(261 days)
The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.
The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.
The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.
I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter and a summary of safety and effectiveness for a medical device called the ULYSS Multi View Sinuscope. It describes the device, its intended use, and compares its technological characteristics to predicate devices.
However, it does not provide details about acceptance criteria for performance metrics or a study that specifically proves the device meets those criteria in the way you've outlined (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).
The "Performance Data" section (on page 4) mentions "bench testing and a cadaver study" and that "The ULYSS Multi View Sinuscope has met all specified design and performance requirements." but it does not elaborate on the specific acceptance criteria, the methodology of these studies, or the results in a quantifiable manner that would allow me to populate the tables you've requested.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Sopro-Comeg GmbH % Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-1 Amsterdam, 1017AP NL
Re: K153701
Trade/Device Name: ULYSS Multi View Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: August 4, 2016 Received: August 8, 2016
Dear Ms. Scherp:
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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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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) K153701
Device Name ULYSS Multi View Sinuscope
Indications for Use (Describe)
The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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ULYSS Multi View Sinuscope
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | August 29, 2016 |
|---|---|
| Submitter: | Name: SOPRO-COMEG GmbHAddress: Dornierstrasse 55 78532 Tuttlingen GermanyContact Person: Angelika ScherpTelephone: (31) 20-612-5626Fax: (31) 84-735-7788 |
| Product: | Trade Name: ULYSS Multi View SinuscopeCommon Name: EndoscopeClassification: Nasopharyngoscope (flexible or rigid) and accessoriesName:Regulation Number: 21 CFR 874.4760Product Code: EOB |
| Predicate Device: | K132433 -Acclarent Cyclops Multi-Angle Endoscope |
| Reference Device: | K944656 – Optus Sinuscopes and Accessories |
| Device Description: | The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use. |
| Description of Accessories: | The following optional accessories are available for use with the ULYSS Multi View Sinuscope to provide a conduit for suction and irrigation of the operating site during surgical procedures. Both incorporate standard connections for suction and irrigation tubing. Suction Irrigation Handle and Adaptable Tube Suctions Irrigation Sheaths |
| Indications for Use: | The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx. |
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ULYSS Multi View Sinuscope
| PerformanceData: | Performance testing of the ULYSS Multi View Sinuscope consisted of benchtesting and a cadaver study, as summarized below:Thermal safety testing in accordance with IEC 60601-2-18 Evaluation of magnetic field strength and potential effects onelectronic devices in immediate vicinity of the ULYSS Multi ViewSinuscope (comparison testing with predicate device) Optical performance comparison with predicate device at completerange of viewing directions Evaluation of quality, illumination, and resolution of images inside thenasal cavity in a cadaver (comparison testing with predicate device) Biocompatibility evaluation in accordance with ISO 10993-1 The ULYSS Multi View Sinuscope has met all specified design andperformance requirements. |
|---|---|
| Reprocessing andSterilizationTesting | Reprocessing and sterilization validation testing met all acceptance criteriaand has demonstrated a sterility assurance level (SAL) of 10-6 for sterilizationvia pre-vacuum steam sterilization. |
| TechnologicalCharacteristics | The technological and performance characteristics of the device are similar tothose of the predicate devices, as shown by the following summary table: |
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | Pending | K132433 | K944656 |
| Device | ULYSS Multi ViewSinuscope | Acclarent Cyclops Multi-Angle Endoscope | Optus Sinuscopes |
| Model # | 161 401 760 | CYE002 | 171.271.xxx161.271.xxx |
| 510(k)Sponsor | SOPRO-COMEGGmbH | ACCLARENT, Inc. | OPTUS, Inc. |
| IntendedUse | The ULYSS MultiView Sinuscope isintended to provide anendoscopic means toview the nasal cavityand nasopharynx. | The Acclarent CyclopsMulti-Angle Endoscope isintended to provide anendoscopic means to viewthe nasal cavity andnasopharynx. | Optus Sinuscopes areintended to be used tovisualize the sinus area. |
| Materials | Glass, stainless steel,titanium, rare-earthpermanent magnets | Glass, stainless steel,titanium, rare-earthpermanent magnets | Glass, stainless steel |
| Rigidity | Rigid | Rigid | Rigid |
| LensSystem | Rod-lens relay system | Achromatic relay system | Rod-lens relay system |
| Depth ofView | 2.5-45 mm | 5-45 mm | 2-50 mm |
| Field ofView | 60° | 55° | 71°-83° |
| Direction ofView | 10° to 100° | 10° to 90° | 0°, 30° or 70° |
| Rotation ofOuter Tube | 340° | 320° | N.A. |
| ShaftDiameter | 4.3 mm | 4.3 mm | 2.7 mm or 4 mm |
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ULYSS Multi View Sinuscope
| Working Length | 175 mm | 175 mm | 174.5 mm |
|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Reusable | Yes | Yes | Yes |
Conclusion: The information provided in this 510(k) submission provides reasonable assurance that the subject device ULYSS Multi View Sinuscope is safe and effective and that it is substantially equivalent to the predicate device with respect to intended use and technological characteristics.
§ 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.