(269 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of a physical implant and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "knotless suture anchor for the fixation of soft tissue to bone" and is intended for use in various surgical repair procedures, which are therapeutic interventions.
No
This device is a surgical implant (suture anchor) used for fixation of soft tissue to bone, not to diagnose a condition.
No
The device description explicitly states that the system includes physical components such as suture anchors made of PEEK, repair sutures, passing sutures, inserters, drills, and guide tubes. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) 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 the Responsive Arthroscopy Wedge Push-In Suture Anchors are used for the "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed inside the body (in vivo).
- No Mention of Specimen Testing: The document does not mention any testing of biological specimens or analysis of bodily fluids or tissues.
- Bench Testing: The performance studies described are bench tests (mechanical testing, biocompatibility, sterility) which evaluate the physical properties and safety of the device itself, not its ability to diagnose a condition based on biological samples.
Therefore, based on the provided information, the Responsive Arthroscopy Wedge Push-In Suture Anchor is a surgical implant/device used for tissue repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
Product codes
MBI
Device Description
The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, hip, knee, hand/wrist, and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Bench testing was performed: Suture Characterization (previously cleared device reference), Insertion Force Testing, Static & Cyclic Pullout Force Testing, Static & Cyclic Suture Locking Force Testing, Biocompatibility, pyrogenicity and sterility testing.
Key Metrics
Not Found
Predicate Device(s)
K140855, K101679, K171020, K112965, K121018
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 18, 2019
Responsive Arthroscopy LLC % Benjamin Arnold Managing Member Cor Medical Ventures LLC 215 S. Highway 101 Suite 200 Solana Beach, California 92075
Re: K181076
Trade/Device Name: Responsive Arthroscopy Wedge Push-In Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 6, 2018 Received: December 7, 2018
Dear Mr. Arnold:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Responsive Arthroscopy Wedge Push-In Suture Anchors
Indications for Use (Describe)
The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(K) SUMMARY
SUBMITTER:
Submitted By:
| Company Name:
Address:
Telephone: | Responsive Arthroscopy LLC
701 N. 3rd Street, Suite 202
Minneapolis, MN 55401
858-720-1847 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Benjamin Arnold |
| DATE PREPARED: | April 16, 2018 |
| TRADE NAME: | Responsive Arthroscopy Wedge Push-In Suture Anchor System |
| COMMON NAME: | RA Wedge Push-In Suture Anchor System |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener.
(21 CFR 888.3040) |
| PRODUCT CODE: | MBI |
SUBSTANTIAL EQUIVALENCE:
The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor System is substantially equivalent to the predicate devices in all facets including: function, design, performance, material, and intended use.
| Primary Predicate: | Arthrex SutureTak Suture Anchors: K140855 |
|---|---|
| Additional Predicates: | Arthrex PushLock Anchors: K101679 |
| Arthrex Knotless SutureTak Suture Anchor: K171020 | |
| ConMed Linvatec NANO Suture Anchor: K112965 | |
| Smith & Nephew BIORAPTOR Knotless Suture Anchor: K121018 |
The Wedge Push-In Suture Anchor is of similar size and made from the same basic materials as the predicate devices. The device has similar surgical technique and tissue tensioning to K171020, and offers knotless tissue fixation similar to K101679. K171020, and K121018. Any differences between the Wedge Push-In Suture Anchor and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
DEVICE DESCRIPTION:
The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.
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MATERIALS:
The RA Wedge Push-In Suture Anchor System anchors are machined from extruded PEEK per ASTM F2026. Implantable repair sutures are Riverpoint Medical #2 HS Fiber ultra-high molecular weight polyethylene suture, previously cleared under K100006.
INDICATIONS FOR USE:
The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in 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/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair,
Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
PERFORMANCE TESTING:
The following bench testing was performed on the Responsive Arthroscopy Wedge Push-In Suture Anchor System:
Suture Characterization (previously cleared device reference) Insertion Force Testing Static & Cyclic Pullout Force Testing Static & Cyclic Suture Locking Force Testing Biocompatibility, pyrogenicity and sterility testing
In summary, mechanical testing, biocompatibility, sterility and pyrogenicity of the Responsive Arthroscopy Wedge Push-In Suture Anchor System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
CONCLUSIONS:
The Responsive Arthroscopy Wedge Push-In Suture Anchor System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.