The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydroCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse, and other fascial deficiencies that require support material.

Device Description

The HydroCoat Mesh is a polypropylene surgical mesh coated with polyurethane and intended for trauma and reconstructive surgical procedures involving soft tissues. The HydroCoat Mesh is fabricated from a knitted monofilament, medical-grade polypropylene fiber that links each porous window of the mesh, allowing for elasticity in both directions. The HydroCoat Mesh is available in various shapes and sizes for use in reinforcing soft tissues where weakness exists. The HydroCoat Mesh can be cut to most any shape or size for specific soft tissue reinforcement needs.

The Promethean Surgical Devices HydroCoat Mesh is provided in various shapes such as rectangles, ovals, ellipticals and circles and will be provided in other shapes and sizes as needed for particular soft tissue reinforcement applications. The Promethean Surgical Devices HydroCoat Mesh is provided in sheets of various shapes and sizes as outlined in the table below:

Rectangular	Square	Elliptical	Oval	Round	Keyhole.
12" x 12"	12" x 12"	12" x 10"	12" x 9"	8" diameter	1.5" x 8"
12" x 10"	10" x 10"	10" x 8"	10" x 7"	6" diameter	3" x 7"
10" x 8"	8" x 8"	8" x 6"	8" x 5"	5" diameter
8" x 6"	6" x 6"	7" x 5"	7" x 4"	4" diameter
7" x 5"	4" x 4"	6" x 4"	6" x 3"	3" diameter
6" x 4"		5" x 3"	5" x 2"
5" x 3"		4" x 2"	4" x 1"
4" x 2"

The thickness of the Promethean Surgical Devices HydroCoat Mesh ranges from 0.015" to 0.030" (0.38mm to 0.76mm) according to the region to be treated. The Promethean Surgical Devices HydroCoat Mesh is provided in flat sheets that contain micropores that range in size from 3mm2-to 5mm. The HydroCoat Mesh has an overall areal density of 1.1001 oz/yd2 (37.3 g/m2).

AI/ML Overview

The provided document is a 510(k) premarket notification for the Promethean HydroCoat Mesh. This type of regulatory submission establishes substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a new drug or novel medical device. Therefore, the information typically requested in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, ground truth types) is generally not found in a 510(k) submission focused on substantial equivalence based on design and in vitro testing.

The document primarily focuses on demonstrating that the HydroCoat Mesh is substantially equivalent to existing, legally marketed predicate devices, particularly in terms of intended use, design, materials, and mechanical properties (through in vitro testing).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of explicit quantitative acceptance criteria with corresponding device performance metrics in the format you might expect from a clinical or performance study. Instead, the "acceptance criteria" are implicitly defined by the properties of the predicate devices. The "reported device performance" is the HydroCoat Mesh's demonstrated substantial equivalence to these predicates through in vitro mechanical testing.

Acceptance Criteria (Implicit, based on Predicate Devices)	Reported Device Performance (HydroCoat Mesh)
Intended Use: For general surgical procedures for reinforcement of soft tissue where weakness exists (e.g., abdominal wall hernia, uterovaginal prolapse, fascial deficiencies).	Substantially Equivalent to Predicates: "The HydroCoat Mesh and the predicate devices are substantially equivalent with respect to their indications for use as they are all indicated for the same general surgery procedures requiring the reinforcement of soft tissues in the same peritoneal anatomy."
Design: Thin, flat sheets of various shapes/sizes, cuttable with surgical scissors, fabricated from polymeric fiber knitted into a meshed network with uniform pattern of holes.	Substantially Equivalent to Predicates: "The design of the Promethean Surgical Devices HydroCoat Mesh and the [predicate devices] are substantially equivalent as they are all thin, flat sheets of various shapes and sizes that can be cut to shape with surgical scissors and are all fabricated from a polymeric fiber that is knitted into a pattern that creates a meshed network of yarn with a uniform pattern of holes." Specific design features are shared: polypropylene fiber (with Mpathy Medical Minimesh, Ethicon Mersilene Mesh) and polyurethane urea materials (with Mentor Suspend Sling, Artimplant AB SportMesh).
Materials: Consistency with materials used in predicate devices (e.g., polypropylene, polyurethane urea).	Substantially Equivalent to Predicates: "The HydroCoat Mesh is fabricated from a polypropylene yarn that is coated with a polyether urethane urea." This aligns with the material compositions of the predicate devices, where some use polypropylene, and others (or the HydroCoat Mesh itself) use polyurethane urea coatings. Explicitly, it states: "The Promethean Surgical Devices HydroCoat Mesh, the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh devices are substantially equivalent as they share a common design feature of being fabricated from a polypropylene fiber. The Promethean Surgical Devices HydroCoat Mesh and the Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K071887), and Artimplant AB SportMesh (K052830) predicate devices are substantially equivalent as they all share the design feature of utilizing a polyurethane urea materials."
Mechanical Strength: Comparable to predicate devices under indication for use conditions.	Reported Performance: "Mechanical testing was performed on the Promethean Surgical Devices HydroCoat Mesh which determined the HydroCoat Mesh to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." (Specific quantitative values are not provided in this summary, but the conclusion of equivalence is stated). The thickness (0.015" to 0.030"), micropore size (3mm2 to 5mm), and overall areal density (1.1001 oz/yd2) are also specified.

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

Test Set Sample Size: Not applicable in the context of this 510(k) summary for in vitro testing. The document states "Mechanical testing was performed," which implies samples of the HydroCoat Mesh were tested in a laboratory setting. Specific numbers of samples or experimental replicates are not provided.
Data Provenance: The testing was "in vitro" (laboratory-based). The location of the testing is not specified, but the manufacturer is based in East Hartford, CT, USA. The data would be prospective for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert clinical review) is not established in this type of submission. The comparison is against established mechanical properties of predicate devices and general engineering principles.

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

Not applicable. Adjudication methods are relevant for human-based evaluations (e.g., image interpretation), which are not described here.

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. This is a medical device (surgical mesh) and not an AI/diagnostic software. MRMC studies are not relevant for this device.

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

Not applicable. This is a physical surgical mesh, not an algorithm.

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

The "ground truth" for demonstrating substantial equivalence relies on the established technical characteristics (design, materials, indications for use) and mechanical performance of the predicate devices. The HydroCoat Mesh's in vitro mechanical testing results were compared to these established properties to demonstrate equivalence. It is not based on patient outcomes or expert clinical consensus for diagnostic performance.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device.

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

Not applicable. As there is no training set mentioned or implied.

Summary

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Promethean HydroCoat Mesh

090271

JAN 1 4 2010

1 83

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Promethean Surgical Devices 111 Roberts Street. Suite G2, East Hartford, CT 06108

Official Contact:

Kenneth K. Kleinhenz Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994

DEVICE NAME

Classification Name:

Trade/Proprietary Name:

HydroCoat Mesh

Surgical Mesh, Polymeric

ESTABLISHMENT REGISTRATION NUMBER

This is our first device applications to FDA. We will register and pay the fee within 30 days of FDA's approval/clearance of this device.

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 878.3300, Surgical Mesh are polymeric screens intended to be implanted to reinforce soft tissues. These devices are classified as Class II. Surgical Mesh have been assigned Product Code FTL.

INTENDED USE

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DEVICE DESCRIPTION

Rectangular	Square	Elliptical	Oval	Round	Keyhole.
12" x 12"	12" x 12"	12" x 10"	12" x 9"	8" diameter	1.5" x 8"
12" x 10"	10" x 10"	10" x 8"	10" x 7"	6" diameter	3" x 7"
10" x 8"	8" x 8"	8" x 6"	8" x 5"	5" diameter
8" x 6"	6" x 6"	7" x 5"	7" x 4"	4" diameter
7" x 5"	4" x 4"	6" x 4"	6" x 3"	3" diameter
6" x 4"		5" x 3"	5" x 2"
5" x 3"		4" x 2"	4" x 1"
4" x 2"

Material Composition

The Promethean Surgical Devices HydroCoat Mesh is fabricated from a polypropylene yarn that is coated with a polyether urethane urea.

In Vitro Testing

Mechanical testing was performed on the Promethean Surgical Devices HydroCoat Mesh which determined the HydroCoat Mesh to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.

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Page 3 of 3

3 of 3

8090271

EQUIVALENCE TO MARKETED PRODUCT

The Promethean Surgical Devices HydroCoat Mesh shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Mentor Suspend Sling (K980483). Artimplant AB SportMesh / Artelon Tissue Reinforcement (K071887), Artimplant AB SportMesh (K052830), the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh (pre-amendment); Class II medical devices that were cleared for marketing in the United States under K980483, K071887, K052830, K041632, and preamendment respectively.

Indications for Use

The HydroCoat Mesh and the predicate devices are substantially equivalent with respect to their indications for use as they are all indicated for the same general surgerv procedures requiring the reinforcement of soft tissues in the same peritoneal anatomy.

Design and Materials

The design of the Promethean Surgical Devices HydroCoat Mesh and the Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K071887), Artimplant AB SportMesh (K052830), the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh predicate devices are substantially equivalent as they are all thin, flat sheets of various shapes and sizes that can be cut to shape with surgical scissors and are all fabricated from a polymeric fiber that is knitted into a pattern that creates a meshed network of yarn with a uniform pattern of holes. The Promethean Surgical Devices HydroCoat Mesh, the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh devices are substantially equivalent as they share a common design feature of being fabricated from a polypropylene fiber. The Promethean Surgical Devices HydroCoat Mesh and the Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K071887), and Artimplant AB SportMesh (K052830) predicate devices are substantially equivalent as they all share the design feature of utilizing a polyurethane urea materials.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines, symbolizing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Promethean Surgical Devices, Inc. % Mr. Kenneth K. Kleinhenz Regulatory Affairs 111 Roberts Street, Suite G2 East Hartford, Connecticut 06108

JAN 1 4 2010

Re: K090271

Trade/Device Name: HydroCoat Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: January 05, 2010 Received: January 06, 2010

Dear Mr. Kleinhenz:

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. 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.

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Kenneth K. Kleinhenz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm.

Sincerely vours

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090271
pg 1 of 1

Indications for Use

Re: K090271

Device Name: HydroCoat Mesh

Indications for Use:

The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydroCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse and other fascial deficiencies that require support material.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K090271

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.