(492 days)
Not Found
No
The summary describes a system of bone plates and screws for fracture fixation, with no mention of AI, ML, or any software-driven analytical capabilities.
Yes
The device, the Wise-Lock Tibia & Fibula System, is intended for "fracture fixations" for various tibia and fibula plates, which directly treats an injury or condition (fractures), thereby providing a therapeutic benefit.
No
The device is a system of bone plates and screws intended for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly states it consists of bone plates and screws made of stainless steel 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 Wise-Lock Tibia & Fibula System plates are for "fracture fixations for the plates included in the system as follows: ... treating fractures of the tibia," "buttress metaphyseal fractures," "internal fixation of posteromedial proximal tibia fractures," "fixation of complex intra-and extraarticular fractures and osteotomies," and similar indications related to fixing bone fractures and osteotomies.
- Device Description: The device is described as "three types of bone Plates system... and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures."
- Anatomical Site: The anatomical site is the "Tibia and fibula bone, ankle."
- Performance Studies: The performance studies focus on mechanical properties of the plates and screws (static and fatigue tests, driving torque, torsion, axial pull-out), biocompatibility, sterilization, shelf-life, and bacterial endotoxin. These are all relevant to implanted medical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
In summary, the Wise-Lock Tibia & Fibula System is a surgical implant used to fix bone fractures and osteotomies. This falls under the category of a medical device, specifically an orthopedic implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:
3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.
3.5mm Wise-Lock Proximal Tibia Plate:
3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Proximal Tibia Plate:
The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Lateral Distal Fibula Plate:
The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:
The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Pilon Plate:
The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Pilon Plate, Cruciform:
3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and
Malunions
3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:
The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:
Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures.
To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.
The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:
The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:
The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies.
4.5/5.0mm Wise-Lock Proximal Tibia Plate:
4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
AV-Wise Lock Ankle System
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:
Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia,
Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and
Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of
AV-Wise Lock Proximal Tibia Plates
The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, Fibula, Ankle
Indicated Patient Age Range
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused.
The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
The system is indicated for use in adult patients only.
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)
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards and has substantially equivalent performance as the predicate:
a.Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.
We have complied with the following material standards:
- ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium ● ELI (Extra low interstitial) Alloy for surgical implant applications.
- ASTM F899-20: Standard Specification for Wrought Stainless Steels for surgical instruments.
- ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Note: We have used Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-20, Stainless Steel (Grade 316L) for Stainless Steel Implants and Titanium Alloy (Ti-6Al-4V) Grade 5 for Titanium Implants.
We have verified the purchased material and are in compliance to these standards and copies of the relevant test results are attached in Vol 005 Appendix D Implant Material Report and Vol 006 Appendix E ASTM F899 Report of the technical dossier.
b. Performance Standards:
The device performance of Auxein's Tibia and Fibula System has been demonstrated against the following applicable standards:
- ASTM F543-17
- ASTM F382-17
Summary of Biocompatibility
The device in its final, finished form has been evaluated for biocompatibility according to ISO 10993-3.
Conclusion of Performance bench testing:
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates. ●
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws. ●
The following tests were performed with the predicate device:
Plate
- Four-Point Static Test: Conforms ●
- Four-Point Fatigue Test: Conforms
Screw
- Driving Torque Test: Conforms
- Torsion Test: Conforms
- Axial Pull-out Test: Conforms
The results of this testing indicate that the Tibia and Fibula System is equivalent to a predicate device.
Sterilization, shelf-life and packaging for sterile product
- ISO 11137-1:2006, sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 11137-2:2012, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
- ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
- ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO/TS 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
- ISO/TS 17665-3:2013(en), Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.
- ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
- ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
- ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system.
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Bacterial Endotoxin
Bacterial Endotoxin test was performed on bone plates System by using Limulus Amoebocyte Lysate (LAL) test. The Endotoxin testing limit was less or equal to 20EU/Device. The test was performed according to standard USP 32 chapter 85.
- USP Bacterial Endotoxin Test. .
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
Shelf Life
The stability study has been done to determine the shelf life.
We have followed the below standards for performing shelf-life of the device:
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
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.
K013248, K073460, K141680, K020602, K111039, K061098, K052390, K050646, K030597, K011978, K120854, K120689, K050646, K082624, K120360
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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January 27, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Auxein Medical Private Limited Rahul Luthra Director Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, Haryana 131028 India
Re: K213059
Trade/Device Name: Tibia and Fibula System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 5, 2022 Received: May 11, 2022
Dear Rahul Luthra:
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. 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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restoritive, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213059
Device Name Tibia and Fibula System
Indications for Use (Describe) Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:
3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.
3.5mm Wise-Lock Proximal Tibia Plate:
3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Proximal Tibia Plate:
The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Lateral Distal Fibula Plate:
The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:
The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Pilon Plate:
The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3
3.5mm Wise-Lock Pilon Plate, Cruciform:
3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and
Malunions
3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:
The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:
Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures.
To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.
The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:
The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:
The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies.
4.5/5.0mm Wise-Lock Proximal Tibia Plate:
4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
AV-Wise Lock Ankle System
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:
Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia,
Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and
Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of FORM FDA 3881 (6/20) Page 2 of 3
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AV-Wise Lock Proximal Tibia Plates
The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it, followed by the word "Auxein" in blue. There is a small circle above the "i" in "Auxein".
510k Summary
Pre Market Notification 510(k) Summary as required by section 807.92 General Company Information as required by 807.92 (a)
| Submitter's Name: | Auxein Medical Private Limited |
|---|---|
| Address: | Auxein Medical Private Limited |
| Plot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDC, | |
| Sector-57, Sonepat-131028, Haryana, India | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9560557733 |
| Email Id: | info@auxein.com |
| Dated: | 27.01.2023 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar |
|---|---|
| Title: | Sr. Research Engineer |
| Email Id: | m.kumar@auxein.com |
| Dated: | 27.01.2023 |
Proprietary Name:
Tibia and Fibula System
Common or Usual Name:
Plate, Fixation, Bone (Primary) Screw Fixation, Bone
Classification Name:
Single/multiple component metallic bone fixation appliances and accessories (Primary) Smooth or threaded metallic bone fixation fastener
Product Code:
HRS (Primary) HWC
Device Class: II
Review Panel: Orthopedic
Regulation Number:
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21 CFR 888.3030 (Primary)
21 CFR 888.3040
| Primary Product
| Code | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| HRS | Single/multiple component metallic bone fixation appliances and accessories | Plate, Fixation, Bone | 21 CFR 888.3030 |
Variants/Types:
Tibia and Fibula Systems consist of the following Components:
| S.No. | Item Description |
|---|---|
| Wise-Lock Tibia & Fibula System Plates | |
| 1. | 3.5mm Wise-Lock Medial Distal Tibia Plate, (4, 6, 8, 10, 12, 14 Holes), Left and Right |
| 2. | 3.5mm Wise-Lock Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left and Right |
| 3. | 3.5mm Wise-Lock Medial Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16, 18, 20 Holes), Left |
| and Right | |
| 4. | 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate, (1, 2, 4, 6, 8, 10 Holes) |
| 5. | 3.5mm Wise-Lock Anterolateral Distal Tibia Plate, (5, 7, 9, 11, 13, 15, 17, 19, 21 Holes), |
| Left and Right | |
| 6. | 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab, (4, 6, 8, 10, 12, 14 Holes), Left |
| and Right | |
| 7. | 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab, (4, 6, 8, 10, 12, 14 |
| Holes), Left and Right | |
| 8. | 3.5mm Wise-Lock Lateral Distal Fibula Plate, (3, 4, 5, 6, 7, 9, 11 Holes), Left and Right |
| 9. | 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia, (4, 5, 6, 7, 8, 9, 10, 12, 14, |
| 16, 18, 20 Holes), Left and Right | |
| 10. | 3.5mm Wise-Lock Pilon Plate, (7, 9 Holes) |
| 11. | 3.5mm Wise-Lock Pilon Plate, Cruciform, (7, 9 Holes) |
| 12. | 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate, (6, 8, 10, 14, 18 Holes), Left and |
| Right | |
| 13. | 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate, (6, 8, 10, 12, 14, 16 Holes), Left |
| and Right | |
| 14. | 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate, (5, 7, 9, 11, 13 Holes), Left and Right |
| 15. | 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left and |
| Right | |
| 16. | 4.5/5.0mm Wise-Lock Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, Holes), Left and Right |
| AV-Wise Lock Ankle System Plates | |
| 17. | 2.7/3.5mm AV-Wise Lock Anteromedial Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes) |
| 18. | 2.7/3.5mm AV-Wise Lock Medial Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left & Right |
| 19. | 2.7mm AV-Wise Lock Distal Tibia L-Plate, (4, 6 Holes), Left & Right |
| 20. | 2.7mm AV-Wise Lock Distal Tibia T-Plate, (4, 6 Holes) |
| 21. | 2.7mm AV-Wise Lock Lateral Distal Fibula Plate, (3, 4, 5, 6, 7, 9, 11, 13, 15 Holes), Left & Right |
| 22. | 2.7/3.5mm AV-Wise Lock Anterolateral Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16, 18 Holes), Left & Right |
| 23. | 3.5mm AV-Wise Lock Proximal Tibia Plate, Small Bend, (4, 6, 8, 10, 12, 14 Holes), Left & Right |
| 24. | 3.5mm AV-Wise Lock Proximal Tibia Plate, Large Bend, (4, 6, 8, 10, 12, 14 Holes), Left & Right |
| Screws | |
| 25. | 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head), (10-60 mm) Length |
| 26. | 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head), (10-80 mm) Length |
| 27. | 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head), (10-60 mm) Length |
| 28. | 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head), (10-60 mm) Length |
| 29. | 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head), (10-60 mm) Length |
| 30. | 3.5mm Cortical Screw, Self-Tapping, (Hex Head), (10-90 mm) Length |
| 31. | 4.0mm Cancellous Screw, Short Thread, (12-60 mm) Length |
| 32. | 4.0mm Cancellous Screw, Full Thread, (12-60 mm) Length |
| 33. | 4.5mm Cortical Screw, Self-Tapping, (Hex Head), (12-60 mm) Length |
| 34. | 5.0mm Wise-Lock Screw, Self-Tapping, (Hex Head), (12-90 mm) Length |
| 35. | 5.0mm Wise-Lock Screw, Self-Tapping & Self-Drilling, (Hex Head), (12-90 mm) Length |
| 36. | 5.0mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head), (20-110 mm) Length |
| 37. | 5.0mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head), (20-110 mm) Length |
| 38. | 5.0mm Wise-Lock Cannulated Screw, Full Thread, Self-Tapping, (20-120 mm) Length |
| 39. | 5.0mm Wise-Lock Cannulated Screw, Partial Thread, Self-Tapping, (30-100 mm) Length |
| 40. | 6.5mm Cancellous Screw, 16mm Thread, (25-120 mm) Length |
| 41. | 6.5mm Cancellous Screw, 32mm Thread, (35-120 mm) Length |
| 42. | 6.5mm Cancellous Screw, Full Thread, (35-120 mm) Length |
| 43. | 2.7mm Cortical Screw, Self-Tapping, (Hex Head), Titanium, (6-30 mm) Length |
| 44. | 2.7mm AV-Wise Lock Screw, Self-Tapping, (Star Head), (6-70mm) Length |
| 45. | 2.7mm Cortical Screw, Self-Tapping, (Star Head), (6-70mm) Length |
| 46. | 2.7mm Wise-Lock Screw, Self-Tapping, (Star Head), (6-70mm) Length |
| 47. | 3.5mm AV-Wise Lock Screw, Self-Tapping, (10-95mm) Length |
| 48. | 3.5mm Cortical Screw, Self-Tapping, (Star Head), (10-90mm) Length |
| 49. | 3.5mm Wise-Lock Screw, Self-Tapping, (Star Head), (10-95mm) Length |
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Image /page/7/Picture/1 description: The image shows the logo for Auxein. The logo consists of a stylized letter A inside of a circle, followed by the word "Auxein" in a sans-serif font. The logo is blue and the background is white.
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Image /page/8/Picture/1 description: The image contains the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. A registered trademark symbol is located to the right of the word.
Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence: The following is the range of variants covered with their corresponding predicate devices.
Primary Predicate device:
| 510K Number | K013248 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | 3.5mm LCP Medial Distal Tibia Plate |
Reference Predicate device:
| 510K Number | K073460 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | 3.5/2.7 mm LCP Distal Fibula Plates |
| 510K Number | K141680 |
|---|---|
| Applicant | Auxein Medical Pvt. Ltd. India |
| Device Name | Bone Plates |
| 510K Number | K020602 |
|---|---|
| Applicant | Synthes, USA. |
| Device Name | 3.5mm LCP Pilon Plate |
| 510K Number | K111039 |
|---|---|
| Applicant | Zimmer |
| Device Name | Zimmer Periarticular Locking Plate System |
| 510K Number | K061098 |
|---|---|
| Applicant | Zimmer |
| Device Name | EBI OptiLock Periarticular Plating System |
| 510K Number | K052390 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | Synthes LCP Proximal Tibia Plates Line Extension |
| 510K Number | K050646 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | Synthes (USA) 3.5/4.5mm LCP Medial |
| Proximal Tibia Plates |
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Image /page/9/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
| 510K Number | K030597, K011978 |
|---|---|
| Applicant | Synthes (USA) |
| Device Name | 3.5mm Titanium LCP Proximal Tibia Plate, |
| Stainless Steel LCP Proximal Tibia plate |
| 510K Number | K120854 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | Synthes VA LCP Ankle Trauma System |
| 510K Number | K120689 |
|---|---|
| Applicant | Synthes, USA |
| Device Name | Synthes 3.5 mm VA-LCP Proximal Tibia Plate System |
| 510K Number | K050646 |
|---|---|
| Applicant | Synthes,USA |
| Device Name | Synthes (USA) 3.5/4.5mm LCP Medial |
| Proximal Tibia Plates |
| 510K Number | K082624 |
|---|---|
| Applicant | Synthes,USA |
| Device Name | Synthes (USA) 3.5mm LCP Posteromedial |
| Proximal Tibia Plates |
| 510K Number | K120360 |
|---|---|
| Applicant | Ortho Solutions Limited, U.K |
| Device Name | 4.0mm Cancellous Screw, Short thread |
Device Description:
The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.
Indications for Use
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Image /page/10/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. A small "R" in a circle is located to the right of the word "Auxein", indicating that the logo is a registered trademark.
Wise-Lock Tibia & Fibula System
The Wise-Lock Tibia & Fibula System plates are intended for fracture fixation. Indications for the plates included in the system as follows:
3.5mm Wise-Lock Medial Distal Tibia Plate:
Medial distal tibia plates are indicated for treating fractures of the tibia.
3.5mm Wise-Lock Proximal Tibia Plate:
3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Proximal Tibia Plate:
The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of the proximal, distal, and metaphyseal areas of the tibia.
3.5mm Wise-Lock Anterolateral Distal Tibia Plate:
3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab:
The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab:
The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Lateral Distal Fibula Plate:
The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and nonunions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:
The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula.
3.5mm Wise-Lock Pilon Plate:
The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
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Image /page/11/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter A inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it.
3.5mm Wise-Lock Pilon Plate, Cruciform:
3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Z-type Distal Medial Tibial Plate:
The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- Comminuted fractures o
- Supracondylar fractures O
- O Intra-articular and extra-articular condylar fractures
- O Non-unions, and
- O Malunions
3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:
The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is indicated for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:
Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.
The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:
The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, malunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:
The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
4.5/5.0mm Wise-Lock Proximal Tibia Plate:
4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft
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Image /page/12/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and clean, and the blue color gives it a professional look.
fractures.
AV-Wise Lock Ankle System
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:
- Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, fractures, o nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fractures O and bone fragments of the distal tibia, and
- O Lateral Distal Fibula Plates are indicated for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
AV-Wise Lock Proximal Tibia Plates
The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.
Summary of Technological Characteristics as compared to the predicate devices
A comparison between the Auxein's Tibia and Fibula System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Following is the summary of parameters in which the comparison has been verified:
| S.N
| o. | Characteristics | Auxein Device | Predicate Device | Remarks |
|---|---|---|---|---|
| 1. | Product | |||
| Code | HWC (Primary), HRS | HWC (Primary), HRS | Identical as | |
| predicate | ||||
| device | ||||
| 2. | Regulation | |||
| Number | 21 CFR 888.3030 | |||
| (Primary), 21 CFR | ||||
| 888.3040 | 21 CFR 888.3030 | |||
| (Primary), 21 CFR | ||||
| 888.3040 | Identical as | |||
| predicate | ||||
| device | ||||
| 3. | Regulatory | |||
| Class | Class II | Class II | Identical as | |
| predicate | ||||
| device | ||||
| 4. | Indications for use | The bone plates are indicated for use in fracture treatment of Tibia | The bone plates are indicated for use in fracture treatment of Tibia | Identical as |
| predicate | ||||
| device |
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Image /page/13/Picture/1 description: The image shows the logo for Auxein. The logo consists of a stylized letter A inside of a circle, followed by the word "Auxein" in a sans-serif font. The logo is blue. There is a registered trademark symbol to the right of the word "Auxein".
| and fibula bone. | and fibula bone. | |||
|---|---|---|---|---|
| 5. | Material | Titanium Alloy as per | ||
| ASTM F136 and Stainless | ||||
| Steel as per ASTM F138. | Titanium Alloy as per | |||
| ASTM F136 and Stainless | ||||
| Steel as per ASTM F138. | Conform to | |||
| the same | ||||
| material | ||||
| standard as | ||||
| predicate | ||||
| device | ||||
| 6. | Performance | |||
| Standards | The performance testing | |||
| was done on the subject | ||||
| device as per the standard | ||||
| ASTM F382 and F543. | The performance testing | |||
| was done on the subject | ||||
| device as per the standard | ||||
| ASTM F382 and F543. | Identical as | |||
| predicate | ||||
| device | ||||
| 7. | Sterilization | Gamma Sterilization | ||
| Method and Non-Sterile | ||||
| used in subject device. | Gamma Sterilization | |||
| Method and Non-Sterile | ||||
| used in subject device. | Identical as | |||
| predicate | ||||
| device | ||||
| 8. | Shelf-life | 5 Years (For Sterilized | ||
| Product) | 5 Years (For Sterilized | |||
| Product) | Identical as | |||
| predicate | ||||
| device | ||||
| 9. | Single | |||
| Use/Reuse | Single Use | Single Use | Identical as | |
| predicate | ||||
| device | ||||
| 10. | Operating | |||
| Principle | The plate is fixed to the | |||
| bone by application of | ||||
| screws on both sides of the | ||||
| fracture. | The plate is fixed to the | |||
| bone by application of | ||||
| screws on both sides of the | ||||
| fracture. | Identical as | |||
| predicate | ||||
| device | ||||
| 11. | Dimensional | |||
| Verification | The same dimensions are found in both new devices as | |||
| well as Predicate devices. | Identical as | |||
| predicate | ||||
| device |
Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards:
- . Material Standards.
- . Biocompatibility Standards
- Performance Standards.
- Sterilization, shelf-life and packaging for sterile product.
- Bacterial Endotoxin.
Non-Clinical Test Summary:
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards and has substantially equivalent performance as the predicate:
a.Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of
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Image /page/14/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white triangle inside of it, followed by the word "Auxein" in blue, sans-serif font. There is a small "R" in a circle to the right of the word "Auxein".
manufacturing metallic surgical implants.
We have complied with the following material standards:
- ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium ● ELI (Extra low interstitial) Alloy for surgical implant applications.
- ASTM F899-20: Standard Specification for Wrought Stainless Steels for surgical instruments.
- ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Note: We have used Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-20, Stainless Steel (Grade 316L) for Stainless Steel Implants and Titanium Alloy (Ti-6Al-4V) Grade 5 for Titanium Implants.
We have verified the purchased material and are in compliance to these standards and copies of the relevant test results are attached in Vol 005 Appendix D Implant Material Report and Vol 006 Appendix E ASTM F899 Report of the technical dossier.
b. Performance Standards:
The device performance of Auxein's Tibia and Fibula System has been demonstrated against the following applicable standards:
- · ASTM F543-17
- ASTM F382-17
Summary of Biocompatibility
The device in its final, finished form has been evaluated for biocompatibility according to ISO 10993-3.
Conclusion of Performance bench testing:
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates. ●
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws. ●
The following tests were performed with the predicate device:
Plate
- Four-Point Static Test: Conforms ●
- Four-Point Fatigue Test: Conforms
Screw
- Driving Torque Test: Conforms
- Torsion Test: Conforms
- Axial Pull-out Test: Conforms
The results of this testing indicate that the Tibia and Fibula System is equivalent to a predicate device.
Sterilization, shelf-life and packaging for sterile product
- · ISO 11137-1:2006, sterilization of health care products Radiation Part 1: Requirements for
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Image /page/15/Picture/1 description: The image features the logo for Auxein. The logo consists of a stylized letter "A" enclosed within a circle, followed by the word "Auxein" in a bold, sans-serif font. A small registered trademark symbol appears to the upper right of the word "Auxein". The logo is presented in a blue color.
development, validation and routine control of a sterilization process for medical devices.
- . ISO 11137-2:2012, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
- ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
- ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO/TS 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
- . ISO/TS 17665-3:2013(en), Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.
- ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
- ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
- ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system.
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Bacterial Endotoxin
Bacterial Endotoxin test was performed on bone plates System by using Limulus Amoebocyte Lysate (LAL) test. The Endotoxin testing limit was less or equal to 20EU/Device. The test was performed according to standard USP 32 chapter 85.
- USP Bacterial Endotoxin Test. .
- . USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
Shelf Life
The stability study has been done to determine the shelf life.
We have followed the below standards for performing shelf-life of the device:
- . ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
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Image /page/16/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
Conclusion:
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components. From the data available we can justify that the Auxein's Tibia and Fibula System is as safe, and as effective and performs the same indications for use as that of already marketed predicate devices.