(262 days)
Not Found
No
The device description focuses on mechanical and optical features, with no mention of AI/ML, image processing, or data analysis.
No
The device is described as an endoscope for viewing the nasal cavity and nasopharynx, which is a diagnostic function rather than a therapeutic one (treatment).
Yes
The device is an endoscope intended to "view the nasal cavity and nasopharynx," which is a diagnostic purpose to visualize anatomical structures.
No
The device description clearly details a physical, rigid endoscope with mechanical components (direction of view dial, shaft rotation dial, magnets, eyepiece, light post) and accessories (adapters). It also mentions reprocessing and sterilization, which are procedures applied to physical hardware.
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." This describes a device used for direct visualization of internal body structures.
- Device Description: The description details a rigid endoscope with features for manipulating the view and connecting to light sources and cameras. This aligns with the description of a medical device used for examination, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples. The focus is purely on providing a visual pathway.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is solely for visualization.
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.
Product codes
EOB
Device Description
The Acclarent Cyclops Multi-Angle Endoscope is a 4.3 mm rigid unchanneled endoscope that has the capability of varying direction of view from 10° to 90°, 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 55° 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
§ 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
Acclarent /
W132433
Traditional 510(k) Premarket Notification
Acclarent Cyclops Multi-Angle Endoscope
| APPENDIX A: 510(k) Summary | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | -- | ---------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II
Sr. Manager, Regulatory Affairs
Phone: (650) 687-4807
Fax: 650-687-4847 |
| 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)
Entellus Medical FinESS Endoscope (K102366) |
| Device Description: | The Acclarent Cyclops Multi-Angle Endoscope is a 4.3 mm rigid
unchanneled endoscope that has the capability of varying
direction of view from 10° to 90°, 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 55°
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 or subjected to High Level Disinfection according |
1
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
Acclarent Cyclops
Multi-Angle
Endoscope | Subject Device
Acclarent Cyclops
Multi-Angle
Endoscope |
|---------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|
| 510(k) number | K110097 | TBD |
| Model Number | CYE002 | Same |
| Rigidity | Rigid | Same |
| Viewing Optics | Lens
(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.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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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