(263 days)
No
The summary describes a biological tissue graft for hernia repair and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgical graft used to reinforce soft tissue and repair hernias, which is a structural repair rather than a therapeutic treatment for a disease or condition.
No
Explanation: The device is a surgical graft intended for reinforcing and repairing soft tissue defects, specifically abdominal wall defects and hernias. Its function is therapeutic/reparative, not diagnostic.
No
The device description clearly states it is a physical graft made of porcine Small Intestinal Submucosa (SIS), a bioabsorbable material, and is held together with biodegradable suture. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical repair of soft tissue defects and hernias. This is a surgical implant used in vivo (within the body) to reinforce tissue.
- Device Description: The device is a surgical graft made of biological material (porcine SIS) intended for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition.
- Clinical Data: The performance data focuses on surgical outcomes like recurrence rates, not on diagnostic accuracy metrics.
IVD devices 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 used during surgery.
N/A
Intended Use / Indications for Use
The Biodesign® Parastomal Hernia Repair Graft is intended for use as a soft tissue patch 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 wall defects and hernias, including but not limited to parastomal hernias.
Product codes
FTM, OXK
Device Description
The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) 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
abdominal wall, soft tissue membranes
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
Biocompatibility: The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The following biocompatibility tests were performed on finished devices in accordance with the FDA's biocompatibility testing guidance Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995): Cytotoxicity, ISO sensitization, Skin irritation, Acute intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Subchronic systemic toxicity, Genotoxicity, Muscle implantation, Direct contact in vitro hemolysis, LAL endotoxins. Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices.
Product characterization - Mechanical: The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). Mechanical testing was performed on finished devices to evaluate the mechanical performance of the device for its intended use. The following mechanical tests were performed in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' (March 2, 1999): Burst strength, Ultimate tensile strength, Device stiffness, Suture retention strength, Tear strength, Delamination. Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
Safety and Performance - Clinical Data: Clinical data to support the safety and performance of the Biodesign® Parastomal Hernia Repair Graft material for the surgical repair of abdominal wall defects and hernias, including parastomal hernias, is primarily in the form of peer-reviewed publications. The literature describes the safe and effective use of SIS-based devices to treat soft tissue deficiencies in the parastomal anatomy. A study published by Ellis using SIS for the repair of parastomal hernias involved 20 patients with a median follow-up of 18 months (range 6-38 months). Two (2) recurrent parastomal hernias were identified (10%). Graft-related complications included four (4) seromas in the initial 10 patients; drains were subsequently placed, and no additional seromas were reported. Both recurrences were in complicated cases. Unpublished long term data on 19/20 patients (median follow-up of 53 months, range 29-69 months) confirms that the SIS-based devices perform as intended. Three additional recurrences were identified, bringing the total recurrence rate to 25% (5/20 patients). Of these, two were asymptomatic and did not require additional surgical management. The last recurrence occurred in a patient where an SIS graft was used to bridge the defect; after a second repair procedure, no recurrence was detected at 63 months follow-up. No other complications were reported.
Key Metrics
Recurrence Rate: 10% (initial study, 2/20 patients), 25% (long-term data, 5/20 patients).
Graft-Related Complications: 4 seromas (initial 10 patients); no additional seromas after drain placement.
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2017
Cook Biotech Incorporated Ms. Daniela Changkuon Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K162934
Trade/Device Name: Biodesign Parastomal Hernia Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXK Dated: June 7, 2017 Received: June 12, 2017
Dear Ms. Changkuon:
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 devicerelated 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.
1
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" (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.
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,
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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) K162934
Device Name
Biodesign Parastomal Hernia Repair Graft
Indications for Use (Describe)
The Biodesign Parastomal Hernia Repair Graft is intended for use as a soft tissue patch where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
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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3
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: 05 June 2017
DEVICE II.
| Name of Device: | Biodesign® Parastomal Hernia Repair Graft |
|---|---|
| Common or Usual Name: | Surgical graft |
| Classification Name: | Mesh, Surgical (21 CFR §878.3300) |
| Regulatory Class: | II |
| Product Code: | FTM, OXK |
III. PREDICATE DEVICE
Permacol® Surgical Implant (K043366; Medtronic)
Reference Device: SIS Hernia Graft (K133306, Cook Biotech Incorporated)
IV. DEVICE DESCRIPTION
The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) in a sealed double pouch system.
4
V. INDICATIONS FOR USE
The Biodesign® Parastomal Hernia Repair Graft is intended for use as a soft tissue patch 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 wall defects and hernias, including but not limited to parastomal hernias.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Biodesign® Parastomal Hernia Repair Graft is substantially equivalent its predicate in that they are both specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias. The technological principle for both the subject and predicate devices is mechanical reinforcement of soft tissue without leaving behind long-term foreign materials. The two devices are biological scaffolds derived from porcine tissue that are processed and designed to meet the requirements of the intended clinical use. Both devices undergo a remodeling process whereby the scaffold is eventually completely replaced by host tissue.
The predicate device is composed of porcine dermis (predominantly collagen and elastin fibers) which is cross-linked by hexamethylene diisocyanate (HMDI). The subject device is composed of non-crosslinked porcine SIS and biodegradable suture; the Biodesign® Parastomal Hernia Repair Graft is identical in all aspects to the SIS Hernia Graft (K133306; reference device). Table 5-1 below provides a comparison of the subject, predicate and reference devices.
| Device | Biodesign® Parastomal Hernia Repair Graft | Permacol® Surgical Implant | SIS Hernia Repair Graft (reference device) |
|---|---|---|---|
| Manufacturer | Cook Biotech Inc. | Medtronic | Cook Biotech Inc. |
| 510 (k) Number | K162934 | K043366 | K133306 |
| Intended Use | Intended for use as a soft tissue patch 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 wall defects and hernias, including but not limited to parastomal hernias. | Intended for use as a soft tissue patch 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 wall defects and hernias, including but not limited to parastomal hernias. | Intended for implantation to reinforce soft tissue where weakness exists. Indications for use include repair of a hernia or body wall defect. |
| Product Code | FTM, OXK | FTL | FTM, OXK |
Table 5-1. Substantial Equivalence Information
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| Device | Biodesign® Parastomal
Hernia Repair Graft | Permacol® Surgical
Implant | SIS Hernia Repair Graft
(reference device) |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Porcine small intestinal
submucosa (extracellular
matrix - primarily collagen
types I, III, IV and VI) and
polyglycolic acid (PGA)
sutures | Porcine dermis
(extracellular matrix -
primarily collagen and
elastin). | Porcine small intestinal
submucosa (extracellular
matrix - primarily collagen
types I, III, IV and VI) and
polyglycolic acid (PGA)
sutures |
| Crosslinking | Non-crosslinked | Crosslinked (HMDI) | Non-crosslinked |
| Dimensions | 5 cm x 8 cm to 30 x 30 cm | 1 cm x 4 cm to 28 cm x 40
cm | 5 cm x 8 cm to 30 x 30 cm |
| Thickness | 0.1 mm to 1.5 mm | 0.5 mm to 1.5 mm | 0.1 mm to 1.5 mm |
| Sterilization | ethylene oxide | gamma irradiation | ethylene oxide |
| One-time Use | Yes | Yes | Yes |
VII. PERFORMANCE DATA
Biocompatibility:
The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The following biocompatibility tests were performed on finished devices in accordance with the FDA's biocompatibility testing guidance Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995):
- Cytotoxicity
- ISO sensitization ●
- Skin irritation
- Acute intracutaneous reactivity ●
- Acute systemic toxicity ●
- Pyrogenicity
- Subchronic systemic toxicity
- Genotoxicity ●
- Muscle implantation
- Direct contact in vitro hemolysis ●
- LAL endotoxins ●
Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices. Product characterization - Mechanical:
The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). Mechanical testing was performed on finished devices to evaluate the mechanical performance of the device for its intended use. The following mechanical tests were performed in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' (March 2, 1999):
- Burst strength ●
- Ultimate tensile strength
- Device stiffness ●
- Suture retention strength ●
- Tear strength
- Delamination ●
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Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
Safety and Performance - Clinical Data:
Clinical data to support the safety and performance of the Biodesign® Parastomal Hernia Repair Graft material for the surgical repair of abdominal wall defects and hernias, including parastomal hernias, is primarily in the form of peer-reviewed publications. The literature describes the safe and effective use of SIS-based devices to treat soft tissue deficiencies in the parastomal anatomy. Table 5-2 summarizes the results of a study published by Ellis using SIS for the repair of parastomal hernias.
| Study | Number
of
Patients | Follow-
up | Recurrence | Graft-Related
Complications | Comments |
|--------|--------------------------|------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EllisA | 20 | Median:
18
months;
Range:
6-38
months | Two (2)
recurrent
parastomal
hernias
identified
(10%) | There were four
(4) seromas in the
initial 10 patients.
Drains were then
routinely placed
in the final 12
procedures and no
additional
seromas were
reported. | Both recurrences were identified in
patients with complicated cases -
one with 12 previous repair
attempts and removal of infected
mesh, and one, in a patient with a
12 cm fascial defect. Although the
initial repair with SIS failed, both
patients were doing well (at 36 and
14 months) following a second
repair procedure with an SIS graft. |
Table 5-2. Surgical outcomes with the use of SIS for parastomal hernias
Unpublished long term data on 19/20 patients (same patient cohort described above four patients died of cancer, unrelated to their procedures) confirms, by physical or radiological (CT) examination, that the SIS-based devices perform as intended at a median follow-up time of 53 months (range 29-69 months). Three additional recurrences were identified, bringing the total recurrence rate to 25% (5/20 patients). Of the three recurrences diagnosed, two were asymptomatic and did not require additional surgical management at 58 and 47 month follow-up. The last recurrence occurred in a patient where an SIS graft was used to bridge the defect. After a second repair procedure with SIS, no recurrence was detected at 63 month follow-up. No other complications were reported.
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® Parastomal Hernia Repair Graft has the same intended use and functions under the same technological principle as the predicate device. The subject and predicate device are both porcine-derived scaffolds designed to provide mechanical reinforcement of soft tissues where weakness exists, while
A Ellis CN. Short-term outcomes with the use of bioprosthetics for the management of parastomal hernias. Diseases of the Colon and Rectum. 2010;53(3):279-283.
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simultaneously being remodeled and replaced with host tissue. The main technological differences between the subject device and the predicate device are that the Biodesign Parastomal Hernia Repair Graft is composed of non-crosslinked SIS and the predicate device is composed of crosslinked dermal collagen.
. The biocompatibility tests, product characterization tests, and clinical data on the Biodesign® Parastomal Hernia Repair Graft demonstrate that the device is substantially equivalent to the predicate device.