(364 days)
Not Found
No
The device description and performance studies focus on a biological graft material and its clinical outcomes, with no mention of AI or ML technologies.
Yes
The device is described as an "Inguinal Hernia Repair Graft" intended for implantation to "reinforce soft tissues where weakness exists, including the repair of inguinal hernias," which indicates a therapeutic purpose.
No
Explanation: The device is a surgical graft intended for implantation to reinforce soft tissues, specifically for hernia repair. It does not perform any diagnostic function.
No
The device is a physical implantable graft made from animal tissue, 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 for "implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a "flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa." This is a physical material intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural repair.
N/A
Intended Use / Indications for Use
The SIS Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The SIS Inguinal Hernia Repair Graft is a flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa, (SIS). It is intended for soft tissue repair with sizes and shapes appropriate for the repair of inguinal hernias. SIS Inguinal Hernia Repair Graft contains collagens I, III, IV and VI. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
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
18 years of age or older
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)
Clinical Testing:
Three separate clinical studies were conducted using the SIS Inguinal Hernia Repair Graft (also known as Surgisis Inguinal Hernia Matrix SIHM).
Study 1: US randomized clinical trial.
Comparison: SIS Inguinal Hernia Repair Graft (SIHRG) to polypropylene mesh (PP) using the Lichtenstein hernia repair procedure.
Sample Size: 100 male patients randomized with 45 patients in the SIHM group and 50 patients in the Polypropylene group (after 5 withdrawals from SIHM group).
Key Results:
- Hernia recurrence rates at 1 year: 6.7% (3/45 patients) for SIHRG vs. 0% (0/50 patients) for PP. All recurrences in the SIHM group occurred in patients who originally had direct inguinal hernias (15% recurrence rate in this subset).
- Hernia recurrence rates at 3 years (unpublished): 15.6% (7/45 patients) for SIHRG vs. 4.0% (2/50 patients) for PP.
- Post-operative pain at 1 year: 4% SIHM vs. 6% Polypropylene.
- Adverse events:
- Hematoma: 13% SIHM vs 2% PP
- Incisional pain: 4% SIHM vs 8% PP
- Surgical site reaction: 7% SIHM vs 0% PP
- Seroma: 11% SIHM vs 0% PP
- Neuralgia: 9% SIHM vs 12% PP
- Infection: 0% SIHM vs 0% PP
- Testicular Problems: 11% SIHM vs 8% PP
- Urinary retention: 13% SIHM vs 6% PP
- Spermatic cord injury: 0% SIHM vs 2% PP
- One death in SIHM group due to myocardial infarction.
Study 2: OUS prospectively randomized clinical investigation.
Comparison: SIHRG to PP using the Lichtenstein Repair.
Sample Size: 70 patients randomized to Polypropylene or Porcine small intestinal submucosa (Surgisis).
Key Results:
- Hernia recurrence at 36 months: 0% SIHM vs. 2.9% PP.
- Chronic pain: 6 months (11% SIHM / 31% PP), 12 months (8% SIHM / 23% PP), 36 months (3% SIHM / 14% PP).
- Surgical site occurrence at 1 week post-surgery: Hematoma (5.7% SIHM / 5.7% PP), Seroma (5.7% SIHM / 17.1% PP).
Study 3: OUS clinical study.
Comparison: Polypropylene, Polyglactin and polypropylene, Porcine small intestinal submucosa (Surgisis) for Lichtenstein repair.
Sample Size: 45 patients with unilateral primary inguinal hernia.
Key Results:
- All patients received 3-month follow-up, using ultrasound U/S - no evidence of prosthesis in SIS group, prosthesis visible in other groups.
- Hernia recurrence: 0% for all groups.
- Early complications ( 30 days) for Surgisis: none.
Note regarding BMI for SIHRG use: The mean BMI in patients undergoing inguinal herniorraphy in clinical studies using SIHRG was 26 kg/m². Recurrence rates may be higher in obese patients (BMI>30) when using SIHRG in a tensionless inguinal hernia repair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Recurrence rates and post-operative pain percentages are provided.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other. The symbol is black and has a stylized, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
Cook Biotech Incorporated Mr. Perry W. Guinn Vice President/Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K142887
Trade/Device Name: SIS Inguinal Hernia Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: September 10, 2015 Received: September 11, 2015
Dear Mr. Guinn:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and
1
809]); medical device reporting of medical 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
- 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
2
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3
510(k) Summary
Sep. 30, 2015
Cook Biotech Incorporated
SIS Inguinal Hernia Repair Graft
Manufacturer Name: Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709 Official Contact: Perry W. Guinn
DEVICE NAME AND CLASSIFICATION:
| Trade/Proprietary Name: | SIS Inguinal Hernia Repair Graft |
|---|---|
| Common Name: | Surgical graft |
| Classification Regulations: | Class II, 21 CFR §878.3300 (FTM) |
INTENDED USE:
The SIS Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and is intended for one-time use.
DEVICE DESCRIPTION:
The SIS Inguinal Hernia Repair Graft is a flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa, (SIS). It is intended for soft tissue repair with sizes and shapes appropriate for the repair of inguinal hernias. SIS Inguinal Hernia Repair Graft contains collagens I, III, IV and VI. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
EQUIVALENCE TO MARKETED DEVICES:
The SIS Inguinal Hernia Repair Graft is similar with respect to intended use, materials and technological characteristics to its predicate devices in terms of section 510(k) Substantial Equivalence, as shown in pre-clinical (biocompatibility, conducted in accordance to ISO 10993-1 standards), mechanical, and clinical testing.
4
Biocompatibility Testing
The following biocompatibility tests were performed on sterilized SIS devices, which are identical in composition to the SIS Inguinal Hernia Repair Graft (according to the ISO 10993-1 standard):
- Genotoxicity
- Direct contact in vitro hemolysis
- Cytotoxicity ●
- Muscle implantation
- Acute intracutaneous reactivity
- ISO Sensitization
- Acute systemic toxicity
- . Pyrogenicity
- LAL endotoxins ●
- . Subchronic systemic toxicity
The results of these tests provide evidence that the SIS Inguinal Hernia Repair Graft meets the biocompatibility requirements of the ISO standard.
Mechanical Testing
The SIS Inguinal Hernia Repair Graft material was tested for the following:
- Suture retention strength
- Burst strength ●
- . Tensile strength
The results of the mechanical tests provide evidence that the SIS Inguinal Hernia Repair Graft provides adequate mechanical strength for its application.
Clinical Testing
The SIS Inguinal Hernia Repair Graft (also known as Surgisis Inguinal Hernia Matrix SIHM) was implanted in 95 patients in 3 separate clinical studies and the results were published in 3 peer reviewed articles. The results address the durability of repair with resorbable SIS Inguinal Hernia graft as used for open, tensionless repairs of inguinal hernias. One of the studies was a recent US randomized clinical trial comparing the use of SIS Inguinal Hernia Repair Graft (SIHRG) to polypropylene mesh (PP) using the Lichtenstein hernia repair procedure. This repair included bridging the defect. Results showed hernia recurrence rates of 6.7% (3/45 patients) and 0% (0/50 patients) at 1 year follow-up in the treatment (SIHRG) versus control groups. A difference in hernia recurrence rate was also seen at 3 years with 15.6% (7/45 patients) and 4.0% (2/50 patients) for the SIHRG and PP groups, respectively* . In addition, post-operative pain was assessed with a 1 year follow-up. Persistent pain trended higher in the PP group (6% vs. 4%). Authors of the U.S. study note that factors other than device performance could influence hernia recurrence outcomes, e.g., surgical approach, surgical experience, etc.
5
Two OUS prospectively randomized clinical investigations were conducted comparing SIHRG to PP using the Lichtenstein Repair. These studies found no hernia recurrences for SIHRG-treated patients at 1 and 3 years, (0/15, 1 year)2 and 0% (0/35, 3 years) 3, respectively. Recurrence rates for the PP-treated group found hernia recurrences of 0% (0/15, 1 year)2 and 2.9% (1/35, 3 years) 3. Both studies found lower post-operative pain and discomfort in the SIHRG patients at 30 days 2. The reported differences regarding hernia recurrence between the OUS and US clinical investigations may be reflective of many factors, chief among these being the probable difference in surgical procedures.
In clinical studies in which SIHRG was used to repair an inguinal hernia, the mean BMI in patients undergoing inguinal herniorraphy was 26 kg/m². Recurrence rates may be higher in obese patients (BMI>30) when using SIHRG in a tensionless inguinal hernia repair. A synopsis of each study is presented in the following tables.
*Three year follow-up data not yet validated or published.
6
| Number of centers | One center; Baltimore VA hospital; 7 investigators including 4 surgeons |
|---|---|
| Number of patients | 100 male patients randomized in a 1:1 fashion to open |
| Lichtenstein repair of the test groups, Surgisis Inguinal | |
| Hernia Matrix (SIHM) and control polypropylene mesh: | |
| 50:50 patients | |
| Note: In SIHM group 5 patients were withdrawn prior to | |
| surgery due to emergency surgery or traumatic event | |
| resulting in 45:50 patients | |
| Study inclusion/exclusion | |
| criteria | Exclusion Criteria: life expectancy 30 days) 1 hyperesthesia; hernia recurrence 0 |
| • Polyglactin and polypropylene – early complications: 2 hematoma, 1 prolonged pain, 1 sensory loss, 7 discomfort; long term: 1 hyperesthesia, 1 prolonged pain, 1 sensory loss, hernia recurrence 0 | |
| • Porcine small intestinal submucosa (Surgisis) – early: 1 seroma, 2 discomfort; late – none, hernia recurrence 0 |
Table 3: Puccio F, et al.. Comparison of three different mesh materials in tension-free hernia repair: Prolene versus Vypro versus Surgisis. Int Surg 2005:90:S21-S23.
10
Substantial Equivalence
See Table 4 for a comparison of the subject device and its predicates.
| Device | SIS Inguinal Hernia
Repair Graft | SurgiMend Collagen
Matrix | SIS Hernia Repair
Device |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech
Incorporated | TEI Biosciences Inc. | Cook Biotech
Incorporated |
| 510(k) Number | K142887 | K083898 | K062697 |
| Intended Use | For implantation to
reinforce soft tissues where
weakness exists, including
the repair of inguinal
hernias. | For implantation to
reinforce soft tissue
where weakness exists
and for the surgical repair
of damaged or ruptured
soft tissue membranes.
SurgiMend is specifically
indicated for: plastic and
reconstructive surgery,
muscle flap
reinforcement, hernia
repair including
abdominal, inguinal,
femoral, diaphragmatic,
scrotal, umbilical, and
incisional hernias. | For implantation to
reinforce soft tissues
where weakness exists.
Indications for use
include repair of a hernia
or body wall defect. |
| Product code | FTM | FTM | FTL |
| 21 CFR | 878.3300 | 878.3300 | 878.3300 |
| Material | Porcine small intestinal
submucosa (porcine)
Primarily Types I, III, IV
and VI collagen
(constituents of the
extracellular matrix) | Collagen based derived
from fetal bovine dermis | Porcine small intestinal
submucosa (porcine)
Primarily Types I, III, IV
and VI collagen
(constituents of the
extracellular matrix) |
| Dimensions | Rectangular or pre-
shaped
6 x 10 cm
8 x 15 cm
10 x 15 cm
12 x 15 cm
13 x 18 cm | 3 x 3 cm to 20 x 20 cm
square, 0.3 x 25 cm to 25
x 40 cm rectangle, 7 x 17
cm to 10 x 20 rectangle,
8 x 16 cm to 15 x 15 cm
semi-oval | 5 x 8 cm to 20 x 30 cm |
| Thickness | 0.1 - 1.0 mm | 0.5 to 4.4 mm | 0.1 - 1.5 mm |
| EtO Sterilized | Yes | Yes | Yes |
Table 4 – Substantial Equivalence Comparison
CONCLUSION:
The mechanical, pre-clinical, and clinical tests performed on the SIS Inguinal Hernia Repair Graft show that the device is substantially equivalent to its predicates.
REFERENCES:
1.Bochicchio, GV, et al., J Am Coll Surg, 2014. 218(4): p. 751-7.
- 2.Puccio, F, et al., Int Surg, 2005. 90(3 Suppl): p. S21-3.
- 3.Ansaloni, L, et al., Am J Surg, 2009. 198(3): p. 303-12.