The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.

Device Description

The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:

The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.
Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use

AI/ML Overview

The provided text is a 510(k) summary for the Menix®/Menix® Duo Meniscal Suture Systems. It describes a medical device and its equivalence to a predicate device, based on non-clinical performance data. This document does NOT describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it establish ground truth with human experts.

Therefore, I cannot provide information for most of the requested points, as they are not relevant to the content of this 510(k) summary. I can only provide details on the acceptance criteria and performance as they relate to the mechanical and biological testing for this specific type of medical device (surgical suture system).

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document states:

"The mechanical performance data demonstrates that MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)."
"All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe."

However, specific numerical acceptance criteria or the reported performance values (e.g., actual traction strength in Newtons or displacement in mm) are not provided in this summary. The table below reflects the general statements made.

Test Parameter	Acceptance Criteria	Reported Device Performance
Biocompatibility	Met ISO 10993-1 (2018) requirements through risk analysis; existing data and chemical characterization assessed.	"All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe."
Mechanical Performance	Performance specifications for traction strength and fatigue displacement traction strength, based on "state of the art (Baraber's studies)" and comparison to predicate device (FAST-FIX 360 Meniscal Repair System (K121861)).	"MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document for any of the tests (biocompatibility or mechanical performance).
Data Provenance: The device manufacturer (S.B.M. SAS) is located in Lourdes, France. The studies are non-clinical, likely laboratory-based. No mention of retrospective or prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document. The "ground truth" for this device's performance is established via standardized laboratory mechanical and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This document describes a medical device, not an AI/ML diagnostic or assistive tool. The comparison is between the new device's mechanical properties and those of a predicate device, using non-clinical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness relies on results from standardized mechanical performance tests (traction strength, fatigue displacement traction strength) and biocompatibility tests (per ISO 10993-1), compared against established specifications and a predicate device. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

Not applicable. This document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This document does not describe an AI/ML device that requires a training set.

Summary

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August 3, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

S.B.M. SAS (Science & Bio Materials) Anne Cospin-Latapie Quality & Regulatory Affairs Manager ZI du Monge Lourdes. 65100 France

Re: K223122

Trade/Device Name: Menix® / Menix® Duo Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: April 24, 2023 Received: April 27, 2023

Dear Anne Cospin-Latapie:

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

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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).

Sincerelv.

Jesse Muir -S

Jesse Muir, 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) K223122

Device Name MENIX® / MENIX® DUO

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5 - 510(K) SUMMARY 510(k) SUMMARY

1. SUBMITTER

S.B.M. SAS
SCIENCE & BIO MATERIALS
ZI du Monge
F 65100 LOURDES - FRANCE
Registration Number: 3004549189
Phone: +33 (0)5 62 42 21 01
Fax: +33 (0)5 62 42 21 00
Contact Person: Anne COSPIN-LATAPIE
e-mail : anne.cospin@sbm-fr.com
Date prepared: 30 September 2022

2. DEVICE

Trade Name of Device	MENIX® / MENIX® DUO
Common or Usual Name	Meniscal Suture System
Classification Name	Suture, nonabsorbable, synthetic, polyethylene
Regulation number	21 CFR 878.5000
Regulatory Class	II
Product Code	GAT

3. PREDICATE DEVICES (legally marketed devices to which equivalence is claimed)

FAST-FIX 360 Meniscal Repair System (K121861) -

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4. DEVICE DESCRIPTION

The devices included within this 510k are listed below:

Reference	Nom / Name	Cond. /Pack.
MEN0201901	MENIX® DUO Meniscal Suture System, 2 anchors	x1
MEN0201902	MENIX® Meniscal Suture System, 1 anchor	x1

The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:

The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.

Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use

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5. MATERIALS

Implant(s) Anchor: PEEK Suture: UHMWPE, chrome-cobalt-aluminum dye Launcher Needle: 316L steel Transparent cannula: Polyamide PEBAX® Handle & button: Polycarbonate

6. INDICATION FOR USE

The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® / MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

The MENIX ® / MENIX® DUO devices are intended for single use only.

7. PERFORMANCE DATA

The results of non-clinical testing, including biocompatibility, biological and mechanical performances, indicated that the device was functional within its intended use and equivalent to the predicate device.

The biocompatibility was evaluated according to the ISO 10993-1 (2018) through the risk analysis approach. Evaluation included assessment of existing data and chemical characterization. All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe.

The mechanical performance data demonstrates that MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861).

8. SUBSTANTIAL EQUIVALENCE

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The MENIX® & MENIX® DUO Meniscal Suture Systems were demonstrated to be substantially equivalent in indications and design characteristics to the following predicate device previously cleared by the FDA.

FAST-FIX 360 Meniscal Repair System (K121861) .
There are minor differences between the MENIX® & MENIX® DUO Meniscal Suture Systems and the predicate device like the size of the PEEK anchor and the shape of the suture (one uses round suture and one uses flat). Those differences do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

In conclusion, the MENIX® & MENIX® DUO Meniscal Suture Systems are substantially equivalent to their predicate device FAST-FIX 360 Meniscal Repair System.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.