ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K100577 · Acclarent, Inc. · EOB · Jan 6, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K100577
• Device Name: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
• Applicant: Acclarent, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jan 6, 2011
• 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 in an operating room environment.

Device Story

Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigid endoscope for nasal cavity and nasopharynx visualization. Device features a direction-of-view dial (10° to 100°) and a 320° shaft rotation dial, allowing visualization of structures without rotating the scope body. Rare-earth permanent magnets in the proximal control body drive the direction-of-view change. Device includes a standard eyepiece for camera coupler attachment and a light post compatible with standard medical light sources via included adapters. Used in operating room environments by physicians. Output is a visual image transmitted to a camera system for clinical assessment. Benefits include enhanced visualization capabilities during endoscopic procedures.

Clinical Evidence

Bench testing and a cadaver study were performed. Bench testing evaluated distal shaft diameter, working length, field of view, fixed focus, direction of view, rotation of view, illumination, resolution, dial actuation forces, temperature, magnet field strength, electrical safety, EMC, durability, environmental conditioning, compression, vibration, and shock. No clinical data was necessary.

Technological Characteristics

4mm rigid endoscope; stainless steel construction; glass fiber illumination; rare-earth permanent magnets for direction-of-view control; 10°-100° direction of view; 60° field of view; 5-45mm depth of focus; 175mm working length; compatible with standard camera couplers and medical light sources; reusable; requires manual cleaning and steam sterilization.

Indications for Use

Indicated for visualization of the nasal cavity and nasopharynx in an operating room environment.

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

• OPTIM Inc. ENTity Nasoview Nasopharyngoscope (K080622)
• Pollux Endoscopy Inc. Sinuscope (K002214)
• Optus Sinuscope (K944656)
• Karl Storz Hopkins Rigid Autoclavable Telescope (K935279)
• Stryker Endoscopy Arthroscope (K093677)

Submission Summary (Full Text)

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JAN 6 2011

:

K100577

# 510(k) SUMMARY

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| Date of Preparation: | January 5, 2011 |
| Device Trade Name/<br>Model Number: | Acclarent Cyclops Multi-Angle Endoscope<br>CYE001 |
| Common Name: | Endoscope |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4760 |
| Classification Name: | Nasopharyngoscope (Flexible or Rigid) |
| Product Code: | EOB |
| Predicate Devices: | OPTIM Inc. ENTity Nasoview Nasopharyngoscope (K080622)<br>Pollux Endoscopy Inc. Sinuscope (K002214)<br>Optus Sinuscope (K944656)<br>Karl Storz Hopkins Rigid Autoclavable Telescope (K935279)<br>Stryker Endoscopy Arthroscope (K093677) |
| Device Description: | The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigid<br>endoscope that has the capability of varying direction of view from<br>10° to 100°, which is altered by the direction of view dial. The<br>direction of view is indicated by visible markings on the scope body<br>Cyclops provides a 60° field of view and a depth of focus from 5<br>mm to 40mm. The device shaft can also rotate 320° to allow for<br>visualization of structures without rotating the device; this is<br>controlled by the shaft rotation dial. Small rare-earth permanent<br>magnets are incorporated into the proximal scope control body (≤10<br>gauss 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 the<br>subject device is compatible with an ACMI light source.<br>There are two stainless steel adapters that accompany the Acclarent<br>Cyclops Multi-Angle Endoscope to facilitate connection with Wolf<br>or Storz/Olympus medical light sources. The adapters connect to the |

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light post. The Acclarent Cyclops Multi-Angle Endoscope is a reusable device and must be cleaned and sterilized according 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 in an operating room environment.

### Technological Characteristics:

| Attribute | Predicate Device<br>(OPTIM Inc ENTity<br>Nasoview<br>Nasopharyngoscope) | Predicate Device<br>(Pollux<br>Endoscopy, Inc<br>Sinuscope) | Predicate Device<br>(Optus Sinuscope) | Subject Device<br>(Acclarent<br>Cyclops Multi-<br>Angle Endoscope) |
|------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------|
| 510(k)<br>number | K080622 | K002214 | K944656 | K100577 |
| Rigidity | Flexible and Steerable | Rigid | Rigid | Same, Rigid |
| Viewing<br>Optics | Lens | Lens | Lens | Same, Lens |
| Depth of<br>View | 5-50mm | 5mm-45mm | Unknown | Same, 5-45 mm |
| Field of View | 70° | 95° | 71° to 83° | 60° |
| Direction of<br>View | 0° to 135° | 0°, 30°, 45°, 70° | 0°, 30°, 70° | 10° to 100° |
| Shaft Body<br>Diameter | 3.6mm | 2.7mm or 4mm | 2.7mm or 4mm | Same, 4mm |
| Working<br>Length | 11.8 inches (30cm) | 9.06 inches<br>(230mm) | 6.89 inches | Same, 6.89 inches<br>(175mm) |
| Illumination<br>Fibers | Glass Fibers | Glass Fibers | Glass Fibers | Same, Glass Fibers |
| Light Source | Integrated LED | Medical light<br>source | Medical light<br>source | Same, Medical<br>light source |

#### Performance Data:

Performance testing of the Acclarent Cyclops Multi-Angle Endoscope consisted of bench testing and a cadaver study. Bench testing met all acceptance criteria for attributes such as distal shaft diameter, working length, field of view, fixed focus, direction of view, rotation of view, illumination, scope resolution, dial actuation forces, temperature testing, field strength testing of magnets, electrical safety, EMC testing, durability testing, environmental conditioning, compression testing, random vibration testing, and shock (free fall drop) testing. Clinical data was not necessary for the subject device. The performance data demonstrates that the Acclarent Cyclops Multi-Angle Endoscope performs as intended.

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| Validated Reprocessing<br>Methods: | Full manual cleaning with extended enzymatic soak plus general instrument automated washer Pre-vacuum steam sterilization (wrapped) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Substantial<br>Equivalence: | The Acclarent Cyclops Multi-Angle Endoscope is substantially equivalent to the predicate devices as confirmed through relevant |

bstantially The Acclarent Cyclops Multi-Angle Endoscope is substantially
equivalent to the predicate devices as confirmed through relevant performance tests and attributes.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

2011 JAN 6

Acclarent, Inc. c/o Ms. Keri Yen Regulatory Affairs Manager 1525-B O'Brien Dr. Menlo Park, CA 94025

Re: K100577

Trade/Device Name: Acclarent Cyclops Multiangle Endoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Nasopharyngoscope, Flexible or Rigid Regulatory Class: II Product Code: EOB Dated: 12/23/2010 Received: 12/27/2010

1. 11. 1

Dear Ms. Yen:

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 - Ms. Keri Yen

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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K100577

Trade Name:

Acclarent Cyclops Multi-Angle Endoscope

Common Name:

Endoscope

Indications For Use:

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

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use. (Per 21 CFR 801.109)

_
(Division Sign Off)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

.10057
510(k) Number