RADIANCE ULTRA 32 4K ZEROWIRE DUO

K222890 · Nds Surgical Imaging, LLC · GCJ · Oct 19, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222890
• Device Name: RADIANCE ULTRA 32 4K ZEROWIRE DUO
• Applicant: Nds Surgical Imaging, LLC
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 19, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for patients undergoing endoscopic and general surgical procedures requiring visualization via wireless video transmission. Intended for use in medical facilities by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• ZeroWire G2 (K151609)
• Radiance Ultra series ZeroWire Embedded (K161228)

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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <table><tr><td><span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <table><tr><td> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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, which is a Novanta Company. The logo consists of a grid of blue squares on the left, followed by the letters "NDS" in a bold, blue font. Below the letters, the words "A Novanta Company" are written in a smaller, gray font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

# 510(K) SUMMARY

| A. Manufacturer: | NDS Surgical Imaging, LLC<br>100 Paramount Drive, Suite 101<br>Sarasota, Florida 34232<br>USA |
|-----------------------------|-----------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng<br>Sr. Regulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC<br>100 Paramount Drive, Suite 101<br>Sarasota, Florida 34232, USA |
| C. Date of Preparation: | October 19, 2022 |
| D. Contact Information: | Tel: [phone] |
| 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<br>ZeroWire Embedded and, |

Predicate device K151609 model ZeroWire G2

| | Zero Wire G2 | Radiance Ultra 27" ZeroWire<br>Embedded | Changes : Radiance Ultra 32"<br>4K ZeroWire Duo |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General: | | | |
| K Number | K151609 | K161228 | TBD |
| Product Class | Class II | Same | Same |
| Product Code | GCJ | Same | Same |
| Device Name<br>(FDA) | Laparoscope, General & Plastic<br>Surgery | Same | Same |
| Regulation<br>Description | Endoscope and accessories | Same | Same |
| Indications for<br>Use | The NDS ZeroWire G2 is a<br>paired wireless video<br>communication transmitter<br>and receiver, intended for<br>delivery of video signals from<br>a source such as an<br>endoscopy camera/processor,<br>or other video source over a<br>radio-frequency link to a<br>ZeroWire Receiver for display<br>of images during endoscopic<br>and general surgical<br>procedures. The ZeroWire G2<br>wireless video system is a<br>non-sterile reusable device<br>not intended for use in the<br>sterile field. | The Radiance Ultra series ZeroWire<br>Embedded and ZeroWire G2 is a<br>paired wireless video<br>communication transmitter<br>and receiver, intended for delivery<br>of video signals from a source such<br>as an endoscopy<br>camera/processor, or other video<br>source over a radio-frequency link<br>to a ZeroWire Receiver for display<br>of images during endoscopic and<br>general surgical<br>procedures. The Radiance Ultra<br>series ZeroWire Embedded and<br>ZeroWire G2 wireless video system<br>is a non-sterile<br>reusable device not intended for<br>use in the sterile field | The Radiance® Ultra 32" 4K<br>ZeroWire Duo is a paired<br>wireless video communication<br>transmitter and receiver, intended<br>for delivery of video signals from<br>a source such as an endoscopy<br>camera/processor, or other video<br>source over a radio-frequency<br>link to a ZeroWire Receiver for<br>display of videos during<br>endoscopic and general surgical<br>procedures. The Radiance® Ultra<br>32" 4K ZeroWire Duo is a non-<br>sterile reusable device not<br>intended for use in the sterile<br>field. |
| Where Used | Medical Facility | Same | Same |
| Compatibility with<br>environment and<br>other devices | IEC 60601-1-2 | Same | Same |
| Design<br>Specifications: | | | |
| Frequency<br>Spectrum | 59.40 to 63.56 GHz | Same | Same |
| Time Frequency<br>Coding | No | Same | Same |
| Antenna beam<br>forming | Yes | Same | Same |
| Number of<br>Channels | 6 | Same | Same |
| RF Power out<br>(Max) | 28 dBmi | Same | Same |
| Tx/Rx range | ≤ 30ft (9.1m) | Same | Same |
| RF Bandwidth | 1.76 GHz per channel (HRP<br>Bandwidth), 92 MHz per channel<br>(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-<br>SDI | Same |
| Tx/Rx pairing | single Tx-Rx pair | Same | Same |
| Tx/Rx pairing<br>memory | Pairing is lost when power is<br>removed | Same | Will retain pair information |
| Weight, Tx/Rx<br>pair | 500g | 8.9 kg (19.5 lbs) | 14.5 Kg (32.0 lbs.) |
| Operating<br>Temperature | 32 - 104°F (0-40°C) | Same | Same |
| Storage<br>Temperature | -4 - 140°F (-20 - 60°C) | -20 to 50°C | Same |
| Relative Humidity<br>(non-condensing) | < 70% RH(Non-condensed) | 5 to 85% | 10 to 90% |
| Display Size | N/A | 27" | 32" |
| Maximum<br>Luminance1<br>(cd/m2, typical) | N/A | 900 | 700 |
| Native Resolution | N/A | 1920 x 1080 | 3840 x 2160 |
| Contrast Ratio<br>(nominal) | N/A | 1000:1 | 1350:1 |
| Dot Pitch (mm) | N/A | 0.311 | 0.1845 |
| Vertical and<br>Horizontal<br>Viewing Angle | N/A | 178° | same |
| Advance<br>Encryption<br>Standard for data<br>communication<br>security | 256-bit AES Encryption | Same | Same |
| Input Signals | DVI-D, SDI | DVI-D, HD15,<br>RGB/Component, Y/C,<br>Composite<br>SDI 4:2:2 (optional)<br>HD/D1-SDI (optional)<br>NTSC/PAL :Y/C,<br>Composite (optional)<br>Analog Component<br>(optional)<br>3G/HD/SD-SDI<br>(optional)<br>DVI-D (optional) | 12G-SDI<br>DVI-D<br>DisplayPort<br>DisplayPort Tx<br>HDMI<br>USB Mini B<br>USB Micro AB |
| Output Signals | DVI | Composite output<br>connector<br>Y/C output connector<br>RGB/component output<br>connectors<br>External synchronized<br>output connector | 12G-SDI<br>DVI-D |
| Sterility and<br>Safety: | | | |
| Sterility | Non-sterile | Same | Same |
| Mechanical<br>Safety | N/A | Same | Same |
| Chemical Safety | N/A | Same | Same |
| Electrical Safety | IEC 60601-1 | Same…