(189 days)
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.
The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
The provided text describes a 510(k) summary for the "Delphos Implants Rigid Fixation System," a bone plate device. This summary focuses on establishing substantial equivalence to predicate devices rather than proving a medical device's performance through clinical studies or AI-driven acceptance criteria.
The information you're requesting (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is typically found in submissions for novel devices or AI/machine learning-based medical devices that require rigorous performance evaluation against established clinical endpoints or human performance.
This document does NOT contain the information needed to answer your questions about acceptance criteria performance, study design (sample size, provenance, experts, adjudication, MRMC, standalone), or training set details.
The document details:
- Device Name: Delphos Implants Rigid Fixation System
- Regulation Number: 21 CFR 872.4760 (Bone Plate)
- Regulatory Class: Class II
- Product Code: JEY
- Indications for Use: Fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction.
- Key Comparison: Substantial equivalence to predicate devices (Osteomed Modular Locking Fixation System, LeForte System Bone Plate & Screw, Biomet Microfixation Facial Plating System, CranioMaxillofacial Fixation (CMF) System - CMF Visionare).
- Performance Data: Primarily mechanical testing (ASTM F382 for plates, ASTM F543 for screws) to demonstrate comparable physical properties to predicate devices. Biocompatibility testing was also conducted according to ISO standards.
- Clinical Data: Explicitly states, "No clinical data were included in this submission."
Therefore, I cannot provide the requested information from this document. The provided text is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with performance metrics against acceptance criteria for a novel device or an AI/ML algorithm.
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Delphos Implants - Ind.Com. Importacao e Exportacao de Implantes Medicos S.A. March 29, 2019 % Mauro Malzyner US Agent Passarini Regulatory Affairs of America, LLC 201 S. Biscayne Blvd, Suite 1200 Miami, Florida 33131
Re: K182609
Trade/Device Name: Delphos Implants Rigid Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: February 15, 2019 Received: February 25, 2019
Dear Mauro Malzyner:
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 mav, 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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.03.29
14:59:31 -04'00'
For 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) K182609
Device Name
Delphos Implants Rigid Fixation System
Indications for Use (Describe)
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
| 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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510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Delphos Implants Industria, Comercio, Importacao eExportacao de Implantes Medicos S.A.Estrada Manuel Correia Lopes, Parque Empresarial Progresso,Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785-126Telephone +351 211 955 986 |
|---|---|
| Contact Person | Mauro Malzyner, Mr.US AgentPassarini Regulatory Affairs of America, LLCE-Mail: mauro@rapassarini.com.brTelephone +1 760 936 2301 |
| Date Prepared | 27/Mar/2019 |
| Preparer / Alternate Contact | Janine TreterRegulatory Affairs SpecialistPassarini Regulatory Affairsjanine@rapassarini.com.brTelephone +55 47 3804 0075 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary NameCommon Name | Delphos Implants Rigid Fixation SystemBone Plate |
| Classification RegulationsProduct Code | 21 CFR 872.4760, Class IIJEY |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - OsteomedL.P. |
| Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil MedicalCorporationK121589 - Biomet Microfixation Facial Plating System - BiometMicrofixationK150965 - LeForte System II - Jeil Medical CorporationK180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare- Visionare LLC |
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510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Delphos Implants Industria, Comercio, Importacao eExportacao de Implantes Medicos S.A.Estrada Manuel Correia Lopes, Parque Empresarial Progresso,Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785-126Telephone +351 211 955 986 |
|---|---|
| Contact Person | Mauro Malzyner, Mr.US AgentPassarini Regulatory Affairs of America, LLCE-Mail: mauro@rapassarini.com.brTelephone +1 760 936 2301 |
| Date Prepared | 27/Mar/2019 |
| Preparer / Alternate Contact | Janine TreterRegulatory Affairs SpecialistPassarini Regulatory Affairsjanine@rapassarini.com.brTelephone +55 47 3804 0075 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary NameCommon Name | Delphos Implants Rigid Fixation SystemBone Plate |
| Classification RegulationsProduct Code | 21 CFR 872.4760, Class IIJEY |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - OsteomedL.P. |
| Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil MedicalCorporationK121589 - Biomet Microfixation Facial Plating System - BiometMicrofixationK150965 - LeForte System II - Jeil Medical CorporationK180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare- Visionare LLC |
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INDICATIONS FOR USE
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
SUBJECT DEVICE DESCRIPTION
The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.
The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have a range of plates and screws with equivalent indication for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
Differences in the design features between the subject devices and the primary predicate device K080694 are addressed by comparison to the reference devices as listed in the tables below.
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INDICATIONS FOR USE
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
SUBJECT DEVICE DESCRIPTION
The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.
The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have a range of plates and screws with equivalent indication for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
Differences in the design features between the subject devices and the primary predicate device K080694 are addressed by comparison to the reference devices as listed in the tables below.
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| Table 5.1: Substantial Equivalence on Plates | ||||||
|---|---|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | ||
| Trade NameInformation | K182609 - Delphos ImplantsRigid Fixation System | K080694 - Osteomed ModularLocking System | K112457 - LeForte SystemBone Plate & Screw | K121589 - Biomet MicrofixationFacial Plating System | K180204 - Mini and MicroFragments ReconstructionSystem -CMF Visionare | Substantial Equivalence Discussion |
| Delphos Implants - Ind. Com.Importação e Exportação deImplantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Biomet Microfixation | Visionare LLC | ||
| EquivalentThe subject device indication for useis identical to primary predicatedevice excepting for the reference todrills and the reference to the term"cranio-maxillofacial".Drills are surgical instruments | ||||||
| developed to assist in the installationof plates and screws and are notsubject of this submission. Therefore,information on drills weresuppressed from Delphos Implantsindications for use Statement. | ||||||
| Indication for Use | The Delphos Implants RigidFixation System is intendedfor fracture fixation inmaxillofacial traumareconstruction, mandibularreconstruction andorthognathic reconstruction. | The OsteoMed ModularLocking Fixation System isintended for fracture fixationin cranio-maxillofacial traumareconstruction, mandibularreconstruction andorthognathic reconstruction.The OsteoMed ModularLocking Fixation Systemimplants and drills areintended for single use only. | Intended for use in Selectivetrauma of the mid-face,reconstruction proceduresand selective orthognathicsurgery of the maxilla andchin. | These devices are implantablebone plates and bone screwsfor facial proceduresincluding:1. Fractures2. Osteotomies3. Reconstructive procedures4. Revision procedures whereother treatments or deviceshave failed | CranioMaxillofacial Fixation(CMF) System - CMF Visionareis intended for use in selectivetrauma of the midface,maxillofacial surgery,reconstructive procedures,and selective orthognathicsurgery of the maxilla,mandible and chin. | In a previous submission fromDelphos Implants (K172949), FDAinformed that devices intended forCranial/Neuro applications are to bereviewed by the Neurology Panel.Therefore, the words cranio-maxillofacial were replaced bymaxillofacial. |
| The Delphos Implants RigidFixation System implants areintended for single use only. | The subject device indication for useare within the scope of the referencedevices. | |||||
| Identical | ||||||
| Product Code | JEY | JEY | JEY, DZL | JEY, HWC | JEY, DZL | to Primary Predicate Device andwithin the scope of ReferenceDevices. |
| Class | II | II | II | II | II | Identical |
| Trade NameInformation | SUBJECT DEVICESK182609 - Delphos ImplantsRigid Fixation SystemDelphos Implants - Ind. Com.Importação e Exportação deImplantes Médicos S.A. | PRIMARY PREDICATE DEVICEK080694 - Osteomed ModularLocking SystemOsteoMed L. P. | REFERENCE DEVICE IK112457 - LeForte SystemBone Plate & ScrewJeil Medical Corporation | REFERENCE DEVICE IIK121589 - Biomet MicrofixationFacial Plating SystemBiomet Microfixation | REFERENCE DEVICE IIIK180204 - Mini and MicroFragments ReconstructionSystem -CMF VisionareVisionare LLC | Substantial Equivalence Discussion |
| Regulation Number | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.476021 CFR 872.4880 | 21 CFR 872.476021 CFR 888.3040 | 21 CFR 872.476021 CRF 872.4880 | Identicalto Primary Predicate Device andwithin the scope of ReferenceDevices. |
| Regulation Name | Bone Plate | Bone Plate | Bone PlateIntraosseus fixation screw orwire | Bone PlateScrew, Fixation, Bone | Bone PlateIntraosseus fixation screw orwire | Identicalto Primary Predicate Device andwithin the scope of ReferenceDevices. |
| Raw material | The plates are made fromcommercially pure titanium(ASTM F67) | The plates are made fromTitanium Alloy (ASTM F136 orcommercially pure titanium(ASTM F67) | The plates are made fromcommercially pure titanium(ASTM F67) | The plates are made fromTitanium Alloy (ASTM F136 orcommercially pure titanium(ASTM F67) | The plates are made fromcommercially pure titanium(ASTM F67) | EquivalentThe subject device raw materials arewithin the scope of the predicatesraw materials. |
| Surface treatment | Anodization | Anodization | Anodization | Not informed | Not informed | Identical |
| Use | Single use | Single use | Single use | Single use | Single use | Identical |
| Sterilization | Non-sterile, Steamsterilization prior to use | Non-sterile, Steamsterilization prior to use | Non-sterile, Steamsterilization prior to use | Not informed | Non-sterile, Steamsterilization prior to use | Identical |
| Plates thickness | 0.5, 0.6, 0.7, 0.8, 1.0, 1.3, 1.6,2.5 mm | 0.25mm ~ 2.5mm1.0mm ~2.5mm | 0.1mm, 0.2mm, 0.3mm,0.4mm, 0.5mm, 0.6mm,0.8mm, 1.0mm, 1.3mm,2.5mm | Various | 0.3mm, 0.7mm, 1.0mm,1.5mm, 2.0mm, 2.54mm. | EquivalentThe plates thickness are within therange of the predicate devices. |
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | ||
| Trade NameInformation | K182609 - Delphos ImplantsRigid Fixation System | K080694 - Osteomed ModularLocking System | K112457 - LeForte SystemBone Plate & Screw | K121589 - Biomet MicrofixationFacial Plating System | K180204 - Mini and MicroFragments ReconstructionSystem -CMF Visionare | Substantial Equivalence Discussion |
| Delphos Implants - Ind. Com.Importação e Exportação deImplantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Biomet Microfixation | Visionare LLC | ||
| Plates designs (shapes). | Orbital TypeT TypeStraight TypeH TypeX TypeZ TypeL TypeY TypeCurved TypeRectangular TypeCalvarium PlateMaxillary TypeSquare TypeFitting Adjustment TypeMentoplasty Type (Chin type)Double T TypeBSSO TypeL Adjustment TypeCondylar Fracture Type | Curved TypeStraight TypeL TypeDouble Y TypeX TypeI TypeChin TypeMesh TypeH TypeQuad(Square) TypeY TypeZ TypeBSSO TypeOrbital TypeAngled TypeCondyle PlateComminution TypeStrut TypeReconstruction Type | Curved TypeStraight TypeSquare TypeL TypeDouble Y TypeX TypeI TypeChin TypeCalvarium TypeMesh TypeH TypeHexagon TypeQuad TypeT TypeY TypeZ TypeRigid Straight TypeMG TypeА ТуреAngled TypeAngledReconstruction TypeMulti Reconstruction TypeReconstruction -TypeBSSO Type | Variations of:StraightAngledCurvedL-shapeT-shapeZ-shapeX-shapeY-shapesDouble Y shapesH-shapeTriangleRectangleMatrixMeshOrbital FloorLeFortChin | Straight PlatesRectangular PlatesT PlatesY PlatesDouble Y PlatesL PlatesL 110° PlatesH PlatesI PlatesX PlatesZ PlatesOrbital PlatesOrbital Floor PlatesStraight Locking PlatesRectangular Locking PlatesOrthognathic L PlatesOrthognathic Y PlatesOrthognathic Canine PillarPlatesOrthognathic Zygomatic PillarPlatesOrthognathic Le Fort PlatesOrthognathic Chin PlatesOrthognathic Paulus PlatesOrthognathic Straight SagittalPlatesOrthognathic StraightAdjustable Sagittal PlatesOrthognathic Y AdjustableSagittal PlatesOrthognathic Locking StraightSagittal PlatesOrthognathic Locking StraightAdjustable Sagittal PlatesOrthognathic Locking YAdjustable Sagittal Plates | EquivalentMost of the plates designs are withinthe scope of Primary PredicateDevice and Reference Devices.There are some minor differences indesign types that do not introducesignificantly different designs andmaintain the same intended use. Allthe subject plates designs wereevaluated through mechanicaltesting on worst casesrepresentatives not raising any issuein performance. |
| 5.2: Substantial Equivalence on Screws | ||||||
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | |||
| Trade Name Information | K182609 - Delphos Implants RigidFixation System | K080694 - Osteomed Modular LockingSystem | K150965 - LeForte System II | K180204 - Mini and Micro FragmentsReconstruction System -CMF Visionare | Substantial Equivalence Discussion | |
| Delphos Implants - Ind. Com.Importação e Exportação deImplantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Visionare LLC | |||
| Indication for Use | The Delphos Implants Rigid FixationSystem is intended for fracturefixation in maxillofacial traumareconstruction, mandibularreconstruction and orthognathicreconstruction.The Delphos Implants Rigid FixationSystem implants are intended forsingle use only. | The OsteoMed Modular LockingFixation System is intended forfracture fixation in cranio-maxillofacial trauma reconstruction,mandibular reconstruction andorthognathic reconstruction.The OsteoMed Modular LockingFixation System implants and drillsare intended for single use only. | The LeForte System II is intended foruse in selective trauma of mid-face,reconstruction procedure andselective orthognathic surgery of themaxilla and chin. | CranioMaxillofacial Fixation (CMF)System - CMF Visionare is intendedfor use in selective trauma of themidface, maxillofacial surgery,reconstructive procedures, andselective orthognathic surgery of themaxilla, mandible and chin. | EquivalentMost of the plates designs are withinthe scope of Primary PredicateDevice and Reference Devices.There are some minor differences indesign types that do not introducesignificantly different designs andmaintain the same intended use. Allthe subject plates designs wereevaluated through mechanicaltesting on worst casesrepresentatives not raising any issuein performance. | |
| Product Code | JEY | JEY | JEY | JEY, DZL | Identicalto Primary Predicate Device andwithin the scope of ReferenceDevices. | |
| Class | II | II | II | II | Identical | |
| Regulation Number | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.476021 CRF 872.4880 | Identicalto Primary Predicate Device andwithin the scope of ReferenceDevices. | |
| Regulation Name | Bone Plate | Bone Plate | Bone Plate | Bone PlateIntraosseus fixation screw or wire | Identicalto Primary Predicate Device andwithin the scope of ReferenceDevices. | |
| Raw material | Titanium Alloy(ASTM F136) | Titanium Alloy(ASTM F136) | Titanium Alloy(ASTM F136) | Titanium Alloy(ASTM F136) | Identical | |
| Surface treatment | Anodization | Anodization | Anodization | Not informed | Identical | |
| Use | Single use | Single use | Single use | Not informed | Identical | |
| Trade Name Information | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | Substantial Equivalence Discussion | |
| K182609 - Delphos Implants RigidFixation System | K080694 - Osteomed Modular LockingSystem | K150965 - LeForte System II | K180204 - Mini and Micro FragmentsReconstruction System -CMF Visionare | |||
| Delphos Implants - Ind. Com.Importação e Exportação deImplantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Visionare LLC | |||
| Sterilization | Non-sterile, Steam sterilization priorto use | Non-sterile, Steam sterilization priorto use | Non-sterile, Steam sterilization priorto use | Non-sterile, Steam sterilization prior touse | ||
| Screw type/ diameter | Self-tapping Screw1.2mm, 1.6mm, 2.0mm, 2.4mm, 2.7 mm | Self-tapping Screw1.2mm, 1.5mm, 1.6mm, 1.9mm,2.0mm, 2.3mm, 2.4mm, 2.7mm | Self-tapping Screw1.3mm, 1.6mm, 2.0mm, 2.4mm | Self-tapping Screw1.5mm, 2.0mm, 2.4mm, 2.7mm | EquivalentThe subject devices diameters arewithin the range of the predicatedevices diameters. | |
| Self-drilling Screw2.0 mm | Self-drilling Screw1.2mm, 1.6mm, 2.0mm | Self-drilling Screw1.4mm, 1.6mm, 2.0mm | Self-drilling Screw1.5mm, 2.0mm | Performance testing were executedfollowing worst case rationales; thesubject devices are supported bymechanical testing. | ||
| Emergency Screws1.6mm, 1.9mm, 2.3mm, 2.7 mm | Emergency Screws1.5 mm, 1.8mm, 2.3mm, 2.7mm | Emergency Screws1.8mm, 2.3mm, 2.7mm | ||||
| Screw Length | Self-tapping Screw3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, 18, 20 mm | Self-tapping Screw2 - 20mm | Self-tapping Screw2 - 20mm | Self-tapping Screw4-20mm | ||
| Self-drilling Screw3 - 8mm | Self-drilling Screw3 - 12mm | Self-drilling Screw4-11mm | The subject devices lengths arewithin the range of the predicatedevices lengths. | |||
| Self-drilling Screw3, 4, 5, 6, 7, 8, 9, 10, 11, 12 mm | Performance testing were executedfollowing worst case rationales; thesubject devices are supported bymechanical testing | |||||
| Emergency Screws4-18mm | ||||||
| Emergency Screws4, 5, 6, 7, 8, 9, 10, 12, 14mm |
Tab
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Table 5.2: Substantial Equivalen . C
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The subject device plates are substantially equivalent to the primary predicate device K080964, or reference devices K112457, K121589 and K180204, in designs and range of dimensions. The reference devices K112457 is for substantial equivalence of the designs not encompassed by the primary predicate that are the Calvarium Type and T Type. The reference device K121589 is for substantial equivalence for the Rectangle plates. The reference device K180204 is for substantial equivalence for the Maxillary Plates (Orthognathic plates).
The subject plates thickness is substantially equivalent to the primary predicate and reference devices since fall in its range of thickness.
The subject device screws are substantially equivalent to the primary predicate device K080964, or reference devices K150965 and K180204, in designs and range of dimensions. The reference devices K150965 is for substantial equivalence of the Emergency Screws diameters and the reference device K180204 is for substantial equivalence of the Emergency Screws lengths.
The following performance data supports the substantial equivalence determination:
The plates are manufactured in commercially pure titanium conforming to ASTM F67 and ISO 5832-2. The plates types of titanium are the same to that used for fabrication of the predicate devices cleared under K080694, K112457, K121589 and K180204.
The screws are made of titanium alloy according to the requirements of ASTM F136 and ISO 5832-3. The screws alloy are the same to that used for fabrication of the predicate devices cleared under K080694, K150965 and K180204.
Biocompatibility of the subject device materials was supported by cytotoxicity, irritation and skin sensitization, and acute systemic toxicity testing according to ISO 10993-5, ISO 10993-10 and ISO 10993-11, respectively.
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F 543.
For the plates the critical points, flexural stiffness, elastic limit stress, bending moment, and structural stiffness was determined based on the requirements of ASTM F 382 - Bending test in 4 static points. lt was also performed the Fatigue Test (Plate Fold) due to the need for conformation by the users. For the screws, torsion, screwing/unscrewing, pullout and screw thread testing were executed.
The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. No clinical data were included in this submission.
The subject devices are provided non-sterile and have no expiration date defined. Steam sterilization validation was performed according to ISO 17665-1.
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 devices.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.