FINESS ENDOSCOPE STERILIZATION TRAY

K103213 · Entellus Medical, Inc. · KCT · Feb 2, 2011 · General Hospital

Device Facts

• Record ID: K103213
• Device Name: FINESS ENDOSCOPE STERILIZATION TRAY
• Applicant: Entellus Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting. The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters. The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Device Story

Rigid plastic sterilization tray designed to house FinESS Endoscope; features perforated base and lid for sterilant penetration; includes silicone inserts to secure endoscope and adapters. Used in clinical settings to protect endoscope during STERRAD 100NX/NX sterilization cycles. Requires external sterilization wrap to maintain sterility post-process. Device ensures instrument stability and sterility maintenance during transport and storage.

Clinical Evidence

Bench testing only. No clinical data. Verification included material stability after repeated sterilization cycles, biocompatibility (dermal irritation/sensitization), and sterilization efficacy (SAL 10^-6) in STERRAD NX and 100NX systems.

Technological Characteristics

Rigid plastic container with perforated lid and base; silicone inserts for instrument retention; requires external sterilization wrap. Materials stable under repeated sterilization cycles. Designed for STERRAD 100NX/NX systems.

Indications for Use

Indicated for encasing and protecting the FinESS Endoscope during sterilization in STERRAD 100NX (standard cycle) and NX (advanced cycle) systems. Intended for use with FDA-cleared STERRAD compatible sterilization wrap to maintain sterility. Maximum load: 1 FinESS Endoscope and 2 light post adapters.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Advance Sterilization Product APTIMAX STERILIZATION Tray and Accessories (K013003)

Submission Summary (Full Text)

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K103213
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FEB - 2 2011

# 510(k) Summary

This 510(k) Summary complies with the format and content requirements in 21 CFR 807.92.

| Date Prepared: | November 19, 2010 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1. Submitter Information: | Entellus Medical, Inc.<br>6705 Wedgwood Court, North<br>Maple Grove, MN 55311 |
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen E Peterson<br>Vice President Clinical, Regulatory and Quality<br>Phone: [phone]<br>[e-mail] |
| 2. Device Information: | |

| Trade Name: | FinESS ^TM Endoscope Sterilization Tray |
|----------------------|---------------------------------------------------|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Product Code: | KCT |
| Regulation Number: | Class II, 21 CFR 880.6850 |

### 3. Predicate Device:

Advance Sterilization Product APTIMAX STERILIZATION Tray and Accessories [K013003].

### 4. Device Description:

The FinESS Endoscope Sterilization Tray is comprised of a bottom, a clear lid, and silicone inserts designed to secure the FinESS Endoscope in place. The lid is clear and secured to the tray with a snap fit mechanism. The FinESS Endoscope Sterilization Tray contains perforations in the base and lid to allow the sterilant to penetrate. The use of commercially available sterilization wrap allows the tray to maintain sterility after sterilization.

### 5. Intended Use:

The FinESS Endoscope Sterilization Tray and the predicate device have the same intended use. Both devices are intended to encase instruments for sterilization when used with commercially available sterilization wrap.

The following is the "Indications For Use" for the FinESS Endoscope Sterilization Tray:

The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.

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- The sterilization cycle parameters of the STERRAD sterilizers are preset by the . manufacturer and are not adjustable.
K103213

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- The maximum product load per FinESS Endoscope Sterilization Tray includes 1 . FinESS Endoscope and 2 light post adapters.
The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

## 6. Technological Characteristics

The FinESS Endoscope Sterilization Tray and the predicate device have similar technological characteristics. Both devices consist of a rigid stable plastic container with lids that have been perforated to allow the penetration of sterilant. In both devices, perforations are found on the bottom and top of the tray thereby falling into the category of devices called "sterilization cassettes". Both devices require the use of a sterilization wrap to continue to maintain sterility during transportation and storage. To secure the device within the tray during sterilization, both devices have silicone inserts to hold the device in place. The materials of both devices are stable and do not degrade when exposed to multiple sterilization cvcles.

### 7. Performance Testing:

Performance testing of the FinESS Endoscope Sterilization Tray consisted of design verification testing, biocompatibility and sterilization. Design verification testing included verification of device and material stability following repeated exposure to the sterilization cycle. Biocompatibility testing included primary dermal irritation and dermal sensitization post exposure to multiple sterilization cycles. Sterilization efficacy testing was conducted on the FinESS endoscope contained within the FinESS Endoscope Sterilization Tray to assure that an SAL of 10° could be achieved when used with the STERRAD NX and STERRAD 100NX sterilization system. In addition, sterilization testing of inoculated FinESS Endoscope Sterilization Tray and similarly inoculated Predicate tray showed that both devices are capable of allowing SAL of 106. All results of the design verification, biocompatibility and sterilization testing met the acceptance criteria.

No clinical evaluations were conducted.

### 8. Conclusion:

The FinESS Endoscope Sterilization Tray is substantially equivalent to the predicate device, APTIMAX Instrument Tray [K013003]. The device has the same intended use, similar indication for use, and similar technological characteristics as the predicate device. Minor differences in the technological characteristics do not raise new questions of safety and efficacy. In addition, performance testing conducted demonstrate that the FinESS Endoscope Sterilization Tray is as safe and effective and performs as well as the predicate device.

Thus, the FinESS Endoscope Sterilization Tray is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.

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

Entellus Medical, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313

FEB - 2 2011

. . . . . . . . . .

:

Re: K103213

Trade/Device Name: FinESSTM Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 14, 2011 Received: January 19, 2011

Dear Mr. Job:

.

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. Register

. . .

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## Page 2- Mr. Job

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 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/ucm 1.1.5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Canter for Devices and Radiological Health

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# Indications for Use Statement

510(k) Number:

Device Name: FinESS™ Endoscope Sterilization Tray

Indications for Use:

The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.

- The sterilization cycle parameters of the STERRAD sterilizers are preset by the ● manufacturer and are not adjustable.
- The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS . Endoscope and 2 light post adapters.

The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDAcleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Prescription Use Over-the-Counter Use X (21 CFR 801 Subpart D) AND/OR (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)

Elizabeth F, Clarin-Will

(Division Sian-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K 103213