(185 days)
No
The device description focuses on the material composition (porcine SIS) and its mechanical properties, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an implantable matrix made from porcine small intestinal submucosa (SIS) that reinforces soft tissue. It is not an active therapeutic device; rather, it is a material intended to facilitate the repair of tissue.
No
The device is a medical implant made of porcine small intestinal submucosa (SIS) intended for reinforcing soft tissue and repairing fistulas, which is a therapeutic function, not diagnostic.
No
The device description clearly states the devices are made of processed porcine small intestinal submucosa (SIS), a physical material for implantation.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these devices are for implantation to reinforce soft tissue for the repair of various types of fistulas and for soft tissue repair or reinforcement in plastic/reconstructive surgery. This is a therapeutic and structural function within the body.
- Device Description: The description details a processed porcine tissue material (SIS) used as an implantable matrix. This is a biological material intended for surgical implantation.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or analysis of specimens.
The device is an implantable medical device used for surgical repair and reinforcement of tissue.
N/A
Intended Use / Indications for Use
- Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
- Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
- Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
- Biodesign Tissue Graft: For implantation to reinforce soft tissue.
Product codes
FTM, OXN, OXH
Device Description
All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.
The four subject devices of this bundled submission share many of the same technological characteristics:
- All four devices are indicated for applications related to reinforcing soft tissue (with various specific indications)
- All four devices are composed of porcine small intestinal submucosa (SIS) manufactured by CBI
- All four devices are labeled with a shelf-life of 18 months
- All four devices are sterilized using ethylene oxide
While the four devices are different from each other in device indications and dimensional specifications, each subject device is unchanged from its respective predicate device in physical form (device itself and packaging) and indications for use. The only difference between each subject device and its corresponding predicate device is in the device labeling, with the subject devices having additional rehydration fluid options included in their instructions for use (IFUs).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anal, Rectal, Enterocutaneous, Recto-vaginal, Anorectal
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
Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options that demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties.
Key Metrics
Not Found
Predicate Device(s)
K161221, K050337, K170016, K034039, K160896, K980431
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 27, 2019
Cook Biotech Incorporated Nick Wang Regulatory Science Manager 1425 Innovation Place West Lafayette, Indiana 47906
Re: K191696
Trade/Device Name: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXN, OXH, OXH Dated: November 22, 2019 Received: November 25, 2019
Dear Nick 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K191696
Device Name Biodesign Anal Fistula Plug
Indications for Use (Describe)
For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K191696
Device Name Biodesign Fistula Plug
Indications for Use (Describe)
For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K191696
Device Name Biodesign Plastic Surgery Matrix
Indications for Use (Describe)
For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known) K191696
Device Name Biodesign Tissue Graft
Indications for Use (Describe) For implantation to reinforce soft tissue.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Summary
| Submitted by: | Perry Guinn |
|---|---|
| Vice President, Quality Assurance and Regulatory Affairs, | |
| Cook Biotech Inc. | |
| 1425 Innovation Place West Lafayette, IN 47906 | |
| (765) 497-3355 | |
| Date: | December 22, 2019 |
| 510(k) Number: | K191696 |
| Device Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | OXH, OXN, FTM |
| Predicate Devices: | K161221, K050337, K170016, K161221, K034039, K160896 |
| K980431 |
This 510(k) is a bundled submission pertaining to four devices manufactured by Cook Biotech Incorporated (CBI):
- Biodesign® Anal Fistula Plug 1.
- Biodesign® Fistula Plug 2.
- Biodesign® Plastic Surgery Matrix 3.
- Biodesign® Tissue Graft 4.
This submission is presented as a bundle because the modification under consideration is the same for all four devices.
Device Descriptions:
All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.
The four subject devices of this bundled submission share many of the same technological characteristics:
- All four devices are indicated for applications related to reinforcing soft tissue (with various specific indications)
- All four devices are composed of porcine small intestinal submucosa (SIS) manufactured by CBI
- All four devices are labeled with a shelf-life of 18 months
- o All four devices are sterilized using ethylene oxide
While the four devices are different from each other in device indications and dimensional specifications, each subject device is unchanged from its respective predicate device in physical form (device itself and packaging) and indications for use. The only difference between each subject device and its corresponding predicate device is in the device labeling, with the subject
7
devices having additional rehydration fluid options included in their instructions for use (IFUs).
| | Biodesign Anal
Fistula Plug
(AFP) | Biodesign Fistula Plug
(FP) | Biodesign Plastic
Surgery Matrix
(PSM) | Biodesign Tissue
Graft (TG) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------|
| Product
Dimensions
(nominal) - same
as in the cleared
predicate 510(k) | 2 mm minor
diameter to 7 mm
major diameter by
100 mm length; | 2 mm minor diameter to 7
mm major diameter by 51
mm length;
Device also contains SIS
flange/button | 2 to 70 mm width
up to 200 mm
length;
100 to 1500 µm
thick | 2 cm x 4 cm
to 20 cm x 40 cm;
40 to 700 µm thick |
| Shape | Plug | Plug | Rectangular | Rectangular |
Table 5-2. Dimensional Specifications
Description of Modifications:
For each subject device, the only modification from the predicate device is in the devicelabeling. The modification that triggered this submission is the inclusion of additional rehydration fluid options in the instructions for use (IFU)4. In addition to saline (which is the rehydration fluid in the predicate devices), autologous body fluid is being added as potential rehydration fluid options for all subject devices of this submission. In addition, example autologous fluids such as blood, bone marrow aspirate, or blood concentrate such as platelet concentrate are also being added to the labeling of the Biodesign Plastic Surgery Matrix and the Biodesign tissue Graft. CBI is making this modification because there is interest in the field to use these fluids to rehydrate the device. There are already several cleared surgical meshes (including the reference devices K132025 and K171817) with this type of rehydration language in their 510(k) summaries.
Summary of Supporting Evidence for Substantial Equivalence:
The following items are provided to demonstrate substantial equivalence to the predicate devices:
- Analysis of 510(k) Substantial Equivalence Decision-Making Process as outlined in FDA's Guidance Document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
- Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options that demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties.
Substantial Equivalence:
Table 5-3 provides a comparison of the subject devices and their respective predicates.
8
| | Biodesign Anal Fistula Plug, Biodesign Fistula Plug
Biodesign Plastic Surgery Matrix,
Biodesign Tissue Graft (Subject Devices) | Predicate Devices all with the
Same Name (Predicate
Devices) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) | K191696 | AFP-K161221/K050337 PF-
K170016
PSM-K161221/K034039 TG-
K160896/K980431 |
| Indication for Use
(The indications for
use of each device in
the bundled 510(k) are
unchanged from that
of its respective
predicate device.) | Biodesign Anal Fistula Plug: For implantation to
reinforce soft tissue where a rolled configuration is
required, for repair of anal, rectal and enterocutaneous
fistulas. | Same |
| | Biodesign Fistula Plug: For implantation to reinforce soft
tissue for repair of recto-vaginal or anorectal fistulas. | Same |
| | Biodesign Plastic Surgery Matrix: For implantation to
reinforce soft tissue where weakness exists in patients
requiring soft tissue repair or reinforcement in plastic or
reconstructive surgery. | Same |
| | Biodesign Tissue Graft: For implantation to reinforce soft
tissue. | Same |
| Material | Porcine small intestinal submucosa; (constituents of the
extracellular matrix) | Same |
| Supplied sterile? | Yes | Same |
| Sterilization method | Ethylene Oxide | Same |
| Rehydration Fluid | All devices in the bundle
Sterile saline and autologous body fluids
Plastic Surgery Matrix and Tissue Graft
Sterile saline and autologous body fluids such as blood,
bone marrow aspirate, or blood concentrates such as
platelet concentrate | Sterile saline |
| | Shelf-Life | 18 months |
| Intended for single
use? | Yes | Same |
Table 5-3. Substantial Equivalence Information
9
Conclusion:
For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, and Biodesign Tissue Graft, the subject devices, have the same intended use and functions under the same mode of action and fundamental scientific technology as the predicate devices with the same name. In addition, the subject devices are composed of the same materials and are manufactured using the same processes as the predicate devices. The only modification is the addition of autologous body fluids as possible rehydration fluids in the devices' IFUs. The absence of changes in the fundamental scientific technology and intended use of the device, as well as the completion of verification and validation activities, provide evidence to support the conclusion that the subject devices perform comparably to the predicate devices that are currently marketed for the same intended use.