The Biodesign Otologic Repair Graft is intended for use as an implant 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 Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.

Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

AI/ML Overview

The provided text describes the Biodesign Otologic Repair Graft and its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table about acceptance criteria and study design for a device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than defining and proving acceptance criteria with specific performance metrics and a detailed study design as might be seen for a novel device or PMA.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets ISO 10993-1 standards	Biodesign Otologic Repair Graft met biocompatibility requirements for genotoxicity, direct contact in vitro hemolysis, cytotoxicity, muscle implantation, acute intracutaneous reactivity, ISO sensitization, acute systemic toxicity, pyrogenicity, LAL endotoxins, and subchronic systemic toxicity.
Mechanical Strength (Burst Strength)	Adequate mechanical strength for application (Specific threshold not provided)	Biodesign Otologic Repair Graft "has adequate mechanical strength for its application" (specific values and comparison not detailed).
Efficacy (Myringoplasty & Tympanoplasty)	Effectiveness comparable to predicate device/autologous tissue repair for myringoplasty.	In a 404-patient study for myringoplasty, stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs (Biodesign material) compared to 204/215 (94.8%) of temporalis fascia (PTF) procedures. This difference was not statistically significant regarding procedural times.
Safety (Adverse Reactions)	No significant adverse reactions	No adverse reactions observed with SIS or PTF repairs in the 404-patient study. "No significant adverse events were reported" in additional unpublished clinical data sets (18, 19, 32, and 8 patients).
Device Degradation/Host Response	Similar to predicate device MeroGel Otologic Pack	Mouse implant study showed Biodesign Otologic Repair Graft performed similarly to MeroGel Otologic Pack in terms of device degradation and non-inflammatory host responses.

Missing Information/Cannot be extracted:

The document focuses on substantial equivalence based on material properties, biocompatibility, and clinical outcomes, rather than specific, quantified acceptance criteria for novel performance claims. For example, while mechanical strength was tested, the acceptance criterion (e.g., "burst strength must exceed X MPa") is not provided, only the qualitative statement that it was "adequate." Similarly, for efficacy, there's no explicitly stated acceptance criteria (e.g., "myringoplasty success rate must be >90%") before the study results are presented.

2. Sample Size for the Test Set and Data Provenance

Biocompatibility Tests: The exact number of samples used for each test (genotoxicity, cytotoxicity, etc.) is not specified. The tests were performed on "sterilized SIS devices," which are identical in composition to the Biodesign Otologic Repair Graft.
Mechanical Testing (Burst Strength): The sample size is not specified.
Animal Testing:
- Efficacy study: Chinchilla model (number of animals not specified).
- Implant study: Mouse model (number of animals not specified).
Clinical Testing (Prospective Data):
- Primary Study: 404 patients (217 SIS repairs, 215 temporalis fascia (PTF) repairs).
- Data Provenance: The study was conducted by D'Eredita, but the country of origin is not explicitly stated. The material was labeled as "Surgisis." The comparison was made against "temporalis fascia (PTF) repairs performed by the same surgeon," implying a clinical setting. The follow-up was 2-11 years (average 7.7 years).
- Additional Unpublished Data:
  - a) 18 patients (Hsu, DuPage Medical Group, 2015)
  - b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK, 2003) - UK origin.
  - c) 32 patients (Ofo E. et al., North West London Hospital, UK, 2009) - UK origin.
  - d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003) - USA origin.
- Retrospective/Prospective: The 404-patient study is explicitly called "Prospective data." The additional data are referred to as "unpublished data" but their specific prospective/retrospective nature is not detailed.

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

This information is not provided. Clinical outcomes (e.g., stable tympanic membrane closures, adverse events) would have been assessed by treating physicians, but the document does not detail a specific expert panel/adjudication process for establishing ground truth for the clinical studies mentioned.

4. Adjudication Method for the Test Set

This information is not provided. For clinical outcomes, the treating surgeon or independent clinicians would typically assess post-operative results, but no specific adjudication method (like 2+1 consensus) is outlined.

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

No, an MRMC comparative effectiveness study was not done. The clinical studies reported involved a comparison of the device material (SIS) with autologous tissue repair (temporalis fascia) or comparison to a predicate in an animal model, and observations of patient outcomes. These are not MRMC studies as typically understood for AI device assessments involving multiple readers evaluating cases with and without AI assistance to measure reader improvement.

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

This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (implantable biomaterial), not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant to this product.

7. The Type of Ground Truth Used

Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards.
Mechanical Testing: Measured burst strength.
Animal Testing: Histological assessment of cellular response and device degradation (observations by researchers), and efficacy observations in chinchilla tympanic membrane repair.
Clinical Testing: Clinical outcomes data (e.g., stable tympanic membrane closures, occurrence/absence of adverse reactions/events) observed post-operatively by treating physicians or study investigators. This would be considered outcomes data or clinical expert observation.

8. The Sample Size for the Training Set

This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (biomaterial), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device itself is manufactured using a specific process and its properties are inherently defined by its material and design, not by being "trained" on data.

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

This is not applicable for the reasons stated in point 8.

Summary

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

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

September 16, 2015

Cook Biotech Incorprated Katie Molland, Ph.D. Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, IN 47906

Re: K150594

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: August 14, 2015 Received: August 17, 2015

Dear Dr. 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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Page 2 - Katie Molland, Ph.D.

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. Deborah L. Falls -5

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) K150594

Device Name Biodesign(R) Otologic Repair Graft

Indications for Use (Describe)

The Biodesign Otologic Repair Graft is intended for use as an implant 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. The device is supplied sterile and is intended for one-time use.

Type of Use (Select one or both, as applicable)

2 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)

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510(k) Summary

March 4, 2015

Cook Biotech Incorporated

Biodesign® Otologic Repair Graft

Manufacturer Name:	Cook Biotech Incorporated1425 Innovation PlaceWest Lafayette, Indiana 47906Telephone: +1 (765) 497-3355FAX: +1 (765) 807-7709
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Official Contact:	Perry W. Guinn
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DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Biodesign Otologic Repair Graft
Common Name	Surgical implant polymer material/Surgicaladjunct polymer material
Classification Regulations:	Class II, 21 CFR §874.3620 (KHJ)

INDICATIONS FOR USE:

PREDICATE DEVICES:	EpiFilm® Otologic Lamina, K982870
	MeroGel®Otologic Pack, K001148

DEVICE DESCRIPTION:

Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square

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configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

EQUIVALENCE TO MARKETED DEVICES

The Biodesign Otologic Repair Graft is similar with respect to intended use, materials (naturally occurring constituents of the extracellular matrix) and technological characteristics of the predicate devices in terms of section 510(k) substantial equivalence. Substantial equivalence is supported by 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 composition to the Biodesign Otologic Repair Graft (according to the ISO 10993-1 standard):

Genotoxicity ●
Direct contact in vitro hemolysis ●
Cytotoxicity ●
Muscle implantation ●
Acute intracutaneous reactivity ●
ISO sensitization
Acute systemic toxicity ●
Pyrogenicity
LAL endotoxins ●
Subchronic systemic toxicity

The results of these tests provide evidence that the Biodesign Otologic Repair Graft meets the biocompatibility requirements of the ISO standard.

Mechanical Testing

The Biodesign Otologic Repair Graft material was tested for burst strength and the results compared with its predicates.

The results of this mechanical test provide evidence that the Biodesign Otologic Repair Graft has adequate mechanical strength for its application.

Animal Testing

The SIS material that comprises the Biodesign Otologic Repair Graft was tested in animal studies that included an efficacy study using a chinchilla model and an implant study using a mouse model to characterize cellular response and device degradation. The efficacy study, which compared SIS repair with autologous tissue repair, suggested that SIS was a viable alternative to autologous tissue for tympanic

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membrane perforation repair. Additionally, the mouse implant study compared the Biodesign Otologic Repair Graft against the MeroGel Otologic Pack and showed that the subject device performed similarly to the predicate in terms of device degradation, and non-inflammatory host responses. These animal studies provide evidence that the Biodesign Otologic Repair Graft is biocompatible and safe for its application.

Clinical Testing

Prospective data was collected on the use of the SIS material (labeled as Surgisis), the same material that comprises the Biodesign Otologic Repair Graft (D'Eredita, 2012, abstract). In this 404 patient study, the SIS material was used in 217 myringoplasty procedures and compared to 215 temporalis fascia (PTF) repairs performed by the same surgeon. Follow- up was from 2-11 years (average 7.7 years) (data from manuscript submitted by invitation to the International Journal of Pediatric Otorhinolaryngology (February 5, 2013) by D'Eredita). Data analysis included safety, efficacy and procedure duration. No adverse reactions were observed with either type of repair. Stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs compared to 204/215 (94.8%) of PTF procedures. The difference in procedural times between the two (2) arms was not statistically significant.

Additional unpublished data are available in which the device was implanted in:

a) 18 patients (Hsu, DuPage Medical Group, 2015);
b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK,2003);
c) 32 patients (Ofo E. et al.,North West London Hospital, UK, 2009); and
d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003).

No significant adverse events were reported.

Results of these clinical studies show that the Biodesign Otologic Repair Graft is safe and effective for its intended use.

SUBSTANTIAL EQUIVALENCE

Table 1 below provides a comparison of the subject device and its predicates.

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Device	Biodesign Otologic RepairGraft (subject)	EpiFilm Otologic Lamina(Predicate)	MeroGel™ Otologic Pack(Predicate)
Manufacturer	Cook Biotech Incorporated	Xomed Surgical Products	Medtronic Xomed
510(k) Number	Not assigned	K982870	K001148
Intended Use	The Biodesign Otologic RepairGraft is intended for use as animplant to aid in surgicalrepairs and as an adjunct to aidin the natural healing processin various otologic procedures,including but not limited tomyringoplasty andtympanoplasty.	Intended for use as an implant toaid in surgical repairs and as anadjunct to aid in the naturalhealing process in variousotologic procedures. EpiFilmOtologic Lamina is indicated foruse in myringoplastic andtympanoplastic surgicalprocedures.	MeroGel™ Otologic Pack is aspace occupying dressing and/orstent intended to separatemucosal surfaces, help controlminimal bleeding and act as anadjunct to aid in the naturalhealing process. The device isindicated for use in the middleear and external canal followingcanalplasty, myringoplasty,tympanoplasty, and stapes andmastoid surgery.
Material	Small intestinal submucosa(SIS)Primarily Types I, III, IV andVI collagen (constituents of theextracellular matrix)	HYAFF® (ester of hyaluronicacid, a naturally occurringconstituent of the extracellularmatrix.)	HYAFF® (ester of hyaluronicacid, a naturally occurringconstituent of the extracellularmatrix.)
Method of action	Has a scaffold structure whichis infiltrated with host cells,forms gel as the process ofremodeling occurs	Has micro-perforation providingpermeable surface and acts as ascaffold for migrating host cells	Hygroscopic, forms gelatinousmass in contact with fluids
Dimensions	4 mm, 6mm, 9 mm diameter2.5 x 2.5 cm5 x 5 cm	8 mm diameter (EpiDisc)*2.5 cm x 2.5 cm	1 cm x 5 cm, 4 cm x 4 cm
Thickness	100 μm to 500 μm	NA	340 μm†
Sterilization	Ethylene oxide	Gamma irradiation	Gamma irradiation
Shelf life	18 months	NA	48 months

Table 1 – Substantial Equivalence Comparison

NA – Not available

†N=2

*EpiDisc and EpiFilm Otologic Lamina are the same material and sold under the same 510(k). EpiDisc is a smaller sized device than EpiFilm

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

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.