K Number

Validate with FDA (Live)

Device Name

COVAMAX RESORBABLE COLLAGEN MEMBRANE

Manufacturer

BIOM'UP SAS

Date Cleared

2011-08-26

(311 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K042197,K053260

Predicate For

N/A

Intended Use

Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:

-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants;

-Augmentation around implants placed in immediate extraction sockets;

-Augmentation around implants placed in delayed extraction sockets;

-Localized ridge augmentation for later implantation;

-Alveolar ridge reconstruction for prosthetic treatment;

-Filling of bone defects after root resection, cystectomy and removal of retained teeth;

-Guided bone regeneration in dehiscence defects;

-Guided tissue regeneration procedures in periodontal and recession defects.

Device Description

Cova™MAX is a resorbable acellular membrane for guided tissue and bone regeneration in dental applications. Cova™MAX membranes are manufactured using a standardized, controlled process. Each Cova™MAX membrane is fabricated solely from Type I collagen extracted from veterinary certified pig tendon. Porcine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial quantities. It is packaged in a double package and sterilized by gamma irradiation.

Cova™MAX membranes serve as a barrier to guide the healing process between anatomic plans of tissues. It has been designed in accordance with the accepted principles or guided bone regeneration (GBR) as a wound healing material post surgery. They are designed to be resorbable, non inflammatory and biocompatible for uses in clinical periodontics.

The Cova™MAX membrane is completely resorbable within a timeframe compatible with the healing process. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™MAX is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm and 30 x 40 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the periodontal defect or zone to be treated.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study specifically designed to prove the device meets those criteria for the Cova™MAX Resorbable Collagen Membrane. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.

In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating that the device has similar characteristics and performance to legally marketed predicate devices, and that any differences do not raise new questions of safety or efficacy. The "study" proving this largely relies on comparisons, some preclinical (animal) data, and a review of existing literature.

Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:

Acceptance Criteria and Device Performance (Implicit Basis of Substantial Equivalence)

Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (Cova™MAX)
Origin: Porcine	Porcine (Type I collagen from veterinary certified pig tendon)
Intended Use: For guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus	Intended for use in oral surgical procedures as a resorbable membrane material for specific GBR/GTR applications (listed in document)
Device Characteristics: Membrane-like, Easy to manipulate, Flexible, Implantable, Wettable, Smooth	Membrane-like, Easy to manipulate, Flexible, Implantable, Wettable, Smooth
Biocompatibility: Established (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing)	Established (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing; confirmed by studies)
Non-pyrogenic: Yes	Yes
Resorbable: Yes (within a timeframe compatible with healing process)	Yes (completely resorbable within a timeframe compatible with the healing process; 13-week estimate from rat study, clinical estimate by clinician needed)
Suturable: Yes	Yes
Reusable: Single-use device	Single-use device
Shelf-Life: Comparable to predicates (36 months for predicates, Cova™MAX 18 months)	18 months (Acknowledged as similar enough not to raise new safety/efficacy concerns)
Sterilization Method: Gamma irradiation	Gamma irradiation
Packaging: Double-peel packages	Double-peel packages
Safety: No new issues of safety raised	All biocompatibility studies demonstrated no new safety issues.
Effectiveness: No new issues of efficacy raised; effective as a barrier to aid in wound healing	Animal model studies and human literature support effectiveness as a barrier to aid in wound healing.

Study Information (Based on 510(k) Summary)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" for substantial equivalence relied on:
  - Biocompatibility studies (number of samples/animals/tests not specified). Provenance not specified, but typically conducted by certified labs.
  - Animal Data: Literature review of "numerous materials" including predicates across various animal models. The document refers to "a rat implantation study" for the 13-week resorption claim, but no specific sample size is given for Cova™MAX studies. The provenance is implied to be existing literature and an internal rat study.
  - Clinical Data: Literature review of "human studies" consistent with animal studies. No specific clinical study using Cova™MAX is presented. Provenance is existing literature.
- Data Provenance: Primarily literature review (animal and human studies on guided bone regeneration and similar membranes), and internal biocompatibility tests and a rat implantation study for Cova™MAX. The origin of the literature is not specified, but general "clinical practice of periodontics" is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there was no specific "test set" with ground truth established by a panel of experts for Cova™MAX in this summary. The ground truth for the effectiveness claims comes from the established scientific literature on Guided Bone Regeneration (GBR) and similar resorbable membranes, which implicitly relies on the consensus and findings of experts in the dental and periodontal fields over time.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no specific test set requiring adjudication in this 510(k) summary.
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 device is a resorbable collagen membrane, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For safety, ground truth was established through standard biocompatibility tests (cytotoxicity, irritation, systemic toxicity, genotoxicity, pyrogenicity, implantation/absorption, sub-chronic/chronic toxicity, hemolysis) and compliance with animal tissue sourcing and viral inactivation standards.
- For effectiveness, the ground truth is derived from the established scientific understanding and clinical acceptance of Guided Bone Regeneration (GBR) and Guided Tissue Regeneration (GTR) using resorbable barrier membranes, as documented in animal model studies and human clinical literature. This is a form of expert consensus and accumulated outcomes data from past research and clinical practice.
The sample size for the training set:
- Not applicable for a physical device in the context of a 510(k) submission showing substantial equivalence. There isn't a "training set" in the sense of machine learning. The "training" for the device design and manufacturing would implicitly come from general scientific knowledge, material science, and the characteristics of existing predicate devices.
How the ground truth for the training set was established:
- Not applicable for the same reasons as point 7. The "ground truth" for developing Cova™MAX was the established scientific and clinical understanding of what constitutes a safe and effective resorbable collagen membrane for GBR/GTR, based on decades of research and predicate device performance.

Summary

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AUG 2 6 2011

biom'up

ADVANCED BIOMATERIALS

5. 510(k) Summary, Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration

Submitter's name and address:	Biom'Up S.A.8, Allee Irene Joliot-Curie69800, Saint-Priest,France
Contact person:	Valerie Centis, R&D Project Manager andRegulatory Affairs
	Biom'up S.A.8, Allee Irene Joliot-Curie69800, Saint-Priest, FrancePhone: +33 (0)4 86 57 36 10Fax: +33 (0)4 37 69 00 84Email: regulatory.affairs@biomup.com
Date Summary was prepared:	October 18th 2010
Trade/Proprietary Name:	Cova™MAX
Common/Usual Name:	Resorbable Membrane for Guided Tissue and BoneRegeneration
Classification Name:	Barrier, Animal Source, Dental
Product Code:	NPL
Regulation Number:	21 CFR 872.3930
Device Classification:	Class II
Predicate Devices	BIO-GIDE® (K042197)Ossix™ Plus (K053260)

Device Description

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ADVANCED BIOMATERIALS

Intended Use

Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:

-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants;

-Augmentation around implants placed in immediate extraction sockets;

-Augmentation around implants placed in delayed extraction sockets;

-Localized ridge augmentation for later implantation;

-Alveolar ridge reconstruction for prosthetic treatment;

-Filling of bone defects after root resection, cystectomy and removal of retained teeth;

-Guided bone regeneration in dehiscence defects;

-Guided tissue regeneration procedures in periodontal and recession defects.

Basis for Substantial Equivalence

The intended use, product design, composition, physical structure and target population of Cova™MAX resorbable collagen membranes are substantially equivalent to the FDA cleared and legally marketed predicate devices BIO-GIDE® (K042197) and Ossix™Plus (K053260). Similarities are presented in Table 1.

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Image /page/2/Picture/1 description: The image shows the logo for "biom'up ADVANCED BIOMATERIALS". The logo has the word "biom'up" in bold, black letters, with the "up" portion slightly raised. Above the word is a graphic of several curved lines that are filled with small, vertical black lines. Below the word is the phrase "ADVANCED BIOMATERIALS" in smaller, black letters.

Medical Device Name	Cova™MAX	BIO-GIDE®	Ossix™Plus
Origin	Porcine	Porcine	Porcine
Intended use	Used for guided tissue regenerationprocedures in periodontal defectsto enhance regeneration of the periodontalapparatus	Used for guided tissue regenerationprocedures in periodontal defectsto enhance regeneration of the periodontalapparatus	Used for guided tissue regenerationprocedures in periodontal defectsto enhance regeneration of the periodontalapparatus
Device characteristics	Membrane-likeEasy to manipulateFlexibleImplantableWettableSmooth	Membrane-likeEasy to manipulateFlexibleImplantableWettableSmooth	Membrane-likeEasy to manipulateFlexibleImplantableWettableSmooth
Biocompatibility	Established	Established	Established
Non pyrogenic	Yes	Yes	n/a
Resorbable	Yes	Yes	Yes
Suturable	Yes	Yes	Yes
Reusable	Single-use device	Single-use device	Single-use device
Shelf-Life	18 months	36 months	36 months
Sterilisation Method	Gamma irradiation	Gamma irradiation	Gamma irradiation
Packaging	Double-peel packages	Double-peel packages	Double-peel packages

Table 1. Cova™MAX and its predicates summarized comparison chart.

Any differences in technological characteristics between the Cova™MAX and the predicate devices do not raise any new issues of safety or efficacy. The performance and safety of the material used was evaluated. The collective results have demonstrated that the Cova™MAX is substantially equivalent to the respective predicate devices with regard to safety and efficacy.

Safety

Biocompatibility studies have demonstrated Cova™MAX to be: non-cytotoxic, nonpyrogenic, non-irritating, and non-sensitizing. The following studies were conducted:

a) Cytotoxicity
b) Dermal Sensitization/irritation
c) Acute Systemic Toxicity
d) Acute Intracutaneous Reactivity
e) Genotoxicity
f) Mutagenecity
g) Pyrogenecity
h) Implantation/Absorption
i) Sub-Chronic/Chronic Toxicity
Hemolysis ﻤﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

The Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration manufacturing process complies with the United States Food and Drug Administration and European Standards for animal tissue sourcing and viral inactivation.

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ADVANCED BIOMATERIALS

Summary of Effectiveness Data

Animal Data

Guided Bone Regeneration in periodontics has been proven from animal model studies. That is, during the surgery, a barrier membrane is placed over the wound to prevent contact of connective tissue with the bony surface. Thereby, bone cells can grow into the defect site to fill the space.

A comprehensive literature research showed that numerous materials, including the predicates, have been studied for this use in various animal models. The animal data provided evidence that using equivalent membranes as Cova™MAX as a barrier to aid in wound healing has been verified using resorbable membranes is a valid approach.

Clinical Data

Results from human studies from the literature are consistent with animal studies. Similar to animal studies, resorbable membranes such as Cova™MAX are effective as a barrier to aid in wound healing its use fully accepted in the clinical practice of periodontics.

It should be noted that the 13-week resorption claim is an estimate from a rat implantation study which was similar to predicate animal studies. An estimation for clinical resorption will need to be made by the clinician based on the known resorption times (6 and 8 months) of similar devices: Bio-Gide® and Ossix™Plus and on experience.

Conclusion

Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration is substantially equivalent to its predicate devices: BIO-GIDE® and Ossix™Plus.

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Image /page/4/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three curved lines or strokes, possibly representing human figures or abstract shapes. The seal is black and white.

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

Ms. Valerie Centis R&D Manager and Regulatory Affairs Biom'Up SA 8. Allee Irene Joliot-Curie 69800, Saint-Priest France

AUG 2 6 2011

Re: K103087

Trade/Device Name: Cova™MAX Resorbable Membrane for Guided Tissue and Bone Regeneration Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material

Regulatory Class: II Product Code: NPL

Dated: August 23, 2011

Received: August 24, 2011

Dear Ms. Centis:

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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Page 2 - Ms. Centis

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Kunze

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K103087

Indications for Use

510(k) Number (if known):

Device Name:

Cova™MAX Resorbable Membrane for Guided Tissue and Bone Regeneration

Indications for Use:

Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:

-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants;

-Augmentation around implants placed in immediate extraction sockets;

-Augmentation around implants placed in delayed extraction sockets;

-Localized ridge augmentation for later implantation;

-Alveolar ridge reconstruction for prosthetic treatment;

-Filling of bone defects after root resection, cystectomy and removal of retained teeth;

-Guided bone regeneration in dehiscence defects;

-Guided tissue regeneration procedures in periodontal and recession defects.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Susan Punroe

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100897

Page 1 of 1

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.