(48 days)
No
The 510(k) summary describes a mechanical implant (suture anchor) and its associated driver. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties, biocompatibility, and shelf-life, not algorithmic performance.
No
The device is an implantable suture anchor used for the fixation of soft tissue to bone, which is a structural or mechanical function, not a therapeutic one as defined by the regulation.
No
The device is an implantable all-suture anchor used for surgical fixation of soft tissue to bone. It does not perform any diagnostic functions.
No
The device description clearly states it is an implantable device composed of sutures and a driver made of stainless steel and plastic, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MectaLock and SnugFit All-Suture Anchors are implantable devices used for the fixation of soft tissue to bone during surgical procedures.
- Intended Use: The intended use is for surgical repair procedures in the hip and shoulder, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
- MectaLock All-Suture Anchor
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
- SnugFit All-Suture Anchor
The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures: - Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The purpose of this submission is to gain clearance for the change in driver design of the already cleared MectaLock All-Suture Anchor (K193461) and SnugFit All-Suture Anchor size 2 (K203485), and to add new size 1 implants to SnugFit All-Suture Anchor, as a line extension.
The subject devices are implantable devices indicated for the treatment of hip and shoulder instability. The subject SnugFit All-Suture Anchor size 1 is entirely composed of sutures, made up of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET), which are specifically arranged and braided to create an anchoring point within the bone, after their deployment. The sutures themselves, are also used to secure soft tissues to a supporting structure, i.e. bone.
The sterile, individually packaged, subject device is composed of two parts: an all-suture anchor and a driver made of a stainless-steel shaft with an over-moulded plastic handle. The all-suture anchor is provided pre-loaded on the specifically designed disposable driver.
The new SnugFit All-Suture Anchor size 1 is available in two (2) different configurations depending on the driver length (long and short).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies
- PERFORMANCE TESTING
- SnugFit Size 1 Ø1.8 and SnugFit Size 1 Ø1.4 Substantial Equivalence Assessment;
- MR Safety evaluation SnugFit All-Suture Anchor.
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is O equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free. o
- BIOCOMPATIBILITY evaluation
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
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.
K203485, Medacta International SA.
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
April 17, 2023
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 S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K230544
Trade/Device Name: SnugFit All-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: February 28, 2023 Received: March 20, 2023
Dear Christopher 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,
Sara S. Thompson -S
Sara S. Thompson, D.V.M. 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
Indications for Use
Submission Number (if known)
Device Name
SnugFit All-Suture Anchor extension
Indications for Use (Describe)
- MectaLock All-Suture Anchor
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
- SnugFit All-Suture Anchor
The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon 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)
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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: Chris Lussier, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA
Date Prepared: February 28, 2023
II. Device
| Device Proprietary Name: | SnugFit All-Suture Anchor extension |
|---|---|
| Common or Usual Name: | Soft Tissue Fixation Device |
| Classification Name: | Fastener, Fixation, Non-degradable, 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 primary predicate device:
-
A SnugFit All-Suture Anchor, K203485, Medacta International SA.
In addition, the following predicate devices are mentioned within the submission: -
A MectaLock All-Suture Anchor, K193461, Medacta International SA
-
A MectaLock TI Triple Loaded Suture Anchor, K223582, Medacta International SA
IV. Device Description
The purpose of this submission is to gain clearance for the change in driver design of the already cleared MectaLock All-Suture Anchor (K193461) and SnugFit All-Suture Anchor size 2 (K203485), and to add new size 1 implants to SnugFit All-Suture Anchor, as a line extension.
The subject devices are implantable devices indicated for the treatment of hip and shoulder instability. The subject SnugFit All-Suture Anchor size 1 is entirely composed of sutures, made up of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET), which are specifically arranged and
4
braided to create an anchoring point within the bone, after their deployment. The sutures themselves, are also used to secure soft tissues to a supporting structure, i.e. bone.
The sterile, individually packaged, subject device is composed of two parts: an all-suture anchor and a driver made of a stainless-steel shaft with an over-moulded plastic handle. The all-suture anchor is provided pre-loaded on the specifically designed disposable driver.
The new SnugFit All-Suture Anchor size 1 is available in two (2) different configurations depending on the driver length (long and short).
V. Indications for Use
MectaLock All-Suture Anchor -
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
-SnugFit All-Suture Anchor
The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair ●
- Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair ●
VI. Comparison of Technological Characteristics
The only differences between the subject MectaLock All-Suture Anchor and the SnugFit All-Suture Anchor size 2, with respect to their related predicate devices (K193461 and K203485, respectively), lie in the driver design (suture locking system and interface between the plastic handle and the metal shaft), that has not any impact on devices' safety and performance.
The subject SnugFit All-Suture Anchor size 1 is substantially equivalent to the predicate device, SnugFit All-Suture Anchor (K203485), with regards to the following characteristics:
- Indication for use:
- Size:
- Pre-loaded sutures: ●
- Deployment and fixation mechanism; ●
- Materials (except for the driver clipping mechanism);
- Biocompatibility:
- Device usage:
- Sterility:
- Shelf-life:
- Packaging. .
The subject SnugFit All-Suture Anchor size 1 differs respect to the predicate, SnugFit All-Suture Anchor (K203485), with regards to the following characteristics:
- Anchors diameter;
5
. Driver design.
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
Medacta International SA has not made any change to the indications for use, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices with respect to the predicate devices.
Based on the comparison of technological characteristics and performance data provided within this submission, no new risks are associated with the driver design change of the MectaLock All-Suture Anchor (K193461) and SnugFit All-Suture Anchor size 2 (K203485), and the data supports the substantial equivalence of the new SnugFit All-Suture Anchor Size 1 implants to the identified predicate device.
Performance Data VII.
Based on the risk analysis, performance testing was conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- PERFORMANCE TESTING ●
- 0 SnugFit Size 1 Ø1.8 and SnugFit Size 1 Ø1.4 Substantial Equivalence Assessment;
- o MR Safety evaluation SnugFit All-Suture Anchor.
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is O equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free. o
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Conclusion VIII.
The information provided above supports that the subject devices are substantially equivalent to the predicate devices.