(184 days)
OSSIX® PLUS (K053260)
Not Found
No
The device description and intended use focus on the material properties and physical function of a collagen membrane for guided bone and tissue regeneration. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, OSSIX® PLUS, is intended for use in guided bone and tissue regeneration procedures (GBR and GTR) to aid in the healing and growth of bone and tissue in various dental applications, which clearly falls under therapeutic intervention.
No
This device is a resorbable collagen membrane used for guided bone and tissue regeneration, providing a physical barrier to aid in the healing process. It does not perform any diagnostic function.
No
The device description clearly states it is a biodegradable and biocompatible 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 of OSSIX® PLUS is for guided bone and tissue regeneration during dental procedures. This involves physically acting as a barrier to facilitate the growth of bone and tissue in a specific area.
- Device Description: The device is a resorbable collagen membrane used as a physical barrier.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. OSSIX® PLUS does not perform any such diagnostic function. It is a therapeutic device used in a surgical procedure.
Therefore, OSSIX® PLUS is a medical device used in a surgical context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OSSIX® PLUS is a resorbable collagen membrane intended for use during the process of quided bone regeneration (GBR) and quided 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.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
OSSIX® PLUS is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from tendons of veterinary certified pigs and is purified and cross-linked using ribose.
OSSIX® PLUS 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: 15x25 mm, 25x30 mm, and 30x40 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra bony defects around teeth, furcation defects in multi rooted teeth, alveolar ridge
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 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.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. Tests included: Heavy metals (USP ), Endotoxins (LAL) (USP ), Collagenase resistance (Internal test method: enzymatic degradation), Trypsin resistance (Internal test method: enzymatic degradation), Weight (Weighing on analytical scales), 3D structure (SEM) (Scanning electron microscope), Tensile strength (Maximum Load) (Internal test method), Denaturing temperature (Differential scanning calorimetry), Carbohydrates content (Colorimetric test: sulfuric/phenol method), Ethanol content (Gas chromatography), Porosity (Mercury intrusion porosimetry).
The ethylene oxide sterilization process was validated to assure a minimum sterility assurance level of 10. The OSSIX® PLUS 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.
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 pyrogenicity of the membrane was also tested in vivo using the Rabbit Pyrogen Test as per USP , and the test article was judged as nonpyrogenic.
An additional in vivo animal study was conducted in an L-shape buccal mandibular defect model system in Beagle dogs to evaluate the in vivo performance, degradation and safety of the device, supporting substantial equivalence. The study was conducted on 19 animals followed for 1, 3, and 6 months. Performance of the subject OSSIX® PLUS was compared to the predicate device using an L-shape buccal mandibular defect model system in Beagle dogs for demonstration of substantial equivalence.
Key results: The non-clinical data demonstrates that the modified OSSIX® PLUS is substantially equivalent to the 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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: K160281
Trade/Device Name: Ossix® Plus 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 (OS) 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160281
Device Name
OSSIX® PLUS Indications for Use (Describe)
OSSIX® PLUS is a resorbable collagen membrane intended for use during the process of quided bone regeneration (GBR) and quided 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.
Type of Use (Select one or both, as applicable)
区 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
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: | August 3, 2016 |
II. Device
| Trade name: | OSSIX ® PLUS |
|---|---|
| Common name: | Resorbable Collagen Membrane |
| Classification name: | Bone grafting material (21 CFR 872.3930) |
| Regulatory class: | II |
| Product code: | NPL |
III. Predicate Device
OSSIX® PLUS (K053260)
IV. Device Description
OSSIX® PLUS is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from tendons of veterinary certified pigs and is purified and cross-linked using ribose.
OSSIX® PLUS 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: 15x25 mm, 25x30 mm, and 30x40 mm.
Intended for use by dental surgeons.
4
V. 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.
VI. Comparison of Technological Characteristics with the Predicate Device
OSSIX® PLUS has the same intended use and technological characteristics as the predicate device, OSSIX® PLUS (K053260). The principle difference between the two products is an additional membrane size, an additional tendons supplier and a new contraindication (i.e., patients with sensitivity to porcine-derived materials). The packaging of the current product does not include a template material, as compared with the predicate. Otherwise, both products are identical in their chemical composition (cross-linked porcine type I collagen), their structure (porous membrane made of lattice network of collagen fibers), and manufacturing technology.
The addition of a new source of tendons does not affect the substantial equivalence as was evaluated by bench testing and a comprehensive risk analysis conducted by Datum Dental with regard to the viral safety of the product. As shown in the table below, the key characteristics of the product (porosity %, pore size, resistance to collagenase digestion) remain equivalent to the predicate.
Thus, the subject device is substantially equivalent to the predicate device.
| Parameter | OSSIX® PLUS
K160281
Subject of this submission | OSSIX® PLUS
K053260
Predicate device |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/
Indications for
use | 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. | 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. |
| Parameter | OSSIX® PLUS
K160281
Subject of this submission | OSSIX® PLUS
K053260
Predicate device |
| | • 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. | • 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® PLUS 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. |
| Prescription
designation | RxOnly | RxOnly |
| Composition of
materials | Cross-linked porcine type I collagen | Cross-linked porcine type I collagen |
| | • Biocompatible
• Non-pyrogenic
• 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 | • Biocompatible
• Non-pyrogenic
• 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 |
| Mode of
Action/
Properties | | |
| Device Design | Resorbable dental membrane made of porous lattice network of collagen | Resorbable dental membrane made of porous lattice network of collagen |
| Thickness | Approx. 0.2 mm | Approx. 0.2 mm |
| Size (mm) | 15 x 25 mm
25 x 30 mm | 25 x 30 mm
30 x 40 mm |
| Parameter | OSSIX® PLUS
K160281
Subject of this submission | OSSIX® PLUS
K053260
Predicate device |
| Resistance to
collagenase
digestion | $\geq 25%$ | $\geq 25%$ |
| Porosity (%) | About 80% | About 80% |
| Porosity
(Average pore
size diameter) | About 300 nm | About 300 nm |
| pH level | 6-8 | Not available |
| Packaging
configuration | 1 membrane in a double blister pack | 1 membrane and 1 template 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 |
| Shelf-life | 36 months | 36 months |
| Single
Use/Reuse | A single use device | A single use device |
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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:
-
ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives ● - Part 2: Controls on sourcing, collection and handling.
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.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device, as summarized in the table below.
7
| Test | Test Method |
|---|---|
| Heavy metals | USP |
| Endotoxins (LAL) | USP |
| Collagenase resistance | Internal test method: enzymatic degradation |
| Trypsin resistance | Internal test method: enzymatic degradation |
| Weight | Weighing on analytical scales |
| 3D structure (SEM) | Scanning electron microscope |
| Tensile strength (Maximum Load) | Internal test method |
| Denaturing temperature | Differential scanning calorimetry |
| Carbohydrates content | Colorimetric test: sulfuric/phenol method |
| Ethanol content | Gas chromatography |
| Porosity | Mercury intrusion porosimetry |
The ethylene oxide sterilization process was validated to assure a minimum sterility assurance level of 10 . The OSSIX® PLUS 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.
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 pyrogenicity of the membrane was also tested in vivo using the Rabbit Pyrogen Test as per USP , and the test article was judged as nonpyrogenic.
An additional in vivo animal study was conducted in an L-shape buccal mandibular defect model system in Beagle dogs to evaluate the in vivo performance, degradation and safety of the device, supporting substantial equivalence. The study was conducted on 19 animals followed for 1, 3, and 6 months. Performance of the subject OSSIX® PLUS was compared to the predicate device using an L-shape buccal mandibular defect model system in Beagle dogs for demonstration of substantial equivalence.
VIII. Conclusion
The subject and predicate devices have the same intended use/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 the modified OSSIX® PLUS is substantially equivalent to the predicate device.