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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Biodesign Otologic Repair Graft (K161000). The key information revolves around a packaging change and the demonstration of substantial equivalence to a predicate device (K150594).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Preamble Testing	Demonstration of sterility maintenance over the product's shelf life.	"Sterilization adoption" was performed, implying the sterilization method remains effective with the new packaging configuration. The document states, "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."
Packaging Integrity	The new packaging (snap-top container) must maintain its integrity and protect the device throughout its intended shelf life and under various transport/storage conditions.	"Package performance testing for accelerated aged devices in the snap-top container packaging" was performed, suggesting the new packaging meets performance requirements for integrity and protection.
Biocompatibility	The new packaging component (snap-top tray) must not introduce cytotoxins or other harmful substances that could leach into the device or patient.	"Cytotoxicity testing of the snap-top tray" was performed, indicating the material of the new packaging is biocompatible and does not pose a cytotoxic risk.
Material Composition	The device's material composition should remain identical to the predicate device.	The document explicitly states the "material composition... of both subject and predicate devices are identical." The device is composed of "laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS)."
Intended Use	The intended use of the device should remain unchanged from the predicate device.	The document states, "This intended use is identical to that previously cleared under K150594 for the predicate device."
Sterilization Method	The sterilization method should remain consistent and effective.	The document confirms the sterilization method is "Ethylene Oxide," which is the same as the predicate.
Single Use	The device remains intended for single use.	The document confirms the device is intended for "single use," same as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for the "sterilization adoption," "package performance testing," or "cytotoxicity testing." It only mentions that these tests were "performed to demonstrate substantial equivalence."

Data Provenance: The studies were conducted by Cook Biotech Incorporated, as part of their 510(k) submission. The data is retrospective in the sense that these tests were performed on the device and its new packaging configuration to demonstrate equivalence, rather than being part of a prospective clinical trial. The country of origin of the data is implied to be the USA, where Cook Biotech Incorporated is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not pertain to studies requiring expert adjudication for ground truth (e.g., medical image interpretation). The testing described here is related to device engineering, materials science, and packaging performance. The "ground truth" for these tests would be established through defined scientific methodologies and standards (e.g., ISO standards for biocompatibility or ASTM standards for package testing), rather than expert consensus on a clinical outcome or image.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human reader interpretation or clinical outcomes that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a material and packaging change, not an AI or diagnostic device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a surgical graft, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on:

Scientific Standards: For sterilization adoption, it would be demonstration of sterility in accordance with established standards (e.g., ISO 11135 for ethylene oxide sterilization).
Engineering Standards: For package performance, it would be meeting pre-defined physical and barrier property requirements based on industry standards (e.g., ASTM F1980 for accelerated aging, various ASTM standards for package integrity like peel strength, burst tests, etc.).
Biological Standards: For cytotoxicity, it would be meeting the requirements of recognized biocompatibility standards (e.g., ISO 10993-5 for in vitro cytotoxicity).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary

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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)

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 materialSurgical adjunct polymer
Proposed Classification Name:	Ear, nose, and throat synthetic polymermaterial
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 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:

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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 RepairGraft (Subject Device)	Biodesign® OtologicRepair Graft (PredicateDevice)
Manufacturer	Cook Biotech Inc.	Cook Biotech Inc.
510(k) number	K161000	K150594
Intended Use	Unchanged	Biodesign® OtologicRepair Graft is intended foruse as an implant materialto aid in surgical repairs andas an adjunct to aid in thenatural healing process invarious otologic procedures,including but not limited tomyringoplasty andtympanoplasty.
Product Code		KJH
Material		Porcine small intestinalsubmucosa; primarily TypesI, III, IV and VI collagen(constituents of theextracellular matrix)
Dimensions		circular devices (diameter):4 mm, 6 mm, 9 mmsquare devices:2.5 x 2.5 cm5.0 x 5.0 cm
Supplied sterile?		Yes
Sterilizationmethod		Ethylene Oxide
Intended forsingle use?		Yes
Packagingconfiguration	Circular devices:Snap-top tray within Tyvek®PouchSquare devices:Tyvek® Pouch	Tyvek® Pouch

Table 5-1. Substantial Equivalence Information

Regulation Number and Section

§ 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.