(87 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is an anchor used for soft tissue re-fixation within the shoulder joint. Its primary function is mechanical support during surgical procedures, not to provide therapy or treatment to a disease or condition itself.
No
Explanation: The device is a surgical implant (suture anchors) used for soft tissue re-fixation. Its function is interventional, not diagnostic, as it does not gather information about a patient's condition for the purpose of diagnosis.
No
The device description clearly states it includes implantable hardware components (PEEK anchoring component and UHMWPE suture) and a disposable driver.
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 for diagnosis, monitoring, or screening.
- Device Description: The MectaLock PEEK Suture anchors are implantable devices used for surgical repair of soft tissue within the shoulder joint. They are physically inserted into the patient's body.
- Intended Use: The intended use is for "soft tissue refixation within the shoulder joint," which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgical implant used for structural repair, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches:
- soft tissue refixation within the shoulder joint (i.e .: rotator cuff repair)
Product codes
MBI
Device Description
The MectaLock Suture Anchor Extension includes implantable devices used for soft tissue re-fixation (e.g. muscles, tendons, ligaments) composed of a PEEK anchoring component and an Ultra High Molecular Weight PolyEthylene (UHMWPE) non-absorbable braided suture.
Specifically, the devices subject of this submission are MectaLock PEEK Suture Anchors Ø4.5, Ø5.5 and 06.5 mm with short driver; a range extension of the already cleared MectaLock PEEK Suture Anchor (K190474).
Identically to the reference device cleared within K190474, the MectaLock Suture Anchor Extension implants are knotless devices 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 anchor with the provided non-absorbable suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
arthroscopic or open surgical approaches
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
- DESIGN VALIDATION: MectaLock Suture Anchor Extension Design Validation Report Test Report A1 according to Design Validation Protocol M07.85.003 Nr. A1 and Evaluation forms
- PERFORMANCE TESTING: MR Safety evaluation MectaLock PEEK Suture Anchors Range extension; Cyclic and load-to-failure properties of suture anchors test report according to Test Protocol IL 07.09.488 Rev.4 and Empa Test Report No. 5214'025'712/1e
- 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; The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY: Biocompatibility assessment as per ISO 10993 series and FDA Biocompatibility Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Clinical Studies:
- No clinical studies were conducted.
Key results: Based on the information provided, the MectaLock Suture Anchor Extension implants are substantially equivalent to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
February 22, 2022
Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K203493
Trade/Device Name: MectaLock Suture Anchor Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 25, 2020 Received: November 27, 2020
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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)
K203493
Device Name MectaLock Suture Anchor Extension
Indications for Use (Describe)
The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches:
· soft tissue refixation within the shoulder joint (i.e .: rotator cuff 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
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 and Compliance Director. Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: November 25, 2020 Date Revised: February 4, 2021
II. Device
| Device Proprietary Name: | MectaLock Suture Anchor Extension |
|---|---|
| Common or Usual Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Soft Tissue |
| Primary Product Code: | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification | II |
Predicate Device III.
Substantial equivalence is claimed to the following primary predicate device:
-
Arthrex PushLock Anchors, K101679, Arthrex, Inc
In addition, the following Reference device is referenced within the submission: -
MectaLock PEEK Suture Anchor, K190474, Medacta International SA
Device Description IV.
The MectaLock Suture Anchor Extension includes implantable devices used for soft tissue re-fixation (e.g. muscles, tendons, ligaments) composed of a PEEK anchoring component and an Ultra High Molecular Weight PolyEthylene (UHMWPE) non-absorbable braided suture.
Specifically, the devices subject of this submission are MectaLock PEEK Suture Anchors Ø4.5, Ø5.5 and 06.5 mm with short driver; a range extension of the already cleared MectaLock PEEK Suture Anchor (K190474).
4
Identically to the reference device cleared within K190474, the MectaLock Suture Anchor Extension implants are knotless devices 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 anchor with the provided non-absorbable suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.
V. Indications for Use
The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches:
- . soft tissue refixation within the shoulder joint (i.e.: rotator cuff repair)
VI. Comparison of Technological Characteristics
The MectaLock Suture Anchor Extension implants and the predicate device share the following characteristics:
- external shape and related interference mechanism;
- . suture:
- . disposable driver design:
- . materials:
- biocompatibility;
- device usage: ●
- sterility; and ●
- packaging.
The MectaLock Suture Anchor Extension implants differ from the predicate device with respect to:
- anchors diameters; and
- suture engagement eyelet. ●
5
VII. Performance Data
Based on the risk analysis, design validation and performance testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION ●
- MectaLock Suture Anchor Extension Design Validation Report Test Report A1 according o to Design Validation Protocol M07.85.003 Nr. A1 and Evaluation forms
- PERFORMANCE TESTING ●
- MR Safety evaluation MectaLock PEEK Suture Anchors Range extension o
- Cyclic and load-to-failure properties of suture anchors test report according to Test Protocol o IL 07.09.488 Rev.4 and Empa Test Report No. 5214'025'712/1e
- PYROGENICITY ●
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY
- o Biocompatibility assessment as per ISO 10993 series and FDA Biocompatibility Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
Based on the information provided within this submission, the MectaLock Suture Anchor Extension implants are substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.