These endoscopes are intended to be used for endoscopic surgery within the thoracic and perioneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.

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 will be marketed as individual telescopes. The "ULTRA" Telescopes are available in two different diameters (5.4 mm and 10 mm) with three different directions of view (0°, 30°, 45°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).

AI/ML Overview

This document is a 510(k) premarket notification for the "ULTRA" Telescopes, a type of rigid endoscope. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a specific study demonstrating device performance against quantitative acceptance criteria for a diagnostic AI/ML device.

Here's why the requested information cannot be fully provided based on this document:

Device Type: The "ULTRA" Telescopes are physical medical devices (endoscopes) used for visualization and endoscopic surgery, not a diagnostic AI/ML tool. The performance data presented focuses on physical safety and functional standards rather than diagnostic accuracy or AI performance.
Nature of "Acceptance Criteria" and "Device Performance": For a physical device like an endoscope, acceptance criteria relate to compliance with established engineering and safety standards (e.g., biocompatibility, electrical safety, thermal safety, optical performance, mechanical integrity). "Device performance" in this context refers to successfully passing these tests. This is distinct from the statistical metrics (e.g., sensitivity, specificity, AUC) and clinical study designs typically used to evaluate AI/ML diagnostic tools.

Therefore, the sections requested about sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document as it does not describe an AI/ML device or a study evaluating its diagnostic accuracy.

The document does describe the performance data for the "ULTRA" Telescopes in terms of meeting various standards, which could be considered their "acceptance criteria" and "device performance" for a physical device.

Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" relevant to this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical endoscope):

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Biocompatibility	FDA Blue Book Memo #G95-1, ISO-10993 (Parts 1, 5, 12)	Successful completion of Cytotoxicity and Chemical Analysis testing.
Electrical Safety	AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010	Electrical Safety tested successfully. (EMC stated as not applicable).
Thermal Safety	IEC 60601-2-18:2009, "Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)"	Thermal Safety tested successfully.
Performance (Bench)	Internal design specifications, relevant ISO standards (e.g., ISO 8600 series)	Successfully passed optical and mechanical performance testing, shipping tests, service life tests, and illumination system tests. Design validation/usability tests conducted.
Risk Management	ISO-14971:2007	Risk analysis carried out in accordance with established in-house acceptance criteria.
Sterilization	ISO 17665-1:2006 (for reprocessing procedures)	(Mentioned as "fully autoclavable" and reprocessing procedures defined in IFU; implicit compliance with sterilization standards for reusable devices.)

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

Not applicable for this type of device and performance testing. The "test set" here refers to the actual devices undergoing physical tests, not a dataset for an algorithm.

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)

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant to the engineering and safety tests performed on an endoscope.

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

Not applicable.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

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

Not applicable. For this device, "ground truth" relates to objective measures against engineering standards, not diagnostic outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2015

Olympus Winter & Ibe GmbH Ms. Sheri L. Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034

Re: K150633

Trade/Device Name: "ULTRA" Telescopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, NMH, HET Dated: March 11, 2015 Received: March 11, 2015

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, 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.

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 (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" (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.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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150633

Device Name "ULTRA" Telescopes

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary of Safety and Effectiveness

March 11, 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. Musqnung Requlatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musqnunq@olympus.com Establishment Registration No.: 2429304

2. Device identification

트 Proprietary name:
트 Common name:
Regulation Number:
I Requlation Description:
Device Class:
Product Code:
Review Panel:

"ULTRA" Telescopes Laparoscopes 21 CFR 876.1500 21 CFR 884.1720 Endoscope and Accessories Gynecologic laparoscope and accessories ll GCJ / NMH / HET General & Plastic Surgery

Obstetrics/Gynecology

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3. Predicate device

K923982, Olympus OES Laparoscopy System

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 will be marketed as individual telescopes.

The "ULTRA" Telescopes are available in two different diameters (5.4 mm and 10 mm) with three different directions of view (0°, 30°, 45°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).

Model No.	Model name
WA4KL100	Telescope "ULTRA", 10 mm, 0°
WA4KL130	Telescope "ULTRA", 10 mm, 30°
WA4KL145	Telescope "ULTRA", 10 mm, 45°
WA4KL500	Telescope "ULTRA", 5.4 mm, 0°
WA4KL530	Telescope "ULTRA", 5.4 mm, 30°
WA4KL545	Telescope "ULTRA", 5.4 mm, 45°

5. Indications of use

These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.

6. Comparison of Technological characteristics

The subject and predicate devices are based on the same technological principle with the same elements:

트 Rigid endoscopes consisting of insertion tube, rod-lens and light-guide system, connector and eyepiece cup
Inserted into natural and surgically opened body spaces
I 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
Identical, respectively similar outer diameters
l Telescopes are used with standardized trocars
Identical Direction of Views (DOVs)
I The Field of View (FOV) of subject devices is wider (Ø Factor 1.2)

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Maximum working length of subject device is minimally longer
The same materials in patient contact are used in predicate and subject ■ device

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
. 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 as well as in accordance with the guidance document "Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)".

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

9-61 IEC 60601-2-18:2009: 30 Ed.
ISO 8600-1:2013 9-83
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
5-40 ISO 14971:2007
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and 19-4 a2:2010/(r)2012 (IEC 60601-1:2005, mod).
5-89 IEC 60601-1-6:2013
AAMI ANSI ISO 10993-1: 2009 2-156
2-153 AAMI ANSI ISO 10993-5: 2009
2-198 AAMI ANSI ISO 10993-12: 2012
14-333 ISO 17665-1:2006

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

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.