Duramesh™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. Duramesh™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

Device Description

DURAMESH™ is a polyfilament, synthetic, non-absorbable, sterile surgical suture composed of isotactic polypropylene polymer of high molecular weight. The suture is provided dyed (blue) and is uniform in appearance. The blue dye pigment is Phthalocyaninato (2-) Copper. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical suture, except for diameter.

DURAMESH™ is passed on either side of tissues using an attached swaged needle as an introducing agent and tied to itself with at least two knots composed of two throws each to maintain tension.

DURAMESH™ is supplied sterile and is available with two needle configurations (small and large) in four USP sizes (2-0 through 2), each with a length of approximately 36 inches (91 cm). Each box contains one DURAMESH™ housed in a Tyvek envelope within which the DURAMESH™ is packaged in a sterile protective medical grade tube fixed to a sterile card.

AI/ML Overview

The provided text does not describe an AI/ML medical device, but rather a surgical suture (DURAMESH™ Mesh Suture). Therefore, the concepts of acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC), sample size for test/training sets in an AI/ML context, number of experts for ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the DURAMESH™ Mesh Suture to a predicate device based on material, design, performance, and biological safety. The "acceptance criteria" here refer to the product's ability to meet medical device standards and show equivalence to a predicate, not AI/ML model performance metrics.

Specifically, the "Bench Data" section on page 6 mentions some performance criteria for the suture:

Needle attachment strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 <871> Sutures - Needle Attachment.
Tensile strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 <881> Sutures - Tensile Strength. It also meets USP requirements under simulated surgical deployment, cycle loading, and dynamic loading.
Knot Size and Knot Strength: DURAMESH™ knots were stronger than predicate knots for the same number of throws. Knot security is achieved with 4 throws as per labeling.
Diameter: Diameter decreases with increasing axial load.
"Stripped" samples: Maintain adequate tensile strength to satisfy USP requirements.

The document also describes:

Biocompatibility testing: Per ISO 10993-1, ISO 14971, and 2020 FDA Biocompatibility Guidance, showing biocompatibility based on various tests (cytotoxicity, sensitization, etc.).
Packaging testing: According to ASTM D4169-16 and ASTM F1929-15.
Sterilization: Ethylene Oxide sterilization following AAMI TIR28:2016 and ISO 11135:2014, meeting ISO 10993-7: 2008 limits for residuals.
Shelf-Life: Accelerated and real-time aging stability testing supports a 5-year shelf life with no loss of tensile strength.
Animal Data: Two large-animal porcine implantation studies (1- and 3-month) assessed adverse tissue reaction and dehiscence. Outcomes showed successful closure, tissue ingrowth, and slight irritation compared to standard polypropylene suture.
Clinical Data: A single-investigator clinical trial with 53 patients (80 surgical sites).
- Primary outcome: Surgical site occurrence (SSO). No early or late SSO observed.
- Secondary outcomes: Device-related rehospitalization, return to OR, and wounds. No such events occurred.
- Long-term assessment (12-month): 15 subjects compared to 11 patients with standard sutures, showing equivalent or slightly improved outcomes with DURAMESH™.

Given this context, I cannot generate a response that directly addresses the prompt's specific requirements for AI/ML device acceptance criteria and study design, as the provided document is not about an AI/ML device.

Summary

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September 2, 2022

MSi Greg Dumanian Medical Officer One Magnificent Mile 980 N. Lake Shore Drive, Suite 1400 Chicago, Illinois 60611

Re: K211178

Trade/Device Name: DURAMESH™M Mesh Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: April 19, 2022 Received: April 20, 2022

Dear Greg Dumanian:

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

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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 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 medical devices and radiation-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,

for Deborah Fellhauer, RN, BSN, CQIA Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K211178

Device Name Duramesh™ Mesh Suture

Indications for Use (Describe)

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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510(k) Summary

Contact Details

Applicant Name	MSi
Applicant Address	One Magnificent Mile980 N. Michigan Ave.Suite 1400Chicago, IL 60611United States of America
Applicant Contact Telephone	202 737 9633
Applicant Contact	Jeffrey Shapiro
Applicant Contact Email	JShapiro@hpm.com
Date Prepared	September 2, 2022
Device Name
Device Trade Name	Duramesh™ Mesh Suture
Common Name	Surgical Suture
Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation Number	878.5010
Product Code	GAW

Legally Marketed Predicate Device

Predicate #	Predicate Trade Name
K131224	SharpointTM polypropylene suture

Indications for Use

DURAMESH™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. DURAMESH™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

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Device Description

DURAMESH™ is passed on either side of tissues using an attached swaged needle as an introducing agent and tied to itself with at least two knots composed of two throws each to maintain tension.

Intended Purpose

DURAMESH™ is a permanent implant intended for single use by surgeons for the purpose of approximating soft tissues such as muscle, tendons, ligaments, and fascia with the exception of epithelial tissues such as skin, bowel, viscera and bladder mucosa. DURAMESH™ is not to be used in the closure of skin and other epithelial tissues, in the treatment of pelvic organ prolapse and stress urethral incontinence, as a dural substitute in intracranial or spinal surgery, in the closure of infected or dirty CDC Class IV wounds, or when an allergy to polypropylene is present. DURAMESH™ is not designed to be removed.

	Subject Device	Predicate Device (K131224)
Trade Name	DURAMESH™	Sharpoint™ polypropylene suture
Indications for use	DURAMESH™ Mesh Suture is indicatedfor general soft tissue approximation and/orligation in clean (CDC Class I) wounds,including tendon repair and midlinelaparotomy where the bowel is not entered.DURAMESH™ is not for use in the skinand other epithelial surfaces,cardiovascular, ophthalmic, and/orneurological procedures.	Sharpoint™ polypropylene suture isindicated for general soft tissueapproximation and/or ligation, including usein cardiovascular, ophthalmic andneurological procedures.
Design, needle	Grade 470 surgical needle with standardizedshapes and sizes	Grade 470 surgical needle with standardizedshapes and sizes
Design, suturebody	Polyfilament suture comprised of 12 to 18polypropylene filaments loosely braided toform a hollow cylinder with outer wall 1.5mm to 4 mm in diameter. Diameter changeswith lateral or axial tension.	Monofilament suture with filament diameterranging from 0.03 mm to 0.5 mm. Diameterdoes not change with lateral or axial tension
Natural / Synthetic	Synthetic	Synthetic

Comparison Table

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Material	Isotactic polypropylene polymer of highmolecular weight, Phthalocyaninato (2-)Copper	Isotactic polypropylene polymer of highmolecular weight, Phthalocyaninato (2-)Copper
SterilizationMethod	Ethylene Oxide	Ethylene Oxide
Available SizeRange	USP 2-0 through 2 (oversized)	USP 10-0 through 1
Specifications andProperties	Each size exceeds USP minimums for knot-pull tensometry (USP <881>) and needleattachment tensometry (USP <871>). Doesnot follow USP for diameter (USP <861>);the suture is oversized in diameter.	Each size exceeds USP minimums for knot-pull tensometry (USP <881>) and needleattachment tensometry (USP <871>). Doesnot follow USP for diameter (USP <861>)
Principle ofOperation	The implant is threaded through two ormore separated tissues with the aid of asurgical needle driver. The surgical needlepierces the tissue to allow the trailing suturebody to be threaded. The surgeon appliesaxial tension on the implant therebyapproximating the separated tissues.Tension is maintained with a self-holdingknot created by the surgeon.	The implant is threaded through two ormore separated tissues with the aid of asurgical needle driver. The surgical needlepierces the tissue to allow the trailing suturebody to be threaded. The surgeon appliesaxial tension on the implant therebyapproximating the separated tissues.Tension is maintained with a self-holdingknot created by the surgeon.
Absorption /residual strength	Polypropylene suture is not absorbed, nor isthere any significant change in tensile	Polypropylene suture is not absorbed, nor isthere any significant change in tensile
profile	strength retention known to occur in vivo.	strength retention known to occur in vivo.

DURAMESH™ has the same principles of operation as its predicate device and achieves soft tissue approximation and/or ligation with substantial equivalence to its predicate. Like its predicate. DURAMESH™ is introduced through tissues with an attached needle in order to achieve soft tissue approximation and/or ligation. Like its predicate, DURAMESH™ is tied with self-holding knots to maintain the required tension for tissue approximation. DURAMESH™ is made of polypropylene and is identical to the predicate in its synthetic material of fabrication and material chemical composition. Both DURAMESH™ and its predicate are sterilized with Ethylene Oxide, are not absorbed, and have no known significant changes in tensile strength occurring in vivo. The DURAMESH™ Indications for use specify use in clean wounds and exclude use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures while the predicate indications for use do not. DURAMESH™ differs from its predicate device in its design: it is a polyfilament mesh suture composed of multiple braided predicate filaments separated by air, while its predicate is a solid monofilament suture. The DURAMESH™ outer diameter is oversized compared to the predicate's, and changes with axial or lateral tension while the predicate diameter does not change. DURAMESH™ is available in USP sizes 2-0 through 2 with oversized outer diameters while the predicate is available in USP sizes 10-0 through 1 and has USP <861> - compliant outer diameters.

Non-Clinical Data

Biocompatibility

A biological risk assessment of DURAMESH™ was performed according to the requirements of the current ISO 10993-1, ISO 14971, and the 2020 FDA Biocompatibility Guidance. Based on cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, rabbit pyrogen,

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genotoxicity, muscle implantation, and chemical characterization studies, DURAMESH™ was shown to be biocompatible per ISO 10993-1 for use as intended.

Packaging

Transport testing for DURAMESH™ in the final packaging and shipping configuration was conducted according to ASTM D4169-16, standard practice for performance testing of shipping containers and systems. Protection of the primary container (sterility) was confirmed via ASTM F1929 - 15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

Sterilization

DURAMESH™ is sterilized with Ethylene Oxide following AAMI TIR28:2016 guidelines [Product Adoption And Process Equivalence For Ethylene Oxide Sterilization]. The adoption standard augments ISO 11135:2014 |Sterilization of health-care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices]. DURAMESH™ meets the ISO 10993-7: 2008 limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) for implanted devices.

Shelf-Life

Accelerated and real-time aging stability testing was completed to support a 5-year shelf for DURAMESH™. Data support no loss of tensile strength over the proposed shelf life.

Bench Data

DURAMESH™ passes prospectively defined acceptance criteria for needle attachment strength and tensile strength per FDA-recognized consensus standards USP43-NF38: 2020 <871> Sutures - Needle Attachment and USP43-NF38: 2020 <881> Sutures - Tensile Strength, respectively. DURAMESH™ diameter decreases with increasing axial load per Diameter vs. Load attribute testing. In Knot Size and Knot Strength testing, DURAMESH™ knots were shown to be stronger than predicate knots for the same number of throws. Testing shows that DURAMESH™ knot security is achieved with 4 throws as recommended in DURAMESH™M labeling. DURAMESH™ passes prospectively defined acceptance criteria for tensile strength, per USP requirements, under three separate loading conditions: simulated surgical deployment, cycle loading, and dynamic loading. An internal company study demonstrated that "stripped" samples of DURAMESH™ (with a loss of bonds between filaments) maintain adequate tensile strength to satisfy USP requirements.

Animal Data

Two large-animal porcine implantation studies for midline incision closure of 1- and 3-month durations were performed with endpoints of adverse tissue reaction (manifesting as excessive fibrosis, bowel adhesions, and infection) and dehiscence. In the 1- month and 3-month porcine studies, DURAMESH™ was able to close a midline incision with either a running or interrupted

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suturing technique. DURAMESH™ exhibited tissue ingrowth and implant incorporation and was a slight irritant in comparison to standard polypropylene suture on semi-quantitative histology.

Clinical Data

Implantation of DURAMESH™ was performed in a single-investigator clinical trial of 53 patients with 80 individual surgery sites treated with DURAMESH™. The primary outcome was surgical site occurrence (SSO). Secondary outcomes included subject device related rehospitalization and return to the operating room, and wounds for any reason.

Fifteen of the total 53 DURAMESH™ subjects were brought back for a long-term assessment (12-month) of healing, function, pain, and quality of life. The remaining 38 subjects did not have evaluation at the 12-month endpoint. The 15 subjects were compared to a cohort of 11 patients who underwent similar orthopedic procedures for cerebral palsy with standard sutures.

The primary outcome showed no early or late SSO. Secondary outcomes showed no DURAMESH™ related rehospitalization or return to the operating room, and no wounds for any reason. One-year cohort comparison of DURAMESH™ to non-DURAMESH™ patients demonstrated equivalent or slightly improved outcomes with DURAMESH™.

Conclusion

All data and information lead to the conclusion that, despite the technological difference of polyfilament mesh suture versus monofilament suture design, DURAMESH™ is substantially equivalent to the predicate device for the proposed indications for use.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.