Vitala® Porcine Derived 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® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vitala® Porcine Derived Collagen Membrane, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria / Parameter	Reported Device Performance (Vitala® Porcine Derived Collagen Membrane)
Indications for Use	Same as Predicate Device: Guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for various dental/periodontal procedures.
Design	Manufactured using a standardized, controlled, multistage process. Porcine pericardium source from USDA-inspected facility in USA. Terminally sterilized by electron beam irradiation in double blister packs.
Mode of Action	Functions as a barrier between bone graft material and soft tissue. Serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Substantially resorbed by 26 weeks.
Operating Principles	Cell-Occlusive, Implantable, Resorbable, Biocompatible.
Material	Intact purified collagen tissue.
Collagen Source	Porcine pericardium.
Form	Membrane.
Color	White to off-white.
Sizes	Variety of sizes.
Resorption Time	Substantially resorbed by 26 weeks.
Sterilization Method	Irradiation.
Sterility	Sterile, SAL 10°.
Single Use/Reuse	Single use only.
Packaging	Double blister pack.
Tensile Strength	Tensile strength ≥ reference device (Bio-Gide® Resorbable Bilayer Membrane).
Denaturation Transition Temperature	Similar to predicate device.
Protein Analysis	Similar to predicate device.
Cytotoxicity	Non-cytotoxic (ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells, ISO 10993-5).
Implantation (Local Tissue Reaction)	Considered a non-irritant compared to the reference device at 2, 13, and 26 weeks of implantation (Intra-Oral Implant Model in Rabbits, ISO 10993-6).
Pyrogenicity	Non-pyrogenic. Test article extract met the requirements of the test (USP Bacterial Endotoxin Testing, Kinetic Chromogenic Method).
Chemical Characterization	All compounds have an acceptable margin of exposure (Chemical Characterization of Materials, ISO 10993-18).

Study Details

Sample sizes used for the test set and the data provenance:
- In vitro product characterization (Bench Tests): Specific sample sizes for tensile strength, denaturation transition temperature, and protein analysis are not explicitly stated. The tests were performed to compare the subject device against a reference device (Bio-Gide® Resorbable Bilayer Membrane) and the predicate device (Vitala® Resorbable Natural Collagen Membrane, K101453).
- Biocompatibility Studies:
  - Cytotoxicity (ISO MEM Elution Assay): Not specified.
  - Implantation (Local Tissue Reaction): An animal study was conducted in a rabbit intra-oral model. The number of rabbits is not specified.
  - Pyrogenicity (USP Bacterial Endotoxin Testing): Not specified.
- Animal Study for Resorption: A canine mandibular molar furcation defect model was used. The sample size (number of canines) is not specified.
Data Provenance: The document does not explicitly state the country of origin for the reported test data. The source collagen for the device itself is specified as pigs from the United States of America. The studies are non-clinical (bench and animal studies).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a device that is compared to a predicate device and a reference device through non-clinical testing. The "ground truth" here is established through scientific methodologies (benchmarking, standardized biological assays, animal studies) rather than expert human interpretation of medical images or patient records. Therefore, a specific number of experts establishing ground truth in the typical clinical sense is not applicable. The studies were performed according to recognized international standards (ISO, ASTM, USP) and FDA guidelines, implying that the validity of the methods is widely accepted by scientific and regulatory experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers and diagnostic discrepancies. This document describes non-clinical (bench and animal) studies, where data is collected objectively through assays and measurements. Therefore, an adjudication method in this sense is not applicable.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a collagen membrane, not an AI-assisted diagnostic tool or an imaging modality requiring human reading.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This is a physical medical device (collagen membrane), not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims relies on:
  - Physical and Chemical Characterization: Standardized laboratory tests (e.g., ASTM D1708 for tensile strength, differential scanning calorimetry for denaturation temperature, SDS-PAGE for protein analysis).
  - Biocompatibility Testing: Results from in vitro assays (cytotoxicity) and in vivo animal models (local tissue reaction, pyrogenicity, chemical characterization), conforming to ISO 10993 standards and USP.
  - Animal Study Observations: Observations from a canine mandibular molar furcation defect model to characterize tissue reaction and resorption.
The sample size for the training set:
- This type of medical device (collagen membrane) does not involve a "training set" in the context of machine learning or AI. Its performance is demonstrated through direct physical, chemical, and biological testing, not by training an algorithm on data.
How the ground truth for the training set was established:
- As there is no "training set" for this device, the concept of establishing ground truth for it is 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

September 15, 2015

Osteogenics Biomedical, Inc. Mr. Shane Shuttlesworth President 4620 71st St. Bldg 78 Lubbock, Texas 79424

Re: K141177

Trade/Device Name: Vitala® Porcine Derived Collagen Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: August 4, 2015 Received: August 6, 2015

Dear Mr. Shuttlesworth:

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

for Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known)

K141177

Device Name

Vitala Porcine Derived Collagen Membrane

Indications for Use (Describe)

Vitala Porcine Derived 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 and to notify the agency of manufacturing changes that resulted in product specification changes.

l. SUBMITTER

Applicant Name:	Osteogenics Biomedical, Inc.
Address:	4620 71st St, Bldg. 78Lubbock, Texas 79424
Phone:	(806) 796-1923
Fax:	(806) 796-0059
Contact Person:	Shane ShuttlesworthPresident
Date Prepared:	September 10, 2015

II. DEVICE

Trade Name:	Vitala® Porcine Derived Collagen Membrane
Common Name:	Porcine Derived Collagen Membrane
Regulation Number:	21 CFR 872.3930
Regulation Name:	Bone Grafting Material
Regulatory Class:	II
Product Code:	NPL (Barrier, Animal Source, Intraoral)

lll. PREDICATE DEVICE

Predicate Device:	Vitala® Resorbable Natural Collagen Membrane (Osteogenics Biomedical, Inc.) K101453
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Bio-Gide® Resorbable Bilayer Membrane (K050466) was used as a reference device in this submission.

IV. DEVICE DESCRIPTION

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Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.

INDICATIONS FOR USE V.

Vitala® Porcine Derived 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, or 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 a coronally positioned flap;
. In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
. Guided bone regeneration of dehiscence defects; and
. Guided tissue regeneration in periodontal defects.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Vitala® Porcine Derived Collagen Membrane has been determined to be substantially equivalent to the predicate device having similar technological characteristics as follows:

Parameter	Vitala® Porcine Derived CollagenMembrane (This submission)	Vitala® Resorbable Natural CollagenMembrane (Predicate Device)
Indications for Use	Vitala® is intended for use during theprocess of guided bone regeneration(GBR) and guided tissueregeneration (GTR) as abiodegradable barrier for:●Simultaneous use withimplants;●Augmentation aroundimplants placed inimmediate extractionsockets;Augmentation around●	Vitala® is intended for use during theprocess of guided bone regeneration(GBR) and guided tissueregeneration (GTR) as abi odegradable barrier for:●Simultaneous use withimplants;●Augmentation aroundimplants placed inimmediate extractionsockets :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.	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.
	Rx Only	Rx Only
Design	The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile.	The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile.
Mode of Action	Vitala® functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and	Vitala® functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and
	resorbed and replaced by hosttissue. Animal studies have shown	resorbed and replaced by hosttissue. Animal studies have shown
	that Vitala is substantially resorbed	that Vitala is substantially resorbed
	by 26 weeks	by 26 weeks
Operating Principles	Cell-OcclusiveImplantableResorbableBiocompatible	Cell-OcclusiveImplantableResorbableBiocompatible
Material	Intact purified collagen tissue	Intact purified collagen tissue
Collagen Source	Porcine pericardium	Porcine pericardium
Form	Membrane	Membrane
Color	White to off-white	White to off-white
Sizes	Variety of sizes	Variety of sizes
Resorption Time	Substantially resorbed by 26 Weeks	Substantially resorbed by 26 weeks
Sterilization Method	Irradiation	Irradiation
Sterility	Sterile, SAL 10°	Sterile, SAL 10°
Singe Use/Reuse	Single use only	Single use only
Packaging	Double blister pack	Double blister pack

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Additional steps in the manufacturing process of Vitala® Porcine Derived Collagen Membrane were added. Minor differences exist in thickness and tensile strength. Non-clinical performance data was compared against the reference device, Bio-Gide® Resorbable Bilayer Membrane, to substantiate thickness and tensile specifications for the subject device.

VII. PERFORMANCE DATA

Nonclinical Tests Submitted

The substantial equivalence of Vitala® Porcine Derived Collagen Membrane and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, in vivo animal studies, and clinical history of the predicate device.

Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows:

ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices – Part 1 Analysis and Risk Management

ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices – Part 2 Controls on Sourcing, Collection, and Handling

ISO 22442-3 Animal Tissues and Their Derivatives Utilizedin the Manufacture of Medical Devices – Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents

ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity

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ISO 10993-6 Biological Evaluation of Medical Devices – Part 6: Test for local effects after implantation

ISO 10993-18 Biological Evaluation of Medical Devices – Part 18: Chemical characterization of materials

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties.

Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification.

Test	Test Method	Results
Tensile Strength	ASTM D1708	Tensile strength ≥ reference device.
DenaturationTransitionTemperature	Internal test method usingdifferential scanning calorimetry	Denaturation transitiontemperature similar to predicate
Protein Analysis	Internal test method using sodiumdodecyl sulfate polyacrylamide gelelectrophoresis	Protein analysis similar to predicatedevice.

The comparative bench testing is summarized in the table below.

A series of in vitro and in vivo biocompatibility testing was performed to assess biocompatibility of the Vitala® Porcine Derived Collagen Membrane as an implantable material.

An animal study was conducted in a rabbit intra-oral model following ISO 10993-6 Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects After Implantation comparing the subject device, Vitala® Porcine Derived Collagen Membrane, to the reference device, Bio-Gide® Resorbable Bilayer Membrane.

The subject device passed the following FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.

Test	Test Method/Model	Results
Cytotoxicity	ISO MEM Elution Assay with L-929	Non-cytotoxic.
	Mouse Fibroblast Cells, ISO 10993-5
Implantation	Assessment of Local Tissue	The subject device is considered a
	Reaction in an Intra-Oral Implant	non-irritant compared to the
	Model in Rabbits, ISO 10993-6	reference device at 2, 13, and 26
		weeks of implantation.
Pyrogenicity	USP Bacterial Endotoxin Testing,	Non-pyrogenic. The test article

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	Kinetic Chromogenic Method	extract met the requirements ofthe test.
ChemicalCharacterization	Chemical Characterization ofMaterials, ISO 10993-18	All compounds have an acceptablemargin of exposure.

Additionally, an animal study was conducted in a canine mandibular molar furcation defect model to characterize tissue reaction and resorption.

VIII. CONCLUSION

Additional steps in the manufacturing process of Vitala® Porcine Derived Collagen Membrane were added to the predicate device, resulting in the subject device. Minor differences exist in thickness and tensile strength. Non-clinical performance data was compared against the reference device, Bio-Gide® Resorbable Bilayer Membrane, to substantiate thickness and tensile specifications for the subject device.

The results of in vitro device characterization tests show that the subject device, Vitala® Porcine Derived Collagen Membrane, is substantially equivalent to the predicate device. Tensile strength tests show that the subject device is at least as strong as the reference device. Biocompatibility testing demonstrated that the subject device is a non-irritant compared to the reference device. An animal study conducted in a canine mandibular molar furcation defect model characterized resorption.

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.