(237 days)
No
The device description and performance studies focus on the material properties and biological performance of a collagen membrane, with no mention of AI or ML.
Yes.
The device is described as a resorbable collagen membrane intended for use during guided bone regeneration and guided tissue regeneration for various dental procedures, which falls under the definition of a therapeutic device designed to treat or alleviate a condition.
No
Explanation: The device is a resorbable collagen membrane intended for guided bone and tissue regeneration, not for diagnosing conditions.
No
The device description clearly states it is a resorbable collagen membrane, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a resorbable collagen membrane used during surgical procedures for guided bone and tissue regeneration within the mouth. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description reinforces that it's a physical barrier made of collagen for surgical use.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro to diagnose a condition, monitor a disease, or screen for health issues.
- Anatomical Site: The device is used intraorally, directly on the patient's tissues, which is typical for a surgical implant or barrier, not an IVD.
IVD devices are used to perform tests on samples taken from the human body outside of the body (in vitro) to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (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 procedure. -
- -In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
- In intra bony defects around teeth. -
- For treatment of recession defects, together with coronally positioned flap. -
- -In furcation defects in multi rooted teeth.
- Localized gingival augmentation. -
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose.
OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide.
Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm.
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
dental surgeons
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)
The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, biocompatibility testing and clinical history of the predicate device.
Non-clinical testing was performed in accordance with the following FDA recognized consensus standards:
- . ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices- Part 1 -Evaluation and testing within a risk management process
- ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: ● Ethylene oxide sterilization residues
- ISO 10993-11:2006 Biological evaluation of medical devices-Part 11-Tests for . systemic toxicity
The control of animal materials is performed following - ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives ● - Part 2: Controls on sourcing, collection and handling
The ethylene oxide sterilization process is performed according to - ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --. Requirements for the development, validation and routine control of a sterilization process for medical devices
The sterilization process was validated to assure a minimum sterility assurance level of 10 6. The OSSIX® VOLUMAX membrane is specified to have minimal residual levels of EtO and ethylene chlorohydrin (ECH) remaining on the product after sterilization, as measured using validated aqueous simulated use extraction methods, that shall not exceed an average daily dose specified in ISO 10993-7:2008.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device in biochemical, physicochemical, mechanical properties, as summarized in the table below. As expected from the increase in the thickness and collagen content, OSSIX® VOLUMAX exhibits a higher resistance to suture pulling.
The biocompatibility, viral inactivation, stability and packaging validation data obtained for the predicate device was used to demonstrate the biocompatibility, viral safety and shelf-life of the subject device.
The following biocompatibility tests leveraged from previous submission were utilized to support the biocompatibility of the subject device: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, 2- and 12-week implantation tests.
In addition, the pyrogenicity of OSSIX® VOLUMAX was tested in vivo using the Rabbit Pyrogen Test as per USP , and the test article was judged as nonpyrogenic.
An in vivo animal study was conducted in an L-shape buccal beagle mandibular defect model system in Beagle dogs to evaluate the in vivo performance, degradation and safety of OSSIX® VOLUMAX dental membrane as compared to OSSIX® PLUS. The study was conducted on 19 animals followed up to 6 months. The subject device performed in a manner substantially equivalent to the cleared predicate device.
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.
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.
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.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Datum Dental Ltd. % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K153549
Trade/Device Name: OSSIX® VOLUMAX Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 5, 2016 Received: July 5, 2016
Dear Ms. Hogan:
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.
1
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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K153549
Device Name
OSSIX® VOLUMAX
Indications for Use (Describe)
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
- Ridge augmentation for later implant insertions. -
- -Simultaneous ridge augmentation and implant insertions.
- Ridge augmentation around implants inserted in delaved 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 procedure. -
- -In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
- In intra bony defects around teeth. -
- For treatment of recession defects, together with coronally positioned flap. -
- -In furcation defects in multi rooted teeth.
- Localized gingival augmentation. -
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. 510(k) Applicant
Datum Dental Ltd. 1 Bat Sheva st. Lod 7120101 Israel Phone: 1-972-8-6705400 Fax: 1-972-8-6705429 Contact person: Arie Goldlust, CEO, VP R&D Date prepared: July 28, 2016
II. Device
| Trade name: | OSSIX® VOLUMAX |
|---|---|
| Common name: | Resorbable Collagen Membrane |
| Classification name: | Bone grafting material (21 CFR 872.3930) |
| Regulatory class: | II |
| Product code: | NPL (Barrier, Animal Source, Intraoral) |
III. Predicate Device
Primary predicate: OSSIX® PLUS (K053260) Reference device: Mucograft® (K073711, K102531, K140518)
IV. Device Description
OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose.
OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide.
Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm.
Intended for use by dental surgeons.
4
V. Indications for Use
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (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 procedure.
- In implants with vertical bone loss due to infection, only in cases where ● satisfactory debridement and implant surface disinfection can be achieved.
- In intra bony defects around teeth.
- For treatment of recession defects, together with coronally positioned flap. ●
- In furcation defects in multi rooted teeth. ●
- . Localized gingival augmentation.
VI. Comparison of Technological Characteristics with the Predicate Device
OSSIX® VOLUMAX has the same intended use and the technological characteristics as the predicate device, OSSIX® PLUS. The principal difference between the two products is the thickness and content of collagen. Otherwise, both products are identical in their chemical composition (porcine type I collagen cross-linked by D-ribose), their structure (porous membrane made of lattice network of collagen fibers) and manufacturing technology. The technological differences do not affect the substantial equivalence as demonstrated by bench and animal testing.
With this submission, the company is including the localized gingival augmentation indications for use to the previously cleared indications. The addition of the localized gingival augmentation indication does not result in any change in the therapeutic effect, mode of action or instructions for use as compared with the predicate device (OSSIX® PLUS) as this indication is similar to the already cleared following indication for OSSIX® PLUS: "For treatment of recession defects, together with coronally positioned flap". This added indication is one of the indications of MUCOGRAFT®, the reference device, which has a similar thickness as OSSIX® VOLUMAX.
Thus, the subject device is substantially equivalent to the predicate device as summarized in the below table.
5
| | OSSIX® VOLUMAX
K153549 | OSSIX® PLUS
K053260 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Subject of this submission | Predicate device |
| Intended use/
Indications for
use | OSSIX® PLUS is a resorbable collagen
membrane intended for use during the
process of guided bone regeneration
(GBR) and guided tissue regeneration
(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 procedure.
• In implants with vertical bone loss
due to infection, only in cases where
satisfactory debridement and implant
surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects,
together with coronally positioned
flap.
• In furcation defects in multi rooted
teeth.
• Localized gingival augmentation. | OSSIX® PLUS biodegradable collagen
membrane is intended for use during
the process of guided bone
regeneration (GBR) and guided tissue
regeneration (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 procedure.
• In implants with vertical bone loss
due to infection, only in cases where
satisfactory debridement and implant
surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects,
together with coronally positioned
flap.
• In furcation defects in multi rooted
teeth. |
| Contra-
indications | OSSIX® VOLUMAX must not be used
in:
- Patients with known collagen
hypersensitivity. - Patients with sensitivity to
porcine-derived materials. - Patients suffering from
autoimmune disease and
connective tissue disease, such
as: systemic lupus
erythematosous,
dermatomyositis etc. | OSSIX® PLUS must not be used in: - Patients with known collagen
hypersensitivity. - Patients suffering from
autoimmune disease and
connective tissue disease, such
as: systemic lupus
erythematosous,
dermatomyositis etc. |
| Composition of
materials | Cross-linked porcine type I collagen | Cross-linked porcine type I collagen |
| Mode of
Action/
Properties | • Biocompatible
• Non-pyrogenic | • Biocompatible
• Non-pyrogenic |
| Parameter | OSSIX® VOLUMAX
K153549
Subject of this submission | OSSIX® PLUS
K053260
Predicate device |
| | • Non-antigenic
• Porous and fibered microstructure
• Readily absorbs body fluid
• Adheres well to the surrounding and
underlying tissues
• Is not disrupted by the closure of the
surgical site
• Slowly resorbed and replaced by new
tissue | • Non-antigenic
• Porous and fibered microstructure
• Readily absorbs body fluid
• Adheres well to the surrounding and
underlying tissues
• Is not disrupted by the closure of the
surgical site
• Slowly resorbed and replaced by new
tissue |
| Device Design | Resorbable dental membrane made of
porous lattice network of collagen | Resorbable dental membrane made of
porous lattice network of collagen |
| Thickness (dry) | Approx. 1-2 mm | Approx. 0.2 mm |
| Porosity | Approx. 90% | Approx. 80% |
| Size (mm) | 10 x 12.5 mm
15 x 25 mm
25 x 30 mm
10 x 40 mm | 25 x 30 mm
30 x 40 mm |
| Packaging
configuration | Packed in a double blister pack | Packed in a double blister pack |
| Sterilization | Sterilized in double blisters by
ethylene oxide | Sterilized in double blisters by
ethylene oxide |
| Principle of
operation | Surgically implanted over a bony or
periodontical defect | Surgically implanted over a bony or
periodontical defect |
| Reusability | Single use only | Single use only |
6
VII. Summary of Data to Support Substantial Equivalence
The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, biocompatibility testing and clinical history of the predicate device.
Non-clinical testing was performed in accordance with the following FDA recognized consensus standards:
- . ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices- Part 1 -Evaluation and testing within a risk management process
- ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: ● Ethylene oxide sterilization residues
- ISO 10993-11:2006 Biological evaluation of medical devices-Part 11-Tests for . systemic toxicity
The control of animal materials is performed following
7
-
ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives ● - Part 2: Controls on sourcing, collection and handling
The ethylene oxide sterilization process is performed according to -
ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --. Requirements for the development, validation and routine control of a sterilization process for medical devices
The sterilization process was validated to assure a minimum sterility assurance level of 10 6. The OSSIX® VOLUMAX membrane is specified to have minimal residual levels of EtO and ethylene chlorohydrin (ECH) remaining on the product after sterilization, as measured using validated aqueous simulated use extraction methods, that shall not exceed an average daily dose specified in ISO 10993-7:2008.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device in biochemical, physicochemical, mechanical properties, as summarized in the table below. As expected from the increase in the thickness and collagen content, OSSIX® VOLUMAX exhibits a higher resistance to suture pulling.
| Test | Test Method |
|---|---|
| Heavy metals | USP |
| Inductively coupled plasma optical emission spectrometry | |
| (ICP-OES)--full screen of heavy metals | |
| Endotoxins (LAL) | USP |
| Collagenase resistance | Internal test method: enzymatic degradation |
| Trypsin resistance | Internal test method: enzymatic degradation |
| Weight | Weighing on analytical scales |
| Suture pull test | Internal test method |
| 3D structure (SEM) | Scanning electron microscope analysis |
| Tensile strength (Maximum Load) | Internal test method; tensile machine |
| Denaturing temperature | Differential scanning calorimetry (DSC) |
| Carbohydrates content | Colorimetric test: sulfuric/phenol method |
| Ethanol content | Gas chromatography |
| Porosity | Mercury intrusion porosimetry analysis |
| Thickness | Digital micrometer |
| Organic extractables impurities | Gas chromatography-mass spectrometry (GC-MS) |
| Thermo gravimetric analysis | |
| (TGA) | Thermo gravimetric analyzer |
| Amino acid analysis | Amino acid analyzer |
| pH | pH-meter |
8
The biocompatibility, viral inactivation, stability and packaging validation data obtained for the predicate device was used to demonstrate the biocompatibility, viral safety and shelf-life of the subject device.
The following biocompatibility tests leveraged from previous submission were utilized to support the biocompatibility of the subject device: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, 2- and 12-week implantation tests.
In addition, the pyrogenicity of OSSIX® VOLUMAX was tested in vivo using the Rabbit Pyrogen Test as per USP , and the test article was judged as nonpyrogenic.
An in vivo animal study was conducted in an L-shape buccal beagle mandibular defect model system in Beagle dogs to evaluate the in vivo performance, degradation and safety of OSSIX® VOLUMAX dental membrane as compared to OSSIX® PLUS. The study was conducted on 19 animals followed up to 6 months. The subject device performed in a manner substantially equivalent to the cleared predicate device.
VIII. Conclusion
The subject and predicate devices have the same intended use with similar indications for use and substantially similar technological characteristics and principles of operation. In addition, the non-clinical data provided within the 510(k) submission, as summarized above, demonstrate that OSSIX® VOLUMAX is substantially equivalent to the predicate device.