(269 days)
Not Found
No
The description focuses on the physical components and surgical procedure, with no mention of AI or ML.
Yes
The device is a mesh implant used for the repair of ventral hernias, which is a therapeutic intervention.
No
The document describes a surgical device used for repairing hernias, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory, which are physical components, 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 "in the open repair of ventral hernias." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "polypropylene woven mesh implant and a disposable Strap Passer accessory." This is a physical implant and a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not involve the analysis of specimens.
Therefore, the Insightra Freedom Ventral Hernia Repair System is a surgical implant and associated tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.
Product codes (comma separated list FDA assigned to the subject device)
FTL, OXJ
Device Description
The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventral hernias, abdominal wall muscle, muscle tissue
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 in accordance to ISO 10993-1 standards was conducted and the results indicate that the device is biocompatible per these standards.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended use. In support of this submission, whole system simulated use testing was conducted in fresh porcine meat to ensure that the proposed Freedom Ventral Hernia Repair System user needs. The animal testing was also conducted per GLP requirements.
The Freedom Ventral Hernia repair was an effective repair in terms of recurrence rates, lack of migration and acute pain rates. The Freedom Ventral Hernia Repair system enables broad margin coverage in the preperitoneal sublay and retromuscular sublay position. The results of testing demonstrate that the Freedom Ventral Hernia Repair is substantially equivalent to the predicate devices in design, function, and indications for use.
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single image. The profiles are arranged in a way that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2015
Insightra Medical Incorporated Mr. Neerav Parikh Regulatory Affairs and Quality Assurance Specialist 9200 Irvine Center Drive, Suite 200 Irvine, California 92618
Re: K142192
Trade/Device Name: Freedom Ventral Hernia Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OXJ Dated: April 3, 2015 Received: April 7, 2015
Dear Mr. Parikh:
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
1
device-related 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/Resourcesfor You/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.
Sincerely yours,
David Krause -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) K142192
Device Name
Freedom Ventral Hernia Repair System
Indications for Use (Describe)
The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.
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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510(k) Summary
This 510(k) Summary is provided per the requirements of section 807.92(c).
Date: May 6, 2015
Submitter Information:
| Submitters Name: | Insightra Medical Inc. |
|---|---|
| Contact Person: | Neerav Parikh |
| RA/QA Specialist | |
| Address: | 9200 Irvine Center Drive, Suite 200 |
| Irvine, CA 92618 | |
| Telephone: | 949-215-1835 |
| Fax: | 949-625-8625 |
| Email: | neerav@insightra.com |
| Device Name: | |
| 510(k) Number: | K142192 |
| Trade Name: | Freedom Ventral Hernia Repair System |
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Polymeric Mesh |
Predicate Devices:
- . Atrium Prolite Mesh, K002093, FDA cleared on 7/24/2000
- Covidien Surgipro Mesh, K905655, FDA cleared on 12/31/1990 .
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Device Description:
The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.
Intended Use:
The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The Insightra Freedom Ventral Hernia Repair System and the predicate devices have similar technological characteristics. Specifically, the Insightra Freedom Ventral Hernia Repair System and the predicate devices are all designed as surgical polypropylene mesh devices to be used to support soft tissue during hernia repair. These devices are available in a variety of configurations available to accommodate the various patient anatomies and hernia defect types.
The Insightra Freedom Hernia Repair System differs from the predicate devices with the use of the Strap Passer. The Strap Passer is used during the surgical implantation procedure to pass the straps of the implanted mesh through the abdominal wall muscle. The straps are then trimmed below the level of the skin. The straps, used in this manner, provide an equivalent method of securing the mesh to the implantation site as compared to the predicate devices which use sutures, staples, or tissue anchors for attaching the mesh to the muscle tissue.
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There are no new types of safety or effectiveness questions due to the surgical implantation procedure for these types of devices and scientific methods exist for the evaluation of the new characteristics. Performance data provided in this premarket notification demonstrate substantial equivalence between the Insightra Freedom Ventral Hernia Repair System and the predicate devices.
Performance Data:
Biocompatibility testing in accordance to ISO 10993-1 standards was conducted and the results indicate that the device is biocompatible per these standards.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended use. In support of this submission, whole system simulated use testing was conducted in fresh porcine meat to ensure that the proposed Freedom Ventral Hernia Repair System user needs. The animal testing was also conducted per GLP requirements.
All test results provided in this submission support the safety and effectiveness of the device for its intended use utilizing the least burdensome approach and demonstrate that the proposed device is substantially equivalent to its predicate devices.
Conclusions Drawn from Clinical Studies:
The Freedom Ventral Hernia repair was an effective repair in terms of recurrence rates, lack of migration and acute pain rates. The Freedom Ventral Hernia Repair system enables broad margin coverage in the preperitoneal sublay and retromuscular sublay position. The results of testing demonstrate that the Freedom Ventral Hernia Repair is substantially equivalent to the predicate devices in design, function, and indications for use.