(268 days)
Not Found
No
The device description focuses on the biological and mechanical components of the fistula plug and delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas, and its primary function is to fill and aid in the healing of the tract, indicating a therapeutic purpose.
No
This device is intended for the repair of enterocutaneous fistulas by reinforcing soft tissue, not for diagnosing medical conditions. It is an implanted therapeutic device.
No
The device description clearly outlines physical components including an implanted device made of biological material (porcine small intestine) and a delivery system, 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 "for implantation to reinforce soft tissue for repair of enterocutaneous fistulas." This describes a surgical implant used to physically repair tissue within the body.
- Device Description: The description details a physical plug made of biological material (porcine small intestinal submucosa) and other components designed for implantation and tissue repair.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze these specimens.
- Performance Study: The performance study described is an animal study evaluating the safety and biological response of the implanted device in a simulated use model, not a study evaluating the diagnostic accuracy of analyzing biological samples.
In summary, the Biodesign® Enterocutaneous Fistula Plug is a surgical implant intended for tissue repair in vivo, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.
Product codes
FTM
Device Description
The Biodesign® Enterocutaneous Fistula Plug is a bioabsorbable, collagen-derived, minimally invasive treatment option for the repair of enterocutaneous fistulas. The device consists of two parts - an implanted device and a delivery system. The implanted device has four components - the small intestinal submucosa (SIS) plug, the flange/gasket assembly, the suture tether and the Molnar Disc. The SIS plug is manufactured from porcine small intestine that has been stripped of its serosal, mucosal, and muscle layers and virally inactivated. The resulting acellular collagenous layer, termed Small Intestinal Submucosa, is manufactured into a rolled, freeze dried plug. The function of the SIS plug is to fill and aid in the healing of the tract. The plug fully remodels into patient tissue over time. The other three components, the flange/gasket assembly, the suture tether and the Molnar Disc are all temporary implants designed to either naturally pass out of the body or fall off the skin. The function of the flange/gasket assembly is to seal the internal opening of the fistula tract and prevent the ingress of any gastric/intestinal fluid from entering the fistula tract. The suture connects the flange assembly at the internal opening of the fistula to the Molnar Disc at the external opening. Tethering the suture to the Molnar Disc provides tension to keep the flange/gasket assembly securely in place. In addition to the implanted device, a delivery system is provided to ensure proper device delivery and deployment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, enterocutaneous fistulas
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: The biocompatibility assessment of the Biodesign® Enterocutaneous Fistula Plug was conducted in accordance with FDA's biocompatibility testing guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995). The results of the biocompatibility assessment provided evidence that the Biodesign® Enterocutaneous Fistula Plug meets the biocompatibility requirements of the ISO-10993 standard.
Mechanical Testing: Mechanical testing was conducted to ensure the device design is appropriate and the device is able to function as intended. Tests performed include: Leak resistance, Pushability, Deployment, Gasket expansion, Tensile strength, Two-plug deployment. All testing were performed on terminally sterilized devices.
Animal Testing: A GLP animal study was performed using the Biodesign® Enterocutaneous Fistula Plug (subject device) in a domestic swine model. The purpose of the animal study was to characterize the safety and biological response of the Biodesign® Enterocutaneous Fistula Plug under a simulated use animal model. Endpoints of the study included evaluation of local, regional responses of the intestine and adjacent organs, as well as the time over which the flange portion of the device remained in the luminal surface of the intestine. The study showed closure of the surgically created fistulas, complete incorporation of enterocutaneous fistula plugs at five weeks, with no negative clinical sequelae.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2015
Cook Biotech Incorprated Mr. Nick Wang Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K150668
Trade/Device Name: Biodesign Enterocutaneous Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: March 13, 2015 Received: November 10, 2015
Dear Mr. Wang:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
510(k) Number (if known) K150688
Device Name Biodesign® Enterocutaneous Fistula Plug
Indications for Use (Describe)
The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
13 March 2015
Cook Biotech Incorporated
Biodesign® Enterocutaneous Fistula Plug
| 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, VP of Quality Assurance and
Regulatory Affairs |
| Device Name and Classification: | |
e Name and Classification:
| Trade Name: | Biodesign® Enterocutaneous Fistula Plug |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Proposed classification name: | Surgical Mesh |
| 21 CFR 878.3300 (FTM) | |
| Class II |
Indications for Use:
The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.
Predicate Device:
The predicate device is the Surgisis® Biodesign® Enterocutaneous Fistula Plug (K082682), also manufactured by Cook Biotech Incorporated.
Device Description:
The Biodesign® Enterocutaneous Fistula Plug is a bioabsorbable, collagen-derived, minimally invasive treatment option for the repair of enterocutaneous fistulas. The device consists of two parts - an implanted device and a delivery system. The implanted device
4
has four components - the small intestinal submucosa (SIS) plug, the flange/gasket assembly, the suture tether and the Molnar Disc. The SIS plug is manufactured from porcine small intestine that has been stripped of its serosal, mucosal, and muscle layers and virally inactivated. The resulting acellular collagenous layer, termed Small Intestinal Submucosa, is manufactured into a rolled, freeze dried plug. The function of the SIS plug is to fill and aid in the healing of the tract. The plug fully remodels into patient tissue over time. The other three components, the flange/gasket assembly, the suture tether and the Molnar Disc are all temporary implants designed to either naturally pass out of the body or fall off the skin. The function of the flange/gasket assembly is to seal the internal opening of the fistula tract and prevent the ingress of any gastric/intestinal fluid from entering the fistula tract. The suture connects the flange assembly at the internal opening of the fistula to the Molnar Disc at the external opening. Tethering the suture to the Molnar Disc provides tension to keep the flange/gasket assembly securely in place. In addition to the implanted device, a delivery system is provided to ensure proper device delivery and deployment.
Equivalence of Market Device:
The Biodesign® Enterocutaneous Fistula Plug, the subject device, is a design improvement of the predicate device, Surgisis® Biodesign® Enterocutaneous Fistula Plug (K082682). The modifications described in this 510(k) are made based on user feedback and clinical experience resulting from use of the predicate device. Analysis and comparison of the intended use, and material and technological characteristics, in conjunction with relevant testing, support the determination that the subject and predicate devices are substantially equivalent. A brief summary of the relevant testing and the substantial equivalence comparison are provided below in this 510(k) summary.
Biocompatibility
The biocompatibility assessment of the Biodesign® Enterocutaneous Fistula Plug was conducted in accordance with FDA's biocompatibility testing guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995). Based on the standard, the plug, the flange/gasket assembly, the delivery system and the Molnar Disc each have different classifications. The classifications are summarized in Table 5-1.
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| Device | Biocompatibility Classification | ||
|---|---|---|---|
| Component | Device Type | Contact | Duration |
| SIS Plug | Implant device | Tissue contacting | Permanent (>30 days) |
| Flange/gasket | |||
| assembly | Surface device | Mucosal membrane | |
| contacting | Prolonged contact (24 | ||
| hrs - 30 days) | |||
| Delivery | |||
| device | Externally | ||
| communicating device | Tissue contacting | Limited ( |