(189 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implants, with no mention of AI or ML.
Yes
The device is described as a "Rigid Fixation System" intended for "fracture fixation" in various reconstructive surgeries, which directly addresses a health condition (fractures) and is therefore therapeutic.
No
This device is a rigid fixation system intended for fracture fixation and reconstruction, not for diagnosing medical conditions.
No
The device description explicitly details physical components (plates and screws made of titanium) and mentions manufacturing, cleaning, disinfection, sterilization, and mechanical testing, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details plates and screws made of titanium, which are implants designed to be surgically placed within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on samples.
The Delphos Implants Rigid Fixation System is a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial, mandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
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 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. It 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.
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.
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.
K112457, K121589, K150965, K180204
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
§ 872.4760 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services - USA and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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
1
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
2
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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3
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Delphos Implants Industria, Comercio, Importacao e
Exportacao de Implantes Medicos S.A.
Estrada Manuel Correia Lopes, Parque Empresarial Progresso,
Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785-
126
Telephone +351 211 955 986 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mauro Malzyner, Mr.
US Agent
Passarini Regulatory Affairs of America, LLC
E-Mail: mauro@rapassarini.com.br
Telephone +1 760 936 2301 |
| Date Prepared | 27/Mar/2019 |
| Preparer / Alternate Contact | Janine Treter
Regulatory Affairs Specialist
Passarini Regulatory Affairs
janine@rapassarini.com.br
Telephone +55 47 3804 0075 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Delphos Implants Rigid Fixation System
Bone Plate |
| Classification Regulations
Product Code | 21 CFR 872.4760, Class II
JEY |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - Osteomed
L.P. |
| Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil Medical
Corporation
K121589 - Biomet Microfixation Facial Plating System - Biomet
Microfixation
K150965 - LeForte System II - Jeil Medical Corporation
K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- Visionare LLC |
4
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Delphos Implants Industria, Comercio, Importacao e
Exportacao de Implantes Medicos S.A.
Estrada Manuel Correia Lopes, Parque Empresarial Progresso,
Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785-
126
Telephone +351 211 955 986 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mauro Malzyner, Mr.
US Agent
Passarini Regulatory Affairs of America, LLC
E-Mail: mauro@rapassarini.com.br
Telephone +1 760 936 2301 |
| Date Prepared | 27/Mar/2019 |
| Preparer / Alternate Contact | Janine Treter
Regulatory Affairs Specialist
Passarini Regulatory Affairs
janine@rapassarini.com.br
Telephone +55 47 3804 0075 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Delphos Implants Rigid Fixation System
Bone Plate |
| Classification Regulations
Product Code | 21 CFR 872.4760, Class II
JEY |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - Osteomed
L.P. |
| Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil Medical
Corporation
K121589 - Biomet Microfixation Facial Plating System - Biomet
Microfixation
K150965 - LeForte System II - Jeil Medical Corporation
K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- Visionare LLC |
5
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.
6
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.
7
| Table 5.1: Substantial Equivalence on Plates | ||||||
|---|---|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | ||
| Trade Name | ||||||
| Information | K182609 - Delphos Implants | |||||
| Rigid Fixation System | K080694 - Osteomed Modular | |||||
| Locking System | K112457 - LeForte System | |||||
| Bone Plate & Screw | K121589 - Biomet Microfixation | |||||
| Facial Plating System | K180204 - Mini and Micro | |||||
| Fragments Reconstruction | ||||||
| System - | ||||||
| CMF Visionare | Substantial Equivalence Discussion | |||||
| Delphos Implants - Ind. Com. | ||||||
| Importação e Exportação de | ||||||
| Implantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Biomet Microfixation | Visionare LLC | ||
| Equivalent | ||||||
| The subject device indication for use | ||||||
| is identical to primary predicate | ||||||
| device excepting for the reference to | ||||||
| drills and the reference to the term | ||||||
| "cranio-maxillofacial". | ||||||
| Drills are surgical instruments | ||||||
| developed to assist in the installation | ||||||
| of plates and screws and are not | ||||||
| subject of this submission. Therefore, | ||||||
| information on drills were | ||||||
| suppressed from Delphos Implants | ||||||
| indications for use Statement. | ||||||
| Indication for Use | The Delphos Implants Rigid | |||||
| Fixation System is intended | ||||||
| for fracture fixation in | ||||||
| maxillofacial trauma | ||||||
| reconstruction, mandibular | ||||||
| reconstruction and | ||||||
| orthognathic reconstruction. | The OsteoMed Modular | |||||
| Locking Fixation System is | ||||||
| intended for fracture fixation | ||||||
| in cranio-maxillofacial trauma | ||||||
| reconstruction, mandibular | ||||||
| reconstruction and | ||||||
| orthognathic reconstruction. | ||||||
| The OsteoMed Modular | ||||||
| Locking Fixation System | ||||||
| implants and drills are | ||||||
| intended for single use only. | Intended for use in Selective | |||||
| trauma of the mid-face, | ||||||
| reconstruction procedures | ||||||
| and selective orthognathic | ||||||
| surgery of the maxilla and | ||||||
| chin. | These devices are implantable | |||||
| bone plates and bone screws | ||||||
| for facial procedures | ||||||
| including: |
- Fractures
- Osteotomies
- Reconstructive procedures
- Revision procedures where
other treatments or devices
have failed | CranioMaxillofacial Fixation
(CMF) System - CMF Visionare
is intended for use in selective
trauma of the midface,
maxillofacial surgery,
reconstructive procedures,
and selective orthognathic
surgery of the maxilla,
mandible and chin. | In a previous submission from
Delphos Implants (K172949), FDA
informed that devices intended for
Cranial/Neuro applications are to be
reviewed by the Neurology Panel.
Therefore, the words cranio-
maxillofacial were replaced by
maxillofacial. |
| | The Delphos Implants Rigid
Fixation System implants are
intended for single use only. | | | | | The subject device indication for use
are within the scope of the reference
devices. |
| | | | | | | Identical |
| Product Code | JEY | JEY | JEY, DZL | JEY, HWC | JEY, DZL | to Primary Predicate Device and
within the scope of Reference
Devices. |
| Class | II | II | II | II | II | Identical |
| Trade Name
Information | SUBJECT DEVICES
K182609 - Delphos Implants
Rigid Fixation System
Delphos Implants - Ind. Com.
Importação e Exportação de
Implantes Médicos S.A. | PRIMARY PREDICATE DEVICE
K080694 - Osteomed Modular
Locking System
OsteoMed L. P. | REFERENCE DEVICE I
K112457 - LeForte System
Bone Plate & Screw
Jeil Medical Corporation | REFERENCE DEVICE II
K121589 - Biomet Microfixation
Facial Plating System
Biomet Microfixation | REFERENCE DEVICE III
K180204 - Mini and Micro
Fragments Reconstruction
System -
CMF Visionare
Visionare LLC | Substantial Equivalence Discussion |
| Regulation Number | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760
21 CFR 872.4880 | 21 CFR 872.4760
21 CFR 888.3040 | 21 CFR 872.4760
21 CRF 872.4880 | Identical
to Primary Predicate Device and
within the scope of Reference
Devices. |
| Regulation Name | Bone Plate | Bone Plate | Bone Plate
Intraosseus fixation screw or
wire | Bone Plate
Screw, Fixation, Bone | Bone Plate
Intraosseus fixation screw or
wire | Identical
to Primary Predicate Device and
within the scope of Reference
Devices. |
| Raw material | The plates are made from
commercially pure titanium
(ASTM F67) | The plates are made from
Titanium Alloy (ASTM F136 or
commercially pure titanium
(ASTM F67) | The plates are made from
commercially pure titanium
(ASTM F67) | The plates are made from
Titanium Alloy (ASTM F136 or
commercially pure titanium
(ASTM F67) | The plates are made from
commercially pure titanium
(ASTM F67) | Equivalent
The subject device raw materials are
within the scope of the predicates
raw 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, Steam
sterilization prior to use | Non-sterile, Steam
sterilization prior to use | Non-sterile, Steam
sterilization prior to use | Not informed | Non-sterile, Steam
sterilization 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 ~ 2.5mm
1.0mm ~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. | Equivalent
The plates thickness are within the
range of the predicate devices. |
| | | | | | | |
| | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | |
| Trade Name
Information | K182609 - Delphos Implants
Rigid Fixation System | K080694 - Osteomed Modular
Locking System | K112457 - LeForte System
Bone Plate & Screw | K121589 - Biomet Microfixation
Facial Plating System | K180204 - Mini and Micro
Fragments Reconstruction
System -
CMF Visionare | Substantial Equivalence Discussion |
| | Delphos Implants - Ind. Com.
Importação e Exportação de
Implantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Biomet Microfixation | Visionare LLC | |
| Plates designs (shapes). | Orbital Type
T Type
Straight Type
H Type
X Type
Z Type
L Type
Y Type
Curved Type
Rectangular Type
Calvarium Plate
Maxillary Type
Square Type
Fitting Adjustment Type
Mentoplasty Type (Chin type)
Double T Type
BSSO Type
L Adjustment Type
Condylar Fracture Type | Curved Type
Straight Type
L Type
Double Y Type
X Type
I Type
Chin Type
Mesh Type
H Type
Quad(Square) Type
Y Type
Z Type
BSSO Type
Orbital Type
Angled Type
Condyle Plate
Comminution Type
Strut Type
Reconstruction Type | Curved Type
Straight Type
Square Type
L Type
Double Y Type
X Type
I Type
Chin Type
Calvarium Type
Mesh Type
H Type
Hexagon Type
Quad Type
T Type
Y Type
Z Type
Rigid Straight Type
MG Type
А Туре
Angled Type
Angled
Reconstruction Type
Multi Reconstruction Type
Reconstruction -Type
BSSO Type | Variations of:
Straight
Angled
Curved
L-shape
T-shape
Z-shape
X-shape
Y-shapes
Double Y shapes
H-shape
Triangle
Rectangle
Matrix
Mesh
Orbital Floor
LeFort
Chin | Straight Plates
Rectangular Plates
T Plates
Y Plates
Double Y Plates
L Plates
L 110° Plates
H Plates
I Plates
X Plates
Z Plates
Orbital Plates
Orbital Floor Plates
Straight Locking Plates
Rectangular Locking Plates
Orthognathic L Plates
Orthognathic Y Plates
Orthognathic Canine Pillar
Plates
Orthognathic Zygomatic Pillar
Plates
Orthognathic Le Fort Plates
Orthognathic Chin Plates
Orthognathic Paulus Plates
Orthognathic Straight Sagittal
Plates
Orthognathic Straight
Adjustable Sagittal Plates
Orthognathic Y Adjustable
Sagittal Plates
Orthognathic Locking Straight
Sagittal Plates
Orthognathic Locking Straight
Adjustable Sagittal Plates
Orthognathic Locking Y
Adjustable Sagittal Plates | Equivalent
Most of the plates designs are within
the scope of Primary Predicate
Device and Reference Devices.
There are some minor differences in
design types that do not introduce
significantly different designs and
maintain the same intended use. All
the subject plates designs were
evaluated through mechanical
testing on worst cases
representatives not raising any issue
in performance. |
| 5.2: Substantial Equivalence on Screws | | | | | | |
| | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | | |
| Trade Name Information | K182609 - Delphos Implants Rigid
Fixation System | K080694 - Osteomed Modular Locking
System | K150965 - LeForte System II | K180204 - Mini and Micro Fragments
Reconstruction System -
CMF Visionare | Substantial Equivalence Discussion | |
| | Delphos Implants - Ind. Com.
Importação e Exportação de
Implantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Visionare LLC | | |
| Indication 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. | The OsteoMed Modular Locking
Fixation System is intended for
fracture fixation in cranio-
maxillofacial trauma reconstruction,
mandibular reconstruction and
orthognathic reconstruction.
The OsteoMed Modular Locking
Fixation System implants and drills
are intended for single use only. | The LeForte System II is intended for
use in selective trauma of mid-face,
reconstruction procedure and
selective orthognathic surgery of the
maxilla and chin. | CranioMaxillofacial Fixation (CMF)
System - CMF Visionare is intended
for use in selective trauma of the
midface, maxillofacial surgery,
reconstructive procedures, and
selective orthognathic surgery of the
maxilla, mandible and chin. | Equivalent
Most of the plates designs are within
the scope of Primary Predicate
Device and Reference Devices.
There are some minor differences in
design types that do not introduce
significantly different designs and
maintain the same intended use. All
the subject plates designs were
evaluated through mechanical
testing on worst cases
representatives not raising any issue
in performance. | |
| Product Code | JEY | JEY | JEY | JEY, DZL | Identical
to Primary Predicate Device and
within the scope of Reference
Devices. | |
| Class | II | II | II | II | Identical | |
| Regulation Number | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760
21 CRF 872.4880 | Identical
to Primary Predicate Device and
within the scope of Reference
Devices. | |
| Regulation Name | Bone Plate | Bone Plate | Bone Plate | Bone Plate
Intraosseus fixation screw or wire | Identical
to Primary Predicate Device and
within the scope of Reference
Devices. | |
| 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 Rigid
Fixation System | K080694 - Osteomed Modular Locking
System | K150965 - LeForte System II | K180204 - Mini and Micro Fragments
Reconstruction System -
CMF Visionare | | |
| | Delphos Implants - Ind. Com.
Importação e Exportação de
Implantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Visionare LLC | | |
| | Sterilization | Non-sterile, Steam sterilization prior
to use | Non-sterile, Steam sterilization prior
to use | Non-sterile, Steam sterilization prior
to use | Non-sterile, Steam sterilization prior to
use | |
| Screw type/ diameter | Self-tapping Screw
1.2mm, 1.6mm, 2.0mm, 2.4mm, 2.7 mm | Self-tapping Screw
1.2mm, 1.5mm, 1.6mm, 1.9mm,
2.0mm, 2.3mm, 2.4mm, 2.7mm | Self-tapping Screw
1.3mm, 1.6mm, 2.0mm, 2.4mm | Self-tapping Screw
1.5mm, 2.0mm, 2.4mm, 2.7mm | Equivalent
The subject devices diameters are
within the range of the predicate
devices diameters. | |
| | Self-drilling Screw
2.0 mm | Self-drilling Screw
1.2mm, 1.6mm, 2.0mm | Self-drilling Screw
1.4mm, 1.6mm, 2.0mm | Self-drilling Screw
1.5mm, 2.0mm | Performance testing were executed
following worst case rationales; the
subject devices are supported by
mechanical testing. | |
| | Emergency Screws
1.6mm, 1.9mm, 2.3mm, 2.7 mm | | Emergency Screws
1.5 mm, 1.8mm, 2.3mm, 2.7mm | Emergency Screws
1.8mm, 2.3mm, 2.7mm | | |
| | Screw Length | Self-tapping Screw
3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 18, 20 mm | Self-tapping Screw
2 - 20mm | Self-tapping Screw
2 - 20mm | Self-tapping Screw
4-20mm | |
| | | Self-drilling Screw
3 - 8mm | Self-drilling Screw
3 - 12mm | Self-drilling Screw
4-11mm | The subject devices lengths are
within the range of the predicate
devices lengths. | |
| Self-drilling Screw
3, 4, 5, 6, 7, 8, 9, 10, 11, 12 mm | | | | | Performance testing were executed
following worst case rationales; the
subject devices are supported by
mechanical testing | |
| | | | | Emergency Screws
4-18mm | | |
| Emergency Screws
4, 5, 6, 7, 8, 9, 10, 12, 14mm | | | | | | |
Tab
8
9
10
Table 5.2: Substantial Equivalen . C
11
12
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.