Who is the manufacturer of Varixis Elbow System?

Auxein Medical Private Limited filed the 510(k) submission for Varixis Elbow System (K213014).

What is the FDA product code for Varixis Elbow System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Varixis Elbow System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Varixis Elbow System?

Synthes Variable Angle LCP Elbow System (K120070).

Who can help prepare an FDA 510(k) submission like Varixis Elbow System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Varixis Elbow System

K213014 · Auxein Medical Private Limited · HRS · Oct 3, 2022 · Orthopedic

Device Facts

Record ID	K213014
Device Name	Varixis Elbow System
Applicant	Auxein Medical Private Limited
Product Code	HRS · Orthopedic
Decision Date	Oct 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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, 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.

Device Story

Varixis Elbow System comprises metallic bone plates and screws for internal fixation of distal humerus, olecranon, and proximal ulna fractures. Device functions via mechanical stabilization; plates are positioned on bone and secured with screws to provide rigid fixation across fracture sites. Used in clinical/surgical settings by orthopedic surgeons. System includes various plate configurations (medial, lateral, dorsolateral, olecranon, proximal ulna) and self-tapping screws. Implants are provided sterile or non-sterile (requiring sterilization). Output is physical stabilization of bone segments, facilitating healing and restoring structural integrity. Benefits include anatomical alignment and biomechanical support for complex elbow fractures.

Clinical Evidence

Bench testing only. No clinical data presented. Mechanical performance verified via ASTM F382 (bone plates) and ASTM F543 (bone screws) including 4-point static/fatigue testing, driving torque, torsion, and axial pull-out tests. Biocompatibility evaluated per ISO 10993-3. Sterilization and shelf-life validated per ISO 11137 and ASTM F1980.

Technological Characteristics

Materials: Titanium Alloy (Ti-6Al-4V, ASTM F136/ISO 5832-3) and Stainless Steel (316L, ASTM F138/ISO 5832-1; 304, ASTM F899-20). Mechanical fixation via bone plates and screws. Sterilization: Gamma radiation or moist heat. Single-use. No software or electronic components.

Indications for Use

Indicated for fixation of fractures, malunions, and non-unions of the distal humerus, olecranon, and proximal ulna in adults and adolescents (ages 12-21) with fused growth plates.

Regulatory Classification

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.

Predicate Devices

Synthes Variable Angle LCP Elbow System (K120070)

Related Devices

K093433 — VARIAX ELBOW SYSTEM PLATE LINE EXTENSION · Howmedica Osteonics Corp. · Jan 28, 2010
K140892 — DISTAL ELBOW PLATING SYSTEM · Skeletal Dynamics, LLC · Aug 28, 2014
K201656 — ARIX Elbow System · Jeil Medical Corporation · Sep 15, 2020
K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM · Synthes USA · Mar 21, 2012
K101056 — VARIAX ELBOW SYSTEM · Howmedica Osteonics Corp. · May 13, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 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: 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 | {5}------------------------------------------------ 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- {6}------------------------------------------------ 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. | 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 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- | The Synthes VA LCP 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- | Identical as predicate device | | | | unions of the olecranon and proximal ulna. | unions of the olecranon and proximal ulna. | | | 5. | Material | Titanium Alloy and Stainless Steel. | Titanium Alloy and Stainless Steel. | Identical 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 | {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ Image /page/9/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 professional look. 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.