(27 days)
Not Found
No
The device description and performance studies focus on the material properties, sterilization, and mechanical strength of the porcine SIS implants, with no mention of AI or ML.
Yes
The devices are designed for implantation to reinforce weak soft tissues in various anatomical areas, which directly addresses a medical condition to improve health. This aligns with the definition of a therapeutic device.
No
The provided text describes different types of slings and matrices designed for implantation to reinforce soft tissues, treat incontinence, and repair fistulas. Their function is to provide structural support, not to diagnose conditions.
No
The device description explicitly states it is composed of porcine small intestinal submucosa (SIS) and is a physical implantable material, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use of these devices is for implantation to reinforce soft tissues in various anatomical locations (urological, gastroenterological, plastic/reconstructive surgery). This is a direct therapeutic or reconstructive purpose within the body.
- Device Description: The devices are composed of porcine small intestinal submucosa (SIS) and are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device itself is the treatment/reinforcement.
IVD devices are used outside the body to analyze samples and provide diagnostic information. These devices are implanted within the body for structural support and reinforcement.
N/A
Intended Use / Indications for Use
Biodesign Sling: "For implantation to reinforce soft tissues where weakness exists in the urological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency."
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 Anal Fistula Plug: "For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas."
Product codes (comma separated list FDA assigned to the subject device)
FTM, PAJ, PAG
Device Description
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of porcine small intestinal submucosa (SIS)
- Packaged in a Tyvek/PE pouch
- Labeled with a 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 (specific 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.
Dimensional Specifications:
Biodesign Sling: 20 cm^2 to 140 cm^2, 70 to 600 micrometers thick, Rectangular shape.
Biodesign Plastic Surgery Matrix: 2 to 70 mm width, up to 200 mm length, 100 to 1500 micrometers thick, Rectangular shape.
Biodesign Anal Fistula Plug: 2 mm minor diameter to 7 mm major diameter by 100 mm length, Cone shape.
Technological Modifications:
A series of wash steps was added to the depuration process of the base material for all three subject devices. This process modification serves to further remove impurities from the base material.
In addition, two minor technological changes were made to two of the subject devices:
- Addition of perforations to the Biodesign Sling and Biodesign Plastic Surgery Matrix
- Change in drying method for the Biodesign Sling
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biodesign Sling: urological, gynecological and gasteroenterological anatomy (pubourethral, bladder, apical vaginal, colon, rectal)
Biodesign Plastic Surgery Matrix: soft tissue
Biodesign Anal Fistula Plug: anal, rectal and 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)
The submission includes:
- 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)]
- Biocompatibility analysis performed in accordance with ISO 10993
- Viral Inactivation verification performed in accordance with prEN 12442-3: 2000
- Full design control as required by 21CFR 820.30 including review of risk analysis performed in compliance with ISO 14971. Risk analysis methods used include:
- Failure mode, effects and criticality analysis (FMECA)
- Residual risk review
- Post production review
- Mechanical testing for burst force strength and suture retention strength
- Chemical residuals testing
- Measurement of endotoxin levels
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by a flowing line that resembles a ribbon or banner. The profiles are arranged in a way that suggests unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Cook Biotech, Inc. Mr. Perry W. Guinn VP, Regulatory Affairs and Quality Assurance 1425 Innovation Place West Lafayette, IN 47906
Re: K161221
Trade/Device Name: Biodesign Sling, Biodesign Plastic Surgery Matrix,
Biodesign Anal Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II
Product Code: FTM Dated: April 27, 2016
Received: April 29, 2016
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
Jennifer R. Stevenson -A
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
2
Indications for Use
510(k) Number (if known) K161221, Page 1 of 3
Device Name
Biodesign Sling
Indications for Use (Describe)
For implantation to reinforce soft tissues where weakness exists in the urological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
| 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."
3
Indications for Use
510(k) Number (if known)
K161221, Page 2 of 3
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)
| ☒ 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)
K161221, Page 3 of 3
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)
| ☑ 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 27 April 2016
This 510(k) is a bundled submission pertaining to three devices manufactured by Cook Biotech Incorporated (CBI):
-
- Biodesign Sling
-
- Biodesign Plastic Surgery Matrix
-
- Biodesign Anal Fistula Plug
This submission is presented as a bundle because the main technological modification under consideration is the same for all three devices. Table 5-1 below compiles the key regulatory elements for each subject device, which remain unchanged from their respective predicates.
| Proprietary Name | Biodesign Sling | Biodesign Plastic
Surgery Matrix | Biodesign Anal
Fistula Plug |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | Surgisis Sling
(K992159) | SIS Plastic Surgery
Matrix (K034039) | SIS Fistula Plug
(K050337) |
| Intended Use | Intended to be used for
implantation to reinforce soft
tissues where weakness exists in
the urological, gynecological and
gasteroenterological anatomy
including but not limited to the
following procedures: transvaginal
repair of stress urinary
incontinence, such as pubourethral
support and bladder support, and
transabdominal repair of apical
vaginal prolapse, colon and rectal
prolapse, and
sacrocolposuspension. By
providing pubourethral support,
the sling may be used for the
treatment of urinary incontinence
resulting from urethral
hypermobility or intrinsic
sphincter deficiency. | Intended for
implantation to
reinforce soft tissue
where weakness
exists in patients
requiring soft tissue
repair or
reinforcement in
plastic or
reconstructive
surgery. | Intended for
implantation to
reinforce soft tissue
where a rolled
configuration is
required, for repair of
anal, rectal and
enterocutaneous
fistulas. |
Table 5-1. Device names, predicates, intended uses and classifications:
6
| Proprietary Name | Biodesign Sling | Biodesign Plastic
Surgery Matrix | Biodesign Anal
Fistula Plug |
|------------------------------------|-----------------|-------------------------------------|--------------------------------|
| Common/Usual
Name | Surgical Mesh | Surgical Mesh | Surgical Mesh |
| Proposed
Classification
Name | Mesh, Surgical | Mesh, Surgical | Mesh, Surgical |
| Product Code | FTM, PAJ, PAG | FTM | FTM |
| Device Class | II | II | II |
| Regulation
Number | 878.3300 | 878.3300 | 878.3300 |
Device Descriptions:
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of porcine small intestinal submucosa (SIS) ●
- Packaged in a Tyvek/PE pouch
- Labeled with a 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 (specific 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 Sling | Biodesign Plastic
Surgery Matrix | Biodesign Anal Fistula
Plug |
|-------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------|
| Product Dimensions
(range) – as cleared
in predicate 510(k) | $20 cm^2$ to $140 cm^2$
$70$ to $600 \u03bcm$ thick | 2 to 70 mm width
up to 200 mm length
$100$ to $1500 \u03bcm$ thick | 2 mm minor diameter to
7 mm major diameter by
100 mm length |
| Shape | Rectangular | Rectangular | Cone |
Table 5-2. Dimensional Specifications
Description of Technological Modifications:
A series of wash steps was added to the depuration process of the base material for all three subject devices. This process modification serves to further remove impurities from the base material.
7
In addition, two minor technological changes were made to two of the subject devices:
- . Addition of perforations to the Biodesign Sling and Biodesign Plastic Surgery Matrix
- . Change in drying method for the Biodesign Sling
The incorporation of the additional wash steps and the minor technological changes do not result in a change to the fundamental technology of the devices.
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)]
- . Biocompatibility analysis performed in accordance with ISO 10993
- Viral Inactivation verification performed in accordance with prEN 12442-3: 2000: . Viral inactivation
- Full design control as required by 21CFR 820.30 including review of risk analysis . performed in compliance with ISO 14971. Risk analysis methods used include:
- Failure mode, effects and criticality analysis (FMECA) o
- Residual risk review o
- o Post production review
- Mechanical testing for burst force strength and suture retention strength ●
- Chemical residuals testing .
- Measurement of endotoxin levels ●
Substantial Equivalence:
Table 5-3 below provides a comparison of the subject devices and their respective predicates.
Conclusion:
CBI modified three of its devices by adding a series of wash steps to the depuration process of SIS. The additional wash steps remove impurities from the base material without affecting the fundamental technology of the devices. Any potential new risks associated with the changes to the predicate devices have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities that meet the pre-determined acceptance criteria to ensure that no change to device safety has occurred.
8
| | Biodesign Sling,
Biodesign Plastic Surgery Matrix,
Biodesign Anal Fistula Plug
(Subject Devices) | Surgisis Sling,
SIS Plastic Surgery Matrix,
SIS Fistula Plug
(Predicate Devices) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) | K161221 | K992159 (Surgisis Sling)
K034039 (SIS Plastic
Surgery Matrix)
K050337 (SIS Fistula Plug) |
| 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 Sling: For implantation to reinforce soft
tissues where weakness exists in the urological,
gynecological and gasteroenterological anatomy
including but not limited to the following
procedures: transvaginal repair of stress urinary
incontinence, such as pubourethral support and
bladder support, and transabdominal repair of
apical vaginal prolapse, colon and rectal prolapse,
and sacrocolposuspension. By providing
pubourethral support, the sling may be used for the
treatment of urinary incontinence resulting from
urethral hypermobility or intrinsic sphincter
deficiency.
Biodesign Plastic Surgery Matrix: For implantation | Surgisis Sling:
Same |
| | to reinforce soft tissue where weakness exists in
patients requiring soft tissue repair or
reinforcement in plastic or reconstructive surgery. | SIS Plastic Surgery Matrix:
Same |
| | Biodesign Anal Fistula Plug: For implantation to
reinforce soft tissue where a rolled configuration is
required, for repair of anal, rectal and
enterocutaneous fistulas. | SIS Fistula Plug:
Same |
| Material | Porcine small intestinal submucosa; (constituents
of the extracellular matrix) | Same |
| Technological
Characteristics | Additional wash steps included in base material
processing | Original base material
processing |
| Supplied sterile? | Yes | Same |
| Sterilization
method | Ethylene Oxide | Same |
| Packaging | Tyvek/PE Pouch | Same |
| Shelf-Life | 18 months | Same |
| Intended for single
use? | Yes | Same |