VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
The ECHO 2™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.
The Subject Device, VENTRALIGHT™ ST Mesh with ECHO 2TM Positioning System is provided sterile for single use and consists of an implantable surgical mesh (VENTRALIGHT™ ST Mesh) with a pre-attached mesh positioning system (ECHO 2™ Positioning System). The Subject Device is designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair.
The provided text describes the regulatory clearance for a medical device, the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System, and its substantial equivalence to a predicate device. However, it does not detail specific acceptance criteria and the comprehensive study results in the format requested for an AI/algorithm-based device.
This document pertains to a surgical mesh and a positioning system, which are physical medical devices, not an AI or algorithm-based system. Therefore, many of the requested sections related to AI/algorithm performance metrics (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.
Based on the provided information, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document states that "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, and "The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System passed all the test requirements and demonstrated substantial equivalence to the test results of the Predicate Device." However, the specific numerical acceptance criteria or the raw performance data are not provided in this summary. The general categories of testing and the conclusion of meeting criteria are mentioned.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Successfully performed tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity. Met established acceptance criteria. |
| Product Testing (Simulated use) | Passed all test requirements; demonstrated substantial equivalence to Predicate Device. Met established acceptance criteria. |
| Product Testing (Mechanical Mesh) | Passed all test requirements; demonstrated substantial equivalence to Predicate Device. Met established acceptance criteria. |
| Product Testing (Mechanical Positioning System) | Passed all test requirements; demonstrated substantial equivalence to Predicate Device. Met established acceptance criteria. |
| Cadaveric Study (Safety and Feasibility) | Demonstrated safe delivery and support of mesh construct without interfering with fixation or frame removal; performed similarly to Predicate Device. Met established acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document states "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, but it does not specify the numerical sample sizes used for these tests.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified, although cadaveric studies would inherently be prospective in their execution given the study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as this isn't an AI/algorithm device requiring expert ground truth for classification. The "ground truth" for this physical device is based on objective measurements and observations during mechanical and cadaveric testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. Clinical studies were not performed, and this is not an AI-assisted device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and successful performance in standardized biological tests. For product testing (mechanical and simulated use) and cadaveric studies, the "ground truth" or acceptance criteria are based on pre-defined engineering specifications, functional requirements, and safety/feasibility observations relative to the predicate device.
8. The sample size for the training set:
Not applicable. There is no AI/algorithm training set for this physical device.
9. How the ground truth for the training set was established:
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2017
C.R. Bard Ms. Christine Lloyd Senior Regulatory Affairs Specialist 100 Crossing Blvd. Warwick, Rhode Island 02886
Re: K170294
Trade/Device Name: Ventralight St Mesh With Echo 2 Positioning System 11cm (4.5") Circle, Ventralight St Mesh With Echo 2 Positioning System 10cm X 15cm (4"x 6") Ellipse. Ventralight St Mesh With Echo 2 Positioning System 15cm (6") Circle, Ventralight St Mesh With Echo 2 Positioning System 15cm X 20cm (6"x8") Ellipse, Ventralight St Mesh With Echo 2 Positioning System 15cm X 25cm (6"x10") Oval Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL, ORQ, GCJ Dated: January 30, 2017 Received: January 31, 2017
Dear Ms. Lloyd:
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.
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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 devicerelated 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 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" (21 CFR 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.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K170294
Device Name
VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System
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™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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I. SUBMITTER
| Davol Inc. | ||
|---|---|---|
| 100 Crossings Boulevard | ||
| Warwick, RI 02886 | ||
| Contact Person: Christine Lloyd | Jennifer Rae (Alternate Contact) | |
| Senior Regulatory Affairs Specialist | Senior Director Regulatory Affairs | |
| Phone: | (401) 825-8447 | (401) 825-8727 |
| Fax: | (401) 825-8765 | (401) 825-8765 |
| E-mail: | christine.lloyd@crbard.com | jennifer.rae@crbard.com |
Date Prepared: January 30, 2017
II. DEVICE
| Name of Device: | VENTRALIGHTTM ST Mesh with ECHO 2TM Positioning System | |
|---|---|---|
| Product Reference Numbers: | 5990011, 5991015, 5990015, 5991520, 5991525, 5991823, 5990020, 5992025, 5992533, and 5993035 | |
| Common or Usual Name: | Surgical Mesh | |
| Classification Name: | Mesh, Surgical, Polymeric | |
| Regulatory Class: | class II | |
| Product Code: | FTL, ORQ, GCJ |
III. PREDICATE DEVICE
The Predicate Device for this submission is the ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh cleared via 510(k) K143743 by Davol Inc. This Predicate has not been subject to a designrelated recall.
The Reference Device for this submission, the VENTRALIGHT™ ST Mesh with ECHO PSTM Positioning System was cleared for use via 510(k) K130968 and is marketed by Davol Inc. This Reference Device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Subject Device, VENTRALIGHT™ ST Mesh with ECHO 2TM Positioning System is provided sterile for single use and consists of an implantable surgical mesh (VENTRALIGHT™ ST Mesh) with a
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pre-attached mesh positioning system (ECHO 2™ Positioning System). The Subject Device is designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair.
Device Accessories
The Mesh Introducer tool (Subject Device accessory) will be distributed with several configurations of the Subject Device. The Mesh Introducer tool assists in rolling and introducing the Subject Device into the trocar. The Predicate Device did not include a Mesh Introducer tool. However the Reference Device, the VENTRALIGHT™ ST Mesh with ECHO PSTM Positioning System (K130968), includes the Mesh Introducer tool.
V. 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™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.
The Indications for Use statement for the Subject Device is similar to the Predicate Device. The Subject, Predicate and Reference Devices all have the same intended use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Subject Device, the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System has the same intended use and technological characteristics with regard to design, materials, and sterilization as the Predicate Device, ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh (K143743). The Devices (Subject and Predicate) are intended for use in the reconstruction/reinforcement of soft tissue deficiencies and utilize a deployment system to support the permanent implantable mesh during positioning and placement. Both the Subject Device and the Predicate feature a mechanism to aid in positioning the device over the center of the defect, the Positioning System.
The Subject Device includes the identical VENTRALIGHT™ ST Mesh as the Predicate Device, ECHO 2.0TM Lap System with VENTRALIGHT™ ST Mesh.
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Both the Subject Device and Predicate utilize a Deployment Frame to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair, however the Deployment Frames differ. The Subject Deployment Frame has been redesigned to separate into one strand for easier removal by the clinician. The Deployment Frame continues to contain a Nitinol wire encased within a welded nylon frame. A suture continues to be attached to nylon supports and is located at the center of the Deployment Frame. Mesh Connectors continue to be utilized to attach the Deployment Frame to the Ventralight STTM Mesh.
The Predicate Device did not include a Mesh Introducer tool. However the Reference Device, the VENTRALIGHT™ ST Mesh with ECHO PS™ Positioning System (K130968), includes the Mesh Introducer tool.
The Subject, Predicate and Reference Devices utilize similar packaging materials, are manufactured in the same facility, use the same manufacturing processes, use the same sterilization facility and are sterilized in the same EtO cycle.
Refer to Table 5-1 for an overview of the general characteristics related to substantial equivalence.
| Device Features | Subject Device | Predicate Device K143743 |
|---|---|---|
| Intended Use | Same as Predicate Device | The ECHO 2.0TM Lap System isintended to help facilitate laparoscopicdeployment of the VENTRALIGHTTMST Mesh. |
| Indication for Use(Mesh) | Same as Predicate Device | VENTRALIGHTTM ST Mesh is indicatedfor use in the reconstruction of softtissue deficiencies, such as for therepair of hernias. |
| Indication for Use(PositioningSystem) | The Subject Device includes“… delivery and positioning of …”which is similar to the PredicateDeviceThe ECHO 2TM Positioning System isintended to facilitate the delivery andpositioning of the soft tissueprostheses during laparoscopic herniarepair. | The ECHO 2.0TM Lap System isintended to facilitate the delivery ofthe soft tissue prostheses duringlaparoscopic hernia repair. |
| Device Sterilization | Same as Predicate Device | EtO |
Table 5-1: Device Substantial Equivalence – General Characteristics
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VII. PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Performance standards
No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Biocompatibility testing
The biocompatibility evaluation for the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System was conducted in accordance with Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, 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.
THE VENTRALIGHT ™ ST Mesh and the Mesh Introducer tool are identical to the devices cleared via K143743 and K130968 respectively therefore, the tests were not repeated.
Biocompatibility testing was required based upon changes to the ECHO 2™ Positioning System. The tissue contacting materials of the Subject Positioning System are categorized as externally communicating with tissue/bone/dentin contact for limited duration (<24hr). The following tests were successfully performed.
- . Cytotoxicity
- . Sensitization
- . Intracutaneous Reactivity
- . Acute Systemic Toxicity
- . Pyrogenicity
Electrical safety and electromagnetic compatibility (EMC)
The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System is not an electro-mechanical medical device nor is it a medical system, therefore this section does not apply.
Software Verification and Validation Testing
The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System does not contain software; therefore this section does not apply.
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Product Testing
The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System passed all the test requirements and demonstrated substantial equivalence to the test results of the Predicate Device. Performance and functional testing of the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System included;
- . Simulated use evaluations using a bench-top simulator
- Mechanical testing of the VENTRALIGHT™ ST Mesh .
- . Mechanical testing of the ECHO 2™ Positioning System
All samples tested met the established acceptance criteria.
Cadaveric Study
The safety and feasibility of the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System was evaluated by human cadaver studies. All samples tested met the established acceptance criteria.
These studies demonstrated that the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System can safely deliver and support the mesh construct without interfering with mesh fixation or removal of the Deployment Frame. The Subject Device performed similar to that of the Predicate Device.
Clinical Studies
Clinical studies were not performed for the submission of this Subject Device nor were clinical studies performed for the Predicate Device.
VIII. CONCLUSIONS
The Subject Device, VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System maintains the same safety and performance as the Predicate Device. The Subject and Predicate Devices have similar indications, the same intended use, the same technological characteristics, the same principles of operation and product testing provides evidence of performance equivalence. Therefore, the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System is substantially equivalent to the Predicate Device.
§ 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.