(311 days)
Not Found
No
The device description focuses on mechanical and optical features of a rigid endoscope. There is no mention of image processing, AI, ML, or any software-driven analysis of the endoscopic view.
No
The device is solely for viewing purposes and does not provide therapy or treatment.
No
An endoscope for viewing anatomical structures is a visualization tool, not a diagnostic device. While the viewing obtained through the endoscope might be used by a physician to make a diagnosis, the device itself does not perform any diagnostic function.
No
The device description clearly outlines a physical, rigid endoscope with mechanical components (direction of view dial, shaft rotation dial, magnets, eyepiece, light post) and requires physical connection to light sources. Performance studies include bench testing of physical attributes and a cadaver study, further indicating a hardware-based device.
Based on the provided information, the Acclarent Cyclops Multi-Angle Endoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide an endoscopic means to view the nasal cavity and nasopharynx in an operating room environment." This describes a device used for direct visualization within the body, not for testing samples (like blood, urine, or tissue) outside the body.
- Device Description: The description details a rigid endoscope with features for viewing and manipulating the view within the nasal cavity and nasopharynx. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVD devices, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or assays.
- Calibration or quality control procedures for sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Acclarent Cyclops Multi-Angle Endoscope is a surgical/procedural device used for direct visualization during a medical procedure.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity and nasopharynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top of the "A" to the top of the "t", creating a visual arc over the word. A small dot or symbol is positioned above the "t", adding a distinctive element to the logo.
JAN 6 2011
:
510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen
Regulatory Affairs Manager
Phone: (650) 687-5874
Fax: (650) 687-4449 |
| Date of Preparation: | January 5, 2011 |
| Device Trade Name/
Model Number: | Acclarent Cyclops Multi-Angle Endoscope
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)
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 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 |
1
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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 ENTity
Nasoview
Nasopharyngoscope) | Predicate Device
(Pollux
Endoscopy, Inc
Sinuscope) | Predicate Device
(Optus Sinuscope) | Subject Device
(Acclarent
Cyclops Multi-
Angle Endoscope) |
|------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------|
| 510(k)
number | K080622 | K002214 | K944656 | K100577 |
| Rigidity | Flexible and Steerable | Rigid | Rigid | Same, Rigid |
| Viewing
Optics | Lens | Lens | Lens | Same, Lens |
| Depth of
View | 5-50mm | 5mm-45mm | Unknown | Same, 5-45 mm |
| Field of View | 70° | 95° | 71° to 83° | 60° |
| Direction of
View | 0° to 135° | 0°, 30°, 45°, 70° | 0°, 30°, 70° | 10° to 100° |
| Shaft Body
Diameter | 3.6mm | 2.7mm or 4mm | 2.7mm or 4mm | Same, 4mm |
| Working
Length | 11.8 inches (30cm) | 9.06 inches
(230mm) | 6.89 inches | Same, 6.89 inches
(175mm) |
| Illumination
Fibers | Glass Fibers | Glass Fibers | Glass Fibers | Same, Glass Fibers |
| Light Source | Integrated LED | Medical light
source | Medical light
source | Same, Medical
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
| Methods: | Full manual cleaning with extended enzymatic soak plus general instrument automated washer Pre-vacuum steam sterilization (wrapped) |
|---|---|
| Summary of Substantial | |
| 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.
3
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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
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.
4
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