(23 days)
K 122436
K 122436
No
The description focuses on the physical components and mechanical function of the mesh and positioning system, with no mention of AI or ML.
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
Explanation: The device is indicated for the reconstruction of soft tissue deficiencies and for facilitating the delivery of soft tissue prosthetics during laparoscopic hernia repair. It is a permanently implantable mesh with an attached positioning system, designed for treatment (repair of hernias) rather than diagnosis.
No
The device description clearly outlines physical components including mesh, a positioning system (balloon), an inflation assembly, and an introducer tool, none of which are software-only.
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, such as for the repair of hernias." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "permanently implantable mesh with a pre-attached disposable mesh positioning system." This is a physical implant and a tool for its delivery during surgery.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or calibrators.
- Being used in a laboratory setting.
The device is a surgical implant and delivery system, not a diagnostic tool used to test samples outside the body.
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 facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Product codes
FTL, OQL, GCJ
Device Description
The proposed Ventralight™ ST Mesh with Echo PS™ Positioning System is comprised of a permanently implantable mesh with a pre-attached disposable mesh positioning system (mesh deployment balloon). All product sizes include an inflation assembly to be used with the mesh positioning system and some will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the entire mesh/positioning system assembly.
The Ventralight™ ST Mesh is a low profile, sterile, single use device 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 30days. The Ventralight ST Mesh to be used with the proposed device is identical to that cleared via K 122436.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon that is preattached to the mesh and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement. 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 K122436.
For user convenience, specific sizes of the proposed product will also include an Introducer Tool which is intended to facilitate delivery to the operative site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K122436 which consists of a handle with a thin stainless steel rod and a Tcap. 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, 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 previously conducted (as presented via K122436) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 122436
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K130968
page 1/3
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 0 1 2013
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 |
| Senior International Regulatory Affairs Specialist | |
| Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8575 |
| Fax: | (401) 825-8765 |
| Email: | Keti.sino@crbard.com |
| Device Name: | |
| Trade Name: | Ventralight™ ST Mesh with Echo PST™ |
| 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 with Echo PS ™ Positioning System, K 122436 (Davol Inc.), . FDA cleared on 11/02/2012
Device Description:
The proposed Ventralight™ ST Mesh with Echo PS™ Positioning System is comprised of a permanently implantable mesh with a pre-attached disposable mesh positioning system (mesh deployment balloon). All product sizes include an inflation assembly to be used with the mesh positioning system and some will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the entire mesh/positioning system assembly.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
SECTION 8
34
, I
. 11:4
1
K130968 Page 2/3
The Ventralight™ ST Mesh is a low profile, sterile, single use device 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 30days. The Ventralight ST Mesh to be used with the proposed device is identical to that cleared via K 122436.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon that is preattached to the mesh and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement. 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 K122436.
For user convenience, specific sizes of the proposed product will also include an Introducer Tool which is intended to facilitate delivery to the operative site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K122436 which consists of a handle with a thin stainless steel rod and a Tcap. 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 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 to be utilized with Echo PSTM Positioning System for the proposed device has the same indications for use and performance characteristics as the mesh cleared via the predicate K 122436.
The proposed Echo PSTM Positioning System maintains the same intended use and performance characteristics as the Echo PSTM Positioning System cleared via the predicate K122436.
The proposed modification to the device is a line extension to offer four (4) additional sizes of Ventralight STTM Mesh with Echo PSTM Positioning System. The new codes will also include an Introducer Tool (where applicable) and inflation assembly, both identical to those previously cleared under the predicate K122436.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
SECTION 8
2
K130968 page 3/3
Performance Data:
Biocompatibility testing previously conducted (as presented via K122436) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.
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.
PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM
· SECTION 8
રૂદ
3
Image /page/3/Picture/0 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 an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 1, 2013
C.R. Bard, Inc % Davol. Inc. Keti Sino Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K130968
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: April 05, 2013 Received: April 08, 2013
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. Ilsting 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 vour 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
4
Page 2 - Keti Sino
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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D库Ruimm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130968
Device Name:
Ventralight™ STMesh with Echo PSTM Positioning System
Indications For Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number:K130968
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