(26 days)
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.
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.
This document describes acceptance criteria and performance data for the Radiance Ultra 32" 4K ZeroWire Duo, a wireless video communication transmitter and receiver intended for displaying images during endoscopic and general surgical procedures.
Important Note: The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to predicate devices. As such, it often refers to "design verification" and "design validation" studies without providing detailed methodologies or specific performance metrics from those studies. Therefore, some requested information may not be explicitly available in the given text, and conclusions will be drawn based on the information provided.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative format with corresponding "reported device performance" in the way one might see for an AI algorithm's diagnostic accuracy. Instead, it compares the technical specifications and standards compliance of the proposed device against its predicate devices. The "performance" in this context refers to meeting these specifications and standards.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (Radiance Ultra 32" 4K ZeroWire Duo) |
|---|---|
| General Characteristics: | |
| Product Class | Class II |
| Product Code | GCJ |
| Regulation Description | Endoscope and accessories |
| Indications for Use | Paired wireless video communication transmitter and receiver for delivery of video signals from a source (e.g., endoscopy camera/processor) to a ZeroWire Receiver for display during endoscopic and general surgical procedures. Non-sterile, reusable device, not for sterile field. |
| Where Used | Medical Facility |
| Compatibility with environment and other devices | Compliant with IEC 60601-1-2 |
| Design Specifications: | |
| Frequency Spectrum | 59.40 to 63.56 GHz |
| Time Frequency Coding | No |
| Antenna beam forming | Yes |
| Number of Channels | 6 |
| RF Power out (Max) | 28 dBmi |
| Tx/Rx range | ≤ 30ft (9.1m) |
| RF Bandwidth | 1.76 GHz per channel (HRP Bandwidth), 92 MHz per channel (LRP Bandwidth) |
| Video Formats | up to 3840x2160 @60 Hz (improvement over predicates) |
| System Latency | less than 1 frame |
| Video Input | 12G-SDI, DVI-D, DisplayPort, DisplayPort Tx, HDMI, USB Mini B, USB Micro AB (more comprehensive than predicates) |
| Tx/Rx pairing | single Tx-Rx pair |
| Tx/Rx pairing memory | Will retain pair information (improvement over predicate's "Pairing is lost when power is removed") |
| Weight, Tx/Rx pair | 14.5 Kg (32.0 lbs.) |
| Operating Temperature | 32 - 104°F (0-40°C) |
| Storage Temperature | -20 to 50°C |
| Relative Humidity (non-condensing) | 10 to 90% (wider range than one predicate, similar to another) |
| Display Size | 32" (larger than predicate) |
| Maximum Luminance1 (cd/m2, typical) | 700 (lower than one predicate, but for 4K display size) |
| Native Resolution | 3840 x 2160 (higher than predicate) |
| Contrast Ratio (nominal) | 1350:1 (higher than predicate) |
| Dot Pitch (mm) | 0.1845 (smaller than predicate) |
| Vertical and Horizontal Viewing Angle | 178° |
| Advance Encryption Standard for data communication security | 256-bit AES Encryption |
| Output Signals | 12G-SDI, DVI-D (more comprehensive than one predicate) |
| Sterility and Safety: | |
| Sterility | Non-sterile |
| Mechanical Safety | Implied by compliance with IEC 60601-1 |
| Chemical Safety | Implied by compliance with IEC 60601-1 |
| Electrical Safety | Compliant with IEC 60601-1 |
| Radiation Safety | Implied by compliance with FCC Part 15 |
| Standards Compliance: | |
| Safety | Compliant with IEC/EN 60601-1, ANSI/AAMI ES60601-1 |
| EMC | Compliant with IEC/EN 60601-1-2; FCC CFR 47 Part 15 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data or images. This device is a display/wireless transmission system, not a diagnostic AI device that processes patient data. The "design validation" mentioned in section N and O would refer to testing the hardware and software functionality against engineering specifications and relevant medical device standards, rather than a clinical study with patients or patient data. Therefore, information on data provenance or sample size for a test set of clinical cases is not applicable/provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as a test set for clinical ground truth is not detailed for this type of device. The "ground truth" for this device would relate to engineering specifications and performance standards (e.g., video resolution accuracy, signal latency, wireless range), which are evaluated through technical testing by qualified engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical display and wireless video transmission system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers assisting with AI is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is hardware, not an algorithm. The "standalone" performance would be about its technical capabilities (e.g., video transmission quality, latency, resolution) which are assessed through engineering tests. The document states in section N and O: "The display has successfully passed design validation to further demonstrate its safety and effectiveness" and "Based upon results from the design verification, Radiance Ultra 32" 4K ZeroWire Duo display demonstrates performance, safety, and effectiveness that are equivalent to the predicate devices." This implies various engineering and performance tests were conducted to verify its operation according to specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by industrial standards (e.g., IEC 60601 series, FCC Part 15), engineering specifications, and validated test methodologies. For example, video resolution is objectively measured against a known signal, latency is measured using precise timing equipment, and electromagnetic compatibility is tested according to regulatory standards to ensure it doesn't interfere with other devices and operates safely in its intended environment.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable for the same reason mentioned above.
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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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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, LLC100 Paramount Drive, Suite 101Sarasota, Florida 34232USA |
|---|---|
| B. Submitted By: | Jim LengSr. Regulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC100 Paramount Drive, Suite 101Sarasota, 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 seriesZeroWire Embedded and, |
Predicate device K151609 model ZeroWire G2
| Zero Wire G2 | Radiance Ultra 27" ZeroWireEmbedded | 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 & PlasticSurgery | Same | Same |
| RegulationDescription | Endoscope and accessories | Same | Same |
| Indications forUse | The NDS ZeroWire G2 is apaired wireless videocommunication transmitterand receiver, intended fordelivery of video signals froma source such as anendoscopy camera/processor,or other video source over aradio-frequency link to aZeroWire Receiver for displayof images during endoscopicand general surgicalprocedures. The ZeroWire G2wireless video system is anon-sterile reusable devicenot intended for use in thesterile field. | The Radiance Ultra series ZeroWireEmbedded and ZeroWire G2 is apaired wireless videocommunication transmitterand receiver, intended for deliveryof video signals from a source suchas an endoscopycamera/processor, or other videosource over a radio-frequency linkto a ZeroWire Receiver for displayof images during endoscopic andgeneral surgicalprocedures. The Radiance Ultraseries ZeroWire Embedded andZeroWire G2 wireless video systemis a non-sterilereusable device not intended foruse in the sterile field | The Radiance® Ultra 32" 4KZeroWire Duo is a pairedwireless video communicationtransmitter and receiver, intendedfor delivery of video signals froma source such as an endoscopycamera/processor, or other videosource over a radio-frequencylink to a ZeroWire Receiver fordisplay of videos duringendoscopic and general surgicalprocedures. The Radiance® Ultra32" 4K ZeroWire Duo is a non-sterile reusable device notintended for use in the sterilefield. |
| Where Used | Medical Facility | Same | Same |
| Compatibility withenvironment andother devices | IEC 60601-1-2 | Same | Same |
| DesignSpecifications: | |||
| FrequencySpectrum | 59.40 to 63.56 GHz | Same | Same |
| Time FrequencyCoding | No | Same | Same |
| Antenna beamforming | Yes | Same | Same |
| Number ofChannels | 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 (HRPBandwidth), 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 pairingmemory | Pairing is lost when power isremoved | Same | Will retain pair information |
| Weight, Tx/Rxpair | 500g | 8.9 kg (19.5 lbs) | 14.5 Kg (32.0 lbs.) |
| OperatingTemperature | 32 - 104°F (0-40°C) | Same | Same |
| StorageTemperature | -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" |
| MaximumLuminance1(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 andHorizontalViewing Angle | N/A | 178° | same |
| AdvanceEncryptionStandard for datacommunicationsecurity | 256-bit AES Encryption | Same | Same |
| Input Signals | DVI-D, SDI | DVI-D, HD15,RGB/Component, Y/C,CompositeSDI 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-SDIDVI-DDisplayPortDisplayPort TxHDMIUSB Mini BUSB Micro AB |
| Output Signals | DVI | Composite outputconnectorY/C output connectorRGB/component outputconnectorsExternal synchronizedoutput connector | 12G-SDIDVI-D |
| Sterility andSafety: | |||
| Sterility | Non-sterile | Same | Same |
| MechanicalSafety | N/A | Same | Same |
| Chemical Safety | N/A | Same | Same |
| Electrical Safety | IEC 60601-1 | Same | Same |
| Radiation Safety | N/A | Same | Same |
| Standards: | |||
| Safety | IEC/EN 60601-1 | Same | Same |
| EMC | IEC/EN 60601-1-2; FCC CFR 47 Part 15 | Same | Same |
Legal entity: NDS Surgical Imaging, LLC.
NDS, a Novanta Company
- 100 Paramount Drive, Suite 101, Sarasota, FL 34232, USA T +1 (888) 982-4469. W ndssi.com
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Image /page/4/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 large, bold, blue font. Below the letters NDS is the text "A Novanta Company" in a smaller font size.
Legal entity: NDS Surgical Imaging, LLC.
NDS, a Novanta Company
100 Paramount Drive, Suite 101, Sarasota, FL 34232, USA
T +1 (888) 982-4469. W ndssi.com
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for NDS, which is a Novanta Company. The logo consists of a blue square pattern on the left, followed by the letters "NDS" in a bold, blue font. Below the letters, the text "A Novanta Company" is written in a smaller, gray font. The logo is simple and modern, with a focus on the company's name and affiliation.
Legal entity: NDS Surgical Imaging, LLC.
NDS, a Novanta Company
100 Paramount Drive, Suite 101, Sarasota, FL 34232, USA T +1 (888) 982-4469. W ndssi.com
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Image /page/6/Picture/0 description: The image shows the logo for NDS, which is a Novanta Company. The logo consists of a blue square pattern on the left, followed by the letters "NDS" in a bold, blue font. Below the letters, the text "A Novanta Company" is written in a smaller, gray font. The logo is simple and professional, and it effectively communicates the company's name and affiliation.
| K. Device Description: | Radiance Ultra 32" 4K ZeroWire Duo is a medical LCDdisplay designed to both wirelessly receive or transmitvideo signal with up to 4K resolution over a radiofrequency link to a partner display. |
|---|---|
| L. Indications for Use: | The Radiance® Ultra 32" 4K ZeroWire Duo is a pairedwireless video communication transmitter and receiver,intended for delivery of video signals from a source such asan endoscopy camera/processor, or other video source overa radio-frequency link to a ZeroWire Receiver for displayof images during endoscopic and general surgicalprocedures. The Radiance® Ultra 32" 4K ZeroWire Duo isa non-sterile reusable device not intended for use in thesterile field. |
| M. Technological Characteristics: | Radiance Ultra 32" 4K ZeroWire Duo is the most advancedmedical-grade wireless video transfer solution forminimally invasive surgery and interventional procedures.By utilizing a directional antenna and beam forming in the60 GHz frequency spectrum, the displays provide a robustdirected wireless video link to minimize interference withother devices. Radiance Ultra 32" 4K ZeroWire Duoenhances safety in the OR by eliminating the need for avideo cable. The proprietary memory-enabled pairingsystem in a LCD display makes installation quick and easy.Radiance Ultra 32" 4K ZeroWire Duo display technologyprovides the highest quality of service and is specificallydesigned for the video transmission challenges of thesurgical environment. |
| N. Performance: | Based upon our design, the Radiance Ultra 32" 4KZeroWire Duo display meets and exceeds IEC 60601-1,ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. |
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Image /page/7/Picture/0 description: The image shows the logo for NDS, which is a Novanta Company. The logo consists of a blue square grid on the left, followed by the letters "NDS" in large, bold, blue font. Below the letters, in a smaller, gray font, is the text "A Novanta Company."
The display has successfully passed design validation to further demonstrate its safety and effectiveness.
O. Conclusion:
Based upon results from the design verification, Radiance Ultra 32" 4K ZeroWire Duo display demonstrates performance, safety, and effectiveness that are equivalent to the predicate devices – predicate device K151609 model ZeroWire G2 and Predicate device K161228 The Radiance Ultra series ZeroWire Embedded in its system operation.
§ 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.