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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh). It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

However, the document does not contain a table of acceptance criteria nor a detailed study description with specific numerical performance metrics, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study proving a device meets acceptance criteria. The performance data section lists the types of tests conducted, but not their results or specific acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request as the specific data regarding acceptance criteria and detailed study results are not present in this 510(k) summary. I can only describe the tests performed, not their outcomes or how they met specific acceptance criteria.

Here's a breakdown of what can be extracted from the text, and what is missing:

What can be extracted:

Types of performance tests performed: Biocompatibility, Bench-top (simulated use, mesh integrity, ball burst, attachment strengths), Mechanical (nylon peel strength, hoisting loop attachment, crimp integrity), and Porcine Animal Model (simulated use, surgeon feedback).
Absence of some types of studies: No electrical safety/EMC or software verification/validation were required as the device doesn't have such components. No clinical study was required.
Intended Use & Indications for Use: The device is for reconstruction of soft tissue deficiencies (hernias), and the Lap System facilitates delivery of prostheses during laparoscopic hernia repair.

What is missing (and therefore cannot be provided in the table or detailed descriptions):

Specific Acceptance Criteria: The document lists types of tests, but not the quantitative or qualitative criteria for success (e.g., "Ball Burst strength > X Newtons").
Reported Device Performance: No actual results from the tests are provided, only that they were conducted "in support of the substantial equivalence determination."
Sample Sizes: While tests were done, e.g., in a "porcine animal model," the number of animals or the number of samples for bench testing is not specified.
Data Provenance: Not specified for bench tests. For biocompatibility, it states testing was conducted "in accordance with FDA Blue Book Memorandum #G95-1" and "leveraged from the primary predicate device." The animal model is porcine. The origin (country/institution) is not mentioned.
Number of Experts/Qualifications for Ground Truth: Not applicable as specific ground truth data for performance metrics is not provided. Surgeon feedback was gathered for the porcine model, but details on "experts" or the number of surgeons are not given.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Explicitly states "No clinical study was required." This implies no MRMC study.
Standalone Performance: While "Performance Testing - Bench" and "Performance Testing - Mechanical" describe tests on the device itself, the results establishing its standalone performance against defined acceptance criteria are not provided.
Type of Ground Truth Used: For the porcine model, it's "surgeon feedback on product performance." For other tests, it would typically be defined metrics based on engineering specifications or ISO standards, but these are not detailed.
Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/software device. The document explicitly states "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
Ground Truth for Training Set: Not applicable.

Based on the provided text, here is what can be inferred/extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria (Not provided in source)	Reported Device Performance (Not provided in source)
Biocompatibility	Cytotoxicity	Based on ISO 10993	(Results not provided)
	Sensitization	Based on ISO 10993	(Results not provided)
	Genotoxicity	Based on ISO 10993	(Results not provided)
	Irritation	Based on ISO 10993	(Results not provided)
	Pyrogenicity	Based on ISO 10993	(Results not provided)
	Hemolysis	Based on ISO 10993	(Results not provided)
	Local Effects	Based on ISO 10993	(Results not provided)
	Acute Toxicity	Based on ISO 10993	(Results not provided)
	Subchronic Toxicity	Based on ISO 10993	(Results not provided)
	Intracutaneous Injection (for Lap System)	Based on ISO 10993	(Results not provided)
	Systemic Injection (for Lap System)	Based on ISO 10993	(Results not provided)
Bench Performance	Bench-Top Simulated Use	(Not provided)	(Results/evaluation not provided)
	Mesh Integrity (following simulated use)	(Not provided)	(Results/evaluation not provided)
	Ball Burst	(Not provided)	(Results/evaluation not provided)
	Connector to Mesh Attachment Strength	(Not provided)	(Results/evaluation not provided)
	Connector to Deployment Frame Attachment Strength	(Not provided)	(Results/evaluation not provided)
Mechanical Performance	Nylon Peel Strength	(Not provided)	(Results/evaluation not provided)
	Center Hoisting Loop to Deployment Frame Attachment Strength	(Not provided)	(Results/evaluation not provided)
	Crimp Integrity	(Not provided)	(Results/evaluation not provided)
Animal Model	Simulated use in porcine model	(Not provided – surgeon feedback)	(Surgeon feedback obtained, details not provided)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the tests (bench, mechanical, or animal model).
Data Provenance:
- Biocompatibility: "leveraged from the primary predicate device" and conducted "in accordance with FDA Blue Book Memorandum #G95-1" and ISO 10993-1.
- Animal Model: Porcine animal model. Country of origin not specified. Retrospective/Prospective not specified, but typically prospective for animal studies.

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

Not applicable/Not provided in detail. For the porcine model, "surveys which captured surgeon feedback on product performance" were used. The number or specific qualifications of these surgeons are not mentioned. For other tests, "ground truth" would be established by engineering specifications or compliance with standards, not expert consensus on performance data.

4. Adjudication method for the test set:

Not applicable/Not provided.

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. The document explicitly states: "No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh." This device is a physical surgical mesh and delivery system, not an AI or imaging device, so an MRMC study is not relevant.

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

Yes, various "standalone" performance tests were conducted on the device components and the assembled system. These include:
- Biocompatibility Testing
- Bench-Top Simulated Use
- Mesh Integrity (following simulated use)
- Ball Burst
- Connector to Mesh Attachment Strength
- Connector to Deployment Frame Attachment Strength
- Nylon Peel Strength
- Center Hoisting Loop to Deployment Frame Attachment Strength
- Crimp Integrity
However, the results of these tests meeting specific acceptance criteria are not detailed in this summary.

7. The type of ground truth used:

For the performance testing, the ground truth would be based on engineering specifications, material properties, and compliance with recognized standards (e.g., ISO for biocompatibility).
For the porcine animal model, "surgeon feedback on product performance" acted as a form of experiential ground truth.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/software device that would require a "training set." The document explicitly states: "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."

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

Not applicable.

Summary

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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

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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 HarrellRegulatory Affairs Specialist
Address:	100 Crossings BoulevardWarwick, 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 FTLClass II, § 878.3300, Product Code ORQClass II, § 876.1500, Product Code GCJ
III. Predicate Devices

Bard® VENTRALIGHT™ ST Mesh with Echo PSTM Positioning System . (Primary Predicate)
- o K110820 (Davol, Inc.), FDA cleared on 04/01/2011
- o K122436 (Davol, Inc.), FDA cleared on 11/02/2012
- K130968 (Davol, Inc.), FDA cleared on 05/01/2013 O
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

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o K021019 (Genzyme Corporation.), FDA cleared on 06/18/2002

V. Device Description

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 (<24hr). Therefore, the following tests are required:

Cytotoxicity
Sensitization
Intracutaneous Injection
Systemic Iniection ●

Electrical safety and electromagnetic compatibility (EMC)

There are no electrical or metal components in the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh; therefore the proposed device does not require EMC and Electrical Safety evaluation.

Software Verification and Validation Testing

The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software.

Performance Testing - Bench

The following physical and performance characteristics were measured to compare the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh to the primary predicate VENTRALIGHT™ ST Mesh with Echo PSTM Positioning System:

. Bench-Top Simulated Use
Mesh Integrity (following simulated use) .
. Ball Burst
Connector to Mesh Attachment Strength
Connector to Deployment Frame Attachment Strength

Performance Testing - Mechanical

Additionally, the following physical characteristics were measured to demonstrate that the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh performs as intended:

Nylon Peel Strength ●
Center Hoisting Loop to Deployment Frame Attachment Strength ●
Crimp Integrity .

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Performance Testing – Porcine Animal Model

Simulated use testing was conducted in a porcine animal model to evaluate the utility of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh. Evaluations were conducted via use of surveys which captured surgeon feedback on product performance.

Clinical Study

No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh.

IX. Conclusions

The test results provided in this submission demonstrate that the device is substantially equivalent to its predicates.

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.