The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

Device Description

The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication. The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

AI/ML Overview

Here's an analysis of the provided text regarding the Biodesign ENT Repair Graft, focusing on acceptance criteria and supporting studies:

This submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving efficacy against a set of predefined performance endpoints. Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device is as safe and effective as the predicate, based on similar intended use, materials, and technological characteristics. There isn't a conventional "device performance" described in terms of specific metrics like sensitivity or accuracy in the way it would be for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Biodesign ENT Repair Graft Performance / Evidence
Intended Use	Similar to predicate	Intended use is substantially similar to the MeroGel™ Control Gel ENT Surgical Dressing.
Material/Technology	Biocompatibility (ISO 10993-1)	Passed all listed biocompatibility tests (Genotoxicity, Hemolysis, Cytotoxicity, Muscle implantation, Intracutaneous reactivity, Skin irritation, Sensitization, Acute systemic toxicity, Pyrogenicity, LAL endotoxins, Subchronic systemic toxicity).
	Mechanical Strength	Achieved adequate mechanical strength for application based on suture retention strength and ultimate tensile strength tests.
	Incorporation into the body / Degradation / Cellular ingrowth	Mouse subcutaneous study confirmed ability to maintain tissue separation, rapid cellular population, and degradation during cellular ingrowth.
Clinical Equivalence	Clinical performance similar to predicate in relevant procedures	A clinical study using SIS material (Surgisis) for nasal septal perforation repair provides evidence of substantial equivalence in nasal/sinus procedures.
Safety	No new safety concerns compared to predicate	Addressed through biocompatibility and preclinical testing, and demonstrated clinical equivalence.

Missing Information: Direct numerical "device performance" metrics (e.g., specific tensile strength values, degradation rates, quantitative clinical outcomes) are not provided in this summary. The focus is on qualitative equivalence ("adequate," "substantially similar," "evidence that...").

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

Biocompatibility Testing: The text states "sterilized SIS devices (which have already been cleared in multiple applications)" were used. The specific number of devices tested for each biocompatibility test is not mentioned.
Mechanical Testing: Specific sample sizes for suture retention strength and ultimate tensile strength tests are not mentioned.
Preclinical Testing (Mouse Study): The number of mice used in the subcutaneous study is not mentioned.
Clinical Testing: The number of patients included in the clinical study for nasal septal perforation repair is not mentioned. The provenance (e.g., country of origin, retrospective/prospective) of the clinical data is not mentioned, though the study was performed using SIS material (Surgisis), implying it could have been a previously conducted study.

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

This type of information is not applicable to this 510(k) submission. For this medical device (a surgical graft), "ground truth" is not established by expert consensus on interpretations as it would be for an AI diagnostic device. Instead, the "truth" is determined by established scientific/engineering test methods (e.g., ISO standards for biocompatibility) and clinical observation of outcomes, which are assessed by medical professionals in the context of a clinical study. The document does not specify the number or qualifications of experts who interpreted the results of the biocompatibility, mechanical, or preclinical tests. For the clinical study, the results would typically be analyzed by clinical researchers and physicians, but their specific roles or number establishing "ground truth" (e.g., pathology confirmation of repair) are not detailed.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods (like 2+1 or 3+1) are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish a robust ground truth. Here, the "test sets" involve physical, chemical, and biological measurements or clinical outcomes, not interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This submission is for a surgical graft, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on a combination of:

Standardized Biocompatibility Test Results: Adherence to ISO 10993-1 standards for various biological responses, with results indicating "meets biocompatibility requirements."
Mechanical Testing Results: Measurements of physical properties like suture retention and tensile strength, deemed "adequate."
Preclinical (Animal) Observations: Post-implant observations in a mouse model regarding tissue separation, cellular ingrowth, and degradation.
Clinical Outcomes Data: The clinical study on nasal septal perforation repair using SIS material implies evaluation of patient outcomes such as healing, complication rates, and efficacy in achieving the intended purpose. The specific endpoints or type of data forming this "ground truth" are not detailed (e.g., surgical success rate, re-perforation rate, symptomatic improvement).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this device.

Summary

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121360

510(k) Summary

21 February 2013

FEB 2 7 2013

Cook Biotech Incorporated

Biodesign® ENT Repair 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: Common Name: Classification Regulations:

Biodesign ENT Repair Graft Ear, nose and throat synthetic polymer material Class II, 21 CFR §874.3620 (KHJ)

INTENDED USE:

The Biodesign ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

DEVICE DESCRIPTION:

The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

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EQUIVALENCE TO MARKETED DEVICES

The Biodesign ENT Repair Graft is similar with respect to intended use, materials and technological characteristics to the predicate device in terms of section 510(k) substantial equivalence, as shown 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 have already been cleared in multiple applications), which are identical in composition to the Biodesign ENT Repair 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 Biodesign ENT Repair Graft meets biocompatibility requirements of the ISO standard.

Mechanical Testing

The Biodesign ENT Repair Graft material was tested for the following:

. Suture retention strength
Ultimate tensile strength .

The results of the mechanical testing provided evidence that the Biodesign ENT Repair Graft provided adequate mechanical strength in its application.

Preclinical Testing

A mouse subcutaneous study confirmed that the Biodesign ENT Repair Graft was able to help maintain tissue separation, is quickly populated with cells, and degrades during cellular ingrowth. This animal study provides evidence that the Biodesign ENT Repair Graft is biocompatible and safe in its application.

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Clinical Testing

A clinical study was performed using the SIS material (Surgisis) for nasal septal perforation repair. The clinical study provides evidence that the Biodesign ENT Repair Graft is substantially equivalent to its predicate in nasal and/or sinus procedures.

Substantial Equivalence

See Table 1 for a comparison of the subject device and its predicate.

Device	Biodesign ENT Repair	MeroGel™ Control Gel
	Graft	ENT Surgical Dressing
Manufacturer	Cook Biotech	Medtronic Xomed
	Incorporated
510(k) Number	K121360	K002972
Intended Use	The Biodesign® ENT	MeroGel Control Gel
	Repair Graft is intended to	ENT Surgical Dressing is
	separate tissue or	a dressing and/or stent
	structures compromised	intended to separate tissue
	by surgical trauma, help	or structures compromised
	control minimal bleeding,	by surgical trauma, help
	and act as an adjunct to	control minimal bleeding,
	aid in the natural healing	and act as an adjunct to
	process. The device is	aid in the natural healing
	indicated for use where an	process. The device is
	open wound dressing	indicated for use in ear,
	material is required in the	nose, and throat, head and
	nasal and/or sinus cavities	neck surgical procedures
	following nasal and/or	where an open wound
	sinus surgery where	dressing material is
	separation of tissues or	required including the
	structures is desired.	middle ear and external
	The device is supplied	ear canal following
	sterile and is intended for	myringoplasty,
	one-time use.	tympanoplasty,
		canalplasty, stapes and
		mastoid surgery, also for
		use in the nasal and/or
		sinus cavities followingnasal, sinus, and/or throat
		surgery where separation
		of tissues or structures is
		desired.
Material	Small intestinal	HY AFF® (ester of
	submucosa	hyaluronic acid, a
	Primarily Types I, III, IV	naturally occurring
	and VI collagen	constituent of the
	(constituents of the	extracellular matrix)
	extracellular matrix)
Dimensions	1 cm x 2 cm to	N/A
	20 x 40 cm
Thickness	100 um to 500 um	N/A

Table 1 - Substantial Equivalence Comparison

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CONCLUSION: The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Biodesign ENT Repair Graft show that the device is substantially equivalent to its predicate.

and the country of the county of

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

February 27, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cook Biotech Incorporated % Mr. Perry W. Guinn VP of OA and Regulatory Affairs 1425 Innovation Place West Lafayette, IN 47906-1000

Re: K121360

Trade/Device Name: Biodesign® ENT 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: February 4. 2013 Received: February 7, 2013

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

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Page 2 - Mr. Perry W. Guinn

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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,

Kesia YAlexander -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):

Biodesign® ENT Repair Graft Device Name:

Indications For Use:

The device is supplied sterile and is intended for one-time use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

Vasant G.
Malshet

Digitally signed by Vasant G.
Malshet
DN: c=US/o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Vasant G. Malshet,
0.9.2342:19200300.100.1.1=130
0087851
Date: 2013.02.26 13:13:30 -05'00'

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.