← Product Code [GCJ](/productcode/GCJ) · K222890
# RADIANCE ULTRA 32 4K ZEROWIRE DUO (K222890)
_Nds Surgical Imaging, LLC · GCJ · Oct 19, 2022 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K222890
## Device Facts
- **Applicant:** Nds Surgical Imaging, LLC
- **Product Code:** [GCJ](/productcode/GCJ.md)
- **Decision Date:** Oct 19, 2022
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
## Indications for Use
The Radiance Ultra 32" 4K ZeroWire Duo 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 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.
## Device Story
Radiance Ultra 32" 4K ZeroWire Duo is a paired wireless video transmitter and receiver system; transmits video signals from sources like endoscopy cameras/processors to a display. Operates in 60 GHz spectrum using directional antenna beamforming to establish robust RF link; supports 4K resolution (3840x2160 @ 60 Hz). Used in medical facilities/ORs by surgical staff to eliminate video cables; enhances OR safety. Features memory-enabled pairing to retain connection settings after power cycles. Healthcare providers use the display for real-time visualization during minimally invasive surgery; facilitates clinical decision-making by providing high-quality surgical imagery. Benefits include reduced cable clutter and improved OR workflow efficiency.
## Clinical Evidence
Bench testing only. Design verification and validation confirmed performance, safety, and effectiveness equivalent to predicates. Compliance with IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, and FCC Part 15 demonstrated.
## Technological Characteristics
Medical-grade LCD display; 32" form factor; 3840x2160 resolution. 60 GHz RF transmission; directional antenna beamforming; 256-bit AES encryption. Inputs: 12G-SDI, DVI-D, DisplayPort, HDMI, USB. Outputs: 12G-SDI, DVI-D. Non-sterile; reusable. Standards: IEC 60601-1, IEC 60601-1-2, FCC CFR 47 Part 15.
## Regulatory 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.
## Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
## Predicate Devices
- ZeroWire G2 ([K151609](/device/K151609.md))
- Radiance Ultra series ZeroWire Embedded ([K161228](/device/K161228.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2022
NDS Surgical Imaging, LLC. Jim Leng Sr. Regulatory Engineer 100 Paramount Drive, Suite 101 Sarasota, Florida 34232
Re: K222890
Trade/Device Name: Radiance Ultra 32" 4k Zerowire Duo Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 16, 2022 Received: September 23, 2022
Dear Jim 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K22890
Device Name RADIANCE ULTRA 32" 4K ZEROWIRE DUO
Indications for Use (Describe)
The Radiance Ultra 32" 4K ZeroWire Duo 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 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
|
X Prescription Use (Part 21 CFR 801 Subpart D)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| Over-The-Counter Use (21 CFR 801 Subpart C) |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
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# 510(K) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC 100 Paramount Drive, Suite 101 Sarasota, Florida 34232 USA |
|-----------------------------|-----------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng Sr. Regulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC 100 Paramount Drive, Suite 101 Sarasota, Florida 34232, USA |
| C. Date of Preparation: | October 19, 2022 |
| D. Contact Information: | Tel: 408-310-0832 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Displays |
| G. Proprietary Name: | RADIANCE ULTRA 32" 4K ZEROWIRE DUO |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device K161228 model Radiance Ultra series ZeroWire Embedded and, |
Predicate device K151609 model ZeroWire G2
| | Zero Wire G2 | Radiance Ultra 27" ZeroWire Embedded | Changes : Radiance Ultra 32" 4K ZeroWire Duo |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General: | | | |
| K Number | K151609 | K161228 | TBD |
| Product Class | Class II | Same | Same |
| Product Code | GCJ | Same | Same |
| Device Name (FDA) | Laparoscope, General & Plastic Surgery | Same | Same |
| Regulation Description | Endoscope and accessories | Same | Same |
| Indications for Use | The NDS 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 radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field. | 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 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 | The Radiance® Ultra 32" 4K ZeroWire Duo 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 radio-frequency link to a ZeroWire Receiver for display of videos during endoscopic and general surgical procedures. The Radiance® Ultra 32" 4K ZeroWire Duo is a non- sterile reusable device not intended for use in the sterile field. |
| Where Used | Medical Facility | Same | Same |
| Compatibility with environment and other devices | IEC 60601-1-2 | Same | Same |
| Design Specifications: | | | |
| Frequency Spectrum | 59.40 to 63.56 GHz | Same | Same |
| Time Frequency Coding | No | Same | Same |
| Antenna beam forming | Yes | Same | Same |
| Number of Channels | 6 | Same | Same |
| RF Power out (Max) | 28 dBmi | Same | Same |
| Tx/Rx range | ≤ 30ft (9.1m) | Same | Same |
| RF Bandwidth | 1.76 GHz per channel (HRP Bandwidth), 92 MHz per channel (LRP Bandwidth) | Same | Same |
| | (LRP Bandwidth) | Same | Same |
| Video Formats | up to 1920 x 1080 @ 60 Hz | Same | up to 3840x2160 @60 Hz |
| System Latency | less than 1 frame | Same | Same |
| Video Input | DVI +3G-SDI | Multiple outputs include DVI +3G- SDI | Same |
| Tx/Rx pairing | single Tx-Rx pair | Same | Same |
| Tx/Rx pairing memory | Pairing is lost when power is removed | Same | Will retain pair information |
| Weight, Tx/Rx pair | 500g | 8.9 kg (19.5 lbs) | 14.5 Kg (32.0 lbs.) |
| Operating Temperature | 32 - 104°F (0-40°C) | Same | Same |
| Storage Temperature | -4 - 140°F (-20 - 60°C) | -20 to 50°C | Same |
| Relative Humidity (non-condensing) | < 70% RH(Non-condensed) | 5 to 85% | 10 to 90% |
| Display Size | N/A | 27" | 32" |
| Maximum Luminance1 (cd/m2, typical) | N/A | 900 | 700 |
| Native Resolution | N/A | 1920 x 1080 | 3840 x 2160 |
| Contrast Ratio (nominal) | N/A | 1000:1 | 1350:1 |
| Dot Pitch (mm) | N/A | 0.311 | 0.1845 |
| Vertical and Horizontal Viewing Angle | N/A | 178° | same |
| Advance Encryption Standard for data communication security | 256-bit AES Encryption | Same | Same |
| Input Signals | DVI-D, SDI | DVI-D, HD15, RGB/Component, Y/C, Composite SDI 4:2:2 (optional) HD/D1-SDI (optional) NTSC/PAL :Y/C, Composite (optional) Analog Component (optional) 3G/HD/SD-SDI (optional) DVI-D (optional) | 12G-SDI DVI-D DisplayPort DisplayPort Tx HDMI USB Mini B USB Micro AB |
| Output Signals | DVI | Composite output connector Y/C output connector RGB/component output connectors External synchronized output connector | 12G-SDI DVI-D |
| Sterility and Safety: | | | |
| Sterility | Non-sterile | Same | Same |
| Mechanical Safety | N/A | Same | Same |
| Chemical Safety | N/A | Same | Same |
| Electrical Safety | IEC 60601-1 | Same…
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**Source:** [https://fda-staging.innolitics.com/device/K222890](https://fda-staging.innolitics.com/device/K222890)
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