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 Description

The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigid endoscope that has the capability of varying direction of view from 10° to 100°, which is altered by the direction of view dial. The direction of view is indicated by visible markings on the scope body Cyclops provides a 60° field of view and a depth of focus from 5 mm to 40mm. The device shaft can also rotate 320° to allow for visualization of structures without rotating the device; this is controlled by the shaft rotation dial. Small rare-earth permanent magnets are incorporated into the proximal scope control body (≤10 gauss at 2cm) and drive the change in the direction of view. A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two stainless steel adapters that accompany the Acclarent Cyclops Multi-Angle Endoscope to facilitate connection with Wolf or Storz/Olympus medical light sources. The adapters connect to the 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.

AI/ML Overview

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. The device's performance was evaluated through bench testing and a cadaver study, which are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Implied by Predicate Devices / Stated Performance)	Reported Device Performance (Acclarent Cyclops Multi-Angle Endoscope)
Distal Shaft Diameter	Not explicitly stated as acceptance criteria, but predicate devices are 2.7mm or 4mm	4mm (Same as predicate)
Working Length	Not explicitly stated as acceptance criteria, but predicate devices vary from 6.89 to 11.8 inches	6.89 inches (175mm) (Same as a predicate)
Field of View	Not explicitly stated as acceptance criteria, but predicate devices are 70°, 95°, 71°-83°	60°
Fixed Focus (Depth of View)	Not explicitly stated as acceptance criteria, but predicate devices are 5-50mm or 5mm-45mm	5mm to 40mm (Matches a predicate device depth of view of 5-45mm)
Direction of View	Not explicitly stated as acceptance criteria, but predicate devices are 0°-135°, 0°, 30°, 45°, 70°	10° to 100°
Rotation of View	Capable of shaft rotation for visualization	320° shaft rotation
Illumination	Effective illumination for endoscopic viewing (implied)	Utilizes Glass Fibers and compatible with Medical light source (Same as predicates)
Scope Resolution	Adequate resolution for visualization (implied)	Bench testing met acceptance criteria for scope resolution
Dial Actuation Forces	Within acceptable ergonomic limits (implied)	Bench testing met acceptance criteria for dial actuation forces
Temperature Testing	Withstands operational temperature ranges (implied)	Bench testing met acceptance criteria for temperature testing
Field Strength Testing of Magnets	≤10 gauss at 2cm	Small rare-earth permanent magnets incorporated (≤10 gauss at 2cm)
Electrical Safety	Compliant with electrical safety standards (implied)	Bench testing met acceptance criteria for electrical safety
EMC Testing	Compliant with electromagnetic compatibility (EMC) standards (implied)	Bench testing met acceptance criteria for EMC testing
Durability Testing	Withstands repeated use and sterilization procedures (implied)	Bench testing met acceptance criteria for durability testing
Environmental Conditioning	Withstands specified environmental conditions (implied)	Bench testing met acceptance criteria for environmental conditioning
Compression Testing	Withstands compressive forces (implied)	Bench testing met acceptance criteria for compression testing
Random Vibration Testing	Withstands vibrational forces (implied)	Bench testing met acceptance criteria for random vibration testing
Shock (Free Fall Drop) Testing	Withstands impact forces (implied)	Bench testing met acceptance criteria for shock (free fall drop) testing
Reprocessing Methods	Validated for cleaning and sterilization (implied)	Full manual cleaning with extended enzymatic soak plus general instrument automated washer; Pre-vacuum steam sterilization (wrapped)
Substantial Equivalence	Demonstrated through relevant performance tests and attributes compared to predicate devices.	The Acclarent Cyclops Multi-Angle Endoscope is substantially equivalent to the predicate devices as confirmed through relevant performance tests and attributes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly mentions "bench testing and a cadaver study". However, it does not specify the sample size for either of these studies.
Data Provenance: The document does not provide details regarding the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the bench testing or cadaver study. The performance data is presented as objective measurements against acceptance criteria.

4. Adjudication Method for the Test Set

As no experts were explicitly mentioned for ground truth establishment, there is no adjudication method specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical data was not necessary for the subject device." This indicates that the evaluation focused on technical performance and equivalence to predicate devices rather than direct clinical comparison or human reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This device is a physical endoscope and not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluation is for the device itself.

7. Type of Ground Truth Used

For the bench testing, the ground truth was based on objective measurements against pre-defined acceptance criteria for various physical and functional attributes of the device (e.g., diameter, length, field of view, resolution, temperature tolerance, etc.).
For the cadaver study, the ground truth would inherently be the anatomical structures and visualization capabilities within a cadaveric model, assessed against the intended use of viewing the nasal cavity and nasopharynx.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As this is not an AI/ML device, there is no training set and thus no ground truth established for a training set.

Summary

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JAN 6 2011

K100577

510(k) SUMMARY

Sponsor/Submitter:	Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025
Contact Person:	Keri YenRegulatory Affairs ManagerPhone: (650) 687-5874Fax: (650) 687-4449
Date of Preparation:	January 5, 2011
Device Trade Name/Model Number:	Acclarent Cyclops Multi-Angle EndoscopeCYE001
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)Pollux Endoscopy Inc. Sinuscope (K002214)Optus Sinuscope (K944656)Karl Storz Hopkins Rigid Autoclavable Telescope (K935279)Stryker Endoscopy Arthroscope (K093677)
Device Description:	The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigidendoscope that has the capability of varying direction of view from10° to 100°, which is altered by the direction of view dial. Thedirection of view is indicated by visible markings on the scope bodyCyclops provides a 60° field of view and a depth of focus from 5mm to 40mm. The device shaft can also rotate 320° to allow forvisualization of structures without rotating the device; this iscontrolled by the shaft rotation dial. Small rare-earth permanentmagnets are incorporated into the proximal scope control body (≤10gauss at 2cm) and drive the change in the direction of view. Astandard eyepiece located on the proximal end of the device iscompatible with a standard camera coupler. The light post on thesubject device is compatible with an ACMI light source.There are two stainless steel adapters that accompany the AcclarentCyclops Multi-Angle Endoscope to facilitate connection with Wolfor 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(OPTIM Inc ENTityNasoviewNasopharyngoscope)	Predicate Device(PolluxEndoscopy, IncSinuscope)	Predicate Device(Optus Sinuscope)	Subject Device(AcclarentCyclops Multi-Angle Endoscope)
510(k)number	K080622	K002214	K944656	K100577
Rigidity	Flexible and Steerable	Rigid	Rigid	Same, Rigid
ViewingOptics	Lens	Lens	Lens	Same, Lens
Depth ofView	5-50mm	5mm-45mm	Unknown	Same, 5-45 mm
Field of View	70°	95°	71° to 83°	60°
Direction ofView	0° to 135°	0°, 30°, 45°, 70°	0°, 30°, 70°	10° to 100°
Shaft BodyDiameter	3.6mm	2.7mm or 4mm	2.7mm or 4mm	Same, 4mm
WorkingLength	11.8 inches (30cm)	9.06 inches(230mm)	6.89 inches	Same, 6.89 inches(175mm)
IlluminationFibers	Glass Fibers	Glass Fibers	Glass Fibers	Same, Glass Fibers
Light Source	Integrated LED	Medical lightsource	Medical lightsource	Same, Medicallight 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 ReprocessingMethods:	Full manual cleaning with extended enzymatic soak plus general instrument automated washer Pre-vacuum steam sterilization (wrapped)
Summary of SubstantialEquivalence:	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. 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.