device Vitoss Scaffold Foam Bone Graft Material. Please refer to the table below that discusses the substantial equivalence of the two devices in detail.

Device Comparison Table
Feature	Proposed device:Cerasorb Ortho Foam	Predicate deviceVitoss Scaffold Foam Bone GraftMaterial
Intended use	Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process.	Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Abbreviated intended use	Bone void filler	Bone void filler

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Device Comparison Table
Feature	Proposed device:Cerasorb Ortho Foam	Predicate deviceVitoss Scaffold Foam Bone GraftMaterial
Target Population	Individual with bony defect resulting from surgery or trauma	Individual with bony defect resulting from surgery or trauma
Anatomical locations	Bony voids or gaps of the skeletal system, i. e., the extremities and pelvis	Bony voids or gaps of the skeletal system, i. e., the extremities, spine and pelvis
Labeling	Contains comparable intended use, warnings, and precautions as the labeling of the Vitoss Scaffold Foam Bone Graft Material. The wording is not identical, but substantially equivalent.	-
Materials
Chemical composition	Calcium salt with Type I and Type III porcine collagen	Calcium salt with Type I bovine collagen
Mineral phases	$ β $ -Tricalcium phosphate Ca3(PO4)2	$ β $ -Tricalcium phosphate Ca3(PO4)2
Design
Physical structure	Trabecular structure similar to cancellos bone	Trabecular structure similar to cancellos bone
Pore size (range)	0.1-500 $ μ $ m	1-1000 $ μ $ m
Performance
Osteoconductivity	Osteoconductive	Osteoconductive
Mechanical strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site
Sterility	Sterilized by gamma irradiation, single use only	Sterilized by gamma irradiation, single use only
Biocompatibility	Established	Established
Dosage Form(s)	Strips, Packs	Cylinders (Blocks), Strips, Packs, Flow, Shapes

One difference between Cerasorb Ortho Foam and the predicate device is that porcine collagen type I and type III was used instead of bovine collagen. This change was done for safety reasons as for porcine collagen the risk of Transmissible Spongiform Encephalopathy transmission is reduced. Moreover, the pore size of the integrated ß-tricalcium phosphate particles is on the average smaller for Cerasorb Ortho Foam, but within the same range. No significant functional implications are expected.

Based on the identified characteristics it is claimed that the device is substantially equivalent to the predicate device.

7. Performance Testing

A comparative study in sheep using the critical size defect model was performed. Cerasorb Ortho Flexible Foam Strip and Cerasorb Ortho Mouldable Foam were tested and compared to the predicate device Vitoss Scaffold Foam Bone Graft Material. The amount and quality

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Cerasorb Ortho Foam

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of the newly formed bone was evaluated as well as the occurrence of fibrosis and inflammation at the surgical site. It was concluded that Cerasorb Ortho Flexible Foam Strip and Cerasorb Ortho Mouldable Foam performed at least as well as the predicate device Vitoss Scaffold Foam Bone Graft.

Based on the functional testing performed, substantial equivalence to the predicate device Vitoss Scaffold Foam Bone Graft Material is given.

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.