(184 days)
Not Found
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.
Yes
The device is intended for the attachment of soft tissue to bone for various repairs and reconstructions, which are therapeutic interventions.
No
The device is described as an implantable suture anchor used for attaching soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical implant (suture anchors made from PEEK) and includes associated hardware (driver, suture, drill bits).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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 implant (suture anchor) made of PEEK, designed to be inserted into bone. This is a medical device used in vivo (within the living body).
- 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 compatibility testing.
IVD devices are used in vitro (outside the living body) to analyze biological samples. This device is used in vivo during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot/Ankle, Elbow, Hand/Wrist, Hip
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
Performance data demonstrated that the ATL Anchors met performance specifications and are comparable to the predicate. ATL Anchors met specification for insertion strength, pull-out strength, and cyclic loading. Side by side testing with the predicates was performed for pull-out strength (Parcus Knotless PEEK) and cyclic loading (Smith and Nephew Bioraptor).
A sterilization validation and routine sterilization has been established in accordance with ISO 11137-1:2006 (R2015) and ISO 11137-2:2011 (R2019). Shelf-life of the ATL Anchors has been established in accordance with ASTM D4169:2016 and ASTM F1980:2016. The biocompatibility of the ATL Anchor was evaluated against the requirements per ISO 10993-1:2018. All acceptance criteria were met. Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI/ ST72:2011.
Key Metrics
insertion strength, pull-out strength, cyclic loading
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
September 2, 2020
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
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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3
510(k) Summary – K200503
| Submitter: | International Life Sciences |
|---|---|
| Contact Person: | Tiffini Wittwer |
| VP of QA, CA, RA | |
| 2252 Northwest Pkwy SE Suite G | |
| Marietta GA 30067 | |
| Phone: 707.799.6732 | |
| E-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-In | |
| Suture Anchors – K193295 | |
| ● Smith and Nephew BIORAPTOR Knotless | |
| Suture Anchor – K093428 | |
| Device Description: | 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). | |
| Indication for Use: | 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 | |
| Separation Repair, 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, Posterior 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, | |
| Ulnar or Radial Collateral Ligament Reconstruction, | |
| TFCC. Hip: Acetabular labral repair. | |
| Technological | |
| Characteristics: | The ATL Anchors are identical in intended use, principles |
| of operation (push / tap in), and material to both predicate | |
| devices. Both the subject device and the predicates are | |
| provided preloaded onto an insertion tool with suture. The | |
| proposed device and predicates are similar in size, | |
| configurations, and packaging. | |
| The subject device differs from the predicates in retention | |
| feature (helical versus radial grooves), driver mating | |
| feature (hexalobe versus square), and the subject device | |
| does not have a suture locking feature whereas the | |
| predicate, Smith and Nephew Bioraptor, does. | |
| Performance bench testing demonstrates that these | |
| differences do not raise new questions of safety and | |
| efficacy of the ATL Suture Anchor when compared to the | |
| predicates. |
4
5
| Summary Performance
Data: | Performance data demonstrated that the ATL Anchors met
performance specifications and are comparable to the
predicate. ATL Anchors met specification for insertion
strength, pull-out strength, and cyclic loading. Side by side
testing with the predicates was performed for pull-out
strength (Parcus Knotless PEEK) and cyclic loading
(Smith and Nephew Bioraptor). |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | A sterilization validation and routine sterilization has been
established in accordance with ISO 11137-1:2006 (R2015)
and ISO 11137-2:2011 (R2019). Shelf-life of the ATL
Anchors has been established in accordance with ASTM
D4169:2016 and ASTM F1980:2016.
The biocompatibility of the ATL Anchor was evaluated
against the requirements per ISO 10993-1:2018. All
acceptance 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 ATL
Anchor is considered substantially equivalent to the
predicates and other currently marketed devices. |