(104 days)
The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)
For each configuration, the implant is supplied sterile, ready to use.
The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.
However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Property) | Reported Device Performance (FIXIT®/ComposiTCP™ Threaded Anchor System) | Reported Predicate Device Performance (FIXIT® Threaded Anchor System) |
|---|---|---|
| Pull-out strength at 12 weeks ($\ge$ 150 N) | 229 $\pm$ 19 N | 220 $\pm$ 12 N |
The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.
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July 25, 2018
S.B.M. SAS Sciences for Bio Materials Anne Cospin-Latapie Quality/Regulatory Affairs Manager ZI du Monge Lourdes, France 65100
Re: K180960
Trade/Device Name: FIXIT®/ComposiTCP™ Threaded Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: June 20, 2018 Received: June 25, 2018
Dear Ms. Cospin-Latapie:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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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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Image /page/2/Picture/0 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M, with the B in a darker color. Below the letters is the text "Science & Bio Materials". To the right of the letters are four right-pointing triangles, with the second triangle from the left having a dotted pattern. The text "K180960 Page 1 of 1" is located in the upper right corner of the image.
INDICATIONS FOR USE
510(k) Number (if known): K180960
Device Name: FIXIT® / ComposiTCP™ Threaded Anchor System Indications for Use:
The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Elbow: Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
Prescription Use Over-The-Counter Use __ > - Prescription Use - - - - - - - - - - - - - - - - AND/OR - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows a logo with the letters S, B, and M in different shades of gray and blue. The letter B is blue, while the letters S and M are gray. Below the letters, the words "Science & Bio Materials" are written in a smaller font. To the right of the letters, there are three right-pointing triangles, with the middle triangle having a blue dotted pattern.
510(k) SUMMARY
1. SUBMITTER
| S.B.M. SAS |
|---|
| SCIENCE & BIO MATERIALS |
| ZI du Monge |
| F 65100 LOURDES - FRANCE |
| Registration Number: 3004549189 |
| Phone: +33 (0)5 62 42 21 01 |
| Fax: +33 (0)5 62 42 21 00 |
| Contact Person: Anne COSPIN-LATAPIE |
| e-mail : anne.cospin@sbm-fr.com |
| Date prepared: June 14, 2018 |
2. DEVICE
| Name of Device | FIXIT®/ ComposiTCP™ Threaded Anchor System |
|---|---|
| Common or Usual Name | Suture Anchor |
| Classification Name | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class | II |
| Product Code | MAI |
3. PREDICATE DEVICE
FIXIT Threaded Anchor System (K170868)
Referenced devices:
K070673 Force Fiber® Black Co-braid Polyethylene non-absorbable Suture
K063778 Force Fiber® Polyethylene non-absorbable Suture
K160854 Blue BroadBand® Single Flat Suture
K160854 White/Green BroadBand® Single Flat Suture
4. DEVICE DESCRIPTION
FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)
For each configuration, the implant is supplied sterile, ready to use.
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Image /page/4/Picture/0 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M in a light gray color, with the words "Science & Bio Materials" written in a smaller font size underneath the letters. To the right of the letters, there are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern.
5. INDICATIONS FOR USE
The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
FIXIT®/ ComposiTCP™ Threaded Anchor System is compared to FIXIT Threaded Anchor System (K170868) manufactured by S.B.M SAS Science and Bio Materials.
The applicant device has the same intended use as the predicate device.
The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design.
| FIXIT®/ ComposiTCP™Threaded AnchorSystem | FIXIT® Threaded AnchorSystem | |
|---|---|---|
| Present submission | K170868 (Predicatedevice) | |
| 21CFR | 888.3030 Single/multiple component metallic bonefixation appliances and accessories | |
| Product's code | MAI | |
| Device | Threaded suture anchors | |
| Indications for use | All these devices include use in soft tissue reattachmentprocedures in the shoulder, wrist/hand, ankle/foot, elbow, | |
| statement | and knee. Specific indications are as follows:Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repairor Capsulolabral Reconstruction; Biceps Tenodesis; andDeltoid RepairWrist/Hand: Scapholunate Ligament Reconstruction andUlnar/Radial Collateral Ligament ReconstructionAnkle/Foot: Lateral Stabilization; Medial Stabilization;Achilles Tendon Repair/Reconstruction; Hallux ValgusReconstruction; and Mid and Forefoot ReconstructionElbow: Ulnar or Radial Collateral LigamentReconstruction; Biceps Tendon Reconstruction; andLateral Epicondylitis RepairKnee: Extra-capsular Repair; Medial Collateral LigamentRepair; Lateral Collateral Ligament Repair; PosteriorOblique Ligament Repair; Joint Capsule Closure; IliotibialBand Tenodesis; Patellar Realignment and Repair;Patellar Ligament/Tendon Repair; and Vastus MedialisObliquus (VMO) Muscle Advancement | |
| Anchor | β-TCP (30%) / Poly LactidCopolymer (70%) | β-TCP (30%) / Poly LactidCopolymer (70%) |
| Resorbable | YES | YES |
| Suture | Pre-loaded on a disposablescrewdriver with 2 roundsutures | Pre-loaded on a disposablescrewdriver with 2 flatsutures, or 1 round + 1 flat |
| Model size | Ø 4.5mm x14.5 mmØ 5.5mm x17.6 mmØ 6.5mm x17.6 mm | Ø 4.5mm x14.5 mmØ 5.5mm x17.6 mmØ 6.5mm x17.6 mm |
| MechanicalProperties | ||
| -Pull-outstrength at 12weeks (≥ 150N) | $229 \pm 19$ N(Cf. RD 1124 Report) | $220 \pm 12$ N(Cf. RD 1204 Report) |
| Sterilizationmethod | Gamma rays 25 kGyminimum | Gamma rays 25 kGyminimum |
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Image /page/5/Picture/0 description: The image shows the logo for Science & Bio Materials, which is represented by the letters S, B, and M. The letter B is blue, while the other letters are gray. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient.
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Image /page/6/Picture/0 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M, with the B in blue and the S and M in gray. Underneath the letters is the text "Science & Bio Materials". To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient.
4. PERFORMANCE DATA
Non-clinical performance testing
Non-clinical testing including chemical, biological and mechanical performances was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices.
Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance testing:
Clinical performance data was not included.
5. CONCLUSIONS
The FIXIT®/ ComposiTCP™ Threaded Anchor System is substantially equivalent to its predicate device FIXIT® Threaded Anchor System (K170868). Verification and validation tests demonstrate that the FIXIT® Threaded Anchor System is as safe, as effective, and performs as safely and effectively as its predicate device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.