VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE

K101453 · Obi Biologics, Inc. · NPL · Jul 21, 2011 · Dental

Device Facts

• Record ID: K101453
• Device Name: VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
• Applicant: Obi Biologics, Inc.
• Product Code: NPL · Dental
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vitala™ is a resorbable natural collagen membrane derived from porcine sources; used as a physical barrier in oral surgery to facilitate guided bone regeneration (GBR) and guided tissue regeneration (GTR). The membrane is cell-occlusive, implantable, and hemostatic; it prevents soft tissue ingrowth into bone defects, allowing bone regeneration. It is applied by dental surgeons during procedures such as implant placement, ridge augmentation, and sinus elevation. The device is provided sterile in a double-tray configuration. By maintaining space and excluding non-osteogenic cells, the membrane supports the healing of bone and periodontal defects, potentially improving clinical outcomes for patients undergoing dental reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material similarity to legally marketed predicate devices.

Technological Characteristics

Resorbable natural collagen membrane sourced from porcine tissue. Cell-occlusive, hemostatic, and implantable. Sterilized via E-beam irradiation. Supplied in various dimensions (e.g., 13mm x 25mm to 40mm x 50mm).

Indications for Use

Indicated for patients requiring guided bone or tissue regeneration in oral surgical procedures, including implant placement, ridge augmentation, ridge preservation, and treatment of periodontal or bone defects.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BIO-GIDE® (K050446)
• CopiOs™ Pericardium Membrane (K073097)
• Ossix™-Plus (K053260)

Submission Summary (Full Text)

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K101453

### JUL 2 1 2011

..

# 510(k) Summary

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

#### 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.

#### 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<br>(K101453)<br>OBI Biologics, Inc. | BIO-GIDE®<br>(K050446)<br>Geistlich-Pharma | CopiOs™ Pericardium Membrane<br>(K073097)<br>RTI Biologics, Inc. | Ossix™-Plus<br>(K053260)<br>Colbar Life Science, Ltd. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SIMILAR<br>MODELS/SIZES | 13mm x 25mm, 15mm x 20mm, 20mm x 30mm,<br>30mm x 40mm, 40mm x 50mm | 13mm x 25mm, 25mm x 25mm,<br>40mm x 50mm | 15mm x 20mm, 20mm x 30mm,<br>30mm x 40mm | 15mm x 25mm, 25mm x 30mm,<br>30mm x 40mm |
| SIMILAR<br>INTENDED USE | Vitala™ Resorbable Natural Collagen Membrane<br>is intended for use during the process of guided<br>bone regeneration (GBR) and guided tissue<br>regeneration (GTR) as a biodegradable barrier<br>for:<br>• Simultaneous use with implants;<br>• Augmentation around implants placed in<br>immediate extraction sockets;<br>• Augmentation around implants placed in<br>delayed extraction sockets;<br>• Localized ridge augmentation for later<br>implantation;<br>• Alveolar ridge reconstruction for prosthetic<br>treatment;<br>• Alveolar ridge preservation consequent to<br>tooth extraction;<br>• Filling of bone defects after root resection,<br>cystectomy, removal of retained teeth;<br>• Over the window in lateral window sinus<br>elevation procedures;<br>• Furcation defects in multi-rooted teeth;<br>• Treatment of recession defects, together<br>with coronally positioned flap;<br>• In implants with vertical bone loss due to<br>infection, only with satisfactory<br>debridement and implant surface<br>disinfection;<br>• Guided bone regeneration in dehiscence<br>defects; and<br>• Guided tissue regeneration in periodontal<br>defects. | BIO-GIDE® is recommended<br>for:<br>• Simultaneous use of GBR-<br>membrane (BIO-GIDE)<br>and implants;<br>• Augmentation around<br>implants placed in<br>immediate extraction<br>sockets;<br>• Augmentation around<br>Implants placed in<br>delayed extraction<br>sockets;<br>• Localized ridge<br>augmentation for later<br>implantation;<br>• Alveolar ridge<br>reconstruction for<br>prosthetic treatment;<br>• Filling of bone defects<br>after root resection,<br>cystectomy, removal of<br>retained teeth;<br>• Guided bone regeneration<br>in dehiscence defects; and<br>• Guided tissue<br>regeneration in<br>periodontal defects. | This membrane is intended for use<br>in oral surgical procedures as a<br>resorbable material for<br>augmentation around implants<br>placed in delayed extraction<br>sockets; localized ridge<br>augmentation for later<br>implantation; alveolar ridge<br>reconstruction for prosthetic<br>treatment; filling of bone defects<br>after root resection, cystectomy,<br>removal of retained teeth; guided<br>bone regeneration in dehiscence<br>defects and guided tissue<br>regeneration procedures in<br>periodontal defects. | Ossix™-Plus biodegradable<br>Collagen membrane is intended<br>For use during the process of<br>guided bone regeneration (GBR)<br>and guided tissue (GTR) as a<br>biodegradable barrier for:<br>• Ridge augmentation for later<br>implant insertions.<br>• Simultaneous ridge<br>augmentation and implant<br>insertions.<br>• Ridge augmentation around<br>implants inserted in delayed<br>extraction sites.<br>• Ridge augmentation around<br>implants inserted in<br>immediate extraction sites.<br>• Alveolar ridge preservation<br>consequent to tooth (teeth)<br>extraction(s).<br>• Over the window in lateral<br>window sinus elevation<br>procedures.<br>• In implants with vertical<br>bone loss due to infection,<br>only in cases where<br>satisfactory debridement<br>and implant surface<br>disinfection can be achieved.<br>• In intrabony defects around<br>teeth.<br>• For treatment of recession<br>defects, together with<br>coronally positioned flap.<br>• In furcation defects in multi-<br>rooted teeth. |
| INCORPORATES<br>SAME BASIC DESIGN | Yes | Yes | Yes | Yes |
| UTILIZES THE SAME<br>OPERATING<br>PRINCIPLE | Cell-occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell-occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell-occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell-occlusive<br>Implantable<br>Resorbable<br>Hemostatic |
| INCORPORATES<br>SIMILAR MATERIALS | Yes, porcine collagen | Yes, porcine collagen | Yes, bovine collagen | Yes, porcine collagen |
| STERILIZATION<br>PROCESS | 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 [phone] or [phone] 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

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510(k) Number: K101453