(193 days)
Not Found
No
The device description focuses on the transmission and reception of video signals over a radio-frequency link, without mentioning any image analysis, processing, or decision-making capabilities that would typically involve AI/ML. The performance studies also focus on signal transmission, safety, and regulatory compliance, not on algorithmic performance metrics.
No
The device is described as a transmitter and receiver for video signals during surgical procedures; it does not directly treat or diagnose a medical condition.
No
The device's intended use is to transmit video signals for display, not to perform analysis or interpretation for diagnostic purposes. It serves as a communication tool for visual information, not a diagnostic one.
No
The device description explicitly states it consists of a Wireless Transmitter and a Wireless Receiver, which are hardware components. The performance studies also mention testing related to mechanical and functional performance, as well as compliance with hardware-related standards (IEC 60601 series, FCC regulations). While software validation was performed, the device is clearly not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures." This describes a function related to transmitting visual information during a medical procedure, not analyzing biological samples in vitro (outside the body).
- Device Description: The description details how the device transmits and receives endoscopic image signals. This aligns with its role in displaying live video during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, urine, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to the transmission of visual data during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
1
- 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
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
5 Indications for Use
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.
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
2
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.
3
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
4
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
5
Indications for Use
510(k) Number (if known): Device Name: WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 Indications For Use:
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.
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 |