(90 days)
No
The summary describes a surgical mesh and a mechanical positioning system, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described for use in the "reconstruction of soft tissue deficiencies, such as for the repair of hernias," which indicates a therapeutic purpose.
No
The device description and intended use clearly state that it is for the "reconstruction of soft tissue deficiencies, such as for the repair of hernias," which is a treatment rather than a diagnostic function.
No
The device description explicitly states it consists of an implantable surgical mesh and a pre-attached mesh positioning system, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System is an implantable surgical mesh and a positioning system used for the reconstruction of soft tissue deficiencies and hernia repair. This is a surgical device used in vivo (within the body) during a procedure, not a device used to test samples in vitro (outside the body).
The information provided aligns with a surgical implant and delivery system, not an IVD.
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™ Positioning System is intended to facilitate the delivery and positioning 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 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.
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)
Performance data:
- Biocompatibility testing: 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. Tests performed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity.
- Product Testing: Passed all test requirements and demonstrated substantial equivalence to the Predicate Device. Included simulated use evaluations using a bench-top simulator, mechanical testing of the VENTRALIGHT™ ST Mesh, and mechanical testing of the ECHO 2™ Positioning System. All samples met established acceptance criteria.
- Cadaveric Study: Evaluated safety and feasibility. All samples met established acceptance criteria. 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. Performed similar to the Predicate Device.
- Clinical Studies: Not performed.
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.
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.
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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.
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
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
4
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 is |
| intended to help facilitate laparoscopic | ||
| deployment of the VENTRALIGHTTM | ||
| ST Mesh. | ||
| Indication for Use | ||
| (Mesh) | Same as Predicate Device | VENTRALIGHTTM ST Mesh is indicated |
| for use in the reconstruction of soft | ||
| tissue deficiencies, such as for the | ||
| repair of hernias. | ||
| Indication for Use | ||
| (Positioning | ||
| System) | The Subject Device includes | |
| “… delivery and positioning of …” | ||
| which is similar to the Predicate | ||
| Device | ||
| The ECHO 2TM Positioning System is | ||
| intended to facilitate the delivery and | ||
| positioning of the soft tissue | ||
| prostheses during laparoscopic hernia | ||
| repair. | The ECHO 2.0TM Lap System is | |
| intended to facilitate the delivery of | ||
| the soft tissue prostheses during | ||
| laparoscopic 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 (