Vitala™ Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

Simultaneous use with 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;
Alveolar ridge preservation consequent to tooth extraction;
Filling of bone defects after root resection, cystectomy, removal of retained teeth;
Over the window in lateral window sinus elevation procedures;
Furcation defects in multi-rooted teeth;
Treatment of recession defects, together with coronally positioned flap;
In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
Guided bone regeneration in dehiscence defects; and
Guided tissue regeneration in periodontal defects.

Device Description

Vitala™ Resorbable Natural Collagen Membrane is a natural collagen membrane sourced from veterinary certified pigs. Vitala™ Resorbable Natural Collagen Membrane, minimally manipulated without further cross-linking, is sterilized in a double tray package configuration via E-beam irradiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Vitala™ Resorbable Natural Collagen Membrane." This submission is focused on demonstrating substantial equivalence to predicate devices, not on a new clinical study to prove adherence to specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, test sets, expert adjudication, and study designs (MRMC, standalone) is not present in this document.

Here's an analysis of the available information:

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

The document does not present specific quantitative acceptance criteria or performance metrics in the way a clinical study or performance testing report would. Instead, it relies on comparison to predicate devices, arguing "substantial equivalence" based on similar properties and characteristics.

The table implicitly shows "acceptance" of the Vitala™ device by demonstrating similarities to established predicate devices across various attributes. The acceptance is that the device is "substantially equivalent" to the predicates, meaning it performs as safely and effectively.

Property	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Vitala™)
Models/Sizes	Similar to predicate devices	13mm x 25mm, 15mm x 20mm, 20mm x 30mm, 30mm x 40mm, 40mm x 50mm
Intended Use	Similar to predicate devices	Wide range of GBR/GTR applications, extensively listed and overlapping with predicates.
Basic Design	Incorporates same basic design as predicates	Yes
Operating Principle	Utilizes the same operating principle as predicates	Cell-occlusive, Implantable, Resorbable, Hemostatic
Materials	Incorporates similar materials to predicates	Yes, porcine collagen
Sterilization Process	Identical to predicates	Irradiation
Biocompatibility	Biocompatible	Yes
Non-pyrogenicity	Non-pyrogenic	Yes

2. Sample size used for the test set and the data provenance

No test set data is provided in this 510(k) submission. The document relies on a comparison table to predicate devices. For 510(k) submissions, in vitro testing or existing biocompatibility data for the material may be submitted, but often detailed clinical study sample sizes are not required if substantial equivalence can be shown through other means (e.g., comparison of materials, manufacturing processes, and indications for use). This document does not detail any specific studies with sample sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

Not applicable. No test set described.

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 collagen membrane, not an AI or imaging device. There is no mention of MRMC studies or AI assistance.

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

Not applicable. This is a collagen membrane, not an algorithm.

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

The "ground truth" for this 510(k) submission is effectively the established safety and efficacy of the predicate devices as determined by their previous regulatory clearances and real-world performance. The new device demonstrates "substantial equivalence" to these established benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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K101453

JUL 2 1 2011

510(k) Summary

Date Prepared:	May 19, 2010
Sponsor :	OBI Biologics, Inc.4620 71st Street, Bldg 79Lubbock, TX 79424
FDA Establishment Registration #:	N/A (registration after 510(k) submission approval)
Contact Person:	Dustyn WebbDirector of Regulatory Affairs806-796-1923 (phone)806-796-0059 (fax)dustyn@cytoplast.com (email)
Proprietary Name:	Vitala™
Common Name:	Resorbable Natural Collagen Membrane
Regulatory Classification Name:(Regulation Number)[Product Code]	Bone Grafting Material(872.3930)[NPL]
Device Classification:	Class II(Class II Special Controls Guidance Document: Dental Bone Grafting MaterialDevice)
Predicate Devices:	BIO-GIDE® (K050446)CopiOs™ Pericardium Membrane (K073097)Ossix™-Plus (K053260)

Device Description

Indications for Use

Vitala''' Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

Simultaneous use with 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; .
- Alveolar ridge preservation consequent to tooth extraction;
. Filling of bone defects after root resection, cystectomy, removal of retained teeth;
� Over the window in lateral window sinus elevation procedures;
. Furcation defects in multi-rooted teeth;
. Treatment of recession defects, together with coronally positioned flap;
In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface . disinfection;
Guided bone regeneration in dehiscence defects; and .
Guided tissue regeneration in periodontal defects. t

OBI Biologics, Inc. Vitolo™ Resorbable Natural Collagen Membrane 510{k) Premarket Notification Submission

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Substantial Equivalence Comparison Chart

Property	Vitala™ Resorbable Natural Collagen Membrane(K101453)OBI Biologics, Inc.	BIO-GIDE®(K050446)Geistlich-Pharma	CopiOs™ Pericardium Membrane(K073097)RTI Biologics, Inc.	Ossix™-Plus(K053260)Colbar Life Science, Ltd.
SIMILARMODELS/SIZES	13mm x 25mm, 15mm x 20mm, 20mm x 30mm,30mm x 40mm, 40mm x 50mm	13mm x 25mm, 25mm x 25mm,40mm x 50mm	15mm x 20mm, 20mm x 30mm,30mm x 40mm	15mm x 25mm, 25mm x 30mm,30mm x 40mm
SIMILARINTENDED USE	Vitala™ Resorbable Natural Collagen Membraneis intended for use during the process of guidedbone regeneration (GBR) and guided tissueregeneration (GTR) as a biodegradable barrierfor:• Simultaneous use with implants;• Augmentation around implants placed inimmediate extraction sockets;• Augmentation around implants placed indelayed extraction sockets;• Localized ridge augmentation for laterimplantation;• Alveolar ridge reconstruction for prosthetictreatment;• Alveolar ridge preservation consequent totooth extraction;• Filling of bone defects after root resection,cystectomy, removal of retained teeth;• Over the window in lateral window sinuselevation procedures;• Furcation defects in multi-rooted teeth;• Treatment of recession defects, togetherwith coronally positioned flap;• In implants with vertical bone loss due toinfection, only with satisfactorydebridement and implant surfacedisinfection;• Guided bone regeneration in dehiscencedefects; and• Guided tissue regeneration in periodontaldefects.	BIO-GIDE® is recommendedfor:• Simultaneous use of GBR-membrane (BIO-GIDE)and implants;• Augmentation aroundimplants placed inimmediate extractionsockets;• Augmentation aroundImplants placed indelayed extractionsockets;• Localized ridgeaugmentation for laterimplantation;• Alveolar ridgereconstruction forprosthetic treatment;• Filling of bone defectsafter root resection,cystectomy, removal ofretained teeth;• Guided bone regenerationin dehiscence defects; and• Guided tissueregeneration inperiodontal defects.	This membrane is intended for usein oral surgical procedures as aresorbable material foraugmentation around implantsplaced in delayed extractionsockets; localized ridgeaugmentation for laterimplantation; alveolar ridgereconstruction for prosthetictreatment; filling of bone defectsafter root resection, cystectomy,removal of retained teeth; guidedbone regeneration in dehiscencedefects and guided tissueregeneration procedures inperiodontal defects.	Ossix™-Plus biodegradableCollagen membrane is intendedFor use during the process ofguided bone regeneration (GBR)and guided tissue (GTR) as abiodegradable barrier for:• Ridge augmentation for laterimplant insertions.• Simultaneous ridgeaugmentation and implantinsertions.• Ridge augmentation aroundimplants inserted in delayedextraction sites.• Ridge augmentation aroundimplants inserted inimmediate extraction sites.• Alveolar ridge preservationconsequent to tooth (teeth)extraction(s).• Over the window in lateralwindow sinus elevationprocedures.• In implants with verticalbone loss due to infection,only in cases wheresatisfactory debridementand implant surfacedisinfection can be achieved.• In intrabony defects aroundteeth.• For treatment of recessiondefects, together withcoronally positioned flap.• In furcation defects in multi-rooted teeth.
INCORPORATESSAME BASIC DESIGN	Yes	Yes	Yes	Yes
UTILIZES THE SAMEOPERATINGPRINCIPLE	Cell-occlusiveImplantableResorbableHemostatic	Cell-occlusiveImplantableResorbableHemostatic	Cell-occlusiveImplantableResorbableHemostatic	Cell-occlusiveImplantableResorbableHemostatic
INCORPORATESSIMILAR MATERIALS	Yes, porcine collagen	Yes, porcine collagen	Yes, bovine collagen	Yes, porcine collagen
STERILIZATIONPROCESS	Irradiation	Irradiation	Irradiation	Irradiation
BIOCOMPATIBLE	Yes	Yes	Yes	Yes
NON-PYROGENIC	Yes	Yes	Yes	Yes

Basis for Substantial Equivalence

The Vitala™ Resorbable Natural Collagen Membrane consists of material (porcine collagen) that is very similar in material composition to the predicate devices, BIO-GIDE® (porcine collagen), contection Membrane (bovine collagen) and Ossix™ -Plus (porcine collagen). Design, function and intended use are substantially equivalent to the corresponding characteristics of the predicate devices. Although minor differences exist in the concessing, medical device packaging, and handling characteristics among Vitala™ Resorbable Natural Collagen Membrane and the three predicate devices, these minor differences raise no new issues of safety and efficacy of Vitala" Resorbable Natural Collagen Mentrane.

OBI Biologics, Inc. Vitala''' Resorbable Natural Collagen Membrane 510(k) Premarket Notification Submission

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Image /page/2/Picture/1 description: The image contains a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a bird-like symbol with three curved lines representing its wings or feathers. The emblem is black, and the text is also in a dark color, providing a clear contrast against the likely white or light background of the seal.

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

Mr. Dustyn Webb Director of Regulatory Affairs OBI Biologics, Incorporated 4620 71st Street, Building 79 Lubbock, Texas 79424

JUL 2 1 2011

Re: K101453

Trade/Device Name: Vitala Resorbable Natural Collagen Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 1, 2011 Received: July 13, 2011

Dear Mr. Webb:

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- Mr. Webb

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. minton

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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Indications for Use

510(k) Number (if known): K101453

Device Name: Vitala™ Resorbable Natural Collagen Membrane

Indications for Use:

Vitala™ Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

. Simultaneous use with 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;
. Alveolar ridge preservation consequent to tooth extraction;
. Filling of bone defects after root resection, cystectomy, removal of retained teeth;
. Over the window in lateral window sinus elevation procedures;
. Furcation defects in multi-rooted teeth;
. Treatment of recession defects, together with coronally positioned flap;
In implants with vertical bone loss due to infection, only with satisfactory debridement and . implant surface disinfection;
. Guided bone regeneration in dehiscence defects; and
Guided tissue regeneration in periodontal defects.

Prescription Use

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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sagar Grover

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

Page 1 of

510(k) Number: K101453

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.