The Olympus Wireless Image Transmitter Unit UWIT-Y0001 is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The Olympus UWIT-Y0001 is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

Device Description

The WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 consists of a Wireless Transmitter UWIT-Y0001-TX, a Wireless Receiver UWIT-Y0001-RX and accessories. The UWIT-Y0001-TX transmits endoscopic image over radio frequency signal and the UWIT-Y0001-RX receives it. The endoscopic image signal output by the Video System Center is sent to the UWIT-Y0001-TX. Then, the UWIT-Y0001-TX converts the endoscopic image signal to the radio frequency signal and transmits it to the UWIT-Y0001-RX. The UWIT-Y0001-RX converts the radio frequency signal received from the UWIT-Y0001-TX to endoscopic image signal and sends it to the video monitor

AI/ML Overview

This 510(k) summary (K120278) describes a Wireless Image Transmitter Unit (UWIT-Y0001) that is substantially equivalent to a predicate device. The document focuses on demonstrating safety and performance rather than diagnostic accuracy or comparative effectiveness with human readers. Therefore, several of the requested categories are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety Standards
IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995	Compliant
IEC 60601-1-1: 2000	Compliant
IEC 60601-1-2: 2007	Compliant
Risk Analysis
ISO 14971: 2007 established in-house acceptance criteria	Risk analysis carried out, design verification tests and acceptance criteria identified and performed.
Software Validation
FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"	Validation activities performed; software considered "Minor Level of Concern."
Radio Frequency Compliance
FCC 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators	Evaluated to verify compliance.
Intended Functionality
Transmit HD video signals in expected use environment without interfering with other devices.	Evaluation testing demonstrated the device can perform as intended.
Mechanical and Functional Performance	Verified

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

The document describes non-clinical testing and verification activities. These types of tests are typically performed on the device itself (hardware and software) and do not involve a "test set" of patient data in the way an AI diagnostic algorithm would. Therefore, this information is Not Applicable (N/A) in this context. The study did not involve patient data for testing.

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)

This is Not Applicable (N/A). The device is a video transmitter, not a diagnostic tool requiring expert interpretation of medical images or data. Ground truth in this context refers to the successful transmission of video signals, meeting safety standards, and functional specifications, which are confirmed through engineering and compliance testing.

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

This is Not Applicable (N/A). Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies involving multiple human readers disagreeing on findings. This document describes engineering and safety testing.

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

This is Not Applicable (N/A). The device is a wireless image transmitter, not an AI diagnostic tool or an assistance system for human readers. No MRMC study was performed.

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

This is Not Applicable (N/A) in the context of an AI algorithm. The device itself (the wireless image transmitter unit) was presumably tested in a standalone capacity to ensure its functional performance (transmitting video signals, compliance with standards) without human intervention in the transmission process. However, this is not equivalent to the "standalone performance of an AI algorithm."

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

The "ground truth" for this device's performance is established through adherence to recognized safety and performance standards (e.g., IEC 60601 series, ISO 14971, FCC Part 15) and successful functionality testing (e.g., transmission of HD video signals without interference). This is an engineering and compliance ground truth, not a medical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

This is Not Applicable (N/A). The device is hardware with embedded software, not a machine learning model that requires a training set of data.

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

This is Not Applicable (N/A). As there is no training set for a machine learning model, there is no ground truth to establish for it.

Summary

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K120278

510(k) SUMMARY WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001

AUG 1 0 2012

January 25, 2012

General Information 1

OLYMPUS MEDICAL SYSTEMS CORP. ■ Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, M.S., RAC ■ Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com SHIRAKAWA OLYMPUS CO., LTD. Manufacturer: .
- 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148

Device Identification ಗಿ

Device Trade Name:	WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y000
Common Name:	Wireless Image Transmitter Unit
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	II
Classification Panel:	Gastroenterology/Urology
Product Code:	GCJ

Predicate Device Information 3

ZeroWire® Duo Wireless HD Video Transfer System 용 Device Name:

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Common Name: UWB Wireless Device
Manufacturer: NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose, CA 95138 USA
K100195 동 510(k) No.

Device Description ব

5 Indications for Use

Comparison of Technological Characteristics 6

The WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 is basically identical to the predicate device in intended use, and similar in specifications.

Compared to the predicate device, the subject device has the same intended use. There are differences in radio-frequency band, number of frequency channel, and compression technology, video input selection. However, these differences are considered as minor.

7 Substantially Equivalence Discussion

The WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 has the same intended use with the predicate device. Both the subject device and predicate device are a paired transmitter and receiver intended for the wireless delivery of video signals over radio frequency during endoscopic procedures. Both systems consist of a single transmitter that is linked to single receiver. Both the predicate device and the subject device conform to the relative electrical

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safety standards, EMC standards, FCC part 15 standards and were evaluated for safe use in non-clinical setting testing. The main differences between the subject and predicate devices is the radio frequency band utilized. Therefore, the subject device is considered as substantially equivalent to the predicate device.

Summary of Non-clinical Testing 8

Evaluation testing demonstrated that the WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 can perform as intended and transmit HD video signals in expected use environment without interfering other devices.

Basic safety and performance testing was performed in accordance with IEC 60601-1, IEC 60601-1-1. and IEC 60601-1-2. In addition, verification was conducted to evaluate the mechanical and functional performance.

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

As the UWIT-Y0001 is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators, it has been evaluated to verify compliance with this regulation.

The following standards have been applied to the WRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 :

· IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995
· IEC 60601-1-1: 2000
· IEC 60601-1-2: 2007
· ISO 14971: 2007

Conclusion ರು

When compared to the predicate device, the WiRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 does not incorporate any significant changes in intended use, method of operation, or design that could affect the safety or effectiveness of the device. Therefore the WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 is substantially equivalent to the identified predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a thick, black line.

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

AUG 1 0 2012

Olympus Medical Systems Corporation % Olympus America Incorporation Ms. Sheri Musgnung 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

Re: K120278

Trade/Device Name: WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 25, 2012 Received: July 26, 2012

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

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Page 2 - Ms. Sheri Musgnung

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Device Name: WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 Indications For Use:

Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K120278

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.