(26 days)
Not Found
No
The summary describes a wireless video transmission and display system, with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a display system for video signals from surgical procedures, not an instrument that directly treats a condition or restores function.
No
The device is described as a wireless video communication transmitter and receiver for displaying video signals, such as those from endoscopy cameras, during surgical procedures. Its purpose is to transmit and receive video for display, not to interpret or analyze the video to diagnose a condition.
No
The device description explicitly states it is a "medical LCD display" and a "paired wireless video communication transmitter and receiver," indicating it is a hardware device with wireless transmission capabilities, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Radiance Ultra 32" 4K ZeroWire Duo is described as a wireless video communication system and a medical LCD display. Its purpose is to transmit and display video signals from sources like endoscopy cameras during surgical procedures.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. It simply transmits and displays video feeds.
Therefore, its function falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
GCJ
Device Description
Radiance Ultra 32" 4K ZeroWire Duo is a medical LCD display designed to both wirelessly receive or transmit video signal with up to 4K resolution over a radio frequency link to a partner display.
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
Medical Facility / Not Found
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 32" 4K ZeroWire Duo display meets and exceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. The display has successfully passed design validation to further demonstrate its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
1
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
2
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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3
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
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) |