(53 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (all-suture anchor) and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The SnugFit All-Suture Anchor is an implantable device intended for fixation of soft tissue to bone and indicated for the treatment of hip and shoulder instability, rotator cuff repair, and biceps tenodesis, which are all therapeutic procedures.
No
This device, the SnugFit All-Suture Anchor, is described as an implantable device for surgical fixation of soft tissue to bone. Its purpose is treatment and repair, not diagnosis.
No
The device description explicitly states it is an "implantable device" composed of "sutures" and includes a "disposable stainless steel driver with a plastic handle." These are physical components, not software.
Based on the provided information, the SnugFit All-Suture Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical fixation of soft tissue to bone in the hip and shoulder. This is a surgical procedure performed in vivo (within the living body), not in vitro (outside the living body).
- Device Description: The device is an implantable surgical anchor made of sutures. It is designed to be placed within the body to secure tissues.
- 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 screening.
Therefore, the SnugFit All-Suture Anchor is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
MBI
Device Description
The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).
The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).
The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. 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 provided pre-loaded on the disposable driver.
The SnugFit 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 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
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
- SnugFit All-Suture Anchor Design Validation Report Test Report A1 according to Design о Validation Protocol M07.85.003 Nr. A1 and Evaluation forms
- PERFORMANCE TESTING
- MR Safety evaluation SnugFit All-Suture Anchor o
- Cyclic and load-to-failure properties of SnugFit All-Suture Anchor Test Report A2 o according to Test Protocol IL 07.09.575 Rev.1 and Empa Test Report No. 5214025866 1e
- 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
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation
Clinical Studies: - No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
JuggerKnot Soft Anchors, K150768, MectaLock All-Suture Anchor, K193461
Reference Device(s)
MectaLock PEEK Suture Anchor, K190474
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
January 19, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA, Inc. 3973 Delp Street Memphis, Tennessee 38118
Re: K203485
Trade/Device Name: SnugFit All-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: 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 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. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K203485
Device Name SnugFit All-Suture Anchor
Indications for Use (Describe)
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, Director of Quality and Regulatory, Medacta USA Date Prepared: November 25, 2020 Date Revised: January 19, 2021
II. Device
| Device Proprietary Name: | SnugFit All-Suture Anchor |
|---|---|
| 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:
-
JuggerKnot Soft Anchors, K150768, Biomet Manufacturing Corp.
The following has been identified as a secondary predicate device: -
MectaLock All-Suture Anchor, K193461, Medacta International SA
In addition, the following reference devices are referenced within the submission: -
MectaLock PEEK Suture Anchor, K190474, Medacta International SA A
IV. Device Description
The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).
The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to
4
create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).
The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. 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 provided pre-loaded on the disposable driver.
The SnugFit 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 sutures.
V. Indications for Use
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 SnugFit All-Suture Anchor and the predicate device share the following characteristics:
- anchor deployment and fixation mechanism;
- disposable driver design;
- materials;
- biocompatibility;
- device usage;
- sterility; and
- packaging.
The SnugFit All-Suture Anchor differs from the predicate device with respect to:
- . anchor sizes; and
- preloaded sutures.
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
5
- SnugFit All-Suture Anchor Design Validation Report Test Report A1 according to Design о Validation Protocol M07.85.003 Nr. A1 and Evaluation forms
- PERFORMANCE TESTING ●
- MR Safety evaluation SnugFit All-Suture Anchor o
- Cyclic and load-to-failure properties of SnugFit All-Suture Anchor Test Report A2 o according to Test Protocol IL 07.09.575 Rev.1 and Empa Test Report No. 5214025866 1e
- 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
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
Based on the information provided within this submission, the SnugFit All-Suture Anchor is 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.