(144 days)
An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.
The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "Neoss Ti Reinforced Membrane." It is a regulatory approval document and not a study report that details acceptance criteria and device performance in a clinical context.
Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.
The document states:
- "Clinical Testing: Clinical data was not required to establish the substantial equivalence of the Neoss Ti Reinforced Membrane." This explicitly indicates that a clinical study, with its associated methodologies for acceptance criteria and performance measurement, was not performed or submitted as part of this specific FDA cleared.
The "Performance Testing" section mentions tests conducted according to ISO and ASTM standards (e.g., burst strength, bend testing, biocompatibility). However, these are engineering and material property tests to ensure the device meets specified quality and safety characteristics, not clinical performance acceptance criteria. The document lists the standards applied, but does not provide the specific acceptance criteria values or the reported performance values of the Neoss Ti Reinforced Membrane against those criteria. It only states that these tests were done "in order to confirm the strength, integrity and functionality of the device."
The document focuses on establishing "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and material composition, rather than presenting a standalone study with defined acceptance criteria and performance results in a table.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance (as no clinical test set was described).
- Number of experts or their qualifications (as no ground truth establishment for a clinical test set was described).
- Adjudication method (as no clinical test set was described).
- MRMC comparative effectiveness study (as no human reader study was described).
- Standalone performance (as it refers to clinical performance, which was not assessed in a study described here).
- Type of ground truth used (as no clinical ground truth was established).
- Sample size for the training set (as this is not a machine learning device).
- How ground truth for the training set was established (as this is not a machine learning device).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Neoss, Ltd. c/o Ms. Cherita James M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, NY 10018
Re: K143327
Trade/Device Name: Neoss Ti Reinforced Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: March 12, 2015 Received: March 13, 2015
Dear Ms. James:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Neoss Ti Reinforced Membrane
Indications for Use (Describe)
An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration. Neoss Ti Reinforced Membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of of 6 months.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for the Neoss Ti Reinforced Membrane 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Neoss LtdWindsor HouseCornwall RoadHarrogate, HG1 2PW, UKEstablishment Registration Number: 3005846524 |
|---|---|
| Contact: | Cherita JamesM Squared Associates, Inc.575 8th Avenue, Suite 1212New York, New York 10018Ph: 703-562-9800 ext 257Fax: 702-562-9797E-mail: CJames@MSquaredAssociates.com |
Date of Submission: April 1, 2015
Proprietary Name: Neoss Ti Reinforced Membrane Common Name: Nonresorbable Barrier membrane Regulatory Class: II Regulation: 872.3930 Bone grafting material. Product Code: NPK Predicate Device(s): K960292 Gore-Tex Regenerative Material Ti Reinforced Configurations, K972278 Osteogenics Cytoplast Regentex Ti 250
Device Description: The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material.
The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is
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intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.
| Description/Image | Device Dimensions (mm) | Thickness (mm) |
|---|---|---|
| Neoss Ti Reinforced Membrane - S I | 28.7 x 18 | 0.3 |
| Neoss Ti Reinforced Membrane - M I | 30.4 x 19.4 | 0.3 |
| Neoss Ti Reinforced Membrane - L I | 35.9 x 21.2 | 0.3 |
| Neoss Ti Reinforced Membrane - M | 32.2 x 22 | 0.3 |
| Neoss Ti Reinforced Membrane - L | 34.2 x 24.8 | 0.3 |
Indications for Use: Neoss Ti Reinforced Membrane is an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.
| Neoss Ti ReinforcedMembrane | Gore-TexRegenerativeMaterial Ti | CytoplastRegentex Ti250 | Comment | |
|---|---|---|---|---|
| 510(k) No. | Neoss LTD | W.L. Gore | Osteogenics | - |
| not yet assigned | K960292 | K972278 | - | |
| Product Code | NPK | NPK | LYC | - |
| Indications for Use | An implantabletemporary non-resorbable device(membrane) for useas a spacer creationbarrier in thetreatment of localdefects in the oralcavity inconjunction withtissue regenerationor augmentation.Neoss membranesare intended to besubmerged andclinically implantedmore than 30 dayswith an expectedduration ofimplantation up of 6months. | intended toprovide amechanism forthe ingrowth ofnew hard andsoft tissues intobony defectssurroundingteeth and toaugmentingrowth of hardand soft tissueson alveolarridges. | temporaryimplantablematerial (non-resorbable) foruse as aspace-makingbarrier in thetreatment ofperiodontalbone defects. | Substantiallyequivalentindications foruse |
| Neoss Ti ReinforcedMembrane | Gore-TexRegenerativeMaterial Ti | CytoplastRegentex Ti250 | Comment | |
| Design | 5 configurations, Timesh may be trimmedand shaped to createadditional space forbone growth | "variety" ofconfigurationsand sizes | 8 configurations,Ti frame maybe trimmedand shaped tocreateadditionalspace for bonegrowth | Substantiallyequivalentdesign |
| Design | 5 configurations, Timesh may be trimmedand shaped to createadditional space forbone growth | "variety" ofconfigurationsand sizes | 8 configurations,Ti frame maybe trimmedand shaped tocreateadditionalspace for bonegrowth | Substantiallyequivalentdesign |
| MaterialComposition | Non-resorbableExpanded and densepolytetrafluoroethylene(PTFE) and Titanium | Non-resorbableExpanded PTFEand Titanium | Non-resorbableHigh-DensityPTFE andTitanium | Substantiallyequivalentmaterials |
| Similar Specifications | ||||
| Thickness | 0.3 mm | 0.23 mm | 0.23 mm | Slightlygreaterthickness |
| Tensilestrength | 0.5 bar for 60 sec | Unknown | Unknown | Performs asintended |
| Density (layermass areag/dm2) | 3.5 | 2.8 | 4.0 | Substantiallyequivalentdensity |
| Biocompatible | Yes | Yes | Yes | Substantiallyequivalent |
| Sterility | EtO sterilized | sterile | sterile | Substantiallyequivalent |
Table 1. Comparison to predicate devices
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Technological Characteristics: Neoss Ti Reinforced Membrane, like the predicate devices, is provided sterile. Both the subject and predicate devices are comprised of biocompatible nonresorbable PTFE and Titanium. The PTFE material of the Neoss device is similar in density (mass/area) and thickness to both of the predicate devices.
In the subject device, the Neoss device has a single monodirectional dense PTFE layer and expanded multi-directional layers. The dense surface is intended to be placed towards the soft tissue, while the expanded surface is intended to be placed towards the defect and bone. The Gore predicate device is comprised of an expanded PTFE, while the Cytoplast is composed of dense
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PTFE. Both membrane materials in the Neoss membrane are less dense than the Cytoplast membrane but not as expanded as the Gore membrane. The dense material of the Neoss membrane is similar to the Cytoplast membrane and serves to provide a semi-closed structured surface to facilitate cellular adhesion while providing a barrier function so that only desirable cells can be developed and thereby allowing regeneration to occur by excluding epithelial cell penetration through the barrier. The more expanded material of the Neoss multilayer membrane configuration offers similar strength to the membrane as the Gore product and additional microporosity for cellular attachment providing stability if the membrane during clinical function.
Performance Testing: The Neoss Ti Reinforced Membrane was evaluated for Burst Strength and Bend Testing in order to confirm the strength, integrity and functionality of the device. The subject device and processes were also tested according to the following standards:
- ISO 5832-2:1999 Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium
- · ISO 10993-5 Biological Evaluation Of Medical Devices: Test for in vitro cytotoxicity
- · ISO 10993-7 Biological Evaluation Of Medical Devices: Ethylene Oxide Sterilization Residuals
- · ISO 10993-10 Biological evaluation of medical devices part 10: tests for irritation and skin sensitization
- · ISO 10993-18 Biological Evaluation Of Medical Devices: Chemical Characterization of Material
- · ISO 11135-1 Sterilization of health care products Ethylene Oxide
- · BS EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
- · ASTM F1980-07:2011 Standard Guide for Accelerated aging of Sterile Barrier Systems for Medical Devices
- ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
- ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration-Method A.
Clinical Testing: Clinical data was not required to establish the substantial equivalence of the Neoss Ti Reinforced Membrane.
Conclusion: The Neoss Ti Reinforced Membrane is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological
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characteristics. All evaluations determined that the Neoss Ti Reinforced Membrane is substantially equivalent to the predicate devices.
§ 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.