(134 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a surgical implant (suture anchor) used for fixation of soft tissue to bone, not a therapeutic device that delivers treatment or therapy.
No
This device is a surgical implant (suture anchor) used for fixation of soft tissue to bone, not for diagnosing medical conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly describes a physical bone anchor with sutures and an inserter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the physical fixation of suture to bone during surgical procedures. This is an in-vivo application (within the living body).
- Device Description: The description details a physical implantable device (bone anchor) with sutures and an inserter. This is consistent with a surgical tool/implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in-vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AlphaVent Suture Anchors do not fit this description.
N/A
Intended Use / Indications for Use
The AlphaVent Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot and Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Cigament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL/PCL Reconstruction or Repair
Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair
Product codes
MAI, MBI
Device Description
The AlphaVent Suture Anchors are bone anchors with a screw-in design. Each anchor is vented and cannulated and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
Indicated Patient Age Range
skeletally mature pediatric and adult patients
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
Non-clinical benchtop testing was conducted to evaluate the performance characteristics of the modified AlphaVent Suture Anchors, including ultimate tensile strength ("UTS") and insertion testing. For the Alpha Vent Biocomposite Suture Anchors, UTS testing was also repeated following in vitro degradation. The AlphaVent anchors demonstrated equivalent pull-out strength to the Predicate B devices and no new issues of safety and effectiveness were identified. Testing of the in vitro degradation rate of the AlphaVent Biocomposite Suture Anchors was also performed.
Biocompatibility testing was performed on the final finished devices per ISO 10993-1:2018 to confirm that the AlphaVent devices met all required biocompatibility testing endpoints. Testing for materialmediated pyrogenicity and bacterial endotoxins was also performed, with passing results below the required limits.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
August 30, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Stryker Endoscopy Katie Farraro Senior Staff Regulatory Affairs Specialist Stryker Endoscopy 5900 Optical Ct. San Jose, California 95138
Re: K231093
Trade/Device Name: AlphaVent Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: July 24, 2023 Received: July 24, 2023
Dear Katie Farraro:
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, Jesse Muir -S
Jesse Muir, 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) K231093
Device Name
AlphaVent Suture Anchors
Indications for Use (Describe)
The AlphaVent Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot and Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Cigament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL/PCL Reconstruction or Repair
Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct. San Jose, CA 95138
| Contact Person: | Katie Farraro, PhD, RAC |
|---|---|
| Senior Staff Regulatory Affairs Specialist | |
| Phone: 408-754-2285 |
Date Prepared: April 17, 2023
II. DEVICE
| Name of Device: | Stryker AlphaVent Suture Anchors |
|---|---|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Fastener, Fixation, Biodegradable, Soft Tissue | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Single/multiple component metallic bone fixation appliances and accessories | |
| (21 CFR 888.3030) | |
| Regulatory Class: | II |
| Product Code: | MBI, MAI |
III. PREDICATE AND REFERENCE DEVICES
Predicate A: Stryker AlphaVent PEEK Suture Anchors Company Name: Stryker 510(k) Number: K211502
Predicate B: Arthrex SwiveLock Anchors Company Name: Arthrex 510(k) Number: K203495
Reference Device: Stryker Iconix All Suture Anchors Company Name: Stryker 510(k) Number: K133671
IV. OBJECTIVE
The purpose of this Traditional 510(k) submission is to obtain Food and Drug Administration (FDA) authorization to market modifications to the AlphaVent PEEK Suture Anchors. Specifically, this submission proposes two modifications to Stryker's legally marketed AlphaVent devices: (1) a line extension to introduce new AlphaVent anchor configurations composed of an absorbable material (i.e., "AlphaVent Biocomposite Suture Anchors"), and 2) an expansion in the indications for use to include the
4
use of the AlphaVent Suture Anchors in skeletally mature pediatric patients, as well as to include two additional surgical procedures: gluteal tendon repair and proximal hamstring repair.
V. DEVICE DESCRIPTION
The AlphaVent Suture Anchors are bone anchors with a screw-in design. Each anchor is vented and cannulated and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.
VI. INTENDED USE
The AlphaVent Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL/PCL Reconstruction or Repair
Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The modified AlphaVent Suture Anchors are identical to Predicate A (AlphaVent PEEK devices) in terms of intended use, operational principle, design, and shelf life, and they are equivalent in terms of sterilization and packaging. They are identical to Predicate B (SwiveLock Anchors) in terms of intended use, general design features, and operational principle, and are equivalent in terms of indications for use, materials intended for implantation, and performance attributes. The minor differences between the modified AlphaVent Suture Anchors and predicate devices do not raise new questions of safety and effectiveness, and these devices are substantially equivalent based on the criteria described in 21 CFR 8807.100.
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VIII. PERFORMANCE DATA
Non-clinical benchtop testing was conducted to evaluate the performance characteristics of the modified AlphaVent Suture Anchors, including ultimate tensile strength ("UTS") and insertion testing. For the Alpha Vent Biocomposite Suture Anchors, UTS testing was also repeated following in vitro degradation. The AlphaVent anchors demonstrated equivalent pull-out strength to the Predicate B devices and no new issues of safety and effectiveness were identified. Testing of the in vitro degradation rate of the AlphaVent Biocomposite Suture Anchors was also performed.
Biocompatibility testing was performed on the final finished devices per ISO 10993-1:2018 to confirm that the AlphaVent devices met all required biocompatibility testing endpoints. Testing for materialmediated pyrogenicity and bacterial endotoxins was also performed, with passing results below the required limits.
IX. CONCLUSIONS
The information presented within this Traditional premarket submission demonstrates that the modified AlphaVent Suture Anchors are substantially equivalent to the predicate devices and will perform as safely and effectively within the intended use.