(500 days)
Not Found
No
The device description and performance studies focus on the material properties, mechanical strength, and clinical outcomes of a surgical suture, with no mention of AI or ML technologies.
No.
The device is a surgical suture used for approximation and/or ligation of soft tissues, not for treating a disease or condition itself.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a polyfilament, synthetic, non-absorbable, sterile surgical suture, which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Duramesh™ Mesh Suture is for "general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy." This describes a surgical device used directly on the patient's body during a procedure.
- Device Description: The description details a "polyfilament, synthetic, non-absorbable, sterile surgical suture." This is a physical material used for stitching tissues together.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information about Duramesh™ does not mention any testing of biological samples or diagnostic purposes.
Therefore, based on the provided information, Duramesh™ Mesh Suture is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, tendon, midline laparotomy (where the bowel is not entered)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / 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)
Bench Data:
- DURAMESH™ passes prospectively defined acceptance criteria for needle attachment strength and tensile strength per FDA-recognized consensus standards USP43-NF38: 2020 Sutures - Needle Attachment and USP43-NF38: 2020 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:
- Study Type: Two large-animal porcine implantation studies for midline incision closure of 1- and 3-month durations.
- Key Results: DURAMESH™ was able to close a midline incision with either a running or interrupted 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:
- Study Type: Single-investigator clinical trial.
- Sample Size: 53 patients with 80 individual surgery sites treated with DURAMESH™. 15 of these subjects had a 12-month assessment. A cohort of 11 patients who underwent similar orthopedic procedures with standard sutures was used for comparison.
- Key Results: The primary outcome showed no early or late SSO (surgical site occurrence). 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™.
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.
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.
Not Found
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
§ 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.
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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| 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
Contact Details
| Applicant Name | MSi |
|---|---|
| Applicant Address | One Magnificent Mile |
| 980 N. Michigan Ave. | |
| Suite 1400 | |
| Chicago, IL 60611 | |
| United 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.
4
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.
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 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. | Sharpoint™ polypropylene suture is | |
| indicated for general soft tissue | ||
| approximation and/or ligation, including use | ||
| in cardiovascular, ophthalmic and | ||
| neurological procedures. | ||
| Design, needle | Grade 470 surgical needle with standardized | |
| shapes and sizes | Grade 470 surgical needle with standardized | |
| shapes and sizes | ||
| Design, suture | ||
| body | Polyfilament suture comprised of 12 to 18 | |
| polypropylene filaments loosely braided to | ||
| form a hollow cylinder with outer wall 1.5 | ||
| mm to 4 mm in diameter. Diameter changes | ||
| with lateral or axial tension. | Monofilament suture with filament diameter | |
| ranging from 0.03 mm to 0.5 mm. Diameter | ||
| does not change with lateral or axial tension | ||
| Natural / Synthetic | Synthetic | Synthetic |
Comparison Table
5
| Material | Isotactic polypropylene polymer of high
molecular weight, Phthalocyaninato (2-)
Copper | Isotactic polypropylene polymer of high
molecular weight, Phthalocyaninato (2-)
Copper |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
| Available Size
Range | USP 2-0 through 2 (oversized) | USP 10-0 through 1 |
| Specifications and
Properties | Each size exceeds USP minimums for knot-
pull tensometry (USP ) and needle
attachment tensometry (USP ). Does
not follow USP for diameter (USP );
the suture is oversized in diameter. | Each size exceeds USP minimums for knot-
pull tensometry (USP ) and needle
attachment tensometry (USP ). Does
not follow USP for diameter (USP ) |
| Principle of
Operation | The implant is threaded through two or
more separated tissues with the aid of a
surgical needle driver. The surgical needle
pierces the tissue to allow the trailing suture
body to be threaded. The surgeon applies
axial tension on the implant thereby
approximating the separated tissues.
Tension is maintained with a self-holding
knot created by the surgeon. | The implant is threaded through two or
more separated tissues with the aid of a
surgical needle driver. The surgical needle
pierces the tissue to allow the trailing suture
body to be threaded. The surgeon applies
axial tension on the implant thereby
approximating the separated tissues.
Tension is maintained with a self-holding
knot created by the surgeon. |
| Absorption /
residual strength | Polypropylene suture is not absorbed, nor is
there any significant change in tensile | Polypropylene suture is not absorbed, nor is
there 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 - 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,
6
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 Sutures - Needle Attachment and USP43-NF38: 2020 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
7
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.