(174 days)
Not Found
No
The device description and performance studies focus on the optical and mechanical aspects of a rigid endoscope, with no mention of image processing, AI, or ML.
No.
The device is used for observation, diagnosis and treatment, which are not solely therapeutic functions. While "treatment" is mentioned, the primary functions described (observation, diagnosis) and the nature of the device as an endoscope suggest it is an observational and diagnostic tool that can be used during treatment, rather than being a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" states that the device is for "endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy." The term "diagnosis" clearly indicates its diagnostic function.
No
The device description clearly states it is a rigid endoscope with an image relay system of rod lenses and optical fibers for light transmission, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The "ULTRA" Telescopes are described as rigid endoscopes used for direct visual observation, diagnosis, and treatment during nasal endoscopy and sinuscopy. They transmit an image of the internal anatomy.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is a tool for direct visualization within the body.
Therefore, the function and intended use of this device clearly fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.
Product codes
EOB
Device Description
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "ULTRA" Telescopes are available with four different directions of view (0°, 30°, 45°, and 70°) to allow use for various applications in accordance with the intended use as submitted with this 510(k). To address surgeon's preferences, the 30°, 45°, and 70° models are available as an inverse version as well (the light guide cable adapter is at the bottom, instead of at the top of the telescope).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal
sinus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.
The testing included the following tests:
- Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
Electromagnetic compatibility (EMC) is not applicable. The devices are not electrically powered and are just used with light from a light source.
Thermal Safety
Tested according to IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: IEC 60601-2-18 Edition 3.0 2009-08. medical electrical equipment - part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Performance Testing Bench
Conducted tests cover optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
Key Results: The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird-like figure with three heads or faces, positioned above a wavy line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Olympus, Winter & Ibe GmbH % Ms. Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K153009
Trade/Device Name: Ultra Telescopes Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: March 4, 2016 Received: March 7, 2016
Dear Ms. Musgnung:
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. Isting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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,
Denise L. Hampton -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) K153009
Device Name "ULTRA" Telescopes
Indications for Use (Describe)
Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.
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
510(k) Summary of Safety and Effectiveness
October 12, 2015
1. General information
- I Manufacturer/Holder Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
- 트 Establishment Registration No.: 9610773
- . Official Correspondent: Sheri L. Musqnunq Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 484-896-3147 Phone: 484-896-7128 FAX: Email: sheri.musqnunq@olympus.com Establishment Registration No.: 2429304
2. Device identification
- 트 Proprietary name:
- 트 Common name:
- Regulation Number:
- Regulation Description:
- Device Class:
- Product Code:
- Review Panel:
"ULTRA" Telescopes Sinuscopes 21 CFR 874.4760 Nasopharyngoscope (flexible or rigid) and Accessories ll EOB
Ear Nose & Throat
4
3. Predicate device
K944072, Olympus Nasal & Sinus Endoscopes
4. Description of device
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "ULTRA" Telescopes are available with four different directions of view (0°, 30°, 45°, and 70°) to allow use for various applications in accordance with the intended use as submitted with this 510(k). To address surgeon's preferences, the 30°, 45°, and 70° models are available as an inverse version as well (the light guide cable adapter is at the bottom, instead of at the top of the telescope).
5. Indications of use
Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.
6. Comparison of Technological characteristics
The subject and predicate devices are based on the same technological principles:
- 트 Rigid endoscopes consisting of insertion tube, rod-lens and light-guide system, connector and eyepiece cup. The predicate device additionally had a locking cone for sheath connection.
- A bundle of optical fibers transmits light from an external light source to I illuminate the endoscopic image
- The image relay system of rod lenses transmits the endoscopic image
- Identical insertion portion width and optical system diameter 트
- 트 Maximum working length of subject device is slightly longer
- 트 Identical Direction of Views (DOVs)
- The Field of View (FOV) of the subject devices has been decreased by 2°
- . The same patient contacting materials are used in the predicate and subject device
5
7. Performance Data
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.
The testing included the following tests:
- Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- י Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
Electromagnetic compatibility (EMC) is not applicable. The devices are not electrically powered and are just used with light from a light source.
Thermal Safety
Tested according to IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: IEC 60601-2-18 Edition 3.0 2009-08. medical electrical equipment - part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Performance Testing Bench
Conducted tests cover optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
6
The following standards have been applied to the "ULTRA" Telescopes:
Rec. No. Standard
- 19-5 AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012
- 9-61 IEC 60601-2-18:2009
- 2-89 IEC 60601-1-6:2013
- 9-83 ISO 8600-1:2013
- 9-84 ISO 8600-3:1997 + AM1(2003)
- 9-94 ISO 8600-4:2014
- 9-39 ISO 8600-5:2005
- 9-40 ISO 8600-6:2005
- 2-156 AAMI ANSI ISO 10993-1: 2009
- 2-153 AAMI ANSI ISO 10993-5: 2009
- 2-191 ISO 10993-12: 2012
- 5-40 ISO 14971:2007
- ISO 17665-1:2006 14-333
8 Conclusions
The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.
In summary, we believe the "ULTRA" Telescopes are substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. The "ULTRA" Telescopes raise no new concerns of safety or effectiveness compared to the predicate devices.