(49 days)
Not Found
No
The document describes a wireless video transfer system and does not mention any AI or ML capabilities.
No
The device is described as a video transfer system for transmitting video signals during surgical procedures, not as a device that delivers therapy or direct medical treatment to a patient.
No
This device is a video transfer system designed to wirelessly transmit video signals during surgical procedures to a display, not to diagnose medical conditions.
No
The device description explicitly states it is a "paired transmitter and receiver," which are hardware components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures." This describes a system for transmitting visual information during a procedure, not for analyzing biological samples in vitro (outside the body).
- Device Description: The description reinforces this by explaining it's a "wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
This device is a video transmission system used in a surgical setting, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Product codes
GCJ
Device Description
Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire 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 Endo Vue devices. The device can operate on up to 9 channels.
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
qualified physicians having complete knowledge of these surgical procedures.
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)
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.
The device software (firmware) was modified to increase from 3 channels to 9 channels, and there is no hardware change. Based upon validations results from both design and clinical, ZeroWire device demonstrates performance, safety, and effectiveness that is equivalent to the predicate device - original ZeroWire submission K100195.
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
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.
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Image /page/0/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo features a pattern of squares that decrease in size from left to right. To the right of the squares are the letters "NDS" in a bold, sans-serif font, and below the letters is the text "SURGICAL - IMAGING" in a smaller font.
510(K) SUMMARY
JUN 7 2013
| 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 |
| Bl. Address: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
| C. Date of Preparation: | April 17, 2013 |
| D. Contact Information: | 408-776-0085
Tel:
Fax:
408-776-9878 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | UWB Wireless Device |
| G. Proprietary Name: | ZeroWire Duo Wireless HD Video Transfer System |
| H. Classification number: | 21 CFR 876.1500 |
| I
Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate K100195 ZeroWire Duo Wireless HD Video
Transfer System. |
| K. Device Description: | Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3;
x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire 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
Endo Vue devices. The device can operate on up to 9
channels. |
| L. Indications for Use: | The NDSsi ZeroWire Duo Wireless HD Video Transfer
System is a paired transmitter and receiver, intended for
delivery of video signals over a radio-frequency link to a
video display during endoscopic and general surgical |
.
RADIANCE DOM
1
procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
ZeroWire Duo wireless devices are an advance medical M. Technological Characteristics: grade wireless video transfer solution for minimally invasive surgery and interventional procedures. By utilizing the reserved UWB frequency spectrum, ZeroWire provides a wireless video link that is resistant to interference from other devices. It enhances clinical efficiency and safety in the OR by eliminating the need for a video cable. The proprietary memory-enabled pairing system makes installation quick and easy. ZeroWire technology provides the medical grade quality of service and is specifically designed for the video transmission challenges of the surgical environment.
Clinical data is not needed for this type of wireless device N. Clinical information: 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.
The device software (firmware) was modified to increase from 3 channels to 9 channels, and there is no hardware change. Based upon validations results from both design and clinical, ZeroWire device demonstrates performance, safety, and effectiveness that is equivalent to the predicate device - original ZeroWire submission K100195.
O. Conclusion:
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
NDS Surgical Imaging, LLC % Mr. Jim Leng Regulatory Engineer 5750 Hellver Avenue San Jose, California 95138
Re: K131115
Trade/Device Name: ZeroWire Duo Wireless HD Video Transfer System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 15, 2013 Received: May 20, 2013
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Jim Leng
forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of squares on the left, followed by the letters "NDS" in bold, sans-serif font. Below the letters, the words "SURGICAL - IMAGING" are printed in a smaller, sans-serif font.
Indications for Use
510(k) Number (K131115): K131115
Device Name: ZeroWire Duo Wireless HD Video Transfer System
Indications For Use:
The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a nonsterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogder 2013.06.071 9:07 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510 (k) Number K131115
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Image /page/4/Picture/15 description: The image contains two logos. The first logo on the left has the word "RADIANCE" in bold, block letters. The second logo on the right has the letters "DO" in bold, block letters. The logos are both black and white.