(268 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a bioabsorbable graft, with no mention of AI or ML technology.
No
The device is a graft intended for surgical implantation to reinforce soft tissues, not to provide therapy itself. "Therapeutic device" implies a device that actively treats a disease or condition, which a reinforcing graft does not do directly.
No
The device is a surgical graft intended for implantation to reinforce soft tissues, not to diagnose a condition.
No
The device description clearly states it is a physical graft composed of multiple layers of a bioabsorbable material (SIS) and biodegradable suture, intended for implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias." This describes a surgical implant used directly within the body to repair tissue.
- Device Description: The description details a "bioabsorbable, extracellular collagen membrane matrix" used as a graft for surgical repair. This is a physical device intended for implantation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic device used in vivo (within the body).
The information provided clearly indicates this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 intended for one time use.
Product codes
OWV, FTM
Device Description
The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.
The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
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)
Biocompatibility Testing:
The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material to the Diaphragmatic Hernia Graft (according to the ISO 10993-1 standard):
- Genotoxicity
- Direct contact in vitro hemolysis
- Cytotoxicity
- Muscle implantation
- Acute intracutaneous reactivity
- Skin irritation
- ISO Sensitization
- Acute systemic toxicity
- Pyrogenicity
- LAL endotoxins
- Subchronic systemic toxicity
Results: The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing:
The Diaphragmatic Hernia Graft material was tested for the following:
- Suture retention strength
- Burst strength
- Tensile strength
- Stiffness
Results: The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application.
Animal Testing:
The SIS material that comprises the Diaphragmatic Hernia Graft has been tested in animal studies for diaphragmatic/hiatal hernia repair.
Results: These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application.
Clinical Testing:
The performance of Surgisis (which is made of SIS, the same base material as the Diaphragmatic Hernia Graft) was assessed in several different clinical studies.
Results: The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible. Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients. These studies provide evidence that the Diaphragmatic Hernia Graft is substantially equivalent to its predicates in this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974540/K062697, K022044, K120605
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.
0
510(k) Summary
June 19, 2014
JUN 2 0 2014
Cook Biotech Incorporated
Diaphragmatic Hernia Graft
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
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Diaphragmatic Hernia Graft |
|---|---|
| Common Name: | Surgical mesh |
| Classification Regulations: | Class II, 21 CFR §878.3300 (FTM) |
INTENDED USE:
The 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 intended for one time use.
DEVICE DESCRIPTION:
The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.
The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
1
EQUIVALENCE TO MARKETED DEVICES
The Diaphragmatic Hernia Graft is substantially equivalent to its predicate devices with respect to intended use, materials and technological characteristics, in terms of section 510(k) substantial equivalence, as shown in biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical, pre-clinical and clinical testing.
Biocompatibility Testing
The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material to the Diaphragmatic Hernia Graft (according to the ISO 10993-1 standard):
- Genotoxicity .
- Direct contact in vitro hemolysis .
- Cytotoxicity �
- . Muscle implantation
- Acute intracutaneous reactivity
- Skin irritation .
- . ISO Sensitization
- Acute systemic toxicity ●
- Pyrogenicity ●
- . LAL endotoxins
- Subchronic systemic toxicity ●
The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing
The Diaphragmatic Hernia Graft material was tested for the following:
- Suture retention strength .
- . Burst strength
- Tensile strength �
- Stiffness .
The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application.
2
Animal Testing
The SIS material that comprises the Diaphragmatic Hernia Graft has been tested in animal studies for diaphragmatic/hiatal hernia repair. These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application.
Clinical Testing
The performance of Surgisis (which is made of SIS, the same base material as the Diaphragmatic Hernia Graft) was assessed in several different clinical studies. The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible. Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients. These studies provide evidence that the Diaphragmatic Hernia Graft is substantially equivalent to its predicates in this application.
Substantial Equivalence
See Table 1 for a comparison of the subject device and its predicates.
| Device | Diaphragmatic Hernia
Graft | SIS Hernia Repair Device | Surgisis Staple Line
Reinforcement | Permacol Surgical
Implant |
|---------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Incorporated | Cook Biotech Incorporated | Cook Biotech Incorporated | Covidien |
| 510(k) Number | K133011 | K974540/K062697 | K022044 | K120605 |
| Intended Use | For implantation to reinforce
soft tissues where weakness
exists, including the repair of
diaphragmatic/hiatal hernias. | To be implanted to
reinforce soft tissues where
weakness exists.
Indications for use include
the repair of a hernia or
body wall defect. | For use as a prosthesis for
the surgical repair of soft
tissue deficiencies using
surgical staplers. The
device may be used for
buttressing and reinforcing
staple lines during lung
resection (e.g., wedge
resection, blebectomy,
lobectomy, bullectomy,
bronchial resection,
segmenteectomy,
pneumonectomy/pneumect
omy, pneumoreduction)
and other incisions and
excisions of the lung and
bronchus. The device can
be used for the
reinforcement of the gastric
staple line during the
bariatric surgical | Intended for use as a
soft tissue implant to
reinforce soft tissue
where weakness exists
and for the surgical
repair of damaged or
ruptured soft tissue
membranes. It is
specifically indicated
for the repair of
abdominal, inguinal,
diaphragmatic, femoral,
scrotal, umbilical,
incisional, parastomal
hernias and abdominal
wall defects. |
Table 1 - Substantial Equivalence Comparison
3
| Device | Diaphragmatic Hernia
Graft | SIS Hernia Repair Device | Surgisis Staple Line
Reinforcement | Permacol Surgical
Implant |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | | | bypass and gastric banding.
The device can also be used
for abdominal and thoracic
wall repair, muscle flap
reinforcement, trans-
abdominal rectal and
vaginal prolapse repair,
trans-abdominal
reconstruction of the pelvic
floor, and repair of hernias
(e.g., diaphragmatic,
femoral, incisional,
inguinal, lumbar,
paracolostomy, scrotal,
umbilical). The Surgisis
Staple Line Reinforcement
may be used with
anastomotic staplers or with
non-anastomotic staplers. | |
| Material | Porcine small intestinal
submucosa (porcine)
Primarily Types I, III, IV
and VI collagen
(constituents of the
extracellular matrix) | Porcine small intestinal
submucosa (porcine)
Primarily Types I, III, IV
and VI collagen
(constituents of the
extracellular matrix) | Porcine small intestinal
submucosa (porcine)
Primarily Types I, III, IV
and VI collagen
(constituents of the
extracellular matrix) | Porcine dermis
(collagen) |
| Dimensions | Nominally, 7 x 10 cm (a
rectangular flat sheet
configuration and a U
shaped configuration). The
rectangular sheet has
resorbable stitching across
the graft and the U-shape
graft is stitched on the edges
to reduce delamination
during implantation | 5 x 8 cm to 20 x 30 cm | 1.0 x 3.8 cm to 1.2 x 8.8 cm | 1 cm x 4 cm to 28cm x
40 cm |
| Thickness | 0.1 - 1.5 mm | 0.1 - 1.5 mm | 0.350 mm | 0.5-1.5 mm |
・、・・・・
CONCLUSION: The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Diaphragmatic Hernia Graft show that the device is substantially equivalent to its predicates.
.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is that of an official or formal heading.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
Cook Biotech Incorporated Mr. Perry W. Guinn, Vice President Regulatory Affairs and Quality Assurance 1425 Innovation Place West Lafayette, Indiana 47906
Re: K133011
Trade/Device Name: Diaphragmatic Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWV, FTM Dated: May 20, 2014 Received: May 21, 2014
Dear Mr. Guinn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews 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 that I DI Hos Intellites and regulations administered by other Federal agencies. You must or any I vith 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
5
Page 2 - Mr. Perry W. Guinn
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
David Kranse -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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133011
Device Name
Diaphragmatic Hernia Graft
Indications for Use (Describe)
The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissue where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Peter L. Hudson -S
2014.06.20 13:12:26 -04'00'
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