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).

AI/ML Overview

This document (K153009) describes the 510(k) premarket notification for the "ULTRA" Telescopes, which are rigid endoscopes. It outlines the performance data and testing conducted to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study proving de novo efficacy or significant improvement. Therefore, many of the specific details typically found in a clinical trial report (like MRMC study results, detailed ground truth establishment for a training set, or effect sizes for AI assistance) are not applicable or not present in this type of submission for a medical device cleared via the 510(k) pathway. The performance data presented here are primarily engineering and biocompatibility tests, not clinical performance data in the sense of an algorithm.

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of acceptance criteria with corresponding performance metrics in a format like "Target Value | Achieved Value". Instead, it lists the types of tests conducted and states that the device "functions as intended and meets design specifications" and that "The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified."

Here's a breakdown of the performance tests areas, which implicitly define the acceptance criteria:

Acceptance Criteria (Implied by Test Type)	Reported Device Performance
Biocompatibility: Device materials are not toxic or harmful when in contact with the body.	Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO-10993. Tests included: Biological Safety toxicology (ISO 10993-1), Cytotoxicity (ISO 10993-5), Chemical Analysis (ISO 10993-12).
Electrical Safety: Device does not pose electrical hazards.	Tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010.
Electromagnetic Compatibility (EMC): Device does not interfere with or is not interfered by other electrical devices.	"Not applicable. The devices are not electrically powered and are just used with light from a light source." (This is a statement of non-applicability rather than a test result.)
Thermal Safety: Device does not reach unsafe temperatures during use.	Tested according to IEC 60601-2-18:2009.
Optical Performance: Image quality, field of view (FOV), direction of view (DOV), illumination.	Bench testing conducted. "The Field of View (FOV) of the subject devices has been decreased by 2° [compared to predicate]." (This is a design characteristic, not a performance metric per se, but implies the FOV was evaluated and falls within an acceptable range). "A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image", "The image relay system of rod lenses transmits the endoscopic image" (describes design, not specific performance metrics).
Mechanical Performance: Durability, structural integrity, dimensions.	Bench testing conducted. "Identical insertion portion width and optical system diameter", "Maximum working length of subject device is slightly longer" (comparative statements, implying these were evaluated and found acceptable).
Shipping Tests: Device withstands transportation conditions.	Conducted.
Service Life Expectancy: Device maintains performance over its expected lifespan.	Conducted.
Illumination System Performance: Adequate light delivery.	Bench testing conducted.
Design Validation/Usability: Device is safe and effective for intended use by users.	Conducted.
Reprocessing (Sterilization) Compatibility: Device can be safely and effectively reprocessed for reuse.	Device is "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." (This implies testing was done to validate the reprocessing methods). No specific test results given in the summary, but this is a critical aspect for reusable devices.
Risk Analysis: Identification and mitigation of potential risks.	Carried out in accordance with ISO-14971:2007.

Summary of Reported Performance: The document generally states that the device "functions as intended and meets design specifications" and that the "performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified." It concludes that the device is "substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use," and "raise no new concerns of safety or effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in terms of "patient data" or "image data" as this is not a study assessing an algorithm's performance on patient-derived data. The "test set" here refers to the actual manufactured devices used for the bench and material testing. The specific number of devices tested for each performance test (e.g., how many telescopes were subjected to shipping tests or service life tests) is not provided in this summary.
Data Provenance: Not applicable in the context of patient data. The tests were performed internally by Olympus Winter & Ibe GmbH (Germany) as the manufacturer, and potentially by third-party labs for specific certifications (e.g., biocompatibility). The summary implies the testing was prospective (i.e., conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable in the sense of medical experts establishing ground truth for diagnostic accuracy (e.g., reading images). The "ground truth" for this device relates to engineering specifications, safety standards, and functional performance. Experts involved would be engineers, usability specialists, and quality control personnel within the manufacturing company and potentially external certification bodies, but their number and specific qualifications are not detailed. Usability studies would involve medical professionals (surgeons/ENT specialists) but the extent of their involvement and their role in defining "ground truth" (beyond user feedback regarding intuitive design, handling, etc.) is not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations (e.g., conflicting diagnoses from radiologists). For this device, "adjudication" would refer to the internal quality control processes and the interpretation of test results against predefined engineering specifications and regulatory standards.

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

MRMC Study: No. An MRMC study is typically performed for AI-powered diagnostic devices to assess diagnostic accuracy or the impact of AI assistance on human readers. The "ULTRA" Telescope is a physical, optical endoscope, not an AI-powered device. Therefore, this type of study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No. This question again relates to AI algorithms. The "ULTRA" Telescope is an instrument that a human uses. Its "performance" is inherently linked to its physical characteristics and how it functions when operated by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The ground truth for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC, AAMI/ANSI), and regulatory requirements. For example, the ground truth for biocompatibility is "no cytotoxicity" when tested per ISO 10993-5, or for electrical safety, it's compliance with IEC 60601-1. For optical and mechanical properties, the ground truth is adherence to the design specifications (e.g., specified field of view, clarity, light transmission, durability under specific loads).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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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

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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

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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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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

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3. Predicate device

K944072, Olympus Nasal & Sinus Endoscopes

4. Description of device

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

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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.

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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.

Regulation Number and Section

§ 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.