(30 days)
Not Found
No
The document describes a biological tissue graft and does not mention any computational or algorithmic components.
No
The device is described as an implant to reinforce soft tissue and as a dura substitute, which are functions related to tissue repair and support, not therapeutic treatment of a disease or condition.
No
The device description clearly states its intended uses are for implantation to reinforce soft tissue, as a dura substitute, and for reinforcing soft tissue in urological anatomy. These are all therapeutic or reparative functions, not diagnostic ones.
No
The device description explicitly states the devices are composed of "multilayered sheets of processed porcine small intestinal submucosa (SIS)," which is a physical material, not software.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses described are for implantation to reinforce soft tissue, repair dura mater, and reinforce urological anatomy. These are all surgical or implantable procedures performed in vivo (within the body).
- Device Description: The devices are described as multilayered sheets of processed porcine small intestinal submucosa (SIS), packaged, and sterilized. This aligns with a medical device intended for implantation, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the devices being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. These devices are clearly intended for direct surgical use within a patient's body.
N/A
Intended Use / Indications for Use
Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue.
Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater.
Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.
Product codes (comma separated list FDA assigned to the subject device)
FTM, GXQ
Device Description
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS).
- Packaged in a Tyvek/PE double pouch.
- Shelf-life of 18 months
- Sterilized using ethylene oxide.
The only differences between the three devices are the indications (and associated labeling) and the dimensional specifications (analogous to the indication and anatomic requirement for each device). Both the indications and the dimensional specifications of each subject device, however, are unchanged from the corresponding predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, dura mater, urological anatomy, tunica albuginea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Summary of publications showing SIS performed as expected in versions of the device without the sidedness indicator.
Risk management activities performed in accordance with ISO 14971 on the subject devices did not identify sidedness of the material as a potential risk. Published peer-reviewed literature also confirmed that devices without the sidedness indicator performed as expected, giving evidence of substantial equivalence.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Cook Biotech, Inc. Nick Wang, Ph.D., RAC Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K 160869
Trade/Device Name: Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, GXQ Dated: March 28, 2016 Received: March 30, 2016
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 and 809); medical device reporting
1
(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.
for
Sincerely yours,
David Krause -S
- 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
Indications for Use
510(k) Number (if known)
K160869 Page 1 of 3
Device Name Biodesign Tissue Graft
Indications for Use (Describe) Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K160869 Page 2 of 3
Device Name Biodesign Dural Graft
Indications for Use (Describe) Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K160869 Page 3 of 3
Device Name Biodesign Peyronie's Repair Graft
Indications for Use (Describe)
Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.
| 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
Submitted by: Perry Guinn Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 28 March 2016
This 510(k) is a bundled submission pertaining to three devices manufactured by Cook Biotech Incorporated (CBI):
-
- Biodesign Tissue Graft
-
- Biodesign Dural Graft
-
- Biodesign Peyronie's Repair Graft
This submission is presented as a bundle because the technological modification under consideration is the same for all three devices. Table 5-1 below compiles the main regulatory elements of each subject device, which remain unchanged from their respective predicates.
| Proprietary Name1 | Biodesign Tissue Graft | Biodesign Dural Graft | Biodesign Peyronie's Repair Graft |
|---|---|---|---|
| Predicate Device | Surgisis (K980431) | Durasis Dural Substitute (K031850) | Surgisis Peyronie's Repair Graft (K062320) |
| Intended Use | intended to be used for implantation to reinforce soft tissue | intended for use as a dura substitute for the repair of dura mater | intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease |
| Common/Usual Name | Surgical Mesh | Dura Substitute | Surgical Mesh |
| Table 5-1. Device names, predicates, intended uses and classifications: | ||
|---|---|---|
1 The current proprietary names for the devices are Biodesign Tissue Graft, Biodesign Dural Graft and Biodesign Peyronie's Repair Graft. In the past, Surgisis and Durasis Dural Substitute were the proprietary names for the Biodesign Tissue Graft and the Biodesign Dural Graft respectively.
6
| Proprietary
Name1 | Biodesign Tissue
Graft | Biodesign Dural
Graft | Biodesign Peyronie's
Repair Graft |
|------------------------------------|---------------------------|--------------------------|--------------------------------------|
| Proposed
Classification
Name | Mesh, Surgical | Dura Substitute | Mesh, Surgical |
| Product Code | FTM | GXQ | FTM |
| Device Class | II | II | II |
| Regulation
Number | 878.3300 | 882.5910 | 878.3300 |
Device Descriptions:
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS).
- Packaged in a Tyvek/PE double pouch. ●
- Shelf-life of 18 months ●
- Sterilized using ethylene oxide. ●
The only differences between the three devices are the indications (and associated labeling) and the dimensional specifications (analogous to the indication and anatomic requirement for each device). Both the indications and the dimensional specifications of each subject device, however, are unchanged from the corresponding predicate device. The indications have been described in Table 5-1 and the dimensional specifications are presented in Table 5-2, below:
| | Biodesign Tissue
Graft | Biodesign Dural
Graft | Biodesign
Peyronie's Repair
Graft |
|----------------------------------|---------------------------------|---------------------------------|-----------------------------------------|
| Product
Dimensions
(range) | 2 cm x 4 cm
to 20 cm x 40 cm | 2 cm x 2 cm
to 10 cm x 20 cm | 1 cm x 4 cm
to 7cm x 12 cm |
| Shape | Rectangular | Rectangular | Oval |
Table 5-2. Dimensional Specifications
Description of Technological Modifications:
A technological feature that was present in all three predicate devices was a small hole at the top right corner of the devices, which functioned as a sidedness indicator. Device labeling for predicate devices noted that the functional differences between the sides were
7
minimal, but cell culture data suggested that the growth of epithelial cells moderately favored one of the sides. Subsequent clinician feedback on the use of the predicate devices confirmed that the functional differences between the sides were minimal and additionally reported that the presence of the sidedness indicator was confusing. Therefore, based on the lack of necessity for a sidedness indicator, all three devices have been modified to no longer include this technologic feature.
Summary of Supporting Evidence for Substantial Equivalence:
The following items are provided to demonstrate substantial equivalence to the predicate devices:
- . 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)]
- Review of risk analysis performed in compliance with ISO 14971. Risk analysis ● methods used include:
- Failure mode and effects analysis (FMEA) o
- Residual risk review o
- o Post production review
- Summary of publications showing SIS performed as expected in versions of the . device without the sidedness indicator.
Substantial Equivalence:
Table 5-3 below provides a comparison of the subject devices and their predicates.
Conclusion:
CBI modified three of its devices by removing the sidedness indicator, a small hole at the top right corner of each device. The indicator was initially included in the design of the device based on cell culture data, and not on the functional differences between the sides or reducing specific clinical risk(s). Clinical feedback confirmed functional differences between the sides were minimal and reported that the presence of the sidedness indicator led to confusion. Risk management activities performed in accordance with ISO 14971 on the subject devices did not identify sidedness of the material as a potential risk. Published peer-reviewed literature also confirmed that devices without the sidedness indicator performed as expected, giving evidence of substantial equivalence.
8
| | Biodesign Tissue Graft
Biodesign Dural Graft
Biodesign Peyronie's Repair
Graft
(Subject Devices) | Surgisis,
Durasis Dural Substitute,
Surgisis Peyronie's Repair
Graft
(Predicate Device) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Unassigned | K980431 (Surgisis)
K031850 (Durasis)
K062320 (Surgisis Peyronie's
Repair Graft) |
| Indication for
Use
(The indications
for use of each
device in the
bundled 510(k)
are unchanged
from that of
each respective
predicate
device.) | Biodesign Tissue Graft: intended
to be used for implantation to
reinforce soft tissue. | Surgisis: intended to be used for
implantation to reinforce soft
tissue. |
| | Biodesign Dural Graft: intended
for use as a dura substitute for the
repair of dura mater. | Durasis Dural Substitute:
intended for use as a dura
substitute for the repair of dura
mater. |
| | Biodesign Peyronie's Repair
Graft: intended for implantation
to reinforce soft tissue where
weakness exists in the urological
anatomy, including but not
limited to the repair of tunica
albuginea defects, and
reinforcement in the repair of
Peyronie's disease. | Surgisis Peyronie's Repair Graft:
intended for implantation to
reinforce soft tissue where
weakness exists in the urological
anatomy, including but not
limited to the repair of tunica
albuginea defects, and
reinforcement in the repair of
Peyronie's disease. |
| Material | Processed Porcine small
intestinal submucosa;
(constituents of the extracellular
matrix) | Processed Porcine small
intestinal submucosa;
(constituents of the extracellular
matrix) |
| Technological
Characteristics | Does not include a sidedness
indicator | Includes a sidedness indicator
(small hole at the top right
corner) |
| Supplied
sterile? | Yes | Yes |
| Sterilization
method | Ethylene Oxide | Ethylene Oxide |
| Packaging | Double pouched
Tyvek/PE | Double pouched
Tyvek/PE |
| Shelf-Life | 18 months | 18 months |
| Intended for
single use? | Yes | Yes |