(52 days)
No
The summary describes a purely mechanical implantable device and its associated driver. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies are focused on mechanical properties, biocompatibility, and sterilization.
No.
The device is an implantable suture anchor used for fixation of soft tissue to bone, which is a surgical tool rather than a therapeutic device that treats or cures a disease.
No
The device is an implantable all-suture anchor used for fixation of soft tissue to bone during surgical procedures, not for diagnostic purposes.
No
The device description clearly states it is an implantable, knotted device composed of UHMWPE and includes a disposable stainless steel driver with a plastic handle. This indicates it is a physical medical device, not software only.
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 hip and shoulder in the following procedures: Hip: acetabular labral repair, Shoulder: glenoid labrum repair; cuff rotator repair." This describes a surgical implant used to physically repair tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical implantable device made of UHMWPE and a disposable driver. This is consistent with a surgical tool and implant, not an in vitro diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the MectaLock All-Suture Anchor is a surgical implant used for tissue repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MectaLock All-Suture Anchor is in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; cuff rotator repair
Product codes
MBI
Device Description
The MectaLock All-Suture Anchors are implantable, knotted, devices composed entirely of ultrahigh molecular weight polyethylene (UHMWPE) specifically arranged and braided to create an anchoring point within the bone after deployment. The sutures that compose the anchor are also used to secure soft tissues to a supporting structure (i.e., bone).
The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is pre-loaded on the disposable driver.
MectaLock All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded floating sutures (standard or tape sutures).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, shoulder
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 O Workshop) M07.85.003 and Evaluation forms. Test Report A1.
- MR compatibility, MR Safety Evaluation All-Suture Anchors O
- CHARACTERIZATION TESTING
- Cyclic and load-to-failure properties of All-Suture Anchors according to Empa Test O Report No. 5214'022'720e and Medacta Protocol IL 07.09.575. Test report A2.
- PYROGENICITY
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- O the subject devices are not labeled as non-pyrogenic or pyrogen free
- BIOCOMPATIBILITY
- STERILIZATION
- SHELF-LIFE
Clinical Studies:
- No clinical studies were conducted
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
February 6, 2020
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K193461
Trade/Device Name: MectaLock All-Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 11, 2019 Received: December 16, 2019
Dear Mr. 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 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 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,
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
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name MectaLock-All Suture Anchors
Indications for Use (Describe)
The MectaLock All-Suture Anchor is in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
- · Hip: acetabular labral repair
· Shoulder: glenoid labrum repair; cuff rotator 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.
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EF
3
K193461
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 and Compliance Director. Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: December 11, 2019 Date Revised: January 31, 2020
II. Device
| Device Proprietary Name: | MectaLock All-Suture Anchors |
|---|---|
| Common or Usual Name: | Soft Tissue Fixation Device |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft tissue |
| Product Codes: | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
-
JuggerKnot Soft Anchors, K150768, Biomet Manufacturing Corp. ●
The following device is referenced in the submission: -
MectaLock PEEK Suture Anchor, K190474, Medacta International SA ●
IV. Device Description
The MectaLock All-Suture Anchors are implantable, knotted, devices composed entirely of ultrahigh molecular weight polyethylene (UHMWPE) specifically arranged and braided to create an anchoring point within the bone after deployment. The sutures that compose the anchor are also used to secure soft tissues to a supporting structure (i.e., bone).
4
The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is pre-loaded on the disposable driver.
MectaLock All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded floating sutures (standard or tape sutures).
V. Indications for Use
The MectaLock All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; cuff rotator repair
Comparison of Technological Characteristics VI.
The MectaLock All-Suture Anchors and the predicate device share the following characteristics:
- . anchor deployment and fixation mechanism;
- . driver design and material;
- driver handle design and material; and
- sterilization method.
The MectaLock All-Suture Anchors and the predicate devices are technologically different with respect to suture size and types of sutures provided with each configuration.
Discussion
Based on the comparison of technological characteristics and performance data provided within this submission, the MectaLock All-Suture Anchors are substantially equivalent to the identified predicate device. Technological differences related to suture size and types of sutures provided are addressed through performance testing.
Performance Data VII.
Based on the risk analysis, a cadaver workshop and characterization testing were conducted to written protocols. The following performance tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION ●
- Design Validation, according to Medacta Design Validation Protocol A1 (Cadaver O Workshop) M07.85.003 and Evaluation forms. Test Report A1.
5
- MR compatibility, MR Safety Evaluation All-Suture Anchors O
- . CHARACTERIZATION TESTING
- Cyclic and load-to-failure properties of All-Suture Anchors according to Empa Test O Report No. 5214'022'720e and Medacta Protocol IL 07.09.575. Test report A2.
- PYROGENICITY
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia $2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- O the subject devices are not labeled as non-pyrogenic or pyrogen free
- BIOCOMPATIBILITY ●
- STERILIZATION
- SHELF-LIFE
Clinical Studies
- No clinical studies were conducted
VIII. Conclusion
The information provided with this submission supports that the MectaLock All-Suture Anchors are substantially equivalent to the predicate device. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.