(267 days)
No
The device description focuses on the material composition and physical properties of a biological graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for implantation to reinforce soft tissues, which points to a therapeutic purpose rather than diagnostic or other non-therapeutic uses.
No
The device is an implantable graft intended to reinforce soft tissues, not to diagnose a condition.
No
The device is a physical implantable graft made from porcine small intestine, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias." This describes a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details a "multilayered SIS sheets" made from porcine small intestine, designed to be implanted and remodel into the body. This is consistent with a surgical graft, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.
The graft is supplied sterile and is intended for one time use only.
Product codes
OWV, FTM
Device Description
The Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same indications for use and is physically identical to the predicate device (K133011) with the same name. The only difference between the subject device and the predicate device is the rehydration fluid options described in the devices' instructions for use (IFU).
Both the subject and predicate devices are part of a family of implant devices manufactured from porcine small intestine that have been processed to remove the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer intestinal surface. After further disinfection to ensure the material is virally inactive, the resulting layer is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Both the subject and predicate devices are multilayered SIS sheets configured in two shapes: rectangular shape (7 x 10 cm) and the U-cut shape (7 x 10 cm with U-shaped notch). Both devices are perforated and have polyglycolic acid (PGA) suture stitched across the device and around the perimeter. The purpose of the suture stitching is to prevent delamination due to device handling during implantation. Both devices are provided in a double Tyvek® pouch and are ethylene oxide (EO) sterilized.
Prior to implantation, the Biodesign® Diaphragmatic Hernia Graft, the subject device, can be rehydrated with sterile saline or autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate).
Upon implantation, the Biodesign® Diaphragmatic Hernia Graft (both subject and predicate device) will provide mechanical reinforcement of soft tissue in the repair of diaphragmatic/hiatal hernias. Over time, the device will incorporate (remodel) into the body such that no graft material is left behind.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Diaphragmatic/hiatal hernias
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)
Non-Clinical testing:
Product verification testing was performed on sterilized finished devices to evaluate device mechanical properties after rehydration with body fluids. Comparative tests (rehydration with saline vs. with body fluids) were performed to evaluate the device's tensile strength, suture retention strength, hydration time and simulated use/handling properties.
Results of the testing showed rehydration with body fluids did not significantly change the mechanical and handling properties of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
March 13, 2018
Cook Biotech Incorporated Nick Wang, Ph.D. Regulatory Scientist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K171817
Trade/Device Name: Biodesign Diaphragmatic Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWV, FTM Dated: December 11, 2017 Received: December 13, 2017
Dear Dr. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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)
K171817
Device Name Biodesign® Diaphragmatic Hernia Graft
Indications for Use (Describe)
The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.
The graft is supplied sterile and is intended for one time use only.
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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510(k) Summary
I. SUBMITTER
Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906
Phone: (765) 497-3355
Contact Person: Perry W. Guinn Date Prepared: 12 February 2018
DEVICE II.
| Name of Device: | Biodesign® Diaphragmatic Hernia Graft |
|---|---|
| 510(k) Number: | K171817 |
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
| Regulation number: | 21 CFR §878.3300 |
| Product Code: | OWV, FTM |
| Regulatory Class: | Class II |
III. PREDICATE DEVICE
Biodesign® Diaphragmatic Hernia Graft (K133011, Cook Biotech Incorporated)
IV. REFERENCE DEVICE
Meso Bilayer Surgical Mesh (K132025, DSM Biomedical)
DEVICE DESCRIPTION V.
The Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same indications for use and is physically identical to the predicate device (K133011) with the same name. The only difference between the subject device and the predicate device is the rehydration fluid options described in the devices' instructions for use (IFU).
Both the subject and predicate devices are part of a family of implant devices manufactured from porcine small intestine that have been processed to remove the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer intestinal surface. After further disinfection to ensure the material is virally inactive, the resulting layer is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Both the subject and predicate
4
devices are multilayered SIS sheets configured in two shapes: rectangular shape (7 x 10 cm) and the U-cut shape (7 x 10 cm with U-shaped notch). Both devices are perforated and have polyglycolic acid (PGA) suture stitched across the device and around the perimeter. The purpose of the suture stitching is to prevent delamination due to device handling during implantation. Both devices are provided in a double Tyvek® pouch and are ethylene oxide (EO) sterilized.
Prior to implantation, the Biodesign® Diaphragmatic Hernia Graft, the subject device, can be rehydrated with sterile saline or autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate).
Upon implantation, the Biodesign® Diaphragmatic Hernia Graft (both subject and predicate device) will provide mechanical reinforcement of soft tissue in the repair of diaphragmatic/hiatal hernias. Over time, the device will incorporate (remodel) into the body such that no graft material is left behind.
VI. INDICATIONS FOR USE
The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.
The graft is supplied sterile and is intended for one time use only.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Biodesign® Diaphragmatic Hernia Graft device is identical to its predicate in that they are both intended to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias. Moreover, the subject device's component materials, fundamental scientific technology, and mode of action are identical to that of the predicate device.
The only modification to the Biodesign® Diaphragmatic Hernia Graft (subject device) is the addition of more rehydration fluid options in the instructions for use (IFU). The subject device includes sterile saline and autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate) as possible rehydration fluids whereas the predicate device describes rehydration with saline. The reference device Meso Bilayer Surgical Mesh (K132025) also indicated for hiatal hernia repairs, shares the same rehydration fluid information (rehydration with saline or autologous body fluids) as the subject device. Please see Table 5-1 for a more detailed comparison of the subject, predicate and reference devices.
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| Device | BiodesignⓇ
Diaphragmatic
Hernia Graft
(subject device) | Biodesign® Diaphragmatic
Hernia Graft
(predicate device) | Meso Bilayer Surgical Mesh
(reference device) |
|-----------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CBI | CBI | DSM Biomedical |
| 510 (k)
Number | K171817 | K133011 | K132025 |
| Product Code | | FTM | FTM, OXH |
| Intended Use | Unchanged from
predicate device | For implantation to
reinforce soft tissues where
weakness exists including
the repair of
diaphragmatic/hiatal hernias | For implantation to reinforce
soft tissues where weakness
exists in patients requiring soft
tissue repair and reinforcement
in plastic and reconstructive
surgery including but not
limited to the following
procedures: reinforcement of
primary closure such as suture
line reinforcement and muscle
flap reinforcement; hernia repair
(e.g. hiatal, femoral,
paracolostomy, umbilical) |
| Materials and
Components | | Small intestinal submucosa
PGA suture | Porcine tissue and synthetic
absorbable polymer |
| Device
Configuration | | 7x 10 cm size (rectangular
and U-cut shape) | Unknown (not specified in
510(k) summary) |
| Shelf-Life | | 18 months | 36 months |
| Packaging | | foil pouch | Double peel packages |
| Sterilization | | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| One-time Use | | Yes | Yes |
| Rehydration
Fluid | Saline and
autologous body
fluids | Saline | Saline and autologous body
fluids |
Table 5-1. Substantial Equivalence Information
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical testing
Product verification testing was performed on sterilized finished devices to evaluate device mechanical properties after rehydration with body fluids. Comparative tests (rehydration with saline vs. with body fluids) were performed to evaluate the device's
6
tensile strength, suture retention strength, hydration time and simulated use/handling properties.
Results of the testing showed rehydration with body fluids did not significantly change the mechanical and handling properties of the device.
VIII. CONCLUSIONS
For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same intended use and functions under the same mode of action and fundamental scientific technology as the predicate device with the same name. In addition, the subject device is composed of the same materials and is manufactured using the same processes as the predicate device. The only modification is the addition of autologous body fluids as possible rehydration fluids in the device's IFU. The absence of changes in the fundamental scientific technology and intended use of the device, as well as a review of the risk analysis and completion of verification and validation activities, provide evidence to support the conclusion that the modification does not introduce new risks and that the subject device performs comparably to the predicate device that is currently marketed for the same intended use.