(378 days)
The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused.
Specifically,
Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, malunions and non-unions of the distal humerus.
Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.
The Auxein Varixis Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. Proximal ulna Plates enables the surgeon to address the specific biomechanical requirements of each fracture pattern while minimizing irritations of the adjacent soft tissue.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. All implants are for single use only.
This document is a 510(k) Premarket Notification for the Varixis Elbow System, a set of metallic bone fixation appliances. It focuses on demonstrating the substantial equivalence of the Varixis Elbow System to a legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).
The document does not describe a study involving an AI/ML device where acceptance criteria are set for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and then proven through clinical studies with human readers or standalone algorithm performance. Instead, it describes a medical device, the Varixis Elbow System, which is a physical implant used for fracture fixation.
Therefore, the requested information regarding acceptance criteria for device performance (like sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, ground truth types, and training set details are not applicable to this submission as it pertains to a mechanical orthopedic implant, not an AI/ML diagnostic or assistive device.
The "performance" referred to in this document relates to mechanical properties (e.g., static and fatigue strength of plates, driving torque, torsion, and axial pull-out of screws), material biocompatibility, and sterilization effectiveness.
Here's an analysis of the document in the context of your request, highlighting what is present and what is absent:
Acceptance Criteria and Proof of Device Meeting Criteria (for a mechanical implant)
The acceptance criteria for this device are demonstrated through a comparison to a predicate device and adherence to recognized industry standards for mechanical testing and material properties. The 'proof' is the declaration of substantial equivalence based on these comparisons and test results.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison table (Section A.6) outlining the technological characteristics of the Auxein Varixis Elbow System and the predicate device. This indirectly serves as a basis for acceptance criteria by demonstrating similarity or conformity to established standards, which are the "acceptance criteria" for this type of device.
| S.N. | Characteristics | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Auxein Device) | Remarks (Meeting Criteria) |
|---|---|---|---|---|
| 1. | Product Code | HWC (Primary), HRS (Identical to predicate) | HWC (Primary), HRS | Identical as predicate device |
| 2. | Regulation Number | 21 CFR 888.3030 (Primary), 21 CFR 888.3040 (Identical to predicate) | 21 CFR 888.3030 (Primary), 21 CFR 888.3040 | Identical as predicate device |
| 3. | Regulatory Class | Class II (Identical to predicate) | Class II | Identical as predicate device |
| 4. | Indications for Use | Intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which growth plates have fused. Specific indications for distal humerus plates (intra-articular, comminuted supracondylar, osteotomies, malunions, non-unions) and olecranon/proximal ulna plates (fractures, osteotomies, malunions, non-unions). (Identical to predicate) | The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically; Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. | Identical as predicate device |
| 5. | Material | Titanium Alloy and Stainless Steel (Identical to predicate) | Titanium Alloy and Stainless Steel. (Specific standards met: ASTM F136/ISO 5832-3, ASTM F899-12, ASTM F138/ISO 5832-1) | Identical as predicate device, specific standards met |
| 6. | Performance Standards | Conformance to ASTM F382 (Metallic Bone Plates) and ASTM F543 (Metallic Medical Bone Screws). (Identical to predicate) | The performance testing was done on the subject device as per the standard ASTM F382 and F543. (Specifically, Plates: 4-Point Static Test, 4-Point Fatigue Test. Screws: Driving Torque Test, Torsion Test, Axial Pull-out Test) | Identical as predicate device, results "Conforms" |
| 7. | Sterilization | Gamma Sterilization Method and Non-Sterile (Identical to predicate); Conform to ISO 11137 series, ISO 17665 series, ISO 11140-1, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM F88/F88M, ASTM F1929. | Gamma Sterilization Method and Non-Sterile used in subject device. (Compliance stated for ISO & ASTM sterilization/packaging standards) | Identical as predicate device |
| 8. | Shelf-life | 5 Years (For Sterilized Product) (Identical to predicate) | 5 Years (For Sterilized Product) | Identical as predicate device |
| 9. | Single Use/Reuse | Single Use (Identical to predicate) | 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. (Identical to predicate) | 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. (Implied acceptance based on similarity) | The same dimensions are found in both new Devices as well as Predicate devices. | Identical as predicate device |
| N/A | Biocompatibility | Raw materials evaluated according to ISO 10993-3. | Raw materials have been evaluated for biocompatibility according to ISO 10993-3. | Compliant |
| N/A | Bacterial Endotoxin | USP <85> Bacterial Endotoxin Test; USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | Compliance to USP <85> and USP <161> for Bacterial Endotoxin. | Compliant |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested for ASTM F382 or F543). It simply states that "Bench tests were conducted" and "The results of this testing indicate that the Varixis Elbow System is equivalent to the predicate device."
- Data Provenance: The tests are bench tests performed on the physical device. The company, Auxein Medical Private Limited, is based in India, so it's presumed the testing was conducted there or by affiliated, qualified labs. It is not "retrospective or prospective" in the clinical study sense, as it involves physical testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a submission for a mechanical implant, not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts in the context of analyzing medical images or clinical data for diagnostic purposes. The "ground truth" for this device's performance is adherence to engineering standards and mechanical test results.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, no medical image or clinical data interpretation by human experts requiring adjudication is involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is typically done for diagnostic imaging devices or AI/ML tools to assess human reader performance with and without AI assistance. It is not relevant for a mechanical bone fixation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an AI/ML algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used:
- For mechanical performance: The ground truth is defined by established engineering and medical device standards (e.g., ASTM F382, ASTM F543) and material specifications (e.g., ASTM F136, ISO 5832). The device performance is compared against the requirements of these standards.
- For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set is involved.
Summary of Relevant Information from the Document:
- Device Name: Varixis Elbow System
- Intended Use: Fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) where growth plates have fused.
- Basis for Clearance: Substantial equivalence to predicate device Synthes Variable Angle LCP Elbow System (K120070).
- Key Evidence for Substantial Equivalence:
- Identical product codes, regulation numbers, regulatory class, and indications for use as the predicate device.
- Identical materials (Titanium Alloy and Stainless Steel) as the predicate, meeting specific ASTM/ISO standards.
- Performance testing (bench tests) on the subject device according to ASTM F382 (for plates: 4-Point Static Test, 4-Point Fatigue Test) and ASTM F543 (for screws: Driving Torque Test, Torsion Test, Axial Pull-out Test). The results "Conform" to these standards.
- Compliance with various ISO and ASTM standards for biocompatibility (ISO 10993-3), sterilization (ISO 11137, ISO 17665, ISO 11140, ISO 11737, ISO 11607, ASTM F1980, ASTM F88/F88M, ASTM F1929), shelf-life (5 years, identical to predicate), and bacterial endotoxin (USP <85>, USP <161>).
- Identical operating principle and dimensional characteristics to the predicate device.
In conclusion, this document provides the necessary information for the FDA to confirm substantial equivalence for a mechanical orthopedic implant but does not contain information relevant to an AI/ML driven diagnostic device.
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October 3, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the agency's acronym in blue, followed by the full name "U.S. Food & Drug Administration" in a combination of blue and smaller font sizes.
Auxein Medical Private Limited Rahul Luthra Director, Regulatory Department Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat. Haryana 131028 India
Re: K213014
Trade/Device Name: Varixis Elbow 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: August 16, 2022 Received: August 25, 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/cdrl/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
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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 mediation-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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213014
Device Name Varixis Elbow System
Indications for Use (Describe)
The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused.
Specifically,
Distal humerus plates are indicated for intra-articular fractures, comminuted supracondy lar fractures, malunions and non-unions of the distal humerus.
Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.
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/3/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it.
Section 6.0: 510(k) Summary
Pre Market Notification 510(k) Summary as required by section 807.92 General Company Information as required by 807.92 (a) A.1: The Submitter's Name, address, telephone number, a contact person, and the date the summary was prepared.
| 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 |
| Dated: | 10.08.2022 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar |
|---|---|
| Title | Sr. Research Engineer |
| Email Id: | m.kumar@auxein.com |
| Dated: | 10.08.2022 |
Throughout the submission of Varixis Elbow System is covered under 510(k) Submission.
A.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
Proprietary Name: Varixis Elbow 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
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Image /page/4/Picture/0 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.
Device Class: II
Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3030 (Primary)
21 CFR 888.3040
| Primary ProductCode | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| HRS | Single/multiplecomponent metallicbone fixationappliances andaccessories | Plate, Fixation Bone | 21 CFR 888.3030 |
Variants/Types:
Varixis Elbow Systems consists of the following Components:
| S.No. | Product Description |
|---|---|
| 1. | 2.7/3.5mm Varixis Medial Distal Humerus Plate, (1, 2, 4 ,6, 8, 10 Holes), Left and Right |
| 2. | 2.7/3.5mm Varixis Extended Medial Distal Humerus Plate, (1, 2, 4,6, 8, 10 Holes), Left and Right |
| 3. | 2.7/3.5mm Varixis Lateral Distal Humerus Plate, (1, 2, 5, 7, 9, 11 Holes), Left and Right |
| 4. | 2.7/3.5mm Varixis Dorsolateral Distal Humerus Plate, (3, 4, 7, 9, 11, 13 Holes), Left and Right |
| 5. | 2.7/3.5mm Varixis Dorsolateral Distal Humerus Plate with Lateral Support, (3, 4, 7, 9, 11, 13 Holes), Left and Right |
| 6. | 2.7/3.5mm Varixis Proximal Olecranon Plate, (2 Holes), Left and Right |
| 7. | 2.7/3.5mm Varixis Olecranon Plate, (2, 4, 6, 8 Holes), Left and Right |
| 8. | 2.7/3.5mm Varixis Extra Articular Proximal Ulna Plate, (6, 8, 10, 12 Holes), Left and Right |
| Screws | |
| 9. | 2.7mm Varixis Screw, Self-Tapping, (Star Head), (6-70 mm) Length |
| 10. | 2.7mm Wise-Lock Screw, Self-Tapping, (Star Head), (6-70 mm) Length |
| 11. | 2.7mm Cortical Screw, Self-Tapping, (Star Head), (6-70 mm) Length |
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Image /page/5/Picture/0 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. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
| 12. | 2.7mm Cortical Screw, (Star Head), (6-70 mm) Length |
|---|---|
| 13. | 2.4mm Cortical Screw, Self-Tapping, (Star Head), (6-40 mm) Length |
| 14. | 2.4mm Cortical Screw, (Star Head), (6-40 mm) Length |
| 15. | 3.5mm Cortical Screw, Self-Tapping, (Star Head), (10-90 mm) Length |
| 16. | 3.5mm Cortical Screw, (Star Head), (10-90 mm) Length |
| 17. | 3.5mm Wise-Lock Screw, Self-Tapping, (Star Head), (10-90 mm) Length |
A.3) 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
| 510K Number | K120070 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Device Name | Synthes Variable Angle LCP Elbow System |
A.4) A description of the device that is the subject of the pre market notification submission, such as might be found in the labelling or promotional material for the device.
Device Description:
The Auxein Varixis Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. Proximal ulna Plates enables the surgeon to address the specific biomechanical requirements of each fracture pattern while minimizing irritations of the adjacent soft tissue.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. All implants are for single use only.
A.5) Indications for Use:
The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically;
- . Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-
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Image /page/6/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white triangle inside, followed by 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 sense of trustworthiness and reliability.
unions of the olecranon and proximal ulna.
A.6) Summary of Technological Characteristics as compared to the predicate devices: Substantial equivalence including comparison with predicate devices.
A comparison between the Auxein's Varixis Elbow 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 | Characteristics | Auxein Device | Predicate Device,K120070 | Remarks |
|---|---|---|---|---|
| 0. | ||||
| 1. | ProductCode | HWC (Primary), HRS | HWC (Primary), HRS | Identical aspredicatedevice |
| 2. | RegulationNumber | 21 CFR 888.3030(Primary), 21 CFR888.3040 | 21 CFR 888.3030(Primary), 21 CFR888.3040 | Identical aspredicatedevice |
| 3. | RegulatoryClass | Class II | Class II | Identical aspredicatedevice |
| 4. | Indications for use | The Auxein's Varixis Elbow System is intendedfor fixation of fractures ofthe distal humerus,olecranon and ulna inadults and adolescents (12-21) in which the growthplates have fused.Specifically;● Distal humerus platesare indicated for intra-articular fractures,comminutedsupracondylarfractures, osteotomies,malunions and non-unions of the distalhumerus.● Olecranon andProximal ulna platesare indicated forfractures, osteotomies,malunions and non- | The Synthes VA LCP Elbow System is intendedfor fixation of fractures ofthe distal humerus,olecranon and ulna inadults and adolescents(12-21) in which thegrowth plates have fused.Specifically;● Distal humerus platesare indicated for intra-articular fractures,comminutedsupracondylarfractures, osteotomies,malunions and non-unions of the distalhumerus.● Olecranon andProximal ulna platesare indicated forfractures, osteotomies,malunions and non- | Identical aspredicatedevice |
| unions of theolecranon andproximal ulna. | unions of theolecranon andproximal ulna. | |||
| 5. | Material | Titanium Alloy andStainless Steel. | Titanium Alloy andStainless Steel. | Identical aspredicatedevice |
| 6. | PerformanceStandards | The performance testingwas done on the subjectdevice as per the standardASTM F382 and F543. | The performance testingwas done on the subjectdevice as per the standardASTM F382 and F543. | Identical aspredicatedevice |
| 7. | Sterilization | Gamma SterilizationMethod and Non-Sterileused in subject device. | Gamma SterilizationMethod and Non-Sterileused in subject device. | Identical aspredicatedevice |
| 8. | Shelf-life | 5 Years (For SterilizedProduct) | 5 Years (For SterilizedProduct) | Identical aspredicatedevice |
| 9. | SingleUse/Reuse | Single Use | Single Use | Identical aspredicatedevice |
| 10. | OperatingPrinciple | The plate is fixed to thebone by application ofscrews on both sides of thefracture. | The plate is fixed to thebone by application ofscrews on both sides ofthe fracture. | Identical aspredicatedevice |
| 11. | DimensionalVerification | The same dimensions are found in both new Devices aswell as Predicate devices. | Identical aspredicatedevice |
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Image /page/7/Picture/0 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 small "R" in a circle next to it, indicating that the name is a registered trademark.
B.1) Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards:
- Material Standards. O
- Biocompatibility Standards O
- o Performance Standards.
- O Sterilization, shelf-life and packaging for sterile product.
- O 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:
Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.
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Image /page/8/Picture/0 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 registered trademark symbol to the right of the word "Auxein".
We have complied with the following material standards:
- O ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
- O ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments.
- O 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) as per ISO 5832-3/ASTM F138 for Stainless Steel Implants and Titanium Alloy (Ti-6Al-4V) Grade 5 as per ISO 5832-1/ASTM F136 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.
Summary of Biocompatibility
The Raw materials have been evaluated for biocompatibility according to ISO 10993-3.
Mechanical performance
- 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
- 4-Point Static Test: Conforms .
- . 4-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 Varixis Elbow System is equivalent to the 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
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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
- USP <85> Bacterial Endotoxin Test.
- · USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
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 Varixis Elbow System is as safe, and as effective and perform the same indications for use as those of already marketed predicate devices identified in A.3. of 510(k) summary.
§ 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.