(448 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor made of PEEK material. There is no mention of software, algorithms, data processing, or any other components that would suggest the use of AI or ML. The performance studies are bench tests evaluating mechanical properties.
Yes.
The device is clearly indicated for therapeutic purposes, as it is used to attach soft tissue to bone for various repairs and reconstructions (e.g., rotator cuff repair, ligament repair), which are interventions aimed at treating medical conditions or injuries.
No
Explanation: This device is a surgical anchor used for attaching soft tissue to bone, specifically for repair procedures. It is an implantable device used in treatment, not for diagnosing conditions.
No
The device description clearly states that the device is a physical, non-absorbable threaded suture anchor manufactured in PEEK material, intended for surgical implantation. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "attachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (suture anchor) made of PEEK material, designed to be screwed into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
- AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.
- AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP 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, TFCC.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone.
The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue.
AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures.
AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet.
These implants are sold in sterile conditions (Ethylene Oxide Sterilization).
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow, Hip, Hand/Wrist
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 the following standards:
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.
Biocompatibility:
Evaluated for biocompatibility according to ISO 10993-3.
Mechanical performance bench test:
-
- Insertion Test
-
- Pull-Out Tensile Static.
-
- Pull-out following Cyclic Loading Test.
Sterilization, shelf-life and packaging for sterile product:
- ETO Sterilization following ISO 11135: 2014, ISO 17665-1:2006, ISO/TS 17665-2:2009, ISO/TS 17665-3:2013, ISO 11140-1:2014, ISO 11737-1:2018, ISO 11737-2:2009. EO residual test to ISO 10993-7.
- Tyvek Packaging following ISO 11607-1:2006/AMD 1:2014, ISO 11607-2:2006/AMD 1:2014.
- Shelf-life (5 years) following ASTM F1980:2016, ASTM F88/F88M:2015, ASTM F1929:2015.
Bacterial Endotoxin:
- USP Bacterial Endotoxin Test.
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
- Testing limit
§ 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
December 16, 2022
Image /page/0/Picture/1 description: The image shows the logo of 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: K213110
Trade/Device Name: AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 30, 2022 Received: October 3, 2022
Dear Rahul Luthra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose -S
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) K213110
Device Name AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
Indications for Use (Describe)
- AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.
- AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP 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, TFCC.
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.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized 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.
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 |
| Email Id: | info@auxein.com |
| Phone Number: | +91 9560557733 |
| Dated: | 16.12.2022 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar | |
|---|---|---|
| Title: | Management Representative | |
| Mail Id: | m.kumar@auxein.com | |
| Dated: | 16.12.2022 |
Throughout the submission of AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In 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® PEEK OPTIMA Screw-In Suture Anchor
- AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor ●
Common or Usual Name:
Suture Anchor
Classification Name:
Fastener, fixation, Nondegradable, soft tissue
Product Code:
MBI
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Image /page/5/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a small "R" in a circle next to it, indicating that the name is a registered trademark.
Device Class: II
Review Panel: Orthopedic
Regulation Number:
21 CFR 888.3040
| Primary Product
| Code | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| MBI | Fastener, fixation, | ||
| Nondegradable, soft | |||
| tissue | Bone Anchor, Soft | ||
| Tissue Fixation | |||
| Device | 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.
Primary Predicate:
| 510k Number | K170327 |
|---|---|
| Applicant | Parcus Medical LLC. |
| Common Name | Suture Anchor |
| Device Name | Parcus SLIK Anchor |
Secondary Predicate:
| 510k Number | K120449 |
|---|---|
| Applicant | Depuy Mitek |
| Common Name | Bone Anchor |
| Device Name | HEALIX ADVANCE™ PEEK 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:
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone.
The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue. The detailed description for both of the devices (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor) are as follows:
AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor
AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring
6
Image /page/6/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.
dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures. The following categories of products are included in AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor:
- AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & . White/Blue, with Needles: MO-6
- AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White/Blue & White/Black
- AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Three #2 BioBraid: White/Blue, White/Black & White
- AUXILOCK® 5.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6
- AUXILOCK® 5.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: ● White/Blue & White/Black
- AUXILOCK® 5.5mm PEEK OPTIMA Screw-In Suture Anchor with Three #2 BioBraid: White/Blue, White/Black & White
- . AUXILOCK® 6.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6
- AUXILOCK® 6.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White/Blue & White/Black
AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet. The following categories of products are included in AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor:
- AUXILOCK® Rotador 4.75mm x 15mm PEEK OPTIMA Screw-In Anchor ●
- AUXILOCK® Rotador 5.5mm x 15mm PEEK OPTIMA Screw-In Anchor
- AUXILOCK® Rotador 6.25mm x 15mm PEEK OPTIMA Screw-In Anchor ●
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.
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.
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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 white triangle inside, followed by the word "Auxein" in blue, sans-serif font. The "®" symbol is located to the upper right of the word "Auxein".
Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant.
A.5) Indications for Use:
AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulders: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair.
AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are 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, SLAP 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, 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, TFFCC.
A.6) Summary of Technological Characteristics as compared to the predicate devices:
A comparison between the Auxein's devices (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor & AUXILOCK® ROTADOR PEEK OPTIMA Screw-In 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. | Characteristics | Subject Device | Predicate Device |
|---|---|---|---|
| K120449 (HEALIX | |||
| ADVANCE™ PEEK Anchor) | |||
| K170327 (Parcus SLiK Anchor) |
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Image /page/8/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside a circle, followed by the word "Auxein" in a stylized font. The logo is blue in color and has a registered trademark symbol next to the word Auxein.
| 1. | Product Code | MBI | MBI |
|---|---|---|---|
| 2. | Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 |
| 3. | Regulatory Class | II | II |
| 4. | Indications for Use | AUXILOCK® OPTIMA Screw-In Anchor | |
| The AUXILOCK® OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications: |
Shoulders: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair. | K120449 (HEALIX ADVANCE™ PEEK Anchor )
Shoulders: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.
K170327 (Parcus SLiK Anchor)
The Parcus SLiK Anchor are indicated for attachment of soft tissue to bone. This product is |
| 5. | Sterilization | AUXILOCK® ROTADOR intended for the following
PEEK OPTIMA Screw-In indications:
Anchor
The AUXILOCK® ROTADOR
PEEK OPTIMA Screw-In
Anchor are 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, SLAP 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 (TFCC). | Shoulder: Rotator Cuff Repair,
Acromioclavicular Separation
Repair, Bankart Lesion Repair,
Biceps Tenodesis, Capsular Shift
or Capsulolabral Reconstruction,
Deltoid Repair, SLAP 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, TFCC. |
| | | Provided in Sterile conditions
(EO Sterilization) | Provided in Sterile conditions
(EO Sterilization) |
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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 next to the word "Auxein".
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Image /page/10/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 sans-serif font. The logo is blue in color and the "R" symbol is present to indicate that it is a registered trademark.
| 6. | Dimensional
Verification | The same dimensions are found in both new devices as well as
Predicate devices. | |
|----|-----------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 7. | Shelf-life | 5 Years | 5 Years |
| 8. | Single
Use/Reuse | Single Use | Single Use |
| 9. | Operating
Principle | It can be used for single incision, soft tissue, or bone-tendon-bone fixation. | It can be used for single incision, soft tissue, or bone-tendon-bone fixation. |
| Technological Comparison (between AUXILOCK® ROTADOR PEEK OPTIMA Screw-In | |||||||
|---|---|---|---|---|---|---|---|
| Anchor and Parcus SLiK Anchor): |
| S.No. | Characteristics | Subject Device (AUXILOCK®
ROTADOR PEEK OPTIMA
Screw-In Anchor) | Predicate device, K170327
(Parcus SLiK Anchor) |
|-------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Product Code | MBI | MBI |
| 2. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 |
| 3. | Common Name | Suture Anchor | Suture Anchor |
| 4. | Classification
Name | Fastener, fixation,
Nondegradable, soft tissue | Fastener, fixation, Non
degradable, soft tissue |
| 5. | Regulatory
Class | II | II |
| 6. | Indications for Use | The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In
Anchor are indicated for
attachment of soft tissue to bone.
This product is intended for the
following indications: | The Parcus SLiK Anchor are
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, SLAP Lesion
Repair. | Shoulder: Rotator Cuff Repair,
Acromioclavicular Separation
Repair, Bankart Lesion Repair,
Biceps Tenodesis, Capsular Shift
or Capsulolabral Reconstruction,
Deltoid Repair, SLAP Lesion
Repair. |
| | | Knee: Medial Collateral
Ligament Repair, Lateral
Collateral Ligament Repair,
Posterior Oblique Ligament
Repair, Extra Capsular
Reconstruction, Iliotibial Band | Knee: Medial Collateral
Ligament Repair, Lateral
Collateral Ligament Repair,
Posterior Oblique Ligament
Repair, Extra Capsular
Reconstruction, Iliotibial Band |
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Image /page/11/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 small "R" in a circle to the right of the word "Auxein".
| | | Tenodesis, Patellar Ligament and
Tendon Avulsion Repair. | Tenodesis, Patellar Ligament and
Tendon Avulsion Repair. |
|-----|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Foot/Ankle : Lateral
Stabilization, Medial
Stabilization, Midfoot
Reconstruction, Achilles Tendon
Repair, Hallux Valgus
Reconstruction, Metatarsal
Ligament 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. | Elbow : Tennis Elbow Repair,
Biceps Tendon Reattachment. |
| | | Hand/Wrist : Scapholunate
Ligament Reconstruction, Ulnar
or Radial Collateral Ligament
Reconstruction, Triangular
fibrocartilage complex (TFCC). | Hand/Wrist : Scapholunate
Ligament Reconstruction, Ulnar
or Radial Collateral Ligament
Reconstruction, TFCC. |
| 7. | Sterilization | Provided in Sterile conditions
(EO Sterilization). | Provided in Sterile conditions
(EO Sterilization). |
| 8. | Dimensional
Verification | The same dimensions are found
Predicate devices. | The same dimensions are found in both new devices as well as
Predicate devices. |
| 9. | Shelf-life | 5 Years | 5 Years |
| 10. | Single
Use/Reuse | Single Use | Single Use |
| 11. | Operating
Principle | It can be used for single incision,
soft tissue, or bone-tendon-bone
fixation. | It can be used for single incision,
soft tissue, or bone-tendon-bone
fixation. |
Technological Comparison (between HEALIX ADVANCE™ PEEK Anchor and AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor):
| S.No. | Characteristics | Subject Device (AUXILOCK®
PEEK OPTIMA Screw-In
Suture Anchor) | Predicate Device, K120449
(HEALIX ADVANCE™ PEEK
Anchor ) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Product Code | MBI | HWC |
| 2. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 |
| 3. | Common Name | Suture Anchor | Bone Anchor |
| 4. | Classification
Name | Fastener, fixation,
Nondegradable, soft tissue | Smooth or threaded metallic bone
fixation fasteners |
| 5. | Regulatory
Class | II | II |
| 6. | Indications for Use | The AUXILOCK® PEEK | |
| | | | Shoulder: Rotator Cuff Repair,
Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis,
Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular
Shift or Capsulolabral
Reconstruction. |
| | | | Foot/Ankle: Lateral Stabilization,
Medial Stabilization, Achilles
Tendon Repair. |
| | | | Knee: Medial Collateral
Ligament Repair, Lateral
Collateral Ligament Repair,
Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis. |
| | | | Elbow: Biceps Tendon
Reattachment, Ulnar or Radial
Collateral Ligament
Reconstruction; |
| | | | Hip: Capsular Repair, Acetabular
Labral Repair. |
| 7. | Sterilization | Provided in Sterile conditions
(EO Sterilization). | Provided in Sterile conditions
(EO Sterilization). |
| 8. | Dimensional
Verification | The same dimensions are found in
Predicate devices. | The same dimensions are found in both new devices as well as
Predicate devices. |
| 9. | Shelf-life | 5 Years | 5 Years |
| 10. | Single
Use/Reuse | Single Use | Single Use |
| 11. | Operating
Principle | It can be used for single incision,
soft tissue, or bone-tendon-bone
fixation | It can be used for single incision,
soft tissue, or bone-tendon-bone
fixation. |
| OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone.
This product is intended for the following indications: | | | |
| Shoulder: Rotator Cuff Repair,
Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis,
Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular
Shift or Capsulolabral
Reconstruction. | | | |
| Foot/Ankle: Lateral Stabilization,
Medial Stabilization, Achilles
Tendon Repair. | | | |
| Knee: Medial Collateral
Ligament Repair, Lateral
Collateral Ligament Repair,
Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis. | | | |
| Elbow: Biceps Tendon
Reattachment, Ulnar or Radial
Collateral Ligament
Reconstruction; | | | |
| Hip: Capsular Repair, Acetabular
Labral Repair. | | | |
| 12. | Suture Size | #2 | #2 |
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Image /page/12/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol in the upper right corner.
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Image /page/13/Picture/0 description: The image shows the word "Auxein" in blue font. To the left of the word is a blue circle with a large letter "A" inside. To the right of the word is a small circle with an "R" inside, indicating that the word is a registered trademark.
Justification for difference in Product Code:
The Secondary Predicate, K120449 (HEALIX ADVANCE™ PEEK Anchor) have Product Code HWC (screw, fixation, bone) which falls under regulation 21 CFR 888.3040.
Our Subject device (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor) have Product Code MBI (fastener, fixation, non degradable, soft tissue) which falls under regulation 21 CFR 888.3040.
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor is intended to be used for soft tissue fixation. So, we have included MBI as product Code.
Although there is a difference in product codes of our device and secondary predicate device but design, material, indications are identical between of our device and secondary predicate device.
So, Considering all these points we can conclude that the product code difference is not a significant difference which can affect safety and performance of the subject device.
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 Bench 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 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 Material for instruments as per ASTM F899-20, UHMWPE for Suture as per ASTM F2848-17 and PEEK OPTIMA (Grade LT 1, from Invibio) as per ASTM F2026-17 for Implants.
Summary of Biocompatibility
The device in its final finished form has been evaluated for biocompatibility according to ISO 10993-3.
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Image /page/14/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 small registered trademark symbol is located to the right of the word.
Conclusion of Mechanical performance bench test:
The following are the mechanical tests that have been performed on the Subject device (i.e. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor) and Predicate device (i.e. Depuy Mitek, HEALIX ADVANCE™ PEEK Anchor and K170327, Parcus SLiK Anchor respectively):
-
- Insertion Test
-
- Pull-Out Tensile Static.
-
- Pull-out following Cyclic Loading Test.
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® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In 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/AMD 1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system.
- . ISO 11607-2:2006/AMD 1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
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Image /page/15/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.
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 ● by Dye Penetration.
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