OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

Ridge augmentation for later implant insertions.
Simultaneous ridge augmentation and implant insertions.
Ridge augmentation around implants inserted in delayed extraction sites.
Ridge augmentation around implants inserted in immediate extraction sites.
Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
Over the window in lateral window sinus elevation procedure.
In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
In intra bony defects around teeth.
For treatment of recession defects, together with coronally positioned flap.
In furcation defects in multi rooted teeth.
Localized gingival augmentation.

Device Description

OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm. Intended for use by dental surgeons.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the OSSIX® VOLUMAX resorbable collagen membrane. It aims to demonstrate substantial equivalence to a predicate device, OSSIX® PLUS. The information provided primarily focuses on the comparison between the new device and its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" for performance metrics in the way a typical efficacy study might. Instead, it compares the technological characteristics of the OSSIX® VOLUMAX (subject device) with the OSSIX® PLUS (predicate device) and demonstrates that performance is either substantially equivalent or superior in relevant aspects. The underlying acceptance criterion for the subject device is to perform at least as well as the predicate device for demonstrating substantial equivalence.

Here's a table based on the comparison provided:

Parameter	Acceptance Criteria (Based on Predicate OSSIX® PLUS)	OSSIX® VOLUMAX Performance (Reported in K153549)
Intended Use	Guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for a list of dental procedures.	Matches predicate. OSSIX® VOLUMAX is a resorbable collagen membrane intended for GBR and GTR as a biodegradable barrier for the same list of dental procedures as OSSIX® PLUS, plus an additional indication for "Localized gingival augmentation." This additional indication is noted to be similar to an already cleared indication for OSSIX® PLUS ("For treatment of recession defects, together with coronally positioned flap") and is also covered by a reference device, MUCOGRAFT®, which has similar thickness.
Contra-indications	OSSIX® PLUS contra-indications: 1. Known collagen hypersensitivity. 2. Autoimmune/connective tissue disease.	Similar to predicate, with one addition. OSSIX® VOLUMAX contra-indications: 1. Known collagen hypersensitivity. 2. Sensitivity to porcine-derived materials (added). 3. Autoimmune/connective tissue disease.
Composition of materials	Cross-linked porcine type I collagen.	Matches predicate. Cross-linked porcine type I collagen.
Mode of Action/Properties	Biocompatible, non-pyrogenic, non-antigenic, porous & fibered microstructure, readily absorbs fluid, adheres to tissues, not disrupted by closure, slowly resorbed and replaced by new tissue.	Matches predicate. Same properties listed.
Device Design	Resorbable dental membrane made of porous lattice network of collagen.	Matches predicate. Resorbable dental membrane made of porous lattice network of collagen.
Thickness (dry)	Approx. 0.2 mm (OSSIX® PLUS)	Different from predicate. Approx. 1-2 mm (OSSIX® VOLUMAX). Justification: This is the principal difference but does not affect substantial equivalence, as demonstrated by bench and animal testing. It leads to higher resistance to suture pulling.
Porosity	Approx. 80% (OSSIX® PLUS)	Different from predicate. Approx. 90% (OSSIX® VOLUMAX). Justification: Considered part of technological differences not affecting substantial equivalence, supported by testing.
Size (mm)	25 x 30 mm, 30 x 40 mm (OSSIX® PLUS)	Different from predicate. Multiple sizes: 10 x 12.5 mm, 15 x 25 mm, 25 x 30 mm, 10 x 40 mm (OSSIX® VOLUMAX).
Packaging configuration	Packed in a double blister pack.	Matches predicate. Packed in a double blister pack.
Sterilization	Sterilized in double blisters by ethylene oxide.	Matches predicate. Sterilized in double blisters by ethylene oxide, validated to a minimum sterility assurance level of 10^-6, with minimal residual levels of EtO and ECH per ISO 10993-7:2008.
Principle of operation	Surgically implanted over a bony or periodontical defect.	Matches predicate. Surgically implanted over a bony or periodontical defect.
Reusability	Single use only.	Matches predicate. Single use only.
Biochemical/Physicochemical/Mechanical Properties	Comparable to OSSIX® PLUS and within safety norms.	Demonstrated by in vitro testing. OSSIX® VOLUMAX exhibits higher resistance to suture pulling due to increased thickness and collagen content. Other tests (Heavy metals, Endotoxins, Collagenase/Trypsin resistance, Weight, 3D structure, Tensile strength, Denaturing temperature, Carbohydrates, Ethanol, Porosity, Organic extractables, TGA, Amino acid analysis, pH) were performed, implying comparable results for substantial equivalence.
Biocompatibility	Biocompatible (based on predicate testing).	Leveraged from predicate + additional test. Biocompatibility data (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, implantation tests) leveraged from previous submission (OSSIX® PLUS). Additionally, an in vivo Rabbit Pyrogen Test (USP <151>) for OSSIX® VOLUMAX confirmed it is nonpyrogenic.
In Vivo Performance/Safety	Performance, degradation, and safety comparable to OSSIX® PLUS.	Demonstrated by animal study. An in vivo animal study in Beagle dogs (L-shape buccal mandibular defect model) for up to 6 months demonstrated the subject device performed in a manner substantially equivalent to the cleared predicate device regarding in vivo performance, degradation, and safety.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Non-clinical (In Vitro) Tests: The document lists various in vitro tests (heavy metals, endotoxins, collagenase resistance, tensile strength, etc.). It does not specify sample sizes for each of these in vitro tests, but implies standard laboratory testing was conducted to characterize the material.
In Vivo Animal Study:
- Sample Size: 19 animals (Beagle dogs).
- Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting by the manufacturer or a contract research organization. It is a prospective animal study.
Biocompatibility: Leveraged from previous submission of the predicate device. For the individual pyrogenicity test, sample size for rabbits is not mentioned but usually involves a small number of animals (e.g., 3-8).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This 510(k) submission is for a medical device (collagen membrane) and relies on non-clinical (in vitro and animal) studies, along with a comparison to a predicate device, rather than a clinical study requiring expert ground truth for interpretation of human patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here.

The "experts" involved would be the scientists and veterinarians conducting the animal study, the laboratory personnel performing the in vitro tests, and the regulatory experts overseeing the submission. Their qualifications are implied by adherence to recognized standards like ISO and USP.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers independently interpret data (e.g., images) and discrepancies need to be resolved. This submission relies on objective physical, chemical, and biological measurements from laboratory and animal studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (collagen membrane), not an AI diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the studies performed primarily consists of:

In vitro studies: Objective measurements against established scientific and engineering principles and recognized standards (e.g., tensile strength, chemical composition, porosity).
Biocompatibility: Adherence to recognized ISO standards (ISO 10993 series) and specific tests like the Rabbit Pyrogen Test (USP <151>). The "ground truth" here is the biological response (or lack thereof) confirming safety.
In vivo animal study: Histological analysis, evaluation of degradation, and assessment of tissue response and performance in the defect model, performed by veterinary pathologists and researchers. The "ground truth" is the observed biological outcome in the animal model.
Predicate comparison: The ground truth for substantial equivalence is that the new device is as safe and effective as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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

August 4, 2016

Datum Dental Ltd. % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K153549

Trade/Device Name: OSSIX® VOLUMAX Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 5, 2016 Received: July 5, 2016

Dear Ms. Hogan:

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.

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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 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.

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,

Tina Kiang
-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K153549

Device Name

OSSIX® VOLUMAX

Indications for Use (Describe)

OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

Ridge augmentation for later implant insertions. -
-Simultaneous ridge augmentation and implant insertions.
Ridge augmentation around implants inserted in delaved extraction sites. -
Ridge augmentation around implants inserted in immediate extraction sites. -
Alveolar ridge preservation consequent to tooth (teeth) extraction(s). -
Over the window in lateral window sinus elevation procedure. -
-In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
In intra bony defects around teeth. -
For treatment of recession defects, together with coronally positioned flap. -
-In furcation defects in multi rooted teeth.
Localized gingival augmentation. -

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. 510(k) Applicant

Datum Dental Ltd. 1 Bat Sheva st. Lod 7120101 Israel Phone: 1-972-8-6705400 Fax: 1-972-8-6705429 Contact person: Arie Goldlust, CEO, VP R&D Date prepared: July 28, 2016

II. Device

Trade name:	OSSIX® VOLUMAX
Common name:	Resorbable Collagen Membrane
Classification name:	Bone grafting material (21 CFR 872.3930)
Regulatory class:	II
Product code:	NPL (Barrier, Animal Source, Intraoral)

III. Predicate Device

Primary predicate: OSSIX® PLUS (K053260) Reference device: Mucograft® (K073711, K102531, K140518)

IV. Device Description

OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide.

Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.

Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm.

Intended for use by dental surgeons.

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V. Indications for Use

OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

Ridge augmentation for later implant insertions.
Simultaneous ridge augmentation and implant insertions.
Ridge augmentation around implants inserted in delayed extraction sites. ●
Ridge augmentation around implants inserted in immediate extraction sites.
Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
. Over the window in lateral window sinus elevation procedure.
In implants with vertical bone loss due to infection, only in cases where ● satisfactory debridement and implant surface disinfection can be achieved.
In intra bony defects around teeth.
For treatment of recession defects, together with coronally positioned flap. ●
In furcation defects in multi rooted teeth. ●
. Localized gingival augmentation.

VI. Comparison of Technological Characteristics with the Predicate Device

OSSIX® VOLUMAX has the same intended use and the technological characteristics as the predicate device, OSSIX® PLUS. The principal difference between the two products is the thickness and content of collagen. Otherwise, both products are identical in their chemical composition (porcine type I collagen cross-linked by D-ribose), their structure (porous membrane made of lattice network of collagen fibers) and manufacturing technology. The technological differences do not affect the substantial equivalence as demonstrated by bench and animal testing.

With this submission, the company is including the localized gingival augmentation indications for use to the previously cleared indications. The addition of the localized gingival augmentation indication does not result in any change in the therapeutic effect, mode of action or instructions for use as compared with the predicate device (OSSIX® PLUS) as this indication is similar to the already cleared following indication for OSSIX® PLUS: "For treatment of recession defects, together with coronally positioned flap". This added indication is one of the indications of MUCOGRAFT®, the reference device, which has a similar thickness as OSSIX® VOLUMAX.

Thus, the subject device is substantially equivalent to the predicate device as summarized in the below table.

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VII. Summary of Data to Support Substantial Equivalence

The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, biocompatibility testing and clinical history of the predicate device.

Non-clinical testing was performed in accordance with the following FDA recognized consensus standards:

. ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices- Part 1 -Evaluation and testing within a risk management process
ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: ● Ethylene oxide sterilization residues
ISO 10993-11:2006 Biological evaluation of medical devices-Part 11-Tests for . systemic toxicity

The control of animal materials is performed following

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ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives ● - Part 2: Controls on sourcing, collection and handling
The ethylene oxide sterilization process is performed according to
ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --. Requirements for the development, validation and routine control of a sterilization process for medical devices
The sterilization process was validated to assure a minimum sterility assurance level of 10 6. The OSSIX® VOLUMAX membrane is specified to have minimal residual levels of EtO and ethylene chlorohydrin (ECH) remaining on the product after sterilization, as measured using validated aqueous simulated use extraction methods, that shall not exceed an average daily dose specified in ISO 10993-7:2008.

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device in biochemical, physicochemical, mechanical properties, as summarized in the table below. As expected from the increase in the thickness and collagen content, OSSIX® VOLUMAX exhibits a higher resistance to suture pulling.

Test	Test Method
Heavy metals	USP < 233 >
	Inductively coupled plasma optical emission spectrometry(ICP-OES)--full screen of heavy metals
Endotoxins (LAL)	USP < 85 >
Collagenase resistance	Internal test method: enzymatic degradation
Trypsin resistance	Internal test method: enzymatic degradation
Weight	Weighing on analytical scales
Suture pull test	Internal test method
3D structure (SEM)	Scanning electron microscope analysis
Tensile strength (Maximum Load)	Internal test method; tensile machine
Denaturing temperature	Differential scanning calorimetry (DSC)
Carbohydrates content	Colorimetric test: sulfuric/phenol method
Ethanol content	Gas chromatography
Porosity	Mercury intrusion porosimetry analysis
Thickness	Digital micrometer
Organic extractables impurities	Gas chromatography-mass spectrometry (GC-MS)
Thermo gravimetric analysis(TGA)	Thermo gravimetric analyzer
Amino acid analysis	Amino acid analyzer
pH	pH-meter

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The biocompatibility, viral inactivation, stability and packaging validation data obtained for the predicate device was used to demonstrate the biocompatibility, viral safety and shelf-life of the subject device.

The following biocompatibility tests leveraged from previous submission were utilized to support the biocompatibility of the subject device: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, 2- and 12-week implantation tests.

In addition, the pyrogenicity of OSSIX® VOLUMAX was tested in vivo using the Rabbit Pyrogen Test as per USP <151>, and the test article was judged as nonpyrogenic.

An in vivo animal study was conducted in an L-shape buccal beagle mandibular defect model system in Beagle dogs to evaluate the in vivo performance, degradation and safety of OSSIX® VOLUMAX dental membrane as compared to OSSIX® PLUS. The study was conducted on 19 animals followed up to 6 months. The subject device performed in a manner substantially equivalent to the cleared predicate device.

VIII. Conclusion

The subject and predicate devices have the same intended use with similar indications for use and substantially similar technological characteristics and principles of operation. In addition, the non-clinical data provided within the 510(k) submission, as summarized above, demonstrate that OSSIX® VOLUMAX is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

	OSSIX® VOLUMAXK153549	OSSIX® PLUSK053260
Parameter	Subject of this submission	Predicate device
Intended use/Indications foruse	OSSIX® PLUS is a resorbable collagenmembrane intended for use during theprocess of guided bone regeneration(GBR) and guided tissue regeneration(GTR) as a biodegradable barrier for:• Ridge augmentation for later implantinsertions.• Simultaneous ridge augmentationand implant insertions.• Ridge augmentation around implantsinserted in delayed extraction sites.• Ridge augmentation around implantsinserted in immediate extractionsites.• Alveolar ridge preservationconsequent to tooth (teeth)extraction(s).• Over the window in lateral windowsinus elevation procedure.• In implants with vertical bone lossdue to infection, only in cases wheresatisfactory debridement and implantsurface disinfection can be achieved.• In intra bony defects around teeth.• For treatment of recession defects,together with coronally positionedflap.• In furcation defects in multi rootedteeth.• Localized gingival augmentation.	OSSIX® PLUS biodegradable collagenmembrane is intended for use duringthe process of guided boneregeneration (GBR) and guided tissueregeneration (GTR) as a biodegradablebarrier for:• Ridge augmentation for later implantinsertions.• Simultaneous ridge augmentationand implant insertions.• Ridge augmentation around implantsinserted in delayed extraction sites.• Ridge augmentation around implantsinserted in immediate extractionsites.• Alveolar ridge preservationconsequent to tooth (teeth)extraction(s).• Over the window in lateral windowsinus elevation procedure.• In implants with vertical bone lossdue to infection, only in cases wheresatisfactory debridement and implantsurface disinfection can be achieved.• In intra bony defects around teeth.• For treatment of recession defects,together with coronally positionedflap.• In furcation defects in multi rootedteeth.
Contra-indications	OSSIX® VOLUMAX must not be usedin:1. Patients with known collagenhypersensitivity.2. Patients with sensitivity toporcine-derived materials.3. Patients suffering fromautoimmune disease andconnective tissue disease, suchas: systemic lupuserythematosous,dermatomyositis etc.	OSSIX® PLUS must not be used in:1. Patients with known collagenhypersensitivity.2. Patients suffering fromautoimmune disease andconnective tissue disease, suchas: systemic lupuserythematosous,dermatomyositis etc.
Composition ofmaterials	Cross-linked porcine type I collagen	Cross-linked porcine type I collagen
Mode ofAction/Properties	• Biocompatible• Non-pyrogenic	• Biocompatible• Non-pyrogenic
Parameter	OSSIX® VOLUMAXK153549Subject of this submission	OSSIX® PLUSK053260Predicate device
	• Non-antigenic• Porous and fibered microstructure• Readily absorbs body fluid• Adheres well to the surrounding andunderlying tissues• Is not disrupted by the closure of thesurgical site• Slowly resorbed and replaced by newtissue	• Non-antigenic• Porous and fibered microstructure• Readily absorbs body fluid• Adheres well to the surrounding andunderlying tissues• Is not disrupted by the closure of thesurgical site• Slowly resorbed and replaced by newtissue
Device Design	Resorbable dental membrane made ofporous lattice network of collagen	Resorbable dental membrane made ofporous lattice network of collagen
Thickness (dry)	Approx. 1-2 mm	Approx. 0.2 mm
Porosity	Approx. 90%	Approx. 80%
Size (mm)	10 x 12.5 mm15 x 25 mm25 x 30 mm10 x 40 mm	25 x 30 mm30 x 40 mm
Packagingconfiguration	Packed in a double blister pack	Packed in a double blister pack
Sterilization	Sterilized in double blisters byethylene oxide	Sterilized in double blisters byethylene oxide
Principle ofoperation	Surgically implanted over a bony orperiodontical defect	Surgically implanted over a bony orperiodontical defect
Reusability	Single use only	Single use only