(261 days)
No
The description focuses on the material composition, mechanical properties, and deployment mechanism of the mesh and positioning system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is indicated for use in the reconstruction of soft tissue deficiencies and repair of hernias, which directly involves treating a medical condition or altering the structure/function of the body.
No
Explanation: The device, the ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh, is described as a surgical mesh system intended for the reconstruction of soft tissue deficiencies, such as hernias. Its function is to facilitate the delivery and placement of a prosthesis, not to diagnose a condition.
No
The device is a physical mesh and a deployment system, not software.
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" and to "facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair." This describes a surgical implant and a delivery system used in vivo (within the body) for structural support and procedural assistance.
- Device Description: The description details a surgical mesh made of various materials and a deployment system. It focuses on the physical properties and how it is used 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 biological samples.
Therefore, the VENTRALIGHT™ ST Mesh with ECHO 2.0™ Lap System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL, ORQ, GCJ
Device Description
The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.
VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh 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 uncoated fascial side of the mesh allows for 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 that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, 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 pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
- Study type: Biocompatibility testing conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
- Key results: The following tests were required and leveraged from the primary predicate device: Cytotoxicity, Sensitization, Genotoxicity, Irritation, Pyrogenicity, Hemolysis, Local Effects, Acute Toxicity, Subchronic Toxicity. Required tests for externally communicating materials in the ECHO 2.0™ Lap System (
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, with three faces in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Davol Incorporated. Subsidiary of C. R. Bard Incorporated Mr. Andrew Harrell Regulatory Affairs Specialist September 18, 2015 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K143743
Trade/Device Name: ECHO 2.0" Lap System with VENTRALIGHT" ST Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, ORQ, GCJ Dated: August 14, 2015 Received: August 17, 2015
Dear Mr. Harrell:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143743
Device Name
ECHO 2.0TM Lap System with VENTRALIGHTTM ST Mesh
Indications for Use (Describe)
VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
The ECHO 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This 510(k) Summary has been prepared per the requirements of Section 21 CFR 807.92 on September 17th, 2015.
I. Submitter
| Submitter's Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Contact Person: | Andrew Harrell |
| Regulatory Affairs Specialist | |
| Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8472 |
| Fax: | (401) 825-8765 |
| Email: | andrew.harrell@crbard.com |
II. Device
| Trade Name: | ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh |
|---|---|
| Common/Usual Name: | Surgical Mesh; Mesh, Surgical, Deployer; Laparoscope, General |
| & Plastic Surgery; | |
| Classification Name: | Mesh, Surgical, Polymeric & Deployer |
| Product Classification: | Class II, § 878.3300, Product Code FTL |
| Class II, § 878.3300, Product Code ORQ | |
| Class II, § 876.1500, Product Code GCJ | |
| III. Predicate Devices |
- Bard® VENTRALIGHT™ ST Mesh with Echo PSTM Positioning System . (Primary Predicate)
- Minnesota Medical Development, Inc. (MMDI) REBOUND HRD V™ Hernia Mesh ● Device
- o K083467 (MMDI), FDA cleared on 04/23/2009
IV. Reference Device
- Genzyme Biosurgery COTTONY II Polyester Nonabsorbable Surgical Suture .
PREMARKET NOTIFICATION FOR THE ECHO 2.0™ LAP SYSTEM WITH VENTRALIGHT™ ST MESH K143743 SECTION 6
4
- o K021019 (Genzyme Corporation.), FDA cleared on 06/18/2002
V. Device Description
The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.
VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh 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 uncoated fascial side of the mesh allows for 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 that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, 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 pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.
VI. 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 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.
Comparison of Technological Characteristics with the Predicate Devices VII.
The proposed VENTRALIGHT™ ST Mesh with ECHO 2.0™ Lap System has the same intended use as the primary predicate device Bard® VENTRALIGHT™ ST Mesh with Echo PSTM Positioning System and a similar intended use as the REBOUND HRD VTM Hernia Mesh predicate device. Additionally, all devices (proposed and predicates) are intended for use in the reconstruction/reinforcement of soft tissue deficiencies.
The Ventralight™ ST Mesh utilized for the proposed device is identical to the primary predicate device Bard® VENTRALIGHT™ ST Mesh with Echo PS™ Positioning System and has the same indication for use, physical attributes, and performance characteristics.
PREMARKET NOTIFICATION FOR THE ECHO 2.0™ LAP SYSTEM WITH VENTRALIGHT™ ST MESH K143743 SECTION 6
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In regards to the deployment frame, both the proposed device and the primary predicate utilize the same nylon mesh connectors and similar nylon polyurethane material. The density and color of the nylon polyurethane material slightly differ between the proposed product and primary predicate. The proposed product utilizes smaller denier white nylon polyurethane with larger denier green nylon polyurethane "discs" at the mesh connector location unlike the primary predicate which only utilizes the larger denier green nylon polyurethane without discs for the deployment frame.
The proposed device and the primary predicate's deployment frame feature a pre-attached mechanism to aid in positioning the device over the center of the defect, however the materials used differ. To aid in centering the device, the primary predicate utilizes a pellethane inflation tube with a tecothane needle loop complex, however the proposed product utilizes a commercially available uncoated non-absorbable poly(ethylene) surgical suture.
The proposed device and the predicate REBOUND HRD V™ Hernia Mesh device utilize a nitinol material for the deployment frame, however the method of nitinol attachment differ. The REBOUND HRD V™ Hernia Mesh Device connects the ends of the nitinol material via a welding process. however the proposed device attaches the nitinol ends using a stainless steel crimp. Additionally, the nitinol deployment frame included with the REBOUND HRD V™ Hernia Mesh device is intended to be a part of the permanent mesh implant: however the nitinol deployment frame included with the proposed device has the same limited patient contact exposure as the primary predicate deployment frame.
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
VENTRALIGHT™ ST Mesh is considered a tissue-contacting, permanent implant. Therefore, the following tests are required and were leveraged from the primary predicate device (Bard" VENTRALIGHT™ ST Mesh with Echo PSTM Positioning System) in support of this premarket notification:
- Cytotoxicity ●
- Sensitization ●
- Genotoxicity .
- Irritation
- Pyrogenicity
- Hemolysis ●
- Local Effects
PREMARKET NOTIFICATION FOR THE ECHO 2.0™ LAP SYSTEM WITH VENTRALIGHT™ ST MESH K143743 SECTION 6
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- Acute Toxicity
- Subchronic Toxicity ●
The tissue contacting materials in the ECHO 2.0™ Lap System (comprised of the mesh connectors, center hoisting loop and deployment frame) are categorized as externally communicating with tissue/bone/dentin contact for limited duration (