(304 days)
Not Found
No
The summary describes a mechanical suture system and does not mention any computational or data-driven components indicative of AI/ML.
Yes
This device is a therapeutic device because its intended use is to facilitate meniscal repairs and allograft transplant procedures, which are medical interventions aimed at treating a condition or injury.
No
The device is described as a "suture retention device to facilitate percutaneous or endoscopic soft tissue procedures" and is intended for use in "meniscal repairs and allograft transplant procedures." This indicates it is a surgical tool used for treatment, not for diagnosing a medical condition.
No
The device description clearly outlines physical components like a launcher, anchors, suture, needle, and sheath, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The MENIX® / MENIX® DUO Meniscal Suture Systems are surgical devices used to physically repair or anchor tissue within the body (specifically the meniscus). They are implants and delivery systems for those implants.
- Intended Use: The intended use clearly states they are "suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures" and are used for "meniscal repairs and allograft transplant procedures." This is a surgical function, not a diagnostic one based on analyzing bodily specimens.
The provided information describes a surgical implant and its delivery system, not a device that performs tests on samples outside the body.
N/A
Intended Use / Indications 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® 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.
Product codes
GAT
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus, meniscal rim
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)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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).
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
2
Indications for Use
510(k) Number (if known) K223122
Device Name MENIX® / MENIX® DUO
Indications for Use (Describe)
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.
| 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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3
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) -
4
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
5
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
6
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.