(30 days)
Not Found
No
The device description focuses on the biomaterial composition and its function as a scaffold for healing, with no mention of AI or ML technologies. The performance studies are non-clinical tests related to sterilization, packaging, and cytotoxicity.
No
The device is described as an implant material to aid in surgical repairs and adjunct to natural healing, not as a device that directly treats a disease or condition. It acts as a scaffold for healing rather than a therapeutic intervention itself.
No
The device is described as an implant material for surgical repairs and to aid in natural healing, providing a scaffold for cellular invasion and capillary growth. Its function is therapeutic and reconstructive, not diagnostic.
No
The device description clearly states it is a "porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS)." This is a physical implant, 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 surgical repair and aiding in the natural healing process in otologic procedures. This involves direct implantation into the body to provide structural support and a scaffold for tissue regeneration.
- Device Description: The device is a biomaterial graft made from porcine small intestinal submucosa (SIS). It functions as a scaffold for cellular invasion and capillary growth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on specimens derived from the human body. This device is an implantable surgical material used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KHJ
Device Description
The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
The device, other than the packaging, is identical the predicate device (K150594).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, Throat (Otologic procedures)
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 following testing was performed to demonstrate substantial equivalence to the predicate device:
- Sterilization adoption
- Package performance testing for accelerated aged devices in the snap-top container packaging
- Cytotoxicity testing of the snap-top tray
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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
May 11, 2016
Cook Biotech Incorporated Ms. Katie Molland Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, IN 47906
Re: K161000
Trade/Device Name: Biodesign Otologic Repair Graft Regulation Number: 21 CFR 874.3620 Regulation Name: Ear. Nose. and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: KHJ Dated: April 8, 2016 Received: April 11, 2016
Dear Ms. Molland:
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.
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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.
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 yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161000
Device Name Biodesign Otologic Repair Graft
Indications for Use (Describe)
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is 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) | ☐ |
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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 09 May, 2016
Name of Device:
| Trade/Proprietary Names: | Biodesign® Otologic Repair Graft |
|---|---|
| Common/Usual Names: | Surgical implant polymer material |
| Surgical adjunct polymer | |
| Proposed Classification Name: | Ear, nose, and throat synthetic polymer |
| material | |
| Product Code: | KHJ |
| Device Class: | 21 CFR §874.3620, Class II |
Performance Standards: No performance standards that have been established under Section 514 of the Food, Drug and Cosmetic act apply to this device.
Predicate Device:
The predicate device is Biodesign® Otologic Repair Graft (K150594), cleared September 16, 2015.
Intended Use:
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty.
The device is supplied sterile and is intended for one-time use.
This intended use is identical to that previously cleared under K150594 for the predicate device.
Device Description:
The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin
4
sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
The device, other than the packaging, is identical the predicate device (K150594).
Comparison to Predicate Device:
The modification described in this Special 510(k) is a packaging change. The intended use and available device size configurations for the Biodesign Otologic Repair Graft remain identical. The latest proposed presentation of the Biodesign® Otologic Repair Graft (subject device) includes an additional snap-top container packaging element for the circular device sizes. The packaging for the square sheets will not change.
Summary of Non-Clinical Tests:
The following testing was performed to demonstrate substantial equivalence to the predicate device:
- Sterilization adoption
- Package performance testing for accelerated aged devices in the snap-top ● container packaging
- Cytotoxicity testing of the snap-top tray ●
Substantial Equivalence:
Table 5-1 below provides a comparison of the subject device and its predicate.
Conclusion:
In summary, the subject device, Biodesign® Otologic Repair Graft, has been compared to the predicate device on the bases of fundamental scientific technology and intended use. Biodesign® Otologic Repair Graft is an FDA-cleared device (K150594). The intended use, material composition, and device design of both subject and predicate devices are identical. The sole difference is the addition of the snap-top tray container to the packaging of the circular devices. Any potential new risks associated with the change in device packaging have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities in a manner satisfactory to the pre-determined acceptance criteria to ensure that no change to device safety has occurred. Based on the absence of changes in fundamental scientific technology and intended use of the device, as well as on the results of the performed verification and validation testing, it is the position of CBI that the Biodesign® Otologic Repair Graft is substantially equivalent to the predicate device and that the addition of a snap-top tray container for the circular devices does not raise new questions of safety or effectiveness.
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| Device | Biodesign® Otologic Repair
Graft (Subject Device) | Biodesign® Otologic
Repair Graft (Predicate
Device) |
|-----------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc. |
| 510(k) number | K161000 | K150594 |
| Intended Use | Unchanged | Biodesign® Otologic
Repair Graft is intended for
use as an implant material
to aid in surgical repairs and
as an adjunct to aid in the
natural healing process in
various otologic procedures,
including but not limited to
myringoplasty and
tympanoplasty. |
| Product Code | | KJH |
| Material | | Porcine small intestinal
submucosa; primarily Types
I, III, IV and VI collagen
(constituents of the
extracellular matrix) |
| Dimensions | | circular devices (diameter):
4 mm, 6 mm, 9 mm
square devices:
2.5 x 2.5 cm
5.0 x 5.0 cm |
| Supplied sterile? | | Yes |
| Sterilization
method | | Ethylene Oxide |
| Intended for
single use? | | Yes |
| Packaging
configuration | Circular devices:
Snap-top tray within Tyvek®
Pouch
Square devices:
Tyvek® Pouch | Tyvek® Pouch |