Biodesign Otologic Repair Graft

K161000 · Cook Biotech Incorporated · KHJ · May 11, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161000
• Device Name: Biodesign Otologic Repair Graft
• Applicant: Cook Biotech Incorporated
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: May 11, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Biodesign Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial derived from porcine small intestinal submucosa (SIS). It functions as a scaffold for cellular invasion and capillary growth, supporting wound management in otologic surgeries like myringoplasty and tympanoplasty. The device is implanted by a surgeon during the procedure. It provides a supportive environment for natural healing. The subject device is identical to the predicate in material and design, with the only modification being the addition of a snap-top tray container for circular device sizes to improve packaging.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including sterilization adoption, package performance testing for accelerated aged devices, and cytotoxicity testing of the new snap-top tray.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS) containing collagen (Types I, III, VI), glycosaminoglycans, proteoglycans, and fibronectin. Form factor: Porous, multi-layer absorbable graft. Sterilization: Ethylene Oxide. Packaging: Snap-top tray within Tyvek pouch (circular) or Tyvek pouch (square).

Indications for Use

Indicated for patients undergoing otologic surgical procedures, including myringoplasty and tympanoplasty, requiring an implant material to aid in surgical repair and natural healing.

Regulatory Classification

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.

Predicate Devices

• Biodesign Otologic Repair Graft (K150594)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] 09 May, 2016

#### Name of Device:

| Trade/Proprietary Names: | Biodesign® Otologic Repair Graft |
|-------------------------------|---------------------------------------------------------------|
| Common/Usual Names: | Surgical implant polymer material<br>Surgical adjunct polymer |
| Proposed Classification Name: | Ear, nose, and throat synthetic polymer<br>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

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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 Repair<br>Graft (Subject Device) | Biodesign® Otologic<br>Repair Graft (Predicate<br>Device) |
|-----------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc. |
| 510(k) number | K161000 | K150594 |
| Intended Use | Unchanged | Biodesign® Otologic<br>Repair Graft is intended for<br>use as an implant material<br>to aid in surgical repairs and<br>as an adjunct to aid in the<br>natural healing process in<br>various otologic procedures,<br>including but not limited to<br>myringoplasty and<br>tympanoplasty. |
| Product Code | | KJH |
| Material | | Porcine small intestinal<br>submucosa; primarily Types<br>I, III, IV and VI collagen<br>(constituents of the<br>extracellular matrix) |
| Dimensions | | circular devices (diameter):<br>4 mm, 6 mm, 9 mm<br>square devices:<br>2.5 x 2.5 cm<br>5.0 x 5.0 cm |
| Supplied sterile? | | Yes |
| Sterilization<br>method | | Ethylene Oxide |
| Intended for<br>single use? | | Yes |
| Packaging<br>configuration | Circular devices:<br>Snap-top tray within Tyvek®<br>Pouch<br>Square devices:<br>Tyvek® Pouch | Tyvek® Pouch |

# Table 5-1. Substantial Equivalence Information