(262 days)
The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
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 to the user manual prior to every use.
The provided text describes a 510(k) premarket notification for the "Acclarent Cyclops Multi-Angle Endoscope." This is a medical device and not an AI/ML algorithmic device. Therefore, many of the requested fields regarding AI/ML models (e.g., training set, test set, ground truth establishment, MRMC studies) are not applicable.
The submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and performance data related to device reprocessing and sterilization, rather than algorithmic performance.
Here's an analysis of the provided text in the context of the user's request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative performance metric sense for viewing capabilities, but it does for reprocessing and sterilization. The table below compiles the technological characteristics and reported performance from the document.
| Attribute/Criteria | Predicate Device (Acclarent Cyclops Multi-Angle Endoscope) | Subject Device (Acclarent Cyclops Multi-Angle Endoscope) | Reported Performance / Meets Criteria |
|---|---|---|---|
| Technological Characteristics (for Equivalence) | |||
| 510(k) number | K110097 | TBD (K132433 was assigned later) | N/A (for identification) |
| Model Number | CYE002 | Same | Meets "Same" |
| Rigidity | Rigid | Same | Meets "Same" |
| Viewing Optics | Lens (Sapphire cover) | Same | Meets "Same" |
| Depth of View | 5-45 mm | Same | Meets "Same" |
| Field of View | 55° | Same | Meets "Same" |
| Direction of View | 10° to 90°C | Same | Meets "Same" |
| Shaft Body Diameter | 4.3 mm | Same | Meets "Same" |
| Working Length | 6.89 inches (175mm) | Same | Meets "Same" |
| Magnetic Strength | ≤10 gauss at 2cm | Same | Meets "Same" |
| Performance Data (for Safety & Effectiveness) | |||
| Reprocessing & Sterilization | |||
| Overall Reprocessing | Met all acceptance criteria | Met all acceptance criteria | Met all acceptance criteria |
| Sterilization (Steam/STERRAD) | N/A | Sterility Assurance Level of 10⁻⁶ | Achieved SAL of 10⁻⁶ |
| Validation Method | N/A | Overkill (half-cycle approach) in a fixed chamber | Validated via specified method |
| High-Level Disinfection (OPA) | N/A | Validated using 0.55% ortho-Phthalaldehyde (Cidex OPA®) | Validated |
| High-Level Disinfection (Glutaraldehyde) | N/A | Validated using 2.4% glutaraldehyde (Cidex®) solutions | Validated |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The performance data presented relates to engineering and microbiological testing for reprocessing and sterilization, not a clinical "test set" of patient data for diagnostic accuracy.
- Data Provenance: The data provenance for the reprocessing and sterilization testing is not specified in terms of country of origin or whether it was retrospective/prospective. This testing would typically be performed in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is not an AI/ML device making diagnostic assessments, there's no "ground truth" to be established by experts in the sense of image interpretation. The "ground truth" for sterilization is a sterility assurance level (SAL), and for reprocessing, it's the successful removal of biological debris and chemical residues, determined by laboratory-based assays and methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no human interpretation or adjudication involved in the performance validation described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an endoscope, not an AI-assisted diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm to perform a standalone test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance validation relates to engineering and microbiological standards for device reprocessing and sterilization.
- For sterilization, the ground truth is a demonstrated Sterility Assurance Level (SAL) of 10⁻⁶, which is a microbiological standard indicating the probability of a single viable microorganism remaining on an item after sterilization. This is established through validated sterilization cycles (e.g., half-cycle overkill approach) and biological indicators.
- For reprocessing, the ground truth involves demonstrating effective cleaning (removal of organic and inorganic residues) and high-level disinfection, validated through standardized test methods (e.g., testing for residual protein, hemoglobin, carbohydrates, and successful inactivation of challenge microorganisms).
8. The sample size for the training set:
- Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.
Conclusion on Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria (primarily related to safety and effectiveness through reprocessing and sterilization) involved rigorous engineering and microbiological validation. The document states:
- "Reprocessing and sterilization testing met all acceptance criteria."
- The sterilization process achieved a "sterility assurance level of 10⁻⁶ when the device is sterilized via either steam or STERRAD methods."
- The sterilization validation used an "overkill (half-cycle approach) in a fixed chamber."
- The device was "validated to be high level disinfected using either 0.55% ortho-Phthalaldehyde (Cidex OPA®) or 2.4% glutaraldehyde (Cidex®) solutions."
The specific raw data, detailed methodologies, and precise number of cycles/samples for these tests are not provided in this summary but would have been part of the full 510(k) submission. The FDA's clearance (K132433) indicates that they found these data sufficient to demonstrate substantial equivalence and safety/effectiveness for the stated indications for use.
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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 DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | James Patrick Garvey IISr. Manager, Regulatory AffairsPhone: (650) 687-4807Fax: 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 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 facilitateconnection with Wolf or Storz/Olympus medical light sources. Theadapters connect to the light post. The Acclarent CyclopsMulti-Angle Endoscope is a reusable device and must becleaned and sterilized or subjected to High Level Disinfection according |
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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 DeviceAcclarent CyclopsMulti-AngleEndoscope | Subject DeviceAcclarent CyclopsMulti-AngleEndoscope |
|---|---|---|
| 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.
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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.
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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
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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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§ 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.