(343 days)
Straumann® Jason® Membrane (K173562)
No
The description focuses on the material properties and intended use of a collagen membrane for guided bone and tissue regeneration, with no mention of AI or ML technology.
No
The device, OSSIX® Breeze, is a biodegradable and biocompatible collagen membrane used for guided tissue and bone regeneration. It acts as a barrier to guide tissue growth rather than providing a therapeutic effect itself such as treating or preventing disease.
No
Explanation: This device is a biodegradable collagen membrane used for guided bone and tissue regeneration, not for diagnosing medical conditions. It serves as a barrier to facilitate healing and growth, rather than to identify or analyze diseases.
No
The device description clearly states it is a physical membrane manufactured from decellularized pericardia of pigs, indicating it is a hardware device, 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 a device used for surgical procedures (guided bone and tissue regeneration) within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The device is a physical membrane implanted into the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device described is a surgical implant used in dentistry and oral surgery.
N/A
Intended Use / Indications for Use
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:
- Alveolar ridge augmentation and reconstruction,
- Alveolar ridge preservation consequent to tooth extractions,
- Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
- In intra bony defects around teeth,
- Guided tissue regeneration procedures in periodontal defects.
Product codes
NPL
Device Description
OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose.
OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide.
Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
Available in sizes: 10x12 mm, 15x20 mm, 20x30 mm and 30x40 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Alveolar ridge, sinus, intra bony defects around teeth, periodontal defects
Indicated Patient Age Range
adults
Intended User / Care Setting
trained dentists or oral 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
An in vivo animal study was conducted in a beagle mandibular guided bone regeneration model to evaluate the in vivo performance, degradation and safety of OSSIX® Breeze dental membrane as compared to the predicate membrane, OSSIX® Plus. The study design included defects of 10 ± 1 mm mesiodistally (z-distance), 8 ± 1 mm occlusal-apically (ydistance), and 7 ± 1 mm buccolingually (x-distance). Each defect was either left untreated (negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device). End points for pathology, histology, histomorphology and micro-CT were taken after 4, 12 and 24 weeks.
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, and biocompatibility testing of the subject device.
Non-clinical biocompatibility testing was performed in accordance with the following FDA recognized consensus standards:
- ISO 10993-1:2018 Biological evaluation of medical devices- Part 1 Evaluation and . testing within a risk management process
- . ISO 10993-2:2006 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- ISO/TR10993-33:2015 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residues
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices-Part 11-Tests for systemic . toxicity
- ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample . preparation and reference materials
The control of animal materials is performed following:
- ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives Part ● 1: Application of risk management
- ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Part ● 2: Controls on sourcing, collection and handling
- ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part . 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
The sterilization process is established and 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
A series of bench tests were conducted to evaluate the biochemical and physicochemical properties of the device. In vitro product characterization testing was performed comparing the subject device to the predicate as well as to the reference devices demonstrating substantial equivalence. Specifically, the bench testing includes the following categories:
- . Weight and dimensions (weight, size, thickness, expansion upon hydration and water uptake),
- . Composition and purity (carbohydrates, heavy metals, endotoxins, ethanol, EtO residues, organic extractables, DNA, moisture, total organic content, minerals, amino acids and pH),
- Enzymatic (collagenase and trypsin digestion),
- Structural (SEM analysis, porosity, denaturing temperature, integrity upon wetting, solubility, and FT-IR spectroscopy),
- . Mechanical properties (maximum load/tensile strength, suture retention, fixability).
An in vivo animal study was conducted in a beagle mandibular guided bone regeneration model to evaluate the in vivo performance, degradation and safety of OSSIX® Breeze dental membrane as compared to the predicate membrane, OSSIX® Plus. The subject device performed in a manner substantially equivalent to the cleared predicate membrane, OSSIX® Plus. 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)
OSSIX® Plus (K160281)
Reference Device(s)
Straumann® Jason® Membrane (K173562)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
Datum Dental Ltd. % Janice Hogan Partner Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia, Pennsylvania 19103
7/18/2022
Re: K212509
Trade/Device Name: OSSIX® Breeze Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: June 23, 2022 Received: June 23, 2022
Dear Janice 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
| OSSIX® Breeze |
|---|
| --------------- |
Indications for Use (Describe)
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:
-
- Alveolar ridge augmentation and reconstruction,
-
- Alveolar ridge preservation consequent to tooth extractions,
-
- Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
-
- In intra bony defects around teeth,
-
- Guided tissue regeneration procedures in periodontal defects.
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)
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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Image /page/3/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. A vertical line separates the two logos. The logos are in gray.
510(k) Summary Datum Dental Ltd.'s OSSIX® Breeze K212509
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: | Lyudmila Kipnis, Director of Regulatory Affairs |
|---|---|
| Date prepared: | July 18, 2022 |
II. Device
| Trade name: | OSSIX® Breeze |
|---|---|
| Common name: | Cross-Linked Pericardium Membrane |
| Classification name: | Barrier, animal source, intraoral (21 CFR 872.3930) |
| Regulatory class: | II |
| Product code: | NPL |
III. Predicate Device
Primary predicate: OSSIX® Plus (K160281) Reference device: Straumann® Jason® Membrane (K173562)
IV. Device Description
OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose.
OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide.
Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
4
Image /page/4/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, with a stylized leaf-like shape next to the company name in a sans-serif font. A vertical line separates the two logos, and the datum dental logo is on the right, also in a sans-serif font. The logos are all in a dark gray color.
Available in sizes: 10x12 mm, 15x20 mm, 20x30 mm and 30x40 mm.
OSSIX® Breeze is intended for use in adults and should only be used by trained dentists or oral surgeons.
V. Indications for Use
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:
-
- Alveolar ridge augmentation and reconstruction,
-
- Alveolar ridge preservation consequent to tooth extractions,
-
- Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
-
- In intra bony defects around teeth,
-
- Guided tissue regeneration procedures in periodontal defects.
VI. Comparison of Technological Characteristics with the Predicate Device
OSSIX® Breeze has similar technological characteristics as the predicate device OSSIX® Plus. Both devices are manufactured from porcine collagen that is subjected to identical cross-linking process to provide the product with better resistance to degradation. Both products are highly porous three-dimensional conductive membranes structured with a lattice network of fibrillated cross-linked collagen with a pore size that is occlusive for epithelial gingival cells. The dimensions of both products are comparable, with thickness (dry membrane) of about 0.2 mm for OSSIX® Plus and 0.1-0.2 mm for OSSIX® Breeze, and up to 30x40 mm in the length and width of both devices.
The principal difference between OSSIX® Breeze and OSSIX® Plus is that OSSIX® Plus is manufactured by reconstitution of soluble purified type I collagen derived from porcine tendons, while OSSIX® Breeze is produced from insoluble collagen of decellularized porcine pericardia. In both products, the collagen is subject to similar viral inactivation (alkaline treatment), crosslinking (glycation based), and sterilization (ethylene oxide) methods. Comparative nonclinical testing between the subject OSSIX® Breeze and predicate OSSIX® Plus demonstrates that the devices have comparable physicochemical and biochemical characteristics except for minor differences in porosity, water-uptake, microstructure and mechanical properties. Additional bench testing that compared the subject device OSSIX® Breeze to the reference device
5
Image /page/5/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. The Dentsply Sirona logo consists of a stylized leaf shape and the words "Dentsply Sirona" stacked on top of each other. The datum dental logo consists of the words "datum dental" stacked on top of each other. A vertical line separates the two logos.
Straumann® Jason® membrane, which is also manufactured from acellularized porcine pericardium, demonstrated that both products are comparable in terms of these characteristics.
Regarding principles of operation, the subject device as well as the predicate and reference devices are applied and work in the same manner by adhering to the surrounding tissues and providing a barrier that guides bone and tissue regeneration.
Therefore, both the subject OSSIX® Breeze and the predicate OSSIX® Plus have the same intended use and similar indications for use, composition, structure, manufacturing process, and physicochemical characteristics. The minor technological differences between OSSIX® Breeze and its predicate devices raise no new issues of substantial equivalence. Performance data demonstrate that OSSIX® Breeze is substantially equivalent to OSSIX® Plus.
A comparison chart of OSSIX® Breeze with the predicate and reference devices is provided below:
| | Subject device | OSSIX® Plus (K160281) | Straumann® Jason®
Membrane (K173562) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/
Indications for
use | OSSIX® Breeze
membrane alone or in
combination with
suitable augmentation
materials (like
autologous bone or other
bone replacement
materials) is indicated
for immediate or
delayed guided bone
regeneration (GBR) and
guided tissue
regeneration (GTR) as a
biodegradable
membrane for:
- Alveolar ridge
augmentation and
reconstruction, - Alveolar ridge
preservation
consequent to tooth
extractions, - Over the window in
sinus elevation
procedures and for
support of the | 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 | Jason Membrane alone or
in combination with
suitable augmentation
materials (like
autogenous bone,
allogeneic, xenogeneic or
alloplastic bone
replacement materials) is
indicated for immediate
or delayed guided tissue
and bone regeneration.
• in case of surgical bone
defects and bone wall
defects
• in the context of sinus
floor augmentation and
for support of the
Schneiderian membrane
• in the context of
maxillary ridge
augmentation
• in the context of
maxillary ridge
reconstruction for
prosthetic treatment
• in the context of a
treatment of |
| | Subject device | OSSIX® Plus (K160281) | Straumann® Jason® |
| | | | Membrane (K173562) |
| | Schneiderian
membrane, - In intra bony defects
around teeth, - Guided tissue
regeneration
procedures in
periodontal defects. | 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. | fenestration defects
• in case of periodontal
bone defects (one to
three-wall defects, class
I and II furcation
defects)
• in case of dehiscence
defects
• after apicoectomy,
cystectomy, resection
of retained teeth and
resection of other bone
lesions
• in extraction sockets
after tooth extractions
• in case of immediate or
delayed augmentation
around implants in
extraction sockets |
| Mode of Action | Functions as a barrier
when applied between
bone graft material and
soft tissue.
The membrane serves as
a bioresorbable scaffold
that is eventually
remodeled, resorbed,
and replaced by host
tissue. | Functions as a barrier
when applied between
bone graft material and
soft tissue.
The membrane serves as
a bioresorbable scaffold
that is eventually
remodeled, resorbed, and
replaced by host tissue. | Functions as a barrier
when applied between
bone graft material and
soft tissue.
The membrane serves as
a bioresorbable scaffold
that is eventually
remodeled, resorbed, and
replaced by host tissue. |
| Operating
Principles | • Cell-occlusive
• Implantable
• Resorbable
• Biocompatible | • Cell-occlusive
• Implantable
• Resorbable
• Biocompatible | • Cell-occlusive
• Implantable
• Resorbable
• Biocompatible |
| Material | Porcine decellularized
pericardia | Porcine tendons | Porcine decellularized
pericardia |
| Collagen Source | Porcine pericardium | Porcine tendons | Porcine pericardium |
| Technology | Cross-linked (ribose)
decellularized
pericardium | Cross-linked (ribose)
reconstituted purified
collagen | Non-cross-linked
decellularized
pericardium |
| Form | Membrane | Membrane | Membrane |
| Color | White to off-white | White to off-white | White to off-white |
| Sizes | • 10x12mm
• 15x20mm
• 20x30mm | • 10x12.5mm
• 15x25mm
• 25x30mm | • 15x20mm
• 20x30mm
• 30x40mm |
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Image /page/6/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, with a stylized "S" shape next to the company name. A vertical line separates the two logos, with "datum dental" on the right in a similar sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for Dentsply Sirona Datum Dental. The logo consists of a stylized leaf-like shape on the left, followed by the words "Dentsply Sirona" in a sans-serif font. A vertical line separates "Dentsply Sirona" from the words "datum dental", which are also in a sans-serif font. The overall design is clean and modern.
| | Subject device | OSSIX® Plus (K160281) | Straumann® Jason®
Membrane (K173562) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resorption Time | Substantially resorbed
by 24 weeks | Substantially resorbed by
24 weeks | Substantially resorbed by
12 weeks |
| Single use | Yes | Yes | Yes |
| Packaging | Double blister pack.
Two layers of sterile
barrier packaging to
facilitate the aseptic
delivery of the sterile
device into the sterile
surgical field. | Double blister pack. Two
layers of sterile barrier
packaging to facilitate the
aseptic delivery of the
sterile device into the
sterile surgical field. | Double pouch pack. Two
layers of sterile barrier
packaging to facilitate the
aseptic delivery of the
sterile device into the
sterile surgical field. |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
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, and biocompatibility testing of the subject device.
Non-clinical biocompatibility testing was performed in accordance with the following FDA recognized consensus standards:
- ISO 10993-1:2018 Biological evaluation of medical devices- Part 1 Evaluation and . testing within a risk management process
- . ISO 10993-2:2006 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- ISO/TR10993-33:2015 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residues
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices-Part 11-Tests for systemic . toxicity
8
Image /page/8/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. The Dentsply Sirona logo consists of a stylized "S" shape and the words "Dentsply Sirona" in a sans-serif font. The datum dental logo consists of the words "datum dental" in a sans-serif font, with a vertical line separating the two logos.
-
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample . preparation and reference materials
The control of animal materials is performed following: -
ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives Part ● 1: Application of risk management
-
ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Part ● 2: Controls on sourcing, collection and handling
-
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part . 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
The sterilization process is established and 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
A series of bench tests were conducted to evaluate the biochemical and physicochemical properties of the device. In vitro product characterization testing was performed comparing the subject device to the predicate as well as to the reference devices demonstrating substantial equivalence. Specifically, the bench testing includes the following categories: -
. Weight and dimensions (weight, size, thickness, expansion upon hydration and water uptake),
-
. Composition and purity (carbohydrates, heavy metals, endotoxins, ethanol, EtO residues, organic extractables, DNA, moisture, total organic content, minerals, amino acids and pH),
-
Enzymatic (collagenase and trypsin digestion),
-
Structural (SEM analysis, porosity, denaturing temperature, integrity upon wetting, solubility, and FT-IR spectroscopy),
-
. Mechanical properties (maximum load/tensile strength, suture retention, fixability).
An in vivo animal study was conducted in a beagle mandibular guided bone regeneration model to evaluate the in vivo performance, degradation and safety of OSSIX® Breeze dental membrane as compared to the predicate membrane, OSSIX® Plus. The subject device performed in a manner substantially equivalent to the cleared predicate membrane, OSSIX® Plus. The study design included defects of 10 ± 1 mm mesiodistally (z-distance), 8 ± 1 mm occlusal-apically (ydistance), and 7 ± 1 mm buccolingually (x-distance). Each defect was either left untreated
9
Image /page/9/Picture/0 description: The image shows the logo for Dentsply Sirona datum dental. The Dentsply Sirona part of the logo is on the left, with a stylized leaf-like shape to the left of the text. A vertical line separates the two parts of the logo, and the datum dental part is on the right. The text is all in a gray sans-serif font.
(negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device). End points for pathology, histology, histomorphology and micro-CT were taken after 4, 12 and 24 weeks. The subject device performed in a manner substantially equivalent to the cleared predicate device.
VIII. Conclusion
Based on the data provided within these 510(k) submissions as summarized above, it is concluded that OSSIX® Breeze is substantially equivalent to the predicate device.