(90 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (suture anchor) and its delivery system. There is no mention of software, algorithms, image processing, or data analysis that would suggest the use of AI/ML.
Yes
The device is a PEEK suture anchor used for the fixation of soft tissue to bone, which is a therapeutic intervention aimed at repairing damaged tissue and restoring function.
No
Explanation: The device is an implantable suture anchor used for the re-fixation of soft tissue to bone. Its intended use is for surgical procedures to fix anatomical structures, not to diagnose a condition.
No
The device description clearly states it is an implantable device composed of a PEEK anchor and suture, provided with a disposable driver. This involves physical hardware components, not just software.
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 "fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures: Hip: acetabular labral repair; and Shoulder: glenoid labrum repair." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details an "implantable device used for soft tissue re-fixation" composed of an anchor and suture, inserted into bone. This is a physical implant used during surgery.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:
· Hip: acetabular labral repair; and
· Shoulder: glenoid labrum repair.
Product codes
MBI
Device Description
The purpose of this submission is to gain clearance for the MectaLock PEEK® Suture Anchor. The MectaLock PEEK® Suture Anchor is an implantable device used for soft tissue re-fixation (i.e.: muscles, tendons, ligaments...) composed of an anchoring component (PEEK® anchor) and an Ultra High Molecular Weight PolyEthylene non-absorbable braided suture.
The MectaLock PEEK® Suture Anchor is a knotless device provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the MectaLock PEEK® Suture Anchor with the provided non-absorbable UHMWPE suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.
The MectaLock PEEK® Suture Anchor portfolio is composed of three anchor sizes: ø2.4, ø2.9, and ø3.4mm combined with two driver lengths: short and long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder and hip
Indicated Patient Age Range
Not Found
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 Studies
- DESIGN VALIDATION
- Design Validation, according to Medacta Design Validation Protocol A1 (Cadaver Workshop) M07.85.003 and Evaluation form J-Lock & Aimers. Test Report A1.
- MR compatibility, MR Safety Evaluation MectaLock PEEK Suture Anchors
- CHARACTERIZATION TESTING
- Cyclic and load-to-failure properties of suture anchors according to Empa Test report No. 18-06-25 5214019237 1e Anchor-test final.pdf, according to Medacta Protocol IL 07.09.488 rev.0. Test report A2.
- MectaLock PEEK® Suture Anchors suitability assessment. Rationale A3_Rev0
- PYROGENICITY:
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination.
- STERILIZATION:
- ISO 11135:2014 Sterilization of health-care products Ethylene Oxide Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
PushLock™ K061863 Arthrex.
Reference Device(s)
MectaLIF Anterior Stand-Alone, K160605 Medacta International, MectaLIF Anterior Stand-Alone, K170455 Medacta International, MectaLIF Posterior Extension, K181970 Medacta International, Hs Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries By Size/Need, K100006 - Riverpoint Medical
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K190474
Trade/Device Name: MectaLock PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 25, 2019 Received: February 27, 2019
Dear Chris Lussier:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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, Ph.D. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190474
Device Name MectaLock PEEK Suture Anchor
Indications for Use (Describe)
The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:
· Hip: acetabular labral repair; and
· Shoulder: glenoid labrum 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.
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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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3
2.0 510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs Manager Date Prepared: Feb 25, 2019 Date Revised: Apr 18, 2019 Date Revised: Apr 29, 2019
II. Device
| Device Proprietary Name: | MectaLock PEEK® Suture Anchor |
|---|---|
| Common or Usual Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Primary Product Code: | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
Primary predicate device:
-
PushLock™ K061863 Arthrex. ●
Reference devices: -
MectaLIF Anterior Stand-Alone, K160605 Medacta International ●
-
MectaLIF Anterior Stand-Alone, K170455 Medacta International ●
-
MectaLIF Posterior Extension, K181970 Medacta International ●
-
Hs Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries By Size/Need, K100006 - Riverpoint Medical
IV. Device Description
The purpose of this submission is to gain clearance for the MectaLock PEEK® Suture Anchor. The MectaLock PEEK® Suture Anchor is an implantable device used for soft tissue re-fixation (i.e.: muscles, tendons, ligaments...) composed of an anchoring component (PEEK® anchor) and an Ultra High Molecular Weight PolyEthylene non-absorbable braided suture.
4
The MectaLock PEEK® Suture Anchor is a knotless device provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the MectaLock PEEK® Suture Anchor with the provided non-absorbable UHMWPE suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.
The MectaLock PEEK® Suture Anchor portfolio is composed of three anchor sizes: ø2.4, ø2.9, and ø3.4mm combined with two driver lengths: short and long.
V. Indications for Use
The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:
- · Hip: acetabular labral repair; and
- Shoulder: glenoid labrum repair.
VI. Comparison of Technological Characteristics
The MectaLock PEEK® Suture Anchor and the predicate devices share the following characteristics:
- Materials (Anchor: PEEK® and Suture: Ultra-High molecular weight polyethylene) ●
- Provided Sterile (EtO sterilization overkill approach) ●
- Device Usage
- Disposable driver design (materials and geometrical concepts) ●
- Interference mechanism: external shape (Cylindrical body with circumferential ribs)
- . Diameters
- Manual sutures engagement .
- Shelf life (5 years)
The MectaLock PEEK® Suture Anchor is technologically different from the predicate devices as follows:
-
. Suture engagement: eyelet
The materials used in the MectaLock PEEK® Suture Anchor product are: -
Anchor: PEEK® according to ASTM F2026
-
Suture: Ultra High Molecular Weight PolyEthylene
-
Disposable driver: Stainless steel and Polycarbonate medical grade
All of these materials were chosen in alignment with the predicate device and in according with the most common equivalent products in the orthopedic field.
Due to the extensive history of use in currently marketed medical devices, additional biocompatibility testing was deemed unnecessary for the MectaLock PEEK® Suture Anchor components.
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The MectaLock PEEK® Suture Anchor is the same or similar to the predicate devices in terms of materials of construction, Interference mechanism device usage, Suture typology and sterility.
5
Although there are some differences in the design of the eyelet dedicated to suture engagement, the intended use and functionality of the component are the same. In detail the sutures engagement is performed manually with an equivalent procedure, both for the MectaLock PEEK® Suture Anchor and for the predicate device. The eyelet functions to both keep the sutures connected and push them into the pilot pre-drilled hole in a way that, after the anchor's insertion is complete, the sutures are mechanically locked against the surrounding bone. While in the MectaLock PEEK® Suture Anchor the eyelet is monoblock with the anchor's body, the PushLock® eyelet is a separated body connected to the driver. Nevertheless, once the anchor and eyelet are released from the driver, the final configuration of anchor + eyelet is pushed into the pilot hole in the bone, realizing an equivalent system. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the MectaLock PEEK® Suture Anchor to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, a design comparison and cadaver workshops were conducted to written protocols. The following performance tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION
- o Design Validation, according to Medacta Design Validation Protocol A1 (Cadaver Workshop) M07.85.003 and Evaluation form J-Lock & Aimers. Test Report A1.
- 0 MR compatibility, MR Safety Evaluation MectaLock PEEK Suture Anchors
- CHARACTERIZATION TESTING
- o Cyclic and load-to-failure properties of suture anchors according to Empa Test report No. 18-06-25 5214019237 1e Anchor-test final.pdf, according to Medacta Protocol IL 07.09.488 rev.0. Test report A2.
- 0 MectaLock PEEK® Suture Anchors suitability assessment. Rationale A3_Rev0
- PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- o Pyrogen test according to USP chapter for pyrogenicity determination.
- STERILIZATION:
- o ISO 11135:2014 Sterilization of health-care products Ethylene Oxide Requirements for the development, validation and routine control of a sterilization process for medical devices.
- o ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals.
6
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the MectaLock PEEK® Suture Anchor is as safe and effective as the predicate devices. Therefore, it is concluded that the MectaLock PEEK® Suture Anchor is substantially equivalent to the predicate devices.