(37 days)
K151609 Model ZeroWire G2 Duo
Special K161228
No
The description focuses on the mechanical stand, power management, and wireless video transmission. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a wireless video system and mobile stand intended for displaying medical video signals during procedures. It does not exert a therapeutic effect on the patient.
No
The device is described as a video communication transmitter and receiver for displaying medical video signals for review and analysis, and a mobile stand for a display monitor. It transmits and receives video for review and analysis of medical images, but the device itself does not perform any diagnostic function.
No
The device description clearly outlines hardware components such as a mechanical stand, power modules, a DC-DC converter, and a charger. While there is mention of firmware, the device is fundamentally a physical system for displaying medical video.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of medical video signals for review and analysis of medical images during endoscopic and general surgical procedures. This involves displaying images generated from the body, not analyzing samples from the body in vitro.
- Device Description: The device is described as a mobile stand with a wireless monitor solution for displaying medical video. It's a system for transmitting and displaying visual information, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a system for displaying medical images generated by other devices (like endoscopy cameras), which falls under the category of medical imaging display or communication systems, not IVD.
N/A
Intended Use / Indications for Use
The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures.
The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
ZeroWire Mobile is a medical grade, battery powered pole stand that eliminates the need for a power cord. It will be used as an accessory, secondary monitor display in Endo/GI procedure rooms, surgical operating rooms, or other clinical settings. ZeroWire Mobile is a cordless stand with a wireless monitor solution that provides the procedure or operating room with a mobile second display monitor eliminating the risk of biohazard contamination of cords and cables, and cable/cord trip hazards. The ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228).
The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or
§ 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/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
NDS Surgical Imaging, LLC. % Ms. Shelley Trimm RCQ Consulting Services 1152 Navarro Street Santa Rosa, California 95401
Re: K170598
Trade/Device Name: ZeroWire Mobile Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 23, 2017 Received: March 1, 2017
Dear Ms. Trimm:
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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. 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
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.
Jennifer R. Stevenson -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)
Device Name ZeroWire Mobile
Indications for Use (Describe)
The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures.
The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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[Type here]
Image /page/3/Picture/1 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters NDS in blue. The grid of squares is arranged in a diagonal pattern, with the squares getting smaller as they move to the right. The letters NDS are in a bold, sans-serif font.
510(K) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Shala Famil
Sr. Director QA/RA, NDS Surgical Imaging, LLC |
| B1. Address: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
| C. Date of Preparation: | February 23, 2017 |
| D. Contact Information: | Tel: 408-912-0528
Fax: 408-705-5521 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Displays |
| G. Proprietary Name: | ZeroWire Mobile
Model Number: 90Z0160 |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device: K151609 Model ZeroWire G2 Duo
Predicate device: Special K161228 Model ZeroWire
Radiance Ultra Series Display Monitors |
| K. Device Description: | ZeroWire Mobile is a medical grade, battery powered pole
stand that eliminates the need for a power cord. It will be
used as an accessory, secondary monitor display in
Endo/GI procedure rooms, surgical operating rooms, or
other clinical settings. ZeroWire Mobile is a cordless stand
with a wireless monitor solution that provides the
procedure or operating room with a mobile second display
monitor eliminating the risk of biohazard contamination of
cords and cables, and cable/cord trip hazards. The |
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[Type here]
Image /page/4/Picture/1 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters "NDS" in blue. The letters are large and bold, and they have a slight gradient effect.
| ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228). | |
|---|---|
| L. Indications for Use: | The ZeroWire Mobile, the Radiance Ultra Series ZeroWire Embedded, and ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures. |
| The ZeroWire Mobile, Radiance Ultra Series and ZeroWire G2 Duo wireless video systems are non- sterile reusable devices not intended for use in the sterile field. | |
| M. Technological Characteristics: | The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or ZeroWire Mobile stand column has an adjustable height from 55 inches to 71 inches. |
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N. Performance:
K170598
- Tiltable Vesa mount supporting a display up to 32" in size and / or 33 lbs of weight.
- 5-leg wheel base to provide maximum stability.
- Castors of 5-inch diameter and with an individual lock. ●
The performance standards reports that the ZeroWire Mobile, Power Module, and 4-Bay charger are compliant to are available in Tab 11. The ZeroWire Mobile, ZeroWire G2 Duo Wireless Video System (K151609) and the Radiance Ultra ZeroWire Embedded monitor displays (Special K161228) as a system has successfully passed design verification testing to further demonstrate safety and effectiveness.
The following is a summary of standards have been tested to and passed:
ZeroWire Mobile
Standards IEC 60601-1:2005=Corr.1(2006) + Corr.2 (2007) EN 60601-1:2006
IEC60601-1 3rd Edition (2005)
CAN/CSA-C22.2 No. 60601-1-08 (R2013) ANSI/AAMI ES60601-1:2005+A2 (R2012)
EN 60601-1-2:2007/AC:2010; FCC Part 15B Class B
ZeroWire Power Module
| Document Type |
|---|
| Test Report - Batteries |
| IEC 62133:2012 |
| EN 62133:2013 |
IEC 62133:2012 EN 62133:2013
File MH61123, Vol. 1
IEC 62133(ed.2) EN 62133:2013
4 Bay Charger
Standards
IEC 60601-1:2005+ CORR.
1:2006+ CORR. 2:2007 + AM1:2012 (or UEC 60601-1:2012 reprint)
IEC 60601-1:2005+ CORR.
1:2006+ CORR. 2:2007 + AM1:2012 (or UEC 60601-1:2012 reprint)
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CAN/CSA-C22.:2007 2 No.60601-1:14 ANSI/AAMI ES60601- 1:2005+A2 (R2012)+A1
IEC 60601-1:2005+A1 IEC 60601-6:2010+A1 IEC 62366-2007+A1
EN60601-1-2: 2007/AC: 2010 Class B, FCC Part 15 Subpart B
Radiance 27" Embedded Display Monitor with ZeroWire Mobile
Standards IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006
IEC 60601-1, 3rd Edition (2005)
ANSI/AAMI ES60601- 1:2005+A2 (R2012) CAN/CSA-C22.2 No. 60601-1-08 (R2013)
EN 301 489-1 V1.9.2 (2011-09) EN 301 489-3 V1.6.1 (2013-06)
EN 60601-1-2: 2007/AC: 2010 FCC SubPart 15B Class B
Radiance 32" Embedded Display Monitor with ZeroWire Mobile
| Standards |
|---|
| IEC 60601-1: 2005 + CORR. 1 |
| (2006) + CORR. 2 (2007) EN 60601-1:2006 |
| IEC 60601-1, 3rd Edition (2005) |
| ANSI/AAMI ES60601- 1:2005+A2 |
| CAN/CSA-C22.2 No. 60601-1-08 |
| EN 301 489-1 V1.9.2 (2011-09) |
| EN 301 489-3 V1.6.1 (2013-06) |
| EN 60601-1-2: 2007/AC: 2010 |
| FCC SubPart 15 B Class B |
The ZeroWire Mobile is an accessory to K151609: O. Summary Changes ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228: Radiance Ultra Embedded. As an accessory, ZeroWire Mobile did not require any technology or labeling changes to K151609 or K161228 to be compatible. The ZeroWire Mobile is substantially equivalent to the P. Substantial Equivalency: safety and effectiveness of K151609: ZeroWire Duo
7
Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228: Radiance Ultra Embedded as proven in the safety, performance, and verification reports sited in Section N: Performance.
Q. Conclusion: Based upon the safety, performance, and verification reports, ZeroWire Mobile accessory stand demonstrates safety and effectiveness that is equivalent to the predicate devices: K151609, ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228, Radiance Ultra Embedded.