(261 days)
No
The device description and performance studies focus on optical and mechanical performance, with no mention of AI/ML or image processing capabilities.
No
The device is solely for visualization (diagnostic purposes) and does not perform any therapeutic function like treating, curing, or preventing a disease.
Yes
Explanation: The device is intended to provide an endoscopic means to view the nasal cavity and nasopharynx, which is a diagnostic purpose (visualization to assess the condition of these areas).
No
The device description clearly outlines a rigid endoscope with physical components like a rod lens system, optical fibers, rotating dials, and a handle. It is a hardware device for visualization.
Based on the provided information, the ULYSS Multi View Sinuscope 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 for visualization only, transmitting images and light. It does not mention any components or processes related to testing samples taken from the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The ULYSS Multi View Sinuscope is used for direct visualization within the body.
N/A
Intended Use / Indications for Use
The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Product codes
EOB
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.
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
Not Found
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
Bench testing and a cadaver study.
- Thermal safety testing in accordance with IEC 60601-2-18
- Evaluation of magnetic field strength and potential effects on electronic devices in immediate vicinity of the ULYSS Multi View Sinuscope (comparison testing with predicate device)
- Optical performance comparison with predicate device at complete range of viewing directions
- Evaluation of quality, illumination, and resolution of images inside the nasal 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 and performance requirements.
Reprocessing and Sterilization Testing: Reprocessing and sterilization validation testing met all acceptance criteria and has demonstrated a sterility assurance level (SAL) of 10-6 for sterilization via pre-vacuum steam sterilization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
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.
1
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
2
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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3
ULYSS Multi View Sinuscope
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | August 29, 2016 |
|---|---|
| Submitter: | Name: SOPRO-COMEG GmbH |
| Address: Dornierstrasse 55 78532 Tuttlingen Germany | |
| Contact Person: Angelika Scherp | |
| Telephone: (31) 20-612-5626 | |
| Fax: (31) 84-735-7788 | |
| Product: | Trade Name: ULYSS Multi View Sinuscope |
| Common Name: Endoscope | |
| Classification: Nasopharyngoscope (flexible or rigid) and accessories | |
| Name: | |
| Regulation Number: 21 CFR 874.4760 | |
| Product 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
| Performance
Data: | Performance testing of the ULYSS Multi View Sinuscope consisted of bench
testing 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 on
electronic devices in immediate vicinity of the ULYSS Multi View
Sinuscope (comparison testing with predicate device) Optical performance comparison with predicate device at complete
range of viewing directions Evaluation of quality, illumination, and resolution of images inside the
nasal 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 and
performance requirements. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reprocessing and
Sterilization
Testing | Reprocessing and sterilization validation testing met all acceptance criteria
and has demonstrated a sterility assurance level (SAL) of 10-6 for sterilization
via pre-vacuum steam sterilization. |
| Technological
Characteristics | The technological and performance characteristics of the device are similar to
those 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 View | ||
| Sinuscope | Acclarent Cyclops Multi- | ||
| Angle Endoscope | Optus Sinuscopes | ||
| Model # | 161 401 760 | CYE002 | 171.271.xxx |
| 161.271.xxx | |||
| 510(k) | |||
| Sponsor | SOPRO-COMEG | ||
| GmbH | ACCLARENT, Inc. | OPTUS, Inc. | |
| Intended | |||
| Use | The ULYSS Multi | ||
| View Sinuscope is | |||
| intended to provide an | |||
| endoscopic means to | |||
| view the nasal cavity | |||
| and nasopharynx. | The Acclarent Cyclops | ||
| Multi-Angle Endoscope is | |||
| intended to provide an | |||
| endoscopic means to view | |||
| the nasal cavity and | |||
| nasopharynx. | Optus Sinuscopes are | ||
| intended to be used to | |||
| visualize the sinus area. | |||
| Materials | Glass, stainless steel, | ||
| titanium, rare-earth | |||
| permanent magnets | Glass, stainless steel, | ||
| titanium, rare-earth | |||
| permanent magnets | Glass, stainless steel | ||
| Rigidity | Rigid | Rigid | Rigid |
| Lens | |||
| System | Rod-lens relay system | Achromatic relay system | Rod-lens relay system |
| Depth of | |||
| View | 2.5-45 mm | 5-45 mm | 2-50 mm |
| Field of | |||
| View | 60° | 55° | 71°-83° |
| Direction of | |||
| View | 10° to 100° | 10° to 90° | 0°, 30° or 70° |
| Rotation of | |||
| Outer Tube | 340° | 320° | N.A. |
| Shaft | |||
| Diameter | 4.3 mm | 4.3 mm | 2.7 mm or 4 mm |
5
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.