(184 days)
The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
• Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart 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, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial 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, Unar or Radial Collateral Ligament Reconstruction, TFCC.
· Hip: Acetabular labral repair.
The ATL Anchors are press fit suture anchors designed to secure the implant in bone and provide suture fixation. There are two configurations: with and without an eyelet. The devices are made from PEEK, are provided sterile, and pre-mounted on a single-use driver. The devices are provided with USP 0 ultra-high molecular weight polyethylene (UHMWPE) suture. ATL Anchors are used with Artelon® provided cannulated or solid stainless-steel drill bits. The devices are tapped into a pilot hole using a standard mallet (not provided).
The provided text is a 510(k) summary for the ATL Anchors, a medical device for soft tissue to bone attachment. It details the device description, indications for use, technological characteristics, and summary performance data. However, it does not describe an AI/ML-based device or a study involving human readers or expert consensus for ground truth. Therefore, I cannot generate the requested information about acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies.
The document discusses performance tests for the biomechanical properties of the ATL Anchors, such as insertion strength, pull-out strength, and cyclic loading, to demonstrate equivalence to predicate devices. It also mentions sterilization, shelf-life, and biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance evaluations of an AI algorithm.
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September 2, 2020
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International Life Sciences Tiffini Wittwer VP, Quality, Clinical, Regulatory 2252 Northwest Parkway SE Suite G Marietta, Georgia 30067
Re: K200503
Trade/Device Name: ATL Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 22, 2020 Received: July 29, 2020
Dear Tiffini Wittwer:
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
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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,
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
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Indications for Use
510(k) Number (if known) K200503
Device Name
ATL Anchors
Indications for Use (Describe)
The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
• Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart 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, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial 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, Unar or Radial Collateral Ligament Reconstruction, TFCC.
· Hip: 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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510(k) Summary – K200503
| Submitter: | International Life Sciences |
|---|---|
| Contact Person: | Tiffini WittwerVP of QA, CA, RA2252 Northwest Pkwy SE Suite GMarietta GA 30067Phone: 707.799.6732E-mail: twittwer@mededge.io |
| Trade Name: | ATL Anchors |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II |
| Product Code: | MBI |
| Regulation | 21 CFR 888.3040 |
| Predicate Device(s): | The subject device is equivalent to the following devices:● Parcus Knotless PEEK and PEEK CF Push-InSuture Anchors – K193295● Smith and Nephew BIORAPTOR KnotlessSuture Anchor – K093428 |
| Device Description: | The ATL Anchors are press fit suture anchors designed tosecure the implant in bone and provide suture fixation.There are two configurations: with and without an eyelet.The devices are made from PEEK, are provided sterile, andpre-mounted on a single-use driver. The devices areprovided with USP 0 ultra-high molecular weightpolyethylene (UHMWPE) suture. ATL Anchors are usedwith Artelon® provided cannulated or solid stainless-steeldrill bits. The devices are tapped into a pilot hole using astandard mallet (not provided). |
| Indication for Use: | The ATL Anchors are indicated for attachment of softtissue to bone. This product is intended for the followingindications:Shoulder: Rotator Cuff Repair, AcromioclavicularSeparation Repair, Bankart Repair, Bankart LesionRepair, Biceps Tenodesis, Capsular Shift orCapsulolabral Reconstruction, Deltoid Repair, SLAPLesion Repair. Knee: Medial Collateral Ligament Repair, LateralCollateral Ligament Repair, Posterior ObliqueLigament Repair, Extra Capsular Reconstruction,Illiotibial Band Tenodesis, Patellar Ligament andTendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization,Midfoot Reconstruction, Achilles Tendon Repair,Hallux Valgus Reconstruction, Metatarsal LigamentRepair. Elbow: Tennis Elbow Repair, Biceps TendonReattachment. Hand/Wrist: Scapholunate Ligament Reconstruction,Ulnar or Radial Collateral Ligament Reconstruction,TFCC. Hip: Acetabular labral repair. |
| TechnologicalCharacteristics: | The ATL Anchors are identical in intended use, principlesof operation (push / tap in), and material to both predicatedevices. Both the subject device and the predicates areprovided preloaded onto an insertion tool with suture. Theproposed device and predicates are similar in size,configurations, and packaging.The subject device differs from the predicates in retentionfeature (helical versus radial grooves), driver matingfeature (hexalobe versus square), and the subject devicedoes not have a suture locking feature whereas thepredicate, Smith and Nephew Bioraptor, does.Performance bench testing demonstrates that thesedifferences do not raise new questions of safety andefficacy of the ATL Suture Anchor when compared to thepredicates. |
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| Summary PerformanceData: | Performance data demonstrated that the ATL Anchors metperformance specifications and are comparable to thepredicate. ATL Anchors met specification for insertionstrength, pull-out strength, and cyclic loading. Side by sidetesting with the predicates was performed for pull-outstrength (Parcus Knotless PEEK) and cyclic loading(Smith and Nephew Bioraptor). |
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| A sterilization validation and routine sterilization has beenestablished in accordance with ISO 11137-1:2006 (R2015)and ISO 11137-2:2011 (R2019). Shelf-life of the ATLAnchors has been established in accordance with ASTMD4169:2016 and ASTM F1980:2016.The biocompatibility of the ATL Anchor was evaluatedagainst the requirements per ISO 10993-1:2018. Allacceptance criteria were met.Bacterial endotoxin testing was completed and met | |
| acceptable endotoxin limits per ANSI/AAMI/ ST72:2011.Based on the above testing and information, the ATLAnchor is considered substantially equivalent to thepredicates and other currently marketed devices. |
§ 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.