ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE

K131115 · Nds Surgical Imaging · GCJ · Jun 7, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131115
• Device Name: ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
• Applicant: Nds Surgical Imaging
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 7, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

ZeroWire Duo is a wireless transmitter/receiver pair for HD video transfer in ORs. It accepts video signals and transmits them over a UWB (Ultra-Wideband) radio-frequency link to compatible displays (e.g., Radiance, Endo Vue). Designed for minimally invasive and interventional procedures; eliminates video cables to enhance OR safety and efficiency. Features proprietary memory-enabled pairing. Operated by qualified physicians. Firmware modification allows operation on up to 9 channels (increased from 3 in predicate). No hardware changes. Provides medical-grade video quality resistant to interference.

Clinical Evidence

No clinical data required per 510(k) guidance for this device type. Submission includes test results from a clinical environment to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Wireless video transfer system utilizing UWB (Ultra-Wideband) frequency spectrum. Non-sterile, reusable. Firmware-based channel management (9 channels). Proprietary memory-enabled pairing system. Medical-grade wireless link.

Indications for Use

Indicated for delivery of video signals via radio-frequency link to video displays during endoscopic and general surgical procedures. Intended for use by qualified physicians. Not for use in the sterile field.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ZeroWire Duo Wireless HD Video Transfer System (K100195)

Submission Summary (Full Text)

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- K131115
## 510(K) SUMMARY

#### JUN 7 2013

| A. Manufacturer: | NDS Surgical Imaging, LLC<br>5750 Hellyer Avenue<br>San Jose, CA 95138<br>USA |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng<br>Regulatory Engineer/NDS Surgical Imaging, LLC |
| Bl. Address: | NDS Surgical Imaging, LLC<br>5750 Hellyer Avenue<br>San Jose, CA 95138<br>USA |
| C. Date of Preparation: | April 17, 2013 |
| D. Contact Information: | 408-776-0085<br>Tel:<br>Fax:<br>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<br>Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate K100195 ZeroWire Duo Wireless HD Video<br>Transfer System. |
| K. Device Description: | Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3;<br>x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless device<br>is designed as a wireless transmitter and receiver pair<br>which allows delivery of a video signal over a radio<br>frequency link to video destination such as Radiance and<br>Endo Vue devices. The device can operate on up to 9<br>channels. |
| L. Indications for Use: | The NDSsi ZeroWire Duo Wireless HD Video Transfer<br>System is a paired transmitter and receiver, intended for<br>delivery of video signals over a radio-frequency link to a<br>video display during endoscopic and general surgical |

.

RADIANCE DOM

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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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## 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

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