(422 days)
Not Found
No
The document describes a resorbable collagen membrane for guided bone and tissue regeneration. There is no mention of AI, ML, image processing, or any computational analysis of data. The device is a physical barrier.
Yes
The document describes the device's intended use for guided bone and tissue regeneration during oral surgical procedures to treat various defects and conditions, which falls under the definition of therapeutic use.
No
The device is a resorbable collagen membrane intended for use in guided bone and tissue regeneration procedures, which are therapeutic rather than diagnostic.
No
The device description clearly states it is a "natural collagen membrane sourced from veterinary certified pigs," indicating it is a physical, biological material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Vitala™ Resorbable Natural Collagen Membrane clearly indicate it is a surgical implant/barrier used directly in the body during oral surgical procedures. It is not used to test samples outside the body.
The device's function is to act as a physical barrier to guide tissue and bone regeneration, not to diagnose or provide information about a patient's health through testing of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BIO-GIDE® (K050446), CopiOs™ Pericardium Membrane (K073097), Ossix™-Plus (K053260)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUL 2 1 2011
..
510(k) Summary
| Date Prepared: | May 19, 2010 |
|---|---|
| Sponsor : | OBI Biologics, Inc. |
| 4620 71st Street, Bldg 79 | |
| Lubbock, TX 79424 | |
| FDA Establishment Registration #: | N/A (registration after 510(k) submission approval) |
| Contact Person: | Dustyn Webb |
| Director of Regulatory Affairs | |
| 806-796-1923 (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 Material | |
| Device) | |
| Predicate Devices: | BIO-GIDE® (K050446) |
| CopiOs™ Pericardium Membrane (K073097) | |
| 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
1
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. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SIMILAR
MODELS/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 |
| SIMILAR
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. | BIO-GIDE® is recommended
for:
• Simultaneous use of GBR-
membrane (BIO-GIDE)
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, removal of
retained teeth;
• Guided bone regeneration
in dehiscence defects; and
• Guided tissue
regeneration in
periodontal defects. | This membrane is intended for use
in oral surgical procedures as a
resorbable material for
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,
removal of retained teeth; guided
bone regeneration in dehiscence
defects and guided tissue
regeneration procedures in
periodontal defects. | Ossix™-Plus biodegradable
Collagen membrane is intended
For use during the process of
guided bone regeneration (GBR)
and guided tissue (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
procedures.
• In implants with vertical
bone loss due to infection,
only in cases where
satisfactory debridement
and implant surface
disinfection can be achieved.
• In intrabony defects around
teeth.
• For treatment of recession
defects, together with
coronally positioned flap.
• In furcation defects in multi-
rooted teeth. |
| INCORPORATES
SAME BASIC DESIGN | Yes | Yes | Yes | Yes |
| UTILIZES THE SAME
OPERATING
PRINCIPLE | Cell-occlusive
Implantable
Resorbable
Hemostatic | Cell-occlusive
Implantable
Resorbable
Hemostatic | Cell-occlusive
Implantable
Resorbable
Hemostatic | Cell-occlusive
Implantable
Resorbable
Hemostatic |
| INCORPORATES
SIMILAR MATERIALS | Yes, porcine collagen | Yes, porcine collagen | Yes, bovine collagen | Yes, porcine collagen |
| STERILIZATION
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
2
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.
3
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
4
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