(144 days)
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.
Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and EndoVue devices.
The provided text describes the ZeroWire Duo Wireless HD Video Transfer System G2 (or ZeroWire G2), a device intended for wireless transmission of video signals during endoscopic and general surgical procedures.
Here's an analysis of the acceptance criteria and the study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance results in numerical form (e.g., latency threshold vs. measured latency). Instead, it states that the device "meets and exceeds" certain standards and has undergone "design validation and clinical study to further demonstrate its safety and effectiveness."
| Acceptance Criteria / Standard Met | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Meets and exceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. |
| Robust Wireless Video Link | Utilizes directional antenna and beam forming in the 60 GHz frequency spectrum to minimize interference. Provides highest quality of service. |
| Clinical Efficiency and Safety | Enhances clinical efficiency and safety in the OR by eliminating the need for a video cable. |
| Installation | Proprietary memory-enabled pairing system makes installation quick and easy. |
| Equivalence to Predicate Device | Demonstrates performance, safety, and effectiveness equivalent to predicate device K112621 model WIS1000, based on validations from both design and clinical findings. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "test results in clinical environment" but does not specify a sample size for this test set.
The data provenance is presented as "clinical environment," implying prospective testing. However, details about the country of origin are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The nature of the device (wireless video transfer) suggests that "ground truth" might relate more to technical performance (e.g., signal quality, latency) rather than image-based diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As noted above, the assessment likely focuses on technical performance metrics rather than interpretative agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study is mentioned. The device is a technology for video transfer, not an AI diagnostic tool requiring human-in-the-loop performance evaluation in the typical sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document mentions "design validation and clinical study" and "test results in clinical environment." This implies standalone testing of the device's technical performance characteristics. The device itself (a wireless video transfer system) inherently operates "standalone" in its primary function of transmitting video. The "clinical study" likely evaluated its performance in a clinical setting independent of human interpretation improvements.
7. The Type of Ground Truth Used
The "ground truth" for this device likely refers to objective technical specifications and performance metrics related to video transmission, such as:
- Video quality: Resolution, color accuracy, absence of artifacts.
- Latency: Delay in video transmission.
- Signal integrity and robustness: Ability to maintain a stable connection and quality in varying environments, including the presence of interference.
- Compliance with electrical and electromagnetic compatibility (EMC) standards: As indicated by meeting IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15.
The document implicitly suggests that these technical characteristics were measured and compared to the predicate device and relevant standards.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. Since this device is a wireless video transfer system and not an AI algorithm, a training set in that context is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" for an AI model is not applicable to this device, this question is also not relevant to the information provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NDS Surgical Imaging, LLC Mr. Jim Leng Regulatory Engineer 5750 Hellyer Avenue San Jose, California 95138
November 6, 2015
Re: K151609 Trade/Device Name: ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 26, 2015 Received: October 28, 2015
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 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice
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requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Joshua C. Nipper -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151609
Device Name
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
Indications for Use (Describe)
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.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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Type of Use (Select one or both, as applicable)
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Image /page/3/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of blue squares on the left, followed by the letters "NDS" in large, blue font. Below the letters, the words "SURGICAL・IMAGING" are written in a smaller, gray font.
510(K) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
|---|---|
| B. Submitted By: | Jim LengRegulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
| C. Date of Preparation: | Updated October 22, 2015 |
| D. Contact Information: | Tel: 408-776-0085Fax: 408-776-9878 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Device |
| G. Proprietary Name: | ZeroWire G2 Duo Wireless HD Video Transfer System orZeroWire G2 |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device K112621 model WIS1000 |
| K. Device Description: | Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4;x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wirelessdevice is designed as a wireless transmitter and receiverpair which allows delivery of a video signal over a radiofrequency link to video destination such as Radiance andEndoVue devices. |
| L. Indications for Use: | The NDS ZeroWire G2 is a paired wireless videocommunication transmitter and receiver, intended fordelivery of video signals from a source such as anendoscopy camera/processor, or other video source over a |
Image /page/3/Picture/5 description: The image contains two logos. The first logo is for Radiance, which includes a blue horizontal line, a circular symbol with an arrow, and the word "RADIANCE" in black, with the letters "HD" in blue above it. The second logo is for Dome, with the word "DOME" in black and a blue square above it.
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Image /page/4/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo features a grid of blue squares on the left, followed by the letters "NDS" in large, bold blue font. Below the letters, the words "SURGICAL - IMAGING" are written in a smaller, gray font.
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.
| M. Technological Characteristics: | ZeroWire G2 devices are the most advance medical gradewireless video transfer solution for minimally invasivesurgery and interventional procedures. By utilizingdirectional antenna and beam forming in the 60 GHz+frequency spectrum, ZeroWire G2 provides a robustwireless video link minimize the interference from otherdevices. It enhances clinical efficiency and safety in the OFby eliminating the need for a video cable. The proprietarymemory-enabled pairing system makes installation quickand easy. ZeroWire G2 technology provides the highestquality of service and is specifically designed for the videotransmission challenges of the surgical environment. |
|---|---|
| N. Performance: | Based upon our testing, the ZeroWire G2 meets andexceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC60601-1-2 and FCC part 15 which establish its safe designand operation. The device had gone through its designvalidation and clinical study to further demonstrate itssafety and effectiveness. |
| O. Clinical Information: | Clinical data is not needed for this type of wireless deviceby 510(k) submission guidance document. However, thissubmission provides test results in clinical environment todemonstrate the device is substantial equivalent to thepredicate device |
| P. Conclusion: | Based upon validations results from both design andclinical, ZeroWire G2 device demonstrates performance,safety, and effectiveness that are equivalent to the predicatedevice – Predicate device K112621 model WIS1000. |
Image /page/4/Picture/5 description: The image contains two logos. The first logo is for "RADIANCE" with the letters in bold, black font and a light blue underline. The second logo is a blue square with the letters "DOL" in bold, white font.
§ 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.