(344 days)
Not Found
No
The device description focuses on the material properties, physical characteristics, and intended surgical use of a surgical mesh. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for the reinforcement of soft tissue where weakness exists, including the repair of various hernias and uterovaginal prolapse, which are therapeutic interventions.
No
Explanation: The device, HydroCoat Mesh, is described as a surgical mesh used for reinforcement of soft tissue, such as in hernia repair. Its intended use is for structural support during surgical procedures, not for identifying or assessing a disease or condition.
No
The device description clearly describes a physical surgical mesh made of polypropylene and polyurethane, available in various shapes and sizes. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reinforcement of soft tissue where weakness exists" in surgical procedures. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical mesh made of polypropylene and polyurethane, designed to be implanted for structural support.
- 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 text does not mention any testing of biological samples or diagnostic purposes.
The HydroCoat Mesh is a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
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: 12" x 12", 12" x 10", 10" x 8", 8" x 6", 7" x 5", 6" x 4", 5" x 3", 4" x 2"
Square: 12" x 12", 10" x 10", 8" x 8", 6" x 6", 4" x 4"
Elliptical: 12" x 10", 10" x 8", 8" x 6", 7" x 5", 6" x 4", 5" x 3", 4" x 2"
Oval: 12" x 9", 10" x 7", 8" x 5", 7" x 4", 6" x 3", 5" x 2", 4" x 1"
Round: 8" diameter, 6" diameter, 5" diameter, 4" diameter, 3" diameter
Keyhole: 1.5" x 8", 3" x 7"
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).
Material Composition: The Promethean Surgical Devices HydroCoat Mesh is fabricated from a polypropylene yarn that is coated with a polyether urethane urea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal wall hernia (including inguinal, femoral, and incisional hernia), uterovaginal prolapse, fascial deficiencies
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)
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.
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.
K980483, K071887, K052830, K041632
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
§ 878.3300 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.
0
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
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.
1
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).
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.
2
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.
3
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
4
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
5
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