(332 days)
The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.
AUXILOCK® Draw tight anchor is made with UHMWPE suture anchor body and PEEK OPTIMA eyelet tip. The Auxilock Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The construct of the Draw Tight Anchors is such that when inserted into the bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation. The anchor is designed to deliver efficiency and promote ease of use. The anchor can be used for rotator cuff repair surgeries. The AUXILOCK® Draw tight suture based anchor provides a small footprint and also asserts subcortical fixation for anchor insertion. The Draw tight anchor is available in 1.8mm and 3.2mm diameter with various combination of BioBraid and suture tapes. The drill guide and anchor driver combination is well-designed to improve the performance and reliability. The Auxilock Draw Tight Suture-Based Anchor consists of the following types of implants:
- AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue .
- AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: ● White/Blue
- AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with Two #2 BioBraid: White/Blue & ● White/Black
- AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with One #2 BioBraid And One 1.6mm Suture tape: White/Black & White/Blue
The Auxilock Suture is a dyed or non-dyed braided suture construct made of UHMWPE. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Suture ends are stiffened with cyanoacrylate. The Suture constructs meet USP standards for suture. The Suture is available in straight and loop configurations; and sizes #2 for suture, and 1.6mm (width) for tape.
AUXILOCK® BioBraid Suture
AUXILOCK® BioBraid Sutures are braided sterile sutures prepared from Ultra High Molecular Weight Polyethylene (UHMWPE). Sutures are non-absorbable and do not impose any significant changes in tensile strength retention known to occur in vivo. BioBraid sutures are available in a variety of colour combinations for easy suture management in complicated repairs.
Suture color additives
The UHMWPE sutures when made up of tracers can be with blue polypropylene (pigment ß-Cuphthalocyanine blue) or polyamide black (pigment hematein).
The color additive FD&C Blue 2, color additive Black logwood and color additive phtalocyanine are according to FDA and it is approved for use in medical applications (§74.3102 - FDA), (§73.1410 –FDA) and (§74.3045 – FDA) respectively.
AUXILOCK® BioBraid Suture Tape
AUXILOCK® BioBraid Suture Tape made from UHMPWE has a width of 1.6mm. The suture tape design accommodates the tape in the centre with a suture on the either sides of the tape.
These implants are sold in sterile conditions (EO Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
Surgical instrumentation is included in Auxilock Draw Tight Suture-Based Anchor to allow the placement and attachment of the Anchors with bone. Various drill, anchor driver, Awl, Threading device, Tray, Containers and other components are included with the Auxilock Draw Tight Suture-Based Anchor. These Instruments are made from Stainless steel (SS 304) Material.
The provided text is a 510(k) summary for a medical device (Auxilock Draw Tight Suture-Based Anchor), which is a premarket notification to the FDA for a device that is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices and does not involve an AI/ML component or clinical studies meeting the criteria outlined in your request (e.g., multi-reader multi-case studies, expert consensus ground truth for image data, training/test sets for an algorithm).
Therefore, I cannot provide the specific information requested about acceptance criteria and study proving a device meets them, especially pertaining to AI/ML performance. The document focuses on demonstrating substantial equivalence through:
- Material Standards: Conformance to ASTM F2026-17 (PEEK) and ASTM F2848-17 (UHMWPE) for the anchor and suture, respectively, and ASTM F899-12 (Stainless Steel) for instruments.
- Biocompatibility: Evaluation according to ISO 10993.
- Performance Standards: Bench testing (static and fatigue loading) of pull-out strength, with results compared side-by-side to the predicate device. The document explicitly states "no significant differences."
- Sterilization, Shelf-life, and Packaging: Conformance to various ISO and ASTM standards related to EO sterilization, microbial methods, packaging integrity, and accelerated aging for a 5-year shelf life.
- Bacterial Endotoxin: Testing performed according to USP <85> and <161>.
In summary, the provided text describes a submission for a physical medical device (suture-based anchor) that is not an AI/ML-driven diagnostic or assistive technology. Consequently, there are no details about AI/ML acceptance criteria, test set characteristics (sample size, provenance), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as you've requested.
The "performance standards" mentioned relate to the physical and mechanical properties of the anchor itself, not the diagnostic performance of an AI algorithm.
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August 22, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K213109
Trade/Device Name: Auxilock Draw Tight Suture-Based Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 22, 2022 Received: July 1, 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 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
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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,
Laura C. Rose, Ph.D. 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) K213109
Device Name
Auxilock Draw Tight Suture-Based Anchor
Indications for Use (Describe)
The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder
Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair.
Knee
Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle
Lateral Stabilization, Medial Stabilization, Mid foot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow
Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.
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/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, with a small circle containing the letter "R" in the upper right corner of the word. The logo is simple and clean, and the blue color gives it a professional look.
510k 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 LimitedPlot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDCSector-57, Sonepat-131028, Haryana, India |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9560557733 |
| Dated: | 22.08.2022 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar |
|---|---|
| Title: | Management Representative |
| Mail Id: | m.kumar@auxein.com |
| Dated: | 22.08.2022 |
Throughout the submission of Auxilock Draw Tight Suture-Based Anchor 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: Auxilock Draw Tight Suture-Based Anchor
Common or Usual Name: Soft Tissue Fixation Device
Classification Name: Fastener, Fixation, Non-Degradable, Soft Tissue
Product Code: MBI
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Image /page/4/Picture/0 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 bold, sans-serif font. The color of the logo is a bright blue.
Device Class: II
Review Panel: Orthopedic
Regulation Number:
21 CFR 888.3040
| Primary ProductCode | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| MBI | Fastener, Fixation,Non-Degradable, SoftTissue | Soft Tissue FixationDevice | 21 CFR 888.3040 |
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.
| 510(k) Number | K122805 |
|---|---|
| Applicant | Parcus Medical LLC. |
| Common Name | Suture Anchor |
| Device Name | Parcus Draw Tight Anchor |
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:
AUXILOCK® Draw tight anchor is made with UHMWPE suture anchor body and PEEK OPTIMA eyelet tip. The Auxilock Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The construct of the Draw Tight Anchors is such that when inserted into the bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation. The anchor is designed to deliver efficiency and promote ease of use. The anchor can be used for rotator cuff repair surgeries. The AUXILOCK® Draw tight suture based anchor provides a small footprint and also asserts subcortical fixation for anchor insertion. The Draw tight anchor is available in 1.8mm and 3.2mm diameter with various combination of BioBraid and suture tapes. The drill guide and anchor driver combination is well-designed to improve the performance and reliability. The Auxilock Draw Tight Suture-Based Anchor consists of the following types of implants:
- AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue .
- AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: ● White/Blue
- AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with Two #2 BioBraid: White/Blue & ●
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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 "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. There is a small circle above the "i" in "Auxein", and a registered trademark symbol to the right of the word.
White/Black
- AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with One #2 BioBraid And One 1.6mm Suture tape: White/Black & White/Blue
The Auxilock Suture is a dyed or non-dyed braided suture construct made of UHMWPE. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Suture ends are stiffened with cyanoacrylate. The Suture constructs meet USP standards for suture. The Suture is available in straight and loop configurations; and sizes #2 for suture, and 1.6mm (width) for tape.
AUXILOCK® BioBraid Suture
AUXILOCK® BioBraid Sutures are braided sterile sutures prepared from Ultra High Molecular Weight Polyethylene (UHMWPE). Sutures are non-absorbable and do not impose any significant changes in tensile strength retention known to occur in vivo. BioBraid sutures are available in a variety of colour combinations for easy suture management in complicated repairs.
Suture color additives
The UHMWPE sutures when made up of tracers can be with blue polypropylene (pigment ß-Cuphthalocyanine blue) or polyamide black (pigment hematein).
The color additive FD&C Blue 2, color additive Black logwood and color additive phtalocyanine are according to FDA and it is approved for use in medical applications (§74.3102 - FDA), (§73.1410 –FDA) and (§74.3045 – FDA) respectively.
AUXILOCK® BioBraid Suture Tape
AUXILOCK® BioBraid Suture Tape made from UHMPWE has a width of 1.6mm. The suture tape design accommodates the tape in the centre with a suture on the either sides of the tape.
These implants are sold in sterile conditions (EO Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
Surgical instrumentation is included in Auxilock Draw Tight Suture-Based Anchor to allow the placement and attachment of the Anchors with bone. Various drill, anchor driver, Awl, Threading device, Tray, Containers and other components are included with the Auxilock Draw Tight Suture-Based Anchor. These Instruments are made from Stainless steel (SS 304) Material.
A.5) Indications for Use:
Auxilock Draw Tight Suture-Based Anchor:
The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair.
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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 "A" inside of it, 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.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.
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 Draw Tight Suture-Based Anchor and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
| S.No. | Characteristics | Auxein's Draw Tight Suture-Based Anchor | Predicate device | Remarks |
|---|---|---|---|---|
| 1. | Product Code | MBI | MBI | IdenticalasPredicatedevice |
| 2. | RegulationNumber | 21 CFR 888.3040 | 21 CFR 888.3040 | IdenticalasPredicatedevice |
| 3. | RegulatoryClass | II | II | IdenticalasPredicatedevice |
| 4. | Indications foruse | The Auxilock Draw TightSuture-Based Anchor isindicated for attachment of softtissue to bone. This product isintended for the followingindications:Shoulder: Rotator Cuff Repair,Acromioclavicular Separation | The Parcus Draw Tight Anchoris indicated for attachment ofsoft tissue to bone. This productis intended for the followingindications:Shoulder: Rotator Cuff Repair,Acromioclavicular SeparationRepair, Bankart Lesion Repair, | IdenticalasPredicatedevice |
| K213109 | ||||
| Repair, Bankart Lesion Repair,Biceps Tenodesis, Capsular | ||||
| Biceps Tenodesis, CapsularShift or Capsulolabral | ||||
| Shift or CapsulolabralReconstruction, Deltoid Repair, | ||||
| Reconstruction, Deltoid Repair,SLAP Lesion Repair. | ||||
| Superior Labrum, Anterior toPosterior Lesion Repair.. | ||||
| Knee: Medial Collateral | ||||
| Ligament Repair, Lateral | ||||
| Knee: Medial Collateral | ||||
| Ligament Repair, Lateral | ||||
| Collateral Ligament Repair, | ||||
| Posterior Oblique Ligament | ||||
| Repair, Extra Capsular | ||||
| Collateral Ligament Repair, | ||||
| Posterior Oblique Ligament | ||||
| Reconstruction, Iliotibial Band | ||||
| Repair, Extra Capsular | ||||
| Tenodesis, Patellar Ligament | ||||
| Reconstruction, Iliotibial Band | ||||
| and Tendon Avulsion Repair. | ||||
| Tenodesis, Patellar Ligament | ||||
| and Tendon Avulsion Repair. | ||||
| Foot/Ankle: Lateral | ||||
| Stabilization, Medial | ||||
| Lateral | ||||
| Foot/Ankle: | ||||
| Stabilization, Mid foot | ||||
| Stabilization, Medial | ||||
| Reconstruction, Achilles Tendon | ||||
| Stabilization, Mid foot | ||||
| Repair, Hallux Valgus | ||||
| Reconstruction, Achilles | ||||
| Reconstruction, Metatarsal | ||||
| Tendon Repair, Hallux Valgus | ||||
| Ligament Repair. | ||||
| Reconstruction, Metatarsal | ||||
| Ligament Repair. | ||||
| Elbow: Tennis Elbow Repair, | ||||
| Biceps Tendon Reattachment. | ||||
| Elbow: Tennis Elbow Repair, | ||||
| Biceps Tendon Reattachment. | ||||
| Hand/Wrist: Scapholunate | ||||
| Ligament Reconstruction, Ulnar | ||||
| Hand/Wrist: Scapholunate | ||||
| or Radial Collateral Ligament | ||||
| Ligament Reconstruction, Ulnar | ||||
| Reconstruction, TFCC. | ||||
| or Radial Collateral Ligament | ||||
| Reconstruction, Triangular | ||||
| Fibrocartilage Complex Tear. | ||||
| 5. | Material | Peek OPTIMA as per ASTMF2026-17 and UHMWPE as perASTM F2848-17 used in NewDevice. | Peek OPTIMA as per ASTMF2026-17 and UHMWPE as perASTM F2848-17 used inPredicate Device. | Conformto theIdenticalmaterialstandard |
| 6. | PerformanceStandards | Bench testing of proposeddevice. | Bench testing for predicatedevice. | IdenticalasPredicatedevice |
| 7. | Sterilization | Provided in Sterile conditions(EO Sterilization). | Provided in Sterile conditions(EO Sterilization). | IdenticalasPredicatedevice |
| Predicatedevice | ||||
| 8. | SingleUse/Reuse | Single Use | Single Use | IdenticalasPredicatedevice |
| 9. | OperatingPrinciple | It can be used for singleincision, soft tissue, or bone-tendon-bone fixation. | It can be used for singleincision, soft tissue, or bone-tendon-bone fixation. | IdenticalasPredicatedevice |
| 10. | Shelf-Life | 5 Years | 5 Years | Same asPredicatedevice |
| 11. | DimensionalVerification | The same dimensions are found in both new Devices as well asPredicate devices. | Same asPredicatedevice |
Following is the summary of parameters in which the comparison has been verified:
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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 "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 "Auxein".
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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. The "®" symbol is located to the right of the word "Auxein".
B.1) 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
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 F2026-17: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical . Implant Applications.
- · ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.
- ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments. ●
Note: We have used Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-12 and PEEK OPTIMA as per ASTM F2026-17 for 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.
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Image /page/9/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 upper right of the word "Auxein".
Summary of Biocompatibility
The device in its final finished form has been evaluated for biocompatibility according to ISO 10993.
Summary Performance Data:
The pull out strength (Static & Fatigue Loading) was measured for the Auxilock Draw Tight Suture-Based Anchors and Predicate device. The results were reviewed and side by side comparisons were done with the Parcus predicate device and it demonstrated that there were no significant differences between the Auxilock Draw Tight Suture-Based Anchors and the predicate devices.
Sterilization, shelf-life and packaging for sterile product
- ISO 11138-8:2021, Sterilization of health care products Biological indicators Part 8: . Method for validation of a reduced incubation time for a biological indicator.
- . ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- . ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO/TS 11135-2:2008, Sterilization of health care products Ethylene oxide Part 2: Guidance . on the application of ISO 11135-1.
- 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.
Summary of Bacterial Endotoxin Test:
Bacterial Endotoxin test was performed on Auxilock Draw Tight Suture-Based Anchor 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 USP32 chapter 85.
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Summary of Shelf-Life Study:
The shelf life study (accelerated Stability Study) was conducted on an Auxilock Draw Tight Suture-Based Anchor. As per the expiry assumption of 5 years, we have performed this study at 60°C and calculated that the accelerated stability study will be continued for 8 months. The bioburden test, sterilization, sterility test, visual inspection, dimensional check, Material integrity and package integrity test were performed on the subject device before starting the study and after the completion of the study. After completion of the study, the accelerated stability study was found to be satisfactory. Hence, we have concluded that the expiry of 5 years, which we have assumed complies. ASTM F1980:2016 was used as reference standard for performing this test.
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 Auxilock Draw Tight Suture-Based Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate devices identified in A.3. of 510(k) summary.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.