(144 days)
Not Found
No
The summary describes a wireless video transmission system and does not mention any AI/ML capabilities or image processing that would typically involve such technology.
No
The device is a wireless video communication system designed to transmit video signals during surgical procedures; it does not directly treat or diagnose a medical condition.
No
The device is described as a wireless video communication transmitter and receiver intended for the delivery of video signals from a source (like an endoscopy camera/processor) to a display. Its function is to transmit video signals, not to interpret or analyze them for a diagnosis.
No
The device description explicitly states it is a "wireless transmitter and receiver pair" and a "wireless video system," indicating it is a hardware device that transmits and receives video signals.
Based on the provided information, the NDS ZeroWire G2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "delivery of video signals" from a source like an endoscopy camera/processor for "display of images during endoscopic and general surgical procedures." This describes a device used during a medical procedure to transmit visual information, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its function as a "wireless transmitter and receiver pair which allows delivery of a video signal."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other activities typically associated with IVD devices.
Therefore, the NDS ZeroWire G2 is a medical device used for video transmission during surgical procedures, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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 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.
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
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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 testing, the ZeroWire G2 meets and exceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15 which establish its safe design and operation. The device had gone through its design validation and clinical study to further demonstrate its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a staggered formation, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
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
1
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
2
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)
3
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, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng
Regulatory Engineer/NDS Surgical Imaging, LLC |
| B1, Address: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
| C. Date of Preparation: | Updated October 22, 2015 |
| D. Contact Information: | Tel: 408-776-0085
Fax: 408-776-9878 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Device |
| G. Proprietary Name: | ZeroWire G2 Duo Wireless HD Video Transfer System or
ZeroWire 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 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. |
| L. 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 |
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.
4
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 grade
wireless video transfer solution for minimally invasive
surgery and interventional procedures. By utilizing
directional antenna and beam forming in the 60 GHz
+frequency spectrum, ZeroWire G2 provides a robust
wireless video link minimize the interference from other
devices. It enhances clinical efficiency and safety in the OF
by eliminating the need for a video cable. The proprietary
memory-enabled pairing system makes installation quick
and easy. ZeroWire G2 technology provides the highest
quality of service and is specifically designed for the video
transmission challenges of the surgical environment. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| N. Performance: | Based upon our testing, the ZeroWire G2 meets and
exceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC
60601-1-2 and FCC part 15 which establish its safe design
and operation. The device had gone through its design
validation and clinical study to further demonstrate its
safety and effectiveness. |
| O. Clinical Information: | Clinical data is not needed for this type of wireless device
by 510(k) submission guidance document. However, this
submission provides test results in clinical environment to
demonstrate the device is substantial equivalent to the
predicate device |
| P. Conclusion: | Based upon validations results from both design and
clinical, ZeroWire G2 device demonstrates performance,
safety, and effectiveness that are equivalent to the predicate
device – 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.