ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K132433 · Acclarent, Inc. · EOB · Apr 24, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K132433
• Device Name: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
• Applicant: Acclarent, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

Device Story

The Acclarent Cyclops Multi-Angle Endoscope is a 4.3 mm rigid, unchanneled endoscope used for visualizing the nasal cavity and nasopharynx. The device features a direction-of-view dial that adjusts the view from 10° to 90° using internal rare-earth permanent magnets (≤10 gauss at 2cm). A shaft rotation dial allows 320° rotation of the shaft to visualize structures without rotating the entire device. The device includes a standard eyepiece for camera coupling and a light post compatible with ACMI light sources, with adapters provided for Wolf or Storz/Olympus sources. It is a reusable device requiring cleaning and sterilization or high-level disinfection between uses. The physician operates the device in a clinical setting to inspect anatomical structures, aiding in diagnostic or procedural visualization.

Clinical Evidence

No clinical data were necessary. Substantial equivalence is supported by bench testing, including validation of reprocessing and sterilization methods (steam and STERRAD) to a sterility assurance level of 10^-6, and high-level disinfection validation using ortho-Phthalaldehyde or glutaraldehyde.

Technological Characteristics

Rigid, 4.3 mm diameter endoscope; sapphire cover lens; 55° field of view; 5-45 mm depth of view; 10°-90° direction of view; 320° shaft rotation. Magnetic actuation (≤10 gauss at 2cm). Compatible with standard camera couplers and ACMI/Wolf/Storz/Olympus light sources. Reusable; sterilized via steam or STERRAD; high-level disinfection via OPA or glutaraldehyde.

Indications for Use

Indicated for visualization of the nasal cavity and nasopharynx in patients requiring endoscopic examination.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Acclarent Cyclops Multi-Angle Endoscope (K110097)
• Entellus Medical FinESS Endoscope (K102366)

Submission Summary (Full Text)

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# Acclarent /

W132433

Traditional 510(k) Premarket Notification

Acclarent Cyclops Multi-Angle Endoscope

| | | | | | | | | APPENDIX A: 510(k) Summary | | | | | | | | | | | | | |
|--|--|--|--|--|--|--|--|----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
|--|--|--|--|--|--|--|--|----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II<br>Sr. Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | July 31, 2013 |
| Device Trade Name: | Acclarent Cyclops Multi-Angle Endoscope |
| Common Name: | Endoscope |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4760 |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| Product Code: | EOB |
| Predicate Devices: | Acclarent Cyclops Multi-Angle Endoscope (K110097)<br>Entellus Medical FinESS Endoscope (K102366) |
| Device Description: | The Acclarent Cyclops Multi-Angle Endoscope is a 4.3 mm rigid<br>unchanneled endoscope that has the capability of varying<br>direction of view from 10° to 90°, which is altered by the<br>direction of view dial. The direction of view is indicated by<br>visible markings on the scope body. Cyclops provides a 55°<br>field of view and a depth of focus from 5 mm to 40mm. The<br>device shaft can also rotate 320° to allow for visualization of<br>structures without rotating the device; this is controlled by the<br>shaft rotation dial. Small rare-earth permanent magnets are<br>incorporated into the proximal scope control body ≤ 10 gauss<br>at 2cm) and drive the change in the direction of view. A<br>standard eyepiece located on the proximal end of the device is<br>compatible with a standard camera coupler. The light post on<br>the subject device is compatible with an ACMI light source.<br>There are two stainless steel adapters that accompany the<br>Acclarent Cyclops Multi-Angle Endoscope to facilitate<br>connection with Wolf or Storz/Olympus medical light sources. The<br>adapters connect to the light post. The Acclarent Cyclops<br>Multi-Angle Endoscope is a reusable device and must be<br>cleaned and sterilized or subjected to High Level Disinfection according |

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Acclarent Cyclops Multi-Angle Endoscope

Traditional 510(k) Premarket Notification

to the user manual prior to every use.

Indications for Use:

The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

Technological Characteristics:

| Attribute | Predicate Device<br>Acclarent Cyclops<br>Multi-Angle<br>Endoscope | Subject Device<br>Acclarent Cyclops<br>Multi-Angle<br>Endoscope |
|---------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|
| 510(k) number | K110097 | TBD |
| Model Number | CYE002 | Same |
| Rigidity | Rigid | Same |
| Viewing Optics | Lens<br>(Sapphire cover) | Same |
| Depth of View | 5-45 mm | Same |
| Field of View | 55° | Same |
| Direction of View | 10° to 90°C | Same |
| Shaft Body Diameter | 4.3 mm | Same |
| Working Length | 6.89 inches (175mm) | Same |
| Magnetic Strength | ≤10 gauss at 2cm | Same |

#### Performance Data:

Reprocessing and sterilization testing met all acceptance criteria.

The sterilization process for the Cyclops Multi-Angle Endoscope has been validated and demonstrated a sterility assurance level of 10° when the device is sterilized via either steam or STERRAD methods. The method used for steam and STERRAD

sterilization validation was overkill (half-cycle approach) in a fixed chamber. The Cyclops Multi-Angle Endoscope has also been validated to be high level disinfected using either 0.55% ortho-Phthalaldehyde (Cidex OPA®) or 2.4% glutaraldehyde (Cidex®) solutions.

Clinical data were not necessary for the Cyclops Multi-Angle Endoscope. The testing data demonstrate that the device performs as intended.

Summary of Substantial Equivalence:

The Acclarent Cyclops Multi-Angle Endoscope is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

April 24, 2014

Acclarent. Inc. James Patrick Garvey 11 Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park. California 94025

#### Re: K132433

Trade/Device Name: Acclarent Cyclops Multi-Angle Endoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 26, 2014 Received: March 27, 2014

Dear Mr. Garvey:

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 10 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 warrantjes. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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 - Mr. James Patrick Garvey 11

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.him 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/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): K132433

Device Name: Acclarent Cyclops Multi-Angle Endoscope

Indications for Use:

The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Sunny Park -S 2014.04.22 11:38:32 -04'00'

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