(308 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant designed to reattach soft tissue to bone, which falls under the definition of a therapeutic device as it treats an injury or condition.
No
The device is a screw-in suture anchor intended for the reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, threaded, tapered fastener made from Titanium alloy, intended for surgical implantation. It also mentions associated hardware like drill guides and drill bits. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a "Titanium Screw-In Suture Anchor" intended for the "reattachment of soft tissue to bone" in various anatomical locations. This is a surgical implant used within the body (in vivo) to physically repair tissue.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant used for structural repair, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.
Foot and Ankle:
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.
Elbow, Wrist and Hand:
Scapholunate ligament reconstruction, Unar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.
Knee:
Extra-capsular repairs: Medial collateral ligament repair. Lateral ligament repair. Posterior oblique ligament. Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.
Hip:
Capsular repair, Acetabular labral repair.
Product codes
MBI
Device Description
The Titanium Screw-In Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The self-tapping AUXILOCK® Titanium screw-in suture anchor is mostly used as a medial row anchor in rotator cuff repair surgery, Bankart or SLAP surgeries. It is recommended for use in small and large-joint repairs without the need for tapping or drilling. AUXILOCK® Titanium screw-in anchors are available in diameter of 2.8mm, 3.5mm, 5.0mm and 6.5mm. The anchor design incorporates a cancellous thread with a tiny core diameter to maximize pull-out strength in cancellous or osteoporotic bone. The AUXILOCK® Titanium screw-in anchor is designed for ultimate mechanical properties (pull-out strength, tensile strength, etc.) and ease-of-use. The anchor design incorporates a cortical thread with a small core diameter to maximize pull-out strength in a cortical or hard bone. The drill guide and drill bit are provided in the instrument set for the accurate placement of the anchor. It in turn minimizes the anchor slippage or breakage during the surgery.
All of the Auxein's Non-Absorbable Suture Anchors are provided sterile, for single use only. All Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Auxein's Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a guide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.
The device is made from a Titanium alloy, Ti-6Al-4V (ASTM F136) as per grade 5.
Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant.
These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist and Hand, Knee, Hip
Indicated Patient Age Range
Adult patients only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with material standards (ASTM F136/ISO 5832-3, ASTM F2848-17, ASTM F899-20), biocompatibility standards (ISO 10993-3), and mechanical performance standards, specifically Insertion Test and Pull-Out Tensile Static Test and Pull-Out Tensile Fatigue Test comparing the subject device to the predicate device. Additionally, the device met standards for sterilization (Ethylene Oxide sterilization, ISO 11135, ISO 17665-1, ISO/TS 17665-2, ISO/TS 17665-3, ISO 11140-1, ISO 11737-1, ISO 11737-2), packaging (Tyvek packaging, double sterile barrier, ISO 11607-1, ISO 11607-2), and shelf-life (5 years, ASTM F1980, ASTM F88/F88M, ASTM F1929). Bacterial Endotoxin Test was also performed (USP , USP , ANSI/AAMI ST72:2019).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Endotoxin Test (BET): The testing is done by using Limulus amebocyte lysate (LAL) test. The testing procedure is performed as per the standards USP 85 and ANSI/AAMI ST72:2019.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
July 29, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Auxein Medical Private Limited Rahul Luthra Director Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, Haryana 131028 India
Re: K213104
Trade/Device Name: Auxilock Titanium Screw-In Suture 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: June 27, 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
1
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,
For.
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
2
Indications for Use
510(k) Number (if known) K213104
Device Name Auxilock Titanium Screw-In Suture Anchor
Indications for Use (Describe)
Auxilock Titanium Screw-In Suture Anchor:
The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.
Foot and Ankle:
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.
Elbow, Wrist and Hand:
Scapholunate ligament reconstruction, Unar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.
Knee:
Extra-capsular repairs: Medial collateral ligament repair. Lateral ligament repair. Posterior oblique ligament. Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.
Hip:
Capsular repair, Acetabular labral repair.
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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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, followed by the word "Auxein" in blue, sans-serif font. A registered trademark symbol is located to the right of the word.
510(k) Summary
General Company Information as required by 807.92 (a)
| Submitter's Name: | Auxein Medical Private Limited |
|---|---|
| Address: | Auxein Medical Private Limited |
| Plot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDC, | |
| Sector-57, Sonepat-131028, Haryana, India | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91 9560557733 |
| Dated: | 29.07.2022 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar |
|---|---|
| Title: | Sr. Research Engineer |
| Email Id: | m.kumar@auxein.com |
| Dated: | 29.07.2022 |
Proprietary Name:
Auxilock Titanium Screw-In Suture Anchor
Common or Usual Name:
Soft Tissue Fixation Device
Classification Name:
Fastener, fixation, non-degradable, soft tissue
Product Code: MBI
Device Class: II
Review Panel: Orthopedic
Regulation Number:
21 CFR 888.3040
| Primary Product
| Code | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| MBI | Fastener, fixation, non- | ||
| degradable, soft tissue | Soft Tissue Fixation | ||
| Device | 21 CFR 888.3040 |
4
Image /page/4/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. A small "R" in a circle is located to the upper right of the word "Auxein".
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:
| 510(k) Number | K152566 |
|---|---|
| Applicant | Smith & Nephew |
| Common Name | Suture Anchor |
| Device Name | PEBA Anchor/Suture Combination |
Secondary Predicate:
| 510(k) Number | K053344 |
|---|---|
| Applicant | Smith & Nephew |
| Common Name | Suture Anchor |
| Device Name | TwinFix 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors |
Device Description:
The Titanium Screw-In Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The self-tapping AUXILOCK® Titanium screw-in suture anchor is mostly used as a medial row anchor in rotator cuff repair surgery, Bankart or SLAP surgeries. It is recommended for use in small and large-joint repairs without the need for tapping or drilling. AUXILOCK® Titanium screw-in anchors are available in diameter of 2.8mm, 3.5mm, 5.0mm and 6.5mm. The anchor design incorporates a cancellous thread with a tiny core diameter to maximize pull-out strength in cancellous or osteoporotic bone. The AUXILOCK® Titanium screw-in anchor is designed for ultimate mechanical properties (pull-out strength, tensile strength, etc.) and ease-of-use. The anchor design incorporates a cortical thread with a small core diameter to maximize pull-out strength in a cortical or hard bone. The drill guide and drill bit are provided in the instrument set for the accurate placement of the anchor. It in turn minimizes the anchor slippage or breakage during the surgery.
All of the Auxein's Non-Absorbable Suture Anchors are provided sterile, for single use only. All Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Auxein's Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a guide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.
The device is made from a Titanium alloy, Ti-6Al-4V (ASTM F136) as per grade 5.
Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant.
These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
5
Image /page/5/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
Indications for Use:
Auxilock Titanium Screw-In Suture Anchor:
The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.
Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.
Elbow, Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.
Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.
Hip
Capsular repair, Acetabular labral repair.
Summary of Technological Characteristics as compared to the predicate devices
A comparison between the Auxilock Titanium Screw-In Suture Anchor 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.No. | Characterist
ics | Subject Device (Auxein) | Predicate Devices | Remarks |
|-------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 1. | Product Code | MBI | K152566, PEBA
Anchor/Suture Combination,
(Primary Predicate)
K053344, TwinFix 2.8mm,
3.5mm Suture Anchors
(Secondary Predicate) | Identical |
| | | | | as
predicate
device. |
| 2. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Identical
as
predicate
device. |
| 3. | Regulatory
Class | Class II | Class II | Identical
as
predicate
device. |
| 4. | Indications
for use | Auxilock Titanium
Screw-In Suture Anchor
The Auxilock Titanium Screw-In Suture Anchor is
intended to be used with #2 Biobraid suture with white,
blue, black colors for use for the reattachment of soft
tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs,
Acromiolavicular separation repairs, Rotator
cuff tear repairs, Capsular shift or Capsutolabral
reconstructions, Biceps tenodesis, and Deltoid
Repairs, Anterior Shoulder Instability Repair.
Foot and Ankle:
Hallux valgus reconstruction, Medial or
Lateral instability repairs/reconstructions,
Achilles tendon repair/reconstructions,
Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions | The PeBA Series
Anchor/Suture Combination
(Primary Predicate) is intended
for the fixation of surgical
suture material for the
following indications:
Shoulder:
Bankart lesion repairs, SLAP
lesion repairs, Acromio-
clavicular separation repairs,
Rotator cuff tear repairs,
Capsular shift or capsulolabral
reconstructions, Biceps
tenodesis, Deltoid repairs.
Foot and Ankle:
Hallux Valgus repairs, Medial
or lateral instability repairs,
Achilles tendon
repairs/reconstructions, Midfoot
reconstructions, Metatarsal
ligament/tendon
repairs/reconstructions
Elbow, Wrist, and Hand:
Scapholunate ligament
reconstructions, Ulnar or radial
collateral ligament
reconstructions, Tennis elbow
repair, Biceps tendon
reattachment. | Identical
as
predicate
devices. |
6
Image /page/6/Picture/1 description: The image features the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle, followed by the word "Auxein" in a sans-serif font. The logo and text are both in a light blue color.
7
Image /page/7/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. A small "R" in a circle is located to the right of the word "Auxein" indicating that the logo is a registered trademark.
| | Bunionectomy. | Knee:
Extra-capsular repairs, medial
collateral ligament, lateral
collateral ligament, posterior
oblique ligament, Iliotibial band
tenodesis, Patellar realignment
and tendon, repairs, including
vastus medialis, obliquous
advancement. |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Elbow, Wrist and Hand:
Scapholunate ligament
reconstruction, Ulnar or
radial collateral ligament
reconstructions, Lateral
epicondylitis repair, Biceps
tendon reattachment,
Tennis elbow repair. | The K053344, TwinFix 2.8mm,
3.5mm Suture Anchors
(Secondary Predicate) is
intended for use for the
reattachment of soft tissue to
bone for the following
indications: |
| | Knee:
Extra-capsular repairs:
Medial collateral ligament
repair, Lateral collateral
ligament repair, Posterior
oblique ligament, Iliotibial
band tenodesis, Patellar
tendon repair - Vastus
medialis obliquous
advancement. | Shoulder
Bankart lesion repairs, SLAP
lesion repairs,
Acromiolavicular separation
repairs, Rotator cuff tear
repairs, Capsular shift or
Capsutolabral reconstructions,
Biceps tenodesis, and Deltoid
Repairs, Anterior Shoulder
Instability Repair. |
| | Hip:
Capsular repair, Acetabular
labral repair. | Foot and Ankle
Hallux valgus reconstruction,
Medial or Lateral instability
repairs/reconstructions,
Achilles tendon
repair/reconstructions, Mid-foot
reconstruction, Metatarsal
ligament/tendon
repairs/reconstructions,
Bunionectomy. |
| | | Elbow, Wrist and Hand
Scapholunate ligament
reconstruction, Ulnar or radial
collateral ligament |
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Image /page/8/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a blue triangle inside of it, followed by the word "Auxein" in blue font. There is a registered trademark symbol to the right of the word.
| | | | reconstructions, Lateral
epicondylitis repair, Biceps
tendon reattachment, Tennis
elbow repair. | |
|-----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | | | Knee
Extra-capsular repairs: Medial
collateral ligament repair,
Lateral collateral ligament
repair, Posterior oblique
ligament, Iliotibial band
tenodesis, Patellar tendon repair
- Vastus medialis obliquous
advancement. | |
| | | | Hip
Capsular repair, Acetabular
labral repair. | |
| 5. | Material | Titanium Alloy as per
ASTM F136 and
UHMWPE Suture as per
ASTM F2848-17. | Titanium Alloy as per ASTM
F136 and and UHMWPE
Suture as per ASTM F2848-17. | Conforms
to Identical
standard as
predicate
device. |
| 6. | Performance
Standards | Mechanical Testing
Protocol AMPL-MT-PRT-
002, Rev. 01. was used in
the scoped Device. | Mechanical Testing Protocol
AMPL-MT-PRT-002, Rev. 01.
was used in the predicate
Device. | Identical
as
predicate
device. |
| 7. | Sterilization | Ethylene Oxide
Sterilization Method was
used in the subject device. | Ethylene Oxide Sterilization
Method was used in the
predicate devices. | Identical in
predicate
device. |
| 8. | Dimensional
Verification | Same dimension as of Predicate device. | | Identical
as
predicate
device. |
| 9. | Shelf-life | 5 Years | 5 Years | Identical
as
predicate
device. |
| 10. | Single
Use/Reuse | Single Use | Single Use | Identical
as
predicate
device. |
| 11. | Operating Principle | Secure tendon and ligament reconstructions with increased boney ingrowth at the anchor site with minimal invasive technique. | Secure tendon and ligament reconstructions with increased boney ingrowth at the anchor site with minimal invasive technique. | Identical as predicate device. |
9
Image /page/9/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards:
- Material Standards. ●
- . Biocompatibility Standards
- Performance Standards.
- Sterilization, shelf-life and packaging for sterile product.
- . Bacterial Endotoxin
Non-Clinical Test Summary:
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:
Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.
We have complied with the following material standards:
- ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium . ELI (Extra low interstitial) Alloy for surgical implant applications.
- · ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.
- ASTM F899-20: 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 F899-20, UHMWPE for Suture as per ASTM F2848-17 and Titanium Alloy (Ti- 6Al-4V) Grade 5 for Titanium Implants.
Summary of Biocompatibility
The device in its final finished form has been evaluated for biocompatibility according to ISO 10993-3.
Conclusion of Mechanical performance
The following are the mechanical tests that have been performed on the Subject device (i.e. Auxilock Titanium Screw-In Suture Anchor) and Predicate device (i.e. Smith & Nephew's Twinfix Suture Anchor):
-
- Insertion Test
-
- Pull-Out Tensile Static Test and Pull-Out Tensile Fatigue Test.
10
Image /page/10/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it, followed by the word "Auxein" in blue. There is a registered trademark symbol next to the "n" in "Auxein".
Sterilization, shelf-life and packaging for sterile product
Sterilization: ETO Sterilization
The ETO sterilization has been performed to sterilize this medical device. EO penetrates the packaging, making contact with all accessible surfaces of the product to deliver the required sterility assurance level (SAL).
Trace levels of EO and ethylene chlorohydrin (ECH) may remain on products after an EO sterilization process. To detect these traces, EO residual test was done. ISO 10993-7 outlines the specific limits of EO and ECH that must not be exceeded in order to ensure product and patient safety.
- 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 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements for ● the development, validation and routine control of a sterilization process for medical devices.
- ISO/TS 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
- . ISO/TS 17665-3:2013 (en), Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.
- . ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
- . ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
- ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
Packaging of the Product: Tyvek Packaging
The integrity of the final package is maintained at least for the claimed shelf-life of the medical device.
The tyvek pouch is used for the packaging of Auxilock Titanium Screw-In Suture Anchor. The double sterile barrier is used for the packaging.
We have followed the below standards for packaging of the device:
- · 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.
Shelf-life: 5 years
The stability study has been done to determine the shelf life.
We have followed the below standards for performing shelf-life of the device:
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging ●
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Image /page/11/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white triangle inside, followed by the word "Auxein" in blue, stylized font. There is a small "R" in a circle to the right of the word "Auxein".
by Dye Penetration.
Safety in MRI Not Evaluated
The Auxilock Titanium Screw-In Suture Anchor has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of Auxilock Titanium Screw-In Suture Anchor in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.
Bacterial Endotoxin
- USP Bacterial Endotoxin Test. .
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
Bacterial Endotoxin Test (BET): We perform Bacterial Endotoxin Test of every sterile batch products by using acceptance criteria as endotoxin testing limit must be