FREEDOM INGUINAL HERNIA IMPLANT

{0}------------------------------------------------ # 11 3557 of 7 ### 5 510(k) Summary a. Submitter AUG 2 3 2012 Applicant Name: Insightra Medical 9200 Irvine Center Drive, Suite 200 Irvine, CA 92618 Contact Person: Wayne Noda Date Summary Prepare: Revised August 22, 2012 ### b. Device Information Trade Name: Freedom Inquinal Hernia Implant Common Name: Surgical mesh Classification Name: Surgical polymeric mesh (21 CFR 878.3300) Product Code: FTL ### c. Predicate Devices Bard Perfix Plug (K922916) Ethicon Prolene Hernia System (K984220) ### d. Device Description The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manufactured 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 Inguinal 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. There are two different sizes of implants and corresponding delivery devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use. ### e. Indications for Use: The Freedom Inguinal Hernia Implant is intended to reinforce soft tissues where weakness for open repair of inquinal hernias exists. #### Technological Characteristics and Comparison to Predicate Devices f. The Freedom Inguinal Hernia Implant is of similar design and materials commonly used in other marketed hernia repair meshes. {1}------------------------------------------------ U11 3532 2 of 7 Table 1 provides a comparison of the Freedom Inguinal Hernia Implant with the predicate hernia repair implants. This table illustrates the substantial equivalence of the subject device with the predicates. | | Freedom Inguinal Hernia<br>Implant | Ethicon Prolene Hernia<br>System | Bard Perfix Plug | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | 510(k) Clearance | This submission | K984220 | K922916 | | Indications for Use | The Freedom Inguinal<br>Hernia Implant is intended<br>to be implanted to reinforce<br>soft tissues where<br>weakness for open repair of<br>inguinal hernias exists. | The PROLENE Hernia<br>System is indicated for<br>the repair of abdominal<br>wall hernia defects | This product is<br>indicated for the<br>repair of groin<br>hernia defects | | Shape | Image: Freedom Inguinal Hernia Implant Shape | Image: Ethicon Prolene Hernia System Shape | Image: Bard Perfix Plug Shape | | Texture | Mesh | Mesh | Mesh | | Material | Polypropylene | Polypropylene | Polypropylene | | Configuration | Underlay mesh patch,<br>looped shaped mesh core | Underlay mesh patch,<br>cylindrical mesh core,<br>Onlay mesh patch | Conical multi layer<br>mesh core, Onlay<br>mesh patch | | How is the implant<br>secured? | Inserted into the hernia; no<br>sutures necessary | Inserted into the hernia;<br>no sutures necessary | Inserted into the<br>hernia; no sutures<br>necessary | | Number of models | 2 | 6 | 4 | | Size range (smallest to<br>largest) | 25 mm core & 60 mm dia.<br>underlay patch<br>40 mm core & 70 mm dia.<br>Underlay patch | Onlay patch - 44mm x<br>100mm to 55mm x<br>125mm<br>Core Connector (for all<br>sizes) -<br>19mm dia x 13mm<br>height<br>Underlay patch-75mm<br>to 100mm diameter | 25 x 34 mm to<br>41 x 50 mm;<br>preshaped onlay<br>patch same for all<br>size plugs | | Sterilization | EtO | EtO | EtO | Table 1 – Comparison Table for Freedom Inguinal Hernia Implant {2}------------------------------------------------ ### g. Pre-Clinical Test Results: In vitro, in vivo and biocompatibility tests were performed on the Freedom Inguinal Hernia Implant. The in vitro tests showed that the device meets pre-determined acceptance criteria or specifications that were based on the clinical demands placed on the device. The in vivo testing validated the implantation procedure and a survival study was performed that demonstrated the tissue incorporation of the implant. Results of the in vivo study were published in the journal of Artificial Organ (3). The biocompatibility testing showed the Freedom Inquinal Hernia Implant complies with the requirements for this device classification. Cadaver studies were performed during the development of both the Freedom Inguinal Hernia Implant as well as the delivery device. These studies showed that the implant could be successfully deployed in the proper location and further validated the implantation technique. These results were considered in the final design configurations. ### h. Results of Clinical Experience: Two groups of data from relevant clinical experience were collected and reviewed. The first group of patients (n=61) received custom implants that were fabricated from surgical polypropylene mesh by the implanting surgeon. This was a single center, single surgeon clinical experience. In these patients, the surgeon used both stainless steel and rigid plastic tubes to provide the slight dilation of the defect and access required to deliver the implant. Patients were followed for a minimum of 3 years after the date of implantation. One patient was lost to follow up due to unrelated heart failure death after 14 months. The results demonstrated that defect dilation with tubes and treatment with flower shaped implants was safe and effective for the treatment of inguinal hernias. After 3 years, there have been no reports of unresolved post operative complications, recurrences, or chronic discomfort in these patients. The diameters of the dilation tubes were the diameters of the Insightra Medical Delivery Device, that is subject of this premarket notification. The second group of patients reviewed (n=30) received the Insightra manufactured implant that is the subject of this submission. The implant was delivered using standard open surgical techniques using a previous version of the Freedom Inquinal Hernia Delivery System. This delivery system was identical dimensionally to the delivery system that is included in this premarket notification. Follow-up ranged from perioperative to one year post-implantation. Of these 30 patients, 27 were followed for a year or more with a mean followup of 25 months (ranging 11 to 36 months). There were no reports of unresolved perioperative complications, tissue injury or spermatic cord complications associated with this device. In exceptional cases, an additional flat polypropylene mesh has been deployed to cover the inquinal floor, over the Freedom Inquinal implant that obliterates the hernia opening. This further reinforces the inguinal canal at the hernial protrusion when the groin structures appear obviously weak. The onlay flat mesh is not sutured or fixed to the inguinal structures, instead only connected to the central core of the Freedom Inguinal implant with a single polypropylene suture. Previous experiences of using this procedural variant produced, with the exception of some very seldom reported discomfort during the early postoperative stage, no unusual symptoms reported by patients who received the onlay patch in addition to the Freedom Inguinal implant. {3}------------------------------------------------ For all patients in both groups reviewed with at least one year followup (n= 78) who received this dilation delivery technique, there were no reports of tissue tearing injury or spermatic cord injury. There have been no reports of dislodgements, unresolved post operative complications, chronic discomfort or recurrence of hernia. For the twenty seven patients in the second group who were followed for a year or more and received the Insightra Medical manufactured implant, there were no reports of spermatic cord injury or compression complications due to device rotation or inappropriate sizing. The second study group by Amato (n=30) is summarized along with a third independent investigator sponsored study by Petrella, in the device labeling. Descriptive tables are included in the device "Technique Guide" as follows; These clinical studies followed cohorts of patients (total n=54) that met the following inclusion/exclusion criteria: | Inclusion Criteria: | Exclusion Criteria: | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Scheduled to undergo routine inguinal<br>hernia repair • Competent to give consent • Clinically relevant inguinal hernia<br>(classification: NYHUS I, II, IIIa, IIIb) • Male or female • Over 18 years old to 85 years old • Life expectancy of at least 12-months • Diagnosed with direct, indirect or mixed<br>inguinal hernia, unilateral or bilateral • Primary or recurrent hernia | • Signs of obvious local or systemic<br>infection • Hernia was not in the inguinal area • Presenting with unstable angina or<br>NYHA class of IV • Pregnant • Active drug user • Immunosuppression, prednisone>15<br>mg/day, active chemotherapy • End stage renal disease • Abdominal ascites • Skin infection in area of surgical field • BMI > 35 | Both studies used the following objectives: | Primary Efficacy Objectives | Secondary Complications<br>Objectives | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Procedural success is defined as the ability<br>to successfully deploy the implant into the<br>inguinal hernia defect<br>• Freedom from hernia recurrence at the time<br>points of 1, 6, 12, 24, 36 months | • Collection of data on any<br>perioperative/postoperative<br>complications (1, 6, 12, 24, 36<br>months)<br>• Bleeding, swelling or hematoma<br>from hernia defect dilation or<br>improper delivery or implantation<br>technique<br>• Seroma, infection/abscess, testicular<br>or spermatic cord injury in males,<br>wound complications, symptomatic<br>pain or chronic pain syndrome. | {4}------------------------------------------------ . : | | Prospective study of a single operator<br>case series of a modified plug<br>technique and new 3D hernia implant | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Amato Study | | | Number of centers/investigators | 1 center/ 1 investigators | | Study Enrollment Period | June 2009 to August 2011 | | Number of patients | 30 | | Number of implants* | 25mm: n=12 40mm: n=22<br>*Four cases were double unilateral<br>hernias | | Patient demographics | Male = 30/Female = 0 | | | BMI (Kg/m2) = 28.4 (21.7 – 34.9) | | | Age = 50.23 mean, range 23-82 | | | Hernia types: Indirect=17, Direct=13 | | | Hernia size: Mean 32 mm (range 20 –<br>37.7) | | | Hernia type: | | | NYHUS Type 1 = 5 | | | NYHUS Type 2 = 13 | | | NYHUS Type 3a = 12 | | | NYHUS Type 3b = 4 | | | Anesthesia: Local = 63%<br>Spinal = 17%<br>General = 20% | | Operative procedure specifics | Procedure duration: Mean 29 minutes<br>(range 22 – 38) | | | Defect measurement: Intra operative<br>measurement of the dissected flaccid<br>defect using surgical scale for implant<br>sizing | | | | | Patient Follow up Outcomes/adverse<br>events | Follow up: Mean = 25.23 months (range<br>11.0-36.5) | | | Outcomes/Adverse: no long term<br>complications or recurrences at this time | | | In two exceptional cases, an additional flat<br>polypropylene mesh was deployed to cover the<br>inguinal floor, over the Freedom Inguinal<br>implant that obliterated the hernia opening.<br>This further reinforced the inguinal canal at the<br>hernial protrusion when the groin structures<br>appeared obviously weak. | | Additional Outcomes – Two patients in this<br>cohort received onlay mesh patches | Patient #1 – Male, 82 yrs, Double unilateral<br>hernia – Rt Indirect, Rt Direct, 25mm and<br>40mm implants used, Nyhus 2 & 3a. BMI: 29.<br>Comorbidities: Myocardial ischemic disease,<br>hypertension. Non recurrent hernias. Follow<br>up = 18.2 mos. | | | Patient #2 – Male, 75 yrs, Lf Mixed hernia,<br>40mm implant, Nyhus 3b. BMI: 26.<br>Comorbidities: BPCO, myocardial<br>insufficiency, hypertension. Non recurrent<br>hernia. Follow up = 18.2 | | | Results of these two procedures to date have<br>had no complications or unusual symptoms. | | | Patient #1 reported occasional discomfort | | | during the early postoperative stage but self<br>resolved after 5 months post op. | | Ultrasound findings in cohort of patients | Full and stable obliteration of twelve<br>patients examined at 3, 6 and 12 months. | . · : : 1 . : : . {5}------------------------------------------------ | Petrella/Venditti Study | Prospective single arm study of the<br>ProFlor Inguinal hernia Device | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Number of centers/investigators | 1 center/ 2 investigators | | Study Enrollment Period | Dec 2011 to present | | Number of patients | 24 enrolled; Target enrollment = 80 | | Number of implants | 25mm: n=5 40mm: n=19 | | Patient demographics | Male = 22/Female = 2<br>$BMI (Kg/m^2) = 25.2 (19,4 - 35,2)$<br>Age = 52.3 mean, range (31 - 73)<br>Hernia types: Indirect=20, Direct=4<br>Hernia size: 15mm40mm<br>NYHUS Type 2 = 20<br>NYHUS Type 3a = 4 | | Operative procedure specifics | Local anesthesia<br>Procedure duration: 24 min mean, (20-30)<br>Defect measurement: Intra operative<br>measurement of the dissected flaccid<br>defect using surgical scale for implant<br>sizing | | Patient Follow up Outcomes/adverse<br>events | Follow up: Mean = 4.5 months (range 3.0-<br>6.0)<br>Outcomes/Adverse: None observed | | Ultrasound findings in cohort of patients | Ultrasound scans were not a requirement<br>of the study and were not performed for<br>this cohort | #### 510(k) Summary Conclusion: i. In summary, the Insightra Freedom Inquinal Hernia Implant path through the 510(k) requlatory analysis is as follows: - The Insightra Freedom Inquinal Hernia Implant and the Bard Perfix Plug and Ethicon Prolene Hernia System predicate devices, are all intended for use in the repair of inguinal hernia defects. - The Insightra Freedom Inguinal Hernia Implant has similar key technological . characteristics as the Bard Perfix Plug and Ethicon Prolene Hernia System devices. All three are manufactured from polypropylene mesh, all use mesh patch reinforcements, and all are inserted into the hernia defect without the need for suture; - Although the Insightra Freedom Inguinal Hernia Implant and predicate devices have a . minor technological difference in terms of the method of delivery, this difference does not raise any new types of safety or effectiveness questions. In addition, valid scientific methods exist for assessing the effects of the differences in delivery methods. Preclinical and clinical data demonstrate that these devices are substantially equivalent. {6}------------------------------------------------ V1113552 7 of 7 Therefore, the Insightra Freedom Inguinal Hernia Implant meets the criteria for substantial equivalence to the Bard Perfix Plug and Ethicon Prolene Hernia System predicate devices. : . . · . {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments, representing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Insightra Medical % Mr. Wayne Noda Chief Technology Officer 9200 Irvine Center Drive, Suite 200 Irvine, California 92618 AUG 2 3 2012 ## Re: K113552 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: August 20, 2012 Received: August 21, 2012 Dear Mr. Noda: 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 {8}------------------------------------------------ Page 2 - Mr. Wayne Noda 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours. Sincerely, yours, Erin S. Keith - Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use 510(k) Number (K113552): 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 exists. Prescription Use _ × AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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) David Krane for MM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K113552