(9 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a hernia mesh and positioning system. There is no mention of AI, ML, or any computational processing of data for diagnosis, treatment planning, or device operation.
Yes
The device is indicated for the reconstruction of soft tissue deficiencies, such as for the repair of hernias, which is a therapeutic purpose.
No
This device is a surgical implant (hernia repair mesh) with an associated delivery system, used for the reconstruction of soft tissue deficiencies. It is not intended to diagnose conditions or diseases.
No
The device description clearly outlines physical components including mesh, a positioning system (balloon), and an introducer tool, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstruction of soft tissue deficiencies, specifically hernia repair. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a mesh and positioning system designed to be implanted into the body during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is a surgical implant and delivery system, not a diagnostic tool used on in vitro samples.
N/A
Intended Use / Indications for Use
The Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL, OQL, GCJ
Device Description
The proposed Ventralight™ ST Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). All sizes of the proposed product with the exception of the largest size will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the mesh/positioning system assembly.
The Ventralight™ ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K102766. The positioning system is an RF welded nylon balloon that is pre-attached to the mesh via the use of polycarbonate connectors, and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Ventralight™ ST Mesh. The positioning system is inflated via use of the included inflation assembly, which is also identical to that cleared with the predicate positioning system under K102766.
For user convenience, all sizes of the proposed product with the exception of the largest size also include an Introducer Tool which is intended to facilitate delivery to the operative site. The largest configuration of the proposed product, the 12" x 14" size does not include an Introducer Tool as this size is recommended for deployment directly through a trocar incision site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K102766 which consists of a handle with a thin stainless steel rod and a T-cap. The device is split into two pieces along the length of the entire rod and attached on one end to the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue deficiencies, hernias
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)
Biocompatibility testing in accordance to ISO 10993-1 standards was conducted on the proposed device (mesh and positioning system) and the results indicate that the device is biocompatible per these standards.
No biocompatibility testing was conducted on the Introducer Tool to be packaged with the proposed device as the 304 Stainless Steel material used for the rolling tines is a recognized biocompatible material as per ASTM F899 - 09e1 Standard Specification for Wrought Stainless Steels for Surgical Instruments. In addition, the polymer handle attached to the rolling tines and the T-cap is non patient contacting, and therefore, not subject to biocompatibility testing requirements.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate devices.
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
§ 878.3300 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
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR - 1 2011
This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information:
| Submitter's Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Contact Person: | Keti Sino |
| Regulatory Affairs Specialist | |
| Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8575 |
| Fax: | (401) 825-8763 |
| Email: | Keti.sino@crbard.com |
| Device Name: | |
| Trade Name: | VentralightTM ST Mesh with Echo PSTTM |
| Positioning System | |
| Common/Usual Name: | - Surgical Mesh |
| - Endoscope & Accessories | |
| - Mesh Deployment Balloon | |
| Classification Name: | - Mesh, Surgical, Polymeric |
| - Mesh Deployment Balloon | |
| - Laparoscope, General & Plastic Surgery | |
| Classification Code: | - Class II, § 878.3300, Product Code FTL |
| Subsequent Codes: | - Class II, § 878.3300, Product Code OQL |
| - Class II, § 876.1500, Product Code GCJ |
Predicate Device Names:
- Ventralight™ ST Mesh, K101851 (Davol Inc.), FDA cleared on 07/15/2010 .
- Composix™ L/P Mesh with Echo PS™ Positioning System, K102766 (Davol Inc.), . FDA cleared on 12/16/2010
Device Description:
The proposed Ventralight™ ST Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). All sizes of the proposed product with the exception of the largest size will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the mesh/positioning system assembly.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
-CONFIDENTIAL-SECTION 8
1
K110820 page 2/3
The Ventralight™ ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K102766. The positioning system is an RF welded nylon balloon that is pre-attached to the mesh via the use of polycarbonate connectors, and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Ventralight™ ST Mesh. The positioning system is inflated via use of the included inflation assembly, which is also identical to that cleared with the predicate positioning system under K102766.
For user convenience, all sizes of the proposed product with the exception of the largest size also include an Introducer Tool which is intended to facilitate delivery to the operative site. The largest configuration of the proposed product, the 12" x 14" size does not include an Introducer Tool as this size is recommended for deployment directly through a trocar incision site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K102766 which consists of a handle with a thin stainless steel rod and a T-cap. The device is split into two pieces along the length of the entire rod and attached on one end to the handle.
Intended Use:
The Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The Ventralight™ ST Mesh and the predicate mesh have the same indication: reconstruction of soft tissues deficiencies such as the repair of hernias. Further, the proposed product has the same intended use, physical attributes, and performance characteristics, as the predicate Ventralight™ ST Mesh.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
-CONFIDENTIAL SECTION 8
2
K110820 Page 3/3
The Echo PSTM Positioning System maintains the same intended use, physical attributes, and performance characteristics, as the cleared Echo PSTM Positioning System (K102766). Further, the included inflation assembly intended to be used for the purposes of inflating the positioning system is also identical to the inflation assembly cleared under K102766.
The proposed product will combine into one the currently marketed Ventralight™ ST Mesh cleared under K101851, preassembled with the currently marketed Echo PSTM Positioning System cleared as part of K102766. The proposed product will also include an Introducer Tool and inflation assembly, both identical to those previously cleared as part of the positioning system predicate (K102766).
Performance Data:
Biocompatibility testing in accordance to ISO 10993-1 standards was conducted on the proposed device (mesh and positioning system) and the results indicate that the device is biocompatible per these standards.
No biocompatibility testing was conducted on the Introducer Tool to be packaged with the proposed device as the 304 Stainless Steel material used for the rolling tines is a recognized biocompatible material as per ASTM F899 - 09e1 Standard Specification for Wrought Stainless Steels for Surgical Instruments. In addition, the polymer handle attached to the rolling tines and the T-cap is non patient contacting, and therefore, not subject to biocompatibility testing requirements.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate devices.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
-CONFIDENTIAL-SECTION 8
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized and abstract.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C. R. Bard, Inc. % Davol, Inc. Keti Sino 100 Crossings Boulevard Warwick, Rhode Island 02886
APR - 1 2011
Re: K110820 .
Trade/Device Name: Ventralight™ ST Mesh with Echo PS™ Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OQL, GCJ Dated: March 22, 2011 Received: March 23, 2011
Dear Keti Sino:
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. 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
4
Page 2 – Keti Sino
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 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/ReportalProblem/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.
Aj B. n h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STATEMENT
K 110820 510(k) Number (if known):
Device Name:
Ventralight™ ST Mesh with Echo PSTM Positioning System
Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hemia repair.
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 Kraefer MXM
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110820