(24 days)
Not Found
No
The device description focuses on wireless video transmission and reception, with no mention of AI or ML for image analysis, processing, or any other function.
No
This device is a wireless video communication transmitter and receiver used to display images during endoscopic and general surgical procedures, not to treat a disease or condition.
No
The device is described as a "paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source" for "display of images." Its function is to transmit and receive video signals, not to interpret, analyze, or provide any diagnostic information itself.
No
The device description explicitly details hardware components: a paired wireless video communication transmitter and receiver, monitors with integrated wireless video receiver modules, an external transmitter unit, and power converters. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of video signals during endoscopic and general surgical procedures for display of images. This is related to visualizing internal structures during a medical procedure, not analyzing biological samples outside the body.
- Device Description: The device is described as a wireless video communication transmitter and receiver, and integrated wireless video receiver module. Its function is to transmit and receive video signals.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely related to the transmission and display of video during a medical procedure.
N/A
Intended Use / Indications for Use
The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Radiance Ultra series ZeroWire Embedded monitors are designed with an integrated wireless video receiver module (Rx), enabling the reception of a video signal over a radio frequency link instead of a video cable. These monitors are designed for use in non-sterile healthcare environments. The Radiance Ultra series ZeroWire Embedded is a medical grade wireless video streaming device pair. The external transmitter (Tx) unit is designed to be mounted on a primary display, on an endoscopic cart, or any other elevated location in close vicinity to the video source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.
Radiance Ultra series ZeroWire Embedded Models
Radiance Ultra 24 ZeroWire Embedded
Radiance Ultra 27 ZeroWire Embedded
Radiance Ultra 32 ZeroWire Embedded
Radiance Ultra 55 ZeroWire Embedded
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
Non-sterile healthcare environments.
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)
Based upon our design, the Radiance Ultra series' ZeroWire Embedded displays meet and exceed IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. The displays have successfully passed design validation to further demonstrate their safety and effectiveness.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
NDS Surgical Imaging, LLC. Mr. Jim Leng Regulatory Engineer 5750 Hellyer Ave San Jose, California 95138
Re: K161228
Trade/Device Name: Radiance Ultra Series Zerowire Embedded Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 14, 2016 Received: May 2, 2016
Dear Mr. Leng:
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 of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,
Jennifer R. Stevenson -A
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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Indications for Use
510(k) Number (if known) K161228
Device Name Radiance Ultra Series ZeroWire Embedded
Indications for Use (Describe)
The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters "NDS" in blue. The letters are in a bold, sans-serif font and have a slight gradient effect. The grid of squares is arranged in a perspective view, with the squares appearing smaller as they recede into the distance.
510(K) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng
Regulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
| C. Date of Preparation: | May 24, 2016 |
| D. Contact Information: | Tel: 408-776-0085
Fax: 408-776-9878 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Displays |
| G. Proprietary Name: | Radiance Ultra series ZeroWire Embedded |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device K151609 model ZeroWire G2 |
| K. Device Description: | Radiance Ultra series ZeroWire Embedded monitors are
designed with an integrated wireless video receiver
module (Rx), enabling the reception of a video signal over
a radio frequency link instead of a video cable. These
monitors are designed for use in non-sterile healthcare
environments. The Radiance Ultra series ZeroWire
Embedded is a medical grade wireless video streaming
device pair.
The external transmitter (Tx) unit is designed to be
mounted on a primary display, on an endoscopic cart, or
any other elevated location in close vicinity to the video |
4
source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.
| Radiance Ultra series ZeroWire Embedded Models |
|---|
| Radiance Ultra 24 ZeroWire Embedded |
| Radiance Ultra 27 ZeroWire Embedded |
| Radiance Ultra 32 ZeroWire Embedded |
| Radiance Ultra 55 ZeroWire Embedded |
L. Indications for Use: The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radiofrequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.
M. Technological Characteristics: Radiance Ultra series' ZeroWire Embedded are the most advanced medical grade wireless video transfer solution for minimally invasive surgery and interventional procedures. The ZeroWire product was released with the RF platform based on the Silicon Image 60 GHz 3rd generation Sil6310 / Sil6320 WirelessHD HRTX chipset and Sil6310 / Sil6321 WirelessHD HRRX chipset. By utilizing directional antenna and beam forming in the 60 GHz frequency spectrum, the pair provides a robust narrowbeamed wireless video link to minimize the interference with other devices. Inside the Rx Radiance Ultra series ZeroWire embedded, it still has the same functional partition: a Rx RF module followed by a Rx adapter providing an on-screen display engine to show video messages and RSSI strength bars as a visual interface of the wireless link status to the end user. Radiance Ultra ZeroWire Embedded enhances safety in the OR by eliminating the need for a video cable. The proprietary
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Image /page/5/Picture/0 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters NDS in blue. The letters are large and bold, and they appear to be made of metal. The logo is simple and modern, and it is likely used by a company that specializes in technology or engineering.
memory-enabled pairing mechanism makes installation quick and easy. Radiance series ZeroWire Embedded displays technology provides the highest quality of service and is specifically designed for the video transmission challenges of the surgical environment.
N. Performance: Based upon our design, the Radiance Ultra series' ZeroWire Embedded displays meet and exceed IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. The displays have successfully passed design validation to further demonstrate their safety and effectiveness.
O. Conclusion: Based upon results from the design verification, Radiance Ultra series' ZeroWire Embedded displays demonstrate performance, safety, and effectiveness that are equivalent to the predicate device – predicate device K151609 model ZeroWire G2 in its system operation.