(134 days)
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 Acclarent Cyclops Multi-Angle Endoscope is a 4mm 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 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.
The provided 510(k) summary for the Acclarent Cyclops Multi-Angle Endoscope (K110097) details the device's technical specifications and performance testing to demonstrate substantial equivalence to a predicate device (K100577). However, it does not describe an AI/algorithm-driven device or study. Therefore, most of the requested information regarding acceptance criteria and studies for an AI device is not applicable to this document.
The document describes bench testing and a cadaver study for the Acclarent Cyclops Multi-Angle Endoscope. The "acceptance criteria" are implicitly stated as meeting the requirements of specific international and national standards for medical devices and endoscopes.
Here's a breakdown of what can be extracted from the document, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Implied by Standards) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Distal shaft diameter | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Working length | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Field of view | Met acceptance criteria (no specific value stated, but predicate was 60°, subject device is 55°) | Met all acceptance criteria (subject device's FoV is 55°) |
| Fixed focus | Met acceptance criteria (no specific value stated, but predicate was 5-45mm, subject device is 5-40mm) | Met all acceptance criteria |
| Direction of view | Met acceptance criteria (no specific value stated, but predicate was 10°-100°, subject device is 10°-90°) | Met all acceptance criteria |
| Rotation of view | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Illumination | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Scope resolution | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Dial actuation forces | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Temperature testing | Met acceptance criteria (evaluating temperature at nine locations with 300W Xenon light source at 100% output, time to heat/cool) | Met all acceptance criteria |
| Field strength testing of magnets | Met acceptance criteria (≤10 gauss at 2cm) | Met all acceptance criteria (magnetic strength is ≤10 gauss at 2cm) |
| Electrical safety | Compliance with IEC 60601-2-18 (specific value not stated) | Performance data demonstrates intended function according to IEC 60601-2-18 |
| EMC testing | Compliance with IEC 60601-1-2 (specific value not stated) | Performance data demonstrates intended function according to IEC 60601-1-2 |
| Durability testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Environmental conditioning | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Compression testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Random vibration testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Shock (free fall drop) testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Reprocessing Methods Validation | Compliance with AAMI/ANSI ST35, AAMI TIR 12, AAMI TIR 30, ANSI/AAMI ST79 A1/A2, ANSI/AAMI ST8, ANSI/AAMI ST81, ASTM E1766 | Full manual cleaning with extended enzymatic soak plus general instrument automated washer Pre-vacuum steam sterilization (wrapped) were validated. |
| Biocompatibility | Compliance with ISO10993-1 (specific value not stated) | Performance data demonstrates intended function according to ISO10993-1 |
| Endoscope Characteristics/Requirements | Compliance with ISO 8600-3, ISO 8600-5 (specific value not stated) | Performance data demonstrates intended function according to ISO 8600-3, ISO 8600-5 |
Regarding AI-specific questions (2-9), this document does not describe an AI/algorithm device, so these are not applicable.
- Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/algorithm. Bench testing was performed, and a cadaver study was conducted. No sample sizes for a "test set" in the context of AI are provided. Data provenance would be from laboratory bench testing and a cadaver lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was established through engineering specifications, standard compliance, and physical testing.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
- The type of ground truth used: For the physical device, the ground truth is established by engineering specifications, validated test methods (bench and cadaver), and adherence to recognized medical device standards (e.g., ISO, IEC, AAMI). For surgical device performance in a cadaver, this would likely be direct observation and assessment by qualified personnel (e.g., surgeons).
- The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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MAY 2 7 2011
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: | May 20, 2011 |
| Device Trade Name/Model Number: | Acclarent Cyclops Multi-Angle EndoscopeCYE002 |
| Common Name: | Endoscope |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4760 |
| Classification Name: | Nasopharyngoscope (Flexible or Rigid) |
| Product Code: | EOB |
| Predicate Devices: | Acclarent Cyclops Multi-Angle Endoscope (K100577) |
| Device Description: | The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigidunchanneled endoscope that has the capability of varyingdirection of view from 10° to 90°, which is altered by thedirection of view dial. The direction of view is indicated byvisible markings on the scope body. Cyclops provides a 55°field of view and a depth of focus from 5 mm to 40mm. Thedevice shaft can also rotate 320° to allow for visualization ofstructures without rotating the device; this is controlled by theshaft rotation dial. Small rare-earth permanent magnets areincorporated into the proximal scope control body (≤10 gaussat 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 onthe subject device is compatible with an ACMI light source.There are two stainless steel adapters that accompany theAcclarent Cyclops Multi-Angle Endoscope to facilitate |
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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.
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.
| Characteristics: | ||
|---|---|---|
| Attribute | Predicate Device(Acclarent Cyclops Multi-Angle Endoscope) | Subject Device(Acclarent Cyclops Multi-Angle Endoscope) |
| 510(k) number | K100577 | K110097 |
| Model Number | CYE001 | CYE002 |
| Rigidity | Rigid | Same |
| Viewing Optics | Lens (Sapphire cover) | Same |
| Depth of View | 5-45 mm | Same |
| Field of View | 60° | 55° |
| Direction of View | 10° to 100° | 10° to 90° |
| Shaft BodyDiameter | 4mm | Same |
| Working Length | 6.89 inches (175mm) | Same |
| Magnetic Strength | ≤10 gauss at 2cm | Same |
| Illumination Fibers | Glass Fibers | Same |
Technological
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. Temperature testing consisted of attaching thermocouples at nine locations using adhesive and measuring the temperature at steady state. Test samples were connected to a 300W Xenon light source at 100% light output with both 3.5mm and 5.0mm light cables. The time to heat and time to cool was also evaluated. Clinical data was not necessary for the subject device. The performance data demonstrates that the Acclarent Cyclops Multi-Angle Endoscope performs as
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| intended according to IEC 60601-2-18, IEC 60601-1-2,ISO10993-1, ISO 8600-3, ISO 8600-5. | |
|---|---|
| Validated ReprocessingMethods: | Full manual cleaning with extended enzymatic soakplus general instrument automated washer Pre-vacuum steam sterilization (wrapped) |
| In validating the above, the following standards werereferenced: AAMI/ANSI ST35, AAMI TIR 12, AAMI TIR 30,and ANSI/AAMI ST79 A1/A2, ANSI/AAMI ST8,ANSI/AAMI ST81, ASTM E1766. | |
| Summary of SubstantialEquivalence: | The Acclarent Cyclops Multi-Angle Endoscope is substantiallyequivalent to the predicate devices as confirmed throughrelevant performance tests and attributes. |
. . . . .
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 7 2011
Acclarent, Inc. c/o Ms. Keri Yen. Regulatory Affairs Manager 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K110097
Trade/Device Name: Acclarent Cyclops Multi-Angle Endoscope (Model CYE002) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) Regulatory Class: Class II Product Code: EOB Dated: April 26, 2011 Received: April 27, 2011
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.
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
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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 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 vours.
Ekhm
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 setting.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rudy CRNP
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
K110097. 510(k) Number_
§ 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.