(57 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a hernia implant and delivery system, with no mention of AI or ML.
Yes.
The device is intended to reinforce soft tissues and repair a hernia, which is a therapeutic intervention.
No
The device is an implant used to repair inguinal hernias, not to diagnose a condition.
No
The device description clearly states the device is a physical implant made of polypropylene and includes a delivery device, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reinforce soft tissues where weakness for open repair of inguinal hernias exist." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details a physical implant made of polypropylene, designed to be surgically placed to repair a hernia. It also mentions a delivery device for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo surgical repair.
N/A
Intended Use / Indications for Use
The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inguinal 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)
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 hernia simulators and fresh bovine meat to ensure that the proposed Freedom Inguinal Hernia Implant with Extended Disk met key user needs. All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate.
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.
0
JUN 1 0 2014
510(k) Summary
This 510(k) Summary is provided per the requirements of section 807.92(c).
Date: April 11, 2014
Submitter Information:
| Submitters Name: | Insightra Medical Inc. |
|---|---|
| Contact Person: | Lisa Maloney |
| Senior Regulatory Affairs Specialist | |
| Address: | 9200 Irvine Center Drive, Suite 200 |
| Irvine, CA 92618 | |
| Telephone: | 949-215-1835 |
| Fax: | 949-625-8625 |
| Email: | lisa.maloney@insightra.com |
| Device Name: | |
| Trade Name: | Freedom Inguinal Hernia Implant |
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Polymeric Mesh |
| Classification Code: | Class II, § 878.3300, Product Code FTL |
Predicate Devices:
- Freedom Inquinal Hernia Implant, K113552, FDA cleared on 8/23/2012 .
- Ethicon Prolene Hernia System, K984220, FDA cleared on 2/23/1999 .
- Bard Perfix Pluq, K922916, FDA cleared on 8/24/1992 .
Device Description:
The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi
Premarket Notification for the Freedom Inguinal Hernia Implant
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looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.
Intended Use:
The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist. No changes to the intended use have been made in this submission.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The proposed modification to the device is a line extension to offer an additional 40mm size of the Freedom Inquinal Hernia Implant with a larger or extended underlay patch. The dimensions of the implant core remains identical to the current 40mm implant. The proposed extended 40mm implant underlay patch is identical to the predicate device previously cleared via K113552 in terms of its performance characteristics and has the same indications for use. Also, it has the same maximal dimension to the predicate device cleared via K984220.
The proposed Extended 40mm Implant Disk will differ in that the disk is ovoid in shape (egg shaped) from the current 40mm implant which is a small circle. This will accommodate surgeons who are accustomed to larger diameter underlay patches. Additionally, there is often weakened muscle/tissue structure adjacent to a repair that can benefit from mesh support to prevent a future hernia occurrence. The ovoid shape is similar
Premarket Notification for the Freedom Inguinal Hernia Implant
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to the preperitoneal mesh disk of the predicate device cleared via K98422. However, it is smaller in all axes except for the maximal axis, where it is identical to K98422. This dimensioning is beneficial in that excess mesh is not used all the way around the area treated but only where needed.
The Delivery Device accessory included with the proposed Extended Disk remains the same and has the same intended use when used to deploy the implant as the predicate device cleared via K113552.
Performance Data:
Biocompatibility testing previously conducted (as presented via K113552) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.
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 hernia simulators and fresh bovine meat to ensure that the proposed Freedom Inguinal Hernia Implant with Extended Disk met key user needs.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate.
Conclusions Drawn from Nonclinical Tests:
The results of testing demonstrate that the Freedom Inguinal Hernia Implant with Extended Disk is substantially equivalent to the predicate device in design, function, and indications for use.
Premarket Notification for the Freedom Inguinal Hernia Implant
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2014
Insightra Medical Incorporated Ms. Lisa Maloney Senior Regulatory Affairs Specialist 9200 Irvine Center Drive, Suite 200 Irvine, California 92618
Re: K140967
Trade/Device Name: Freedom Inguinal Hernia Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: May 14, 2014 Received: May 15, 2014
Dear Ms. Maloney:
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 that 1 Dr. Had Intatutes and regulations administered by other Federal agencies. You must or any i 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
4
Page 2 - Ms. Lisa Maloney
forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Radiological Health
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
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
| Device Name: | Freedom Inguinal Hernia Implant |
|---|---|
| Indications for Use: | The Freedom Inguinal Hernia Implant is intended to |
| be implanted to reinforce soft tissues where | |
| weakness for open repair of inguinal hernias exist. |
Prescription Use ______ X (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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