(268 days)
Not Found
No
The device description and performance studies focus on the material properties and biological integration of a bioabsorbable graft, with no mention of AI or ML technology.
Yes
The device is intended for implantation to reinforce soft tissues for the repair of hernias or body wall defects, directly addressing a health condition.
No
Explanation: The device is a hernia graft intended for implantation to reinforce soft tissues, not to diagnose a condition.
No
The device description clearly states it is a physical graft composed of biological material (SIS) and suture, intended for implantation. It is a hardware device, not software.
No, 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- SIS Hernia Graft Function: The SIS Hernia Graft is an implantable device. It is surgically placed inside the body to reinforce soft tissues and repair hernias or body wall defects. It does not analyze or test samples taken from the body.
- Intended Use: The intended use clearly states it's for "implantation to reinforce soft tissues." This is a therapeutic or structural function, not a diagnostic one.
- Device Description: The description details a bioabsorbable collagen matrix for implantation, not a device for analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, mechanical strength, and animal implantation studies, all related to the device's function within the body, not its ability to diagnose conditions from samples.
Therefore, based on the provided information, the SIS Hernia Graft is a medical device (specifically, an implantable surgical device), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXK
Device Description
The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated.
The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. 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
soft tissues where weakness exists, hernia or body wall defect
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: The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material composition to the SIS Hernia Graft (according to the ISO 10993-1 standard): Genotoxicity, Direct contact in vitro hemolysis, Cytotoxicity, Muscle implantation, Acute intracutaneous reactivity, Skin irritation, ISO Sensitization, Acute systemic toxicity, Pyrogenicity, LAL endotoxins, Subchronic systemic toxicity. The results of these tests provided evidence that the SIS Hernia Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing: The SIS Hernia Graft material was tested for the following: Suture retention strength, Burst strength, Ultimate tensile strength, Tear strength, Stiffness test. The results of the mechanical testing provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application.
Animal Testing: A study was performed where the SIS Hernia Graft was implanted in a pig hernia model and examined for gross and histopathological results after 27 days. The results show that the device is well tolerated with minimal localized tissue response. A second pig hernia study used the SIS Hernia Graft as a control article and examined one and 6-months post-implant showed satisfactory remodeling characteristics with minimal inflammation. Another animal study in the mouse examined the angiogenesis of the SIS Hernia Graft showed that the sutured SIS performed as well as its sutureless control SIS with robust vascular penetration. The results of the studies show that the device is safe and biocompatible in its application.
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
JUL 2 3 2014
510(k) Summary
July 18, 2014
Cook Biotech Incorporated
SIS Hernia 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: Common Name: Classification Regulations:
SIS Hernia Graft Surgical graft Class II, 21 CFR §878.3300 (FTM and OXK)
INDICATIONS FOR USE:
The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.
DEVICE DESCRIPTION:
The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated.
The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
1
EQUIVALENCE TO MARKETED DEVICES
The SIS Hernia Graft is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate device in terms of section 510(k) substantial equivalence, as shown in biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical and pre-clinical testing.
Biocompatibility testing
The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material composition to the SIS Hernia Graft (according to the ISO 10993-1 standard):
- Genotoxicity .
- Direct contact in vitro hemolysis .
- Cytotoxicity �
- Muscle implantation .
- Acute intracutaneous reactivity .
- Skin irritation ●
- ISO Sensitization .
- Acute systemic toxicity .
- Pyrogenicity ●
- LAL endotoxins .
- . Subchronic systemic toxicity
The results of these tests provided evidence that the SIS Hernia Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing
The SIS Hernia Graft material was tested for the following:
- Suture retention strength .
- . Burst strength
- Ultimate tensile strength .
- Tear strength .
- Stiffness test .
The results of the mechanical testing provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application.
2
Animal Testing
A study was performed where the SIS Hernia Graft was implanted in a pig hernia model and examined for gross and histopathological results after 27 days. The results show that the device is well tolerated with minimal localized tissue response. A second pig hernia study used the SIS Hernia Graft as a control article and examined one and 6-months post-implant showed satisfactory remodeling characteristics with minimal inflammation. Another animal study in the mouse examined the angiogenesis of the SIS Hernia Graft showed that the sutured SIS performed as well as its sutureless control SIS with robust vascular penetration. The results of the studies show that the device is safe and biocompatible in its application.
Substantial Equivalence
See Table 1 for a comparison of the subject device and its predicate.
| Device | SIS Hernia Graft | SIS Hernia Repair Device | SIS Hernia Repair Device |
|---|---|---|---|
| Manufacturer | Cook Biotech Incorporated | Cook Biotech Incorporated | Cook Biotech Incorporated |
| 510(k) Number | K133306 | K974540 | K062697 |
| Intended Use | Intended for implantation to | ||
| reinforce soft tissues where | |||
| weakness exists. Indications | |||
| for use include the repair of a | |||
| hernia or body wall defect. | Intended to be implanted to | ||
| reinforce soft tissues where | |||
| weakness exists. Indications | |||
| for use include the repair of a | |||
| hernia or body wall defect. | Intended to be implanted to | ||
| reinforce soft tissues where | |||
| weakness exists. Indications | |||
| for use include the repair of a | |||
| hernia or body wall defect. | |||
| Material | Porcine small intestinal | ||
| submucosa (porcine) | |||
| Primarily Types I, III, IV and | |||
| VI collagen (constituents of | |||
| the extracellular matrix) | Porcine small intestinal | ||
| submucosa (porcine) | |||
| Primarily Types I, III, IV and | |||
| VI collagen (constituents of the | |||
| extracellular matrix) | Porcine small intestinal | ||
| submucosa (porcine) | |||
| Primarily Types I, III, IV and | |||
| VI collagen (constituents of the | |||
| extracellular matrix) | |||
| Dimensions | 5 x 8 cm to 30 x 30 cm | 5 x 8 cm to 20 x 30 cm | 1 x 3 to 20 x 30 cm |
| Thickness | 0.1 - 1.5mm | 0.1 - 1.5 mm | 0.1 - 1.5 mm |
| Type of drying | Lyophilized | Vacuum pressed | Vacuum pressed |
| Layers | 8 layers | 8 layers | 8 layers |
| Stitched | |||
| (resorbable | |||
| suture) | Yes | No | No |
| Biocompatible | Yes | Yes | Yes |
| Table 1 - Substantial Equivalence Comparison | |
|---|---|
| ---------------------------------------------- | -- |
While the SIS Hernia Graft is dried differently than the predicate SIS Hernia Repair Device, the SIS material is the same and exhibits similar incorporation and resorption characteristics when implanted. The suture stitching of the SIS Hernia Graft is intended to hold the layers of the device together during the implantation period and is resorbed without any effect on the SIS material.
CONCLUSION: The biocompatibility, mechanical, and animal tests performed on the SIS Hernia Graft show that the device is substantially equivalent to its predicate.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. 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 symbol that resembles a human figure with three flowing lines representing support and care.
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
July 23, 2014
Cook Biotech Incorporated Mr. Perry W. Guinn Vice President. Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K133306
Trade/Device Name: SIS Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXK Dated: June 10, 2014 Received: June 11, 2014
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 cither 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
4
Page 2 - Mr. Perry W. Guinn
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" (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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133306
Device Name SIS Hernia Graft
Indications for Use (Describe)
The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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