(529 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a physical barrier, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used in the treatment of alveolar and periodontal bony defect sites, indicating a therapeutic purpose.
No
Explanation: The device is a temporarily implantable barrier used in dental procedures to facilitate bone regeneration by creating space. Its described function relates to treatment and support, not to identifying a medical condition or disease.
No
The device description clearly states it is a physical, temporarily implantable material composed of PTFE and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "temporarily implantable material indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites." This describes a device that is physically placed within the body to facilitate healing, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details the physical composition and function of the implantable barrier. It explains how it is used in a surgical procedure to support bone grafting. This aligns with a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a therapeutic aid.
N/A
Intended Use / Indications for Use
Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Product codes
NPK
Device Description
Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE. This medical device is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes, the dimensions include: 10mm x 25mm, 14mm x 24mm, 20mm x 25mm, 20mm x 30mm, 17mm x 25mm, 25mm x 30mm, 24mm x 38mm, 38mm x 38mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar and periodontal bony defect sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility of the subject device materials was supported by the following tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Implantation and Subchronic Systemic Toxicity according to the FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated on September 4, 2020.
Sterilization validation for Ethylene Oxide was performed per ISO 11135-1 to achieve a Sterility Assurance Level of 10-6. Shelf-life testing was performed in compliance with ASTM 1980.
The absorption test shows that Lumina-PTFE Titanium presented an absorption rate compatible with the predicate device, thereby it is a non-absorbable membrane.
A wettability test (contact angle) was conducted and demonstrated that the Lumina-PTFE Titanium has a contact angle equivalent with the predicate device.
The tension break and elasticity results demonstrated that the subject device when tested in comparison with the predicate device showed equivalent outcomes.
The Suture Pullout Strength and Peel Resistance results demonstrated that the subject device when tested in comparison with the predicate device showed equivalent outcomes. Although the products have different adhesion methods, Peel Resistance test in accordance with ASTM D 1876-8 have shown that the products have equivalent results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 08, 2023
Criteria Industria e Comercio de Produtos Medicinais % Graziela Brum Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi. 855. 2402 Ribeirao Preto, SP 14096570 BRAZIL
Re: K221851
Trade/Device Name: Lumina-PTFE Titanium Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: NPK Dated: December 5, 2023 Received: December 5, 2023
Dear Graziela Brum:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Sherrill Lathrop Blitzer
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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221851
Device Name Lumina-PTFE Titanium
Indications for Use (Describe)
Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
| 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) |
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Lumina-PTFE Titanium
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Critéria Indústria e Comércio de Produtos
Medicinais e Ondontológicos LTDA
Alameda Sinlioku Tanaka, 170, Galpão 44- Parque
Technologico Damha I
São Carlos, SP - Brazil |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Prepare | Graziela Brum and Tatiana Jabor Botura
Regulatory Affairs Specialist
Passarini Regulatory Affairs
e-mail: graziela@passarini.com.br
Telephone: +55 (16) 3421 8488 |
| Data Prepared | December 5, 2023 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade Name | Lumina-PTFE Titanium |
| Common Name | PTFE Membrane |
| Regulation Number | 21 CFR 872.3930 |
| Regulatory Class | II |
| Product Code | NPK |
| Classification Panel | Dental |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Manufacture | Osteogenics Biomedical, Inc. |
| Predicate Trade Name | Cytoplast™ Titanium-Reinforced PTFE Membranes |
Critéria Indústria e Comércio de Produtos Medicinais e Ondontológicos LTDA
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Predicate 510 (K) K201187
Indications For Use
Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Subject Device Description
Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE.
This medical device is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect.
The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes, the dimensions include:
- . 10mm x 25mm
- 14mm x 24mm .
- 20mm x 25mm ●
- 20mm x 30mm ●
- . 17mm x 25mm
- 25mm x 30mm
- 24mm x 38mm
- 38mm x 38mm
Technological Characteristics
Table 5.1 Compare between Lumina-PTFE Titanium and Cytoplast™ Titanium- Reinforced PTFE.
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| Subject Device | Predicate Device | |
|---|---|---|
| Cytoplast™ Titanium- Reinforced PTFE | ||
| Membranes | ||
| (K201187) | ||
| Lumina-PTFE Titanium | ||
| Product Code | NPK | NPK |
| Indications for use | Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites. | Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites. |
| Principle of Operation | Lumina PTFE-Titanium are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane isolates the space needed for bone-derived cells to repopulate and repair the defect. | Cytoplast ™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane isolates the space needed for bone-derived cells to repopulate and repair the defect. |
| Design | Lumina PTFE Titanium polymeric barrier with titanium structure embedded between two layers of PTFE. | Titanium frame embedded between two layers of PTFE. |
| Composition | Lumina PTFE-Titanium are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. | Cytoplast™ Titanium-reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. |
| Use | Single use | Single use |
| Shelf Life | 2 years | 4 years |
| Biocompatible | Yes | Yes |
| Sterilization | Sterile/Ethylene Oxide | Sterile/Ethylene Oxide |
| Model Sizes* | 10mm x 25mm | |
| 14mm x 24mm | ||
| 20mm x 25mm | ||
| 20mm x 30mm | ||
| 17mm x 25mm | ||
| 25mm x 30mm | ||
| 24mm x 38mm | ||
| 38mm x 38mm | 12 mm x 20 mm | |
| 12 mm x 24 mm | ||
| 12 mm x 30 mm | ||
| 13 mm x 18 mm | ||
| 13 mm x 19 mm | ||
| 14 mm x 24 mm | ||
| 17 mm x 25 mm | ||
| 20 mm x 25 mm | ||
| 24 mm x 38 mm | ||
| 25 mm x 36 mm | ||
| 25 mm x 30 mm | ||
| 30 mm x 41 mm | ||
| 30 mm x 40 mm | ||
| 38 mm x 38 mm | ||
| 40 mm x 50 mm | ||
| Maximum | ||
| Duration of | ||
| Implantation | 12 months | 12 months |
7
*Except for the 10mm x 25mm and 20mm x 30mm size models, all others have the same dimensions as the equivalent product. Despite the small difference present in the two previously mentioned models, the total area of the membrane is similar to the predicate. These small differences in size did not have a clinical effect on the product, because the surgeon chooses the size that best fits the patient's bone defect. In addition, to adjust the size of the bone defect, the surgeon can cut the membrane, as instructed in the instructions for use.
8
The subject and predicate devices have similar intended use and principles of operation, dimensions, and technological characteristics.
The Lumina-PTFE Titanium composition is the same as the one used for the fabrication of the predicate device K201187.
Biocompatibility of the subject device materials was supported by the following tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Implantation and Subchronic Systemic Toxicity according to the FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated on September 4, 2020.
Sterilization validation for Ethylene Oxide was performed per ISO 11135-1 to achieve a Sterility Assurance Level of 10-6. Shelf-life testing was performed in compliance with ASTM 1980.
The absorption test shows that Lumina-PTFE Titanium presented an absorption rate compatible with the predicate device, thereby it is a non-absorbable membrane.
A wettability test (contact angle) was conducted and demonstrated that the Lumina-PTFE Titanium has a contact angle equivalent with the predicate device.
The tension break and elasticity results demonstrated that the subject device when tested in comparison with the predicate device showed equivalent outcomes.
The Suture Pullout Strength and Peel Resistance results demonstrated that the subject device when tested in comparison with the predicate device showed equivalent outcomes. Although the products have different adhesion methods, Peel Resistance test in accordance with ASTM D 1876-8 have shown that the products have equivalent results.
In conclusion, the Lumina-PTFE Titanium is substantially equivalent to the Cytoplast™ Titanium-Reinforced PTFE Membranes.
Non-Clinical Performance Data:
9
Lumina-PTFE Titanium was tested following these standards:
- ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
- . ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
- . ASTM F754-08 Standard Specification for Implantable PTFE Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders.
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices
- . ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ASTM D 1876-08 Standard Teste Method for Peel Resistance of Adhesives
Clinical performance Data:
No clinical data were included in this submission.
Conclusion:
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.