(219 days)
No
The summary describes a mechanical suture anchor and its physical properties and testing, with no mention of AI/ML or related concepts.
Yes.
The device is intended for the fixation of suture to bone in soft tissue repair within the shoulder, specifically for rotator cuff repair and biceps tenodesis, which are therapeutic surgical procedures.
No
Explanation: The device description states that the MectaTap TI Suture Anchor is an implantable device used for refixation of soft tissues to bone during surgical procedures. Its purpose is to fix something, not to diagnose a condition.
No
The device description clearly outlines a physical, implantable suture anchor made of titanium alloy with preloaded sutures and a disposable inserter. It describes the mechanical action of implantation through tapping. There is no mention of software as a component or function of the device.
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 shoulder in the following procedure: Shoulder: cuff rotator repair and biceps tenodesis." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an implantable suture anchor used for soft tissue refixation. This is a physical device used in surgery, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or calibrators
In summary, the MectaTap TI Suture Anchors are a surgical implant used to repair soft tissue to bone, which falls under the category of a medical device used in treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The MectaTap TI Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure: Shoulder: cuff rotator repair and biceps tenodesis.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The MectaTap TI - Suture anchor is an implantable knotted device used for the soft tissues refixation (i.e.: muscles, tendons, ligaments...) composed of a titanium alloy anchoring component preloaded with two Ultra High Molecular Weight PolyEthylene non-absorbable braided sutures and assembled on a disposable inserter.
Due to its specific design, the MectaTap TI Suture anchor is implanted by tapping on the plastic handle of the inserter: the modularity between the internal eyelet and the external sleeve translates the axial movement of tapping into rotation of the anchor's body into the bone.
The MectaTap TI Suture anchor comes in two different sizes: ø5.0 and ø6.5mm (maximum external diameter) with a fixed length of 15mm, to cover the intended population and bone quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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
- Design Validation, according to Medacta Design Validation Protocol A1 (Wetlab) M07.85.003 and Evaluation form Titanium impaction anchor. Test Report A1.
- Impaction Test. Test Report A3.
- MR compatibility, MR Safety Evaluation MectaTap TI Titanium Impaction Suture anchor
- CHARACTERIZATION TESTING
- Cyclic and load-to-failure testing according to Empa Test report No. 18-11-14 5214020346 1e final.pdf, according to Medacta Protocol IL 07.09.488 rev.1. Test report A2.
- Hitting force assessment Workshop. Test Report A4.
- Mectatap Ti: Mechanical Evaluation During Assembly, A Finite Element Study. Test Report A5.
- 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 results: The information provided above supports that the MectaTap TI Suture Anchor is as safe and effective as the predicate devices. Therefore, it is concluded that the MectaTap TI Suture Anchor is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
January 29, 2020
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K191677
Trade/Device Name: MectaTap TI 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: January 7, 2020 Received: January 9, 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
1
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/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,
Laura C. Rose, Ph.D. Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191677
Device Name MectaTap TI Suture Anchor
Indications for Use (Describe)
The MectaTap TI Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure: Shoulder: cuff rotator repair and biceps tenodesis.
|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
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: Christopher Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: Jun 21, 2019 Date Revised: January 15, 2020
II. Device
| Device Proprietary Name: | MectaTap TI 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:
-
ConMed Linvatec, SuperRevo® Herculine TM Suture Anchor (K041713). A
In addition, the following Reference devices is cited within the submission: -
Medacta International SA, M-ARS ACL: Anatomic Ribbon Surgery System (K171640) A
-
Riverpoint Medical, HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), A RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED (K100006)
-
A DePuy Mitek, FASTIN RC Anchor (K060664)
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IV. Device Description
The MectaTap TI - Suture anchor is an implantable knotted device used for the soft tissues refixation (i.e.: muscles, tendons, ligaments...) composed of a titanium alloy anchoring component preloaded with two Ultra High Molecular Weight PolyEthylene non-absorbable braided sutures and assembled on a disposable inserter.
Due to its specific design, the MectaTap TI - Suture anchor is implanted by tapping on the plastic handle of the inserter: the modularity between the internal eyelet and the external sleeve translates the axial movement of tapping into rotation of the anchor's body into the bone.
The MectaTap TI Suture anchor comes in two different sizes: ø5.0 and ø6.5mm (maximum external diameter) with a fixed length of 15mm, to cover the intended population and bone quality.
V. Indications for Use
The MectaTap TI Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
- · Shoulder: cuff rotator repair and biceps tenodesis.
VI. Comparison of Technological Characteristics
The MectaTap TI Suture Anchor and the predicate device share the following characteristics:
- . Materials (Anchor: Ti 6A1-4V ELI [ASTM F136 & ISO 5832-3] and Suture: Ultra-High molecular weight polyethylene)
- Provided Sterile
- Suture typology
- Device Usage
- Shelf-life
- Biocompatibility .
The MectaTap TI Suture Anchor is technologically different from the predicate device as follows:
- Diameters
- External shape (Thread profile and Tip) ●
- Inner shape (Eyelet and Driver connection) ●
The materials used in the MectaTap TI Suture Anchor product are:
- Anchor: Ti 6Al-4V ELI according to ASTM F136 & ISO 5832-3
- 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.
5
Due to the extensive history of use in currently marketed medical devices, additional biocompatibility testing was deemed unnecessary for the MectaTap TI Suture Anchor components.
The MectaTap TI Suture Anchor will be labelled with a 5 year shelf life.
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The MectaTap TI Suture Anchor is the same or similar to the predicate device in terms of materials of construction, device usage, suture typology and disposable driver design and sterility.
Although there is a difference in the modularity and position of the eyelet (free to rotate and internal for the MectaTap TI Suture anchor, while monoblock and external for the predicate device), and in the Driver connection, the intended use and functionality of the component are the same.
Moreover, even if the external shape of the implant is not identical to the predicate, the general external geometric features are equivalent for the expected use and application. Both devices have similar dimensions and the wrap of the external contour creates the same geometrical volume, so that the final encumbrance of the two devices is equivalent.
The product range is shared with the reference device DePuy Mitek, FASTIN RC Anchor (K060664).
Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the MectaTap TI 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 (Wetlab) M07.85.003 and Evaluation form Titanium impaction anchor. Test Report A1.
- 0 Impaction Test. Test Report A3.
- 0 MR compatibility, MR Safety Evaluation MectaTap TI Titanium Impaction Suture anchor
- CHARACTERIZATION TESTING ●
- o Cyclic and load-to-failure testing according to Empa Test report No. 18-11-14 5214020346 1e final.pdf, according to Medacta Protocol IL 07.09.488 rev.1. Test report A2.
- 0 Hitting force assessment Workshop. Test Report A4.
6
- 0 Mectatap Ti: Mechanical Evaluation During Assembly, A Finite Element Study. Test Report A5.
- . PYROGENICITY:
- 0 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.
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the MectaTap TI Suture Anchor is as safe and effective as the predicate devices. Therefore, it is concluded that the MectaTap TI Suture Anchor is substantially equivalent to the predicate device.