(37 days)
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.
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 < 33 lbs in weight, with 2 mounted power modules as DC power supply source for the monitor. The system is completed with a 4-bay wall-mount charger, allowing to charge 4 power modules simultaneously.
Three keys elements of the ZeroWire Mobile stand are the mechanical stand it-self, the DC -DC converter plus battery hot-swap monitoring circuitry, and the firmware allowing the user to interface and monitor the battery status.
Since the power module supply output can vary from 20V to 25V and a 24V +/- 5% output is required to power the monitor, there is a need for a DC-DC converter to regulate the DC output voltage. The system can run with either one or both power modules mounted and replacement of the drained power module shall not affect the voltage output of the running power module.
The provided text describes a 510(k) premarket notification for the "ZeroWire Mobile" device, which is an accessory product. Therefore, the device itself doesn't have "acceptance criteria" in the traditional sense of a diagnostic or treatment device having performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to a predicate device, primarily through compliance with recognized performance standards and safety testing.
Here's an analysis of the provided information based on your request, understanding that the context is about an accessory device's compliance rather than a standalone diagnostic algorithm's performance:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (ZeroWire Mobile), the "acceptance criteria" are compliance with various electrical, medical device, and electromagnetic compatibility (EMC) standards. The "reported device performance" is the successful passing of tests against these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ZeroWire Mobile Standards: | Successfully passed design verification testing |
| IEC 60601-1:2005=Corr.1(2006) + Corr.2 (2007) EN 60601-1:2006 (Medical electrical equipment) | Compliant |
| IEC60601-1 3rd Edition (2005) (Medical electrical equipment) | Compliant |
| CAN/CSA-C22.2 No. 60601-1-08 (R2013) ANSI/AAMI ES60601-1:2005+A2 (R2012) (Medical electrical equipment) | Compliant |
| EN 60601-1-2:2007/AC:2010; FCC Part 15B Class B (EMC) | Compliant |
| ZeroWire Power Module Standards: | Successfully passed design verification testing |
| IEC 62133:2012 EN 62133:2013 (Secondary cells and batteries) | Compliant (Test Report - Batteries, File MH61123, Vol. 1) |
| IEC 62133(ed.2) EN 62133:2013 (Secondary cells and batteries) | Compliant |
| 4 Bay Charger Standards: | Successfully passed design verification testing |
| IEC 60601-1:2005+ CORR. 1:2006+ CORR. 2:2007 + AM1:2012 (Medical electrical equipment) | Compliant |
| CAN/CSA-C22.:2007 2 No.60601-1:14 ANSI/AAMI ES60601-1:2005+A2 (R2012)+A1 (Medical electrical equipment) | Compliant |
| IEC 60601-1:2005+A1 IEC 60601-6:2010+A1 IEC 62366-2007+A1 (Medical electrical equipment) | Compliant |
| EN60601-1-2: 2007/AC: 2010 Class B, FCC Part 15 Subpart B (EMC) | Compliant |
| Radiance 27" and 32" Embedded Display Monitor with ZeroWire Mobile Standards: | Successfully passed design verification testing |
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006 (Medical electrical equipment) | Compliant |
| IEC 60601-1, 3rd Edition (2005) (Medical electrical equipment) | Compliant |
| ANSI/AAMI ES60601- 1:2005+A2 (R2012) CAN/CSA-C22.2 No. 60601-1-08 (R2013) (Medical electrical equipment) | Compliant |
| EN 301 489-1 V1.9.2 (2011-09) EN 301 489-3 V1.6.1 (2013-06) (EMC for radio equipment) | Compliant |
| EN 60601-1-2: 2007/AC: 2010 FCC SubPart 15B Class B (EMC) | Compliant |
The overall study demonstrating safety and effectiveness is referred to as "design verification testing." It concluded that the ZeroWire Mobile accessory stand "demonstrates safety and effectiveness that is equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described is compliance testing against various standards for electrical and safety performance of the hardware components (ZeroWire Mobile stand, power module, charger, and embedded displays with the mobile unit). This type of testing typically involves physical samples of the device and its components, but not a "test set" of clinical data or images like an AI algorithm would use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. The device is hardware (a mobile stand and power system for a monitor) and does not involve interpretation of medical images or diagnostic decisions that would require human expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where there are multiple interpretations or classifications of data, such as in clinical trials or AI performance evaluations. The testing here is against technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not applicable and therefore not provided in the document. An MRMC study is relevant for evaluating the impact of a system (often AI) on human performance in diagnostic tasks. The ZeroWire Mobile is a hardware accessory; it does not involve human readers making diagnostic assessments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided in the document. This concept applies to AI algorithms. The ZeroWire Mobile is a physical device accessory, not an algorithm. The core functionality of wireless video transfer (K151609) and the embedded monitors (K161228), which this device is an accessory to, would have undergone their own standalone performance and safety testing.
7. The Type of Ground Truth Used
This information is not applicable in the context of clinical ground truth (like pathology or outcomes data). For this device, the "ground truth" or reference for its performance is defined by the technical specifications of the relevant regulatory standards (e.g., IEC 60601-1 for safety, EN 301 489 for EMC). The device's performance is measured against these established technical benchmarks.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. "Training set" refers to data used to train an AI algorithm. This device is hardware and does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided in the document, as there is no training set mentioned for this hardware device.
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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
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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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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, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
|---|---|
| B. Submitted By: | Shala FamilSr. Director QA/RA, NDS Surgical Imaging, LLC |
| B1. Address: | NDS Surgical Imaging, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
| C. Date of Preparation: | February 23, 2017 |
| D. Contact Information: | Tel: 408-912-0528Fax: 408-705-5521 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Displays |
| G. Proprietary Name: | ZeroWire MobileModel Number: 90Z0160 |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device: K151609 Model ZeroWire G2 DuoPredicate device: Special K161228 Model ZeroWireRadiance Ultra Series Display Monitors |
| K. Device Description: | ZeroWire Mobile is a medical grade, battery powered polestand that eliminates the need for a power cord. It will beused as an accessory, secondary monitor display inEndo/GI procedure rooms, surgical operating rooms, orother clinical settings. ZeroWire Mobile is a cordless standwith a wireless monitor solution that provides theprocedure or operating room with a mobile second displaymonitor eliminating the risk of biohazard contamination ofcords and cables, and cable/cord trip hazards. The |
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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 < 33 lbs in weight, with 2 mounted power modules as DC power supply source for the monitor. The system is completed with a 4-bay wall-mount charger, allowing to charge 4 power modules simultaneously. |
| Three keys elements of the ZeroWire Mobile stand are the mechanical stand it-self, the DC -DC converter plus battery hot-swap monitoring circuitry, and the firmware allowing the user to interface and monitor the battery status. | |
| Since the power module supply output can vary from 20V to 25V and a 24V +/- 5% output is required to power the monitor, there is a need for a DC-DC converter to regulate the DC output voltage. The system can run with either one or both power modules mounted and replacement of the drained power module shall not affect the voltage output of the running power module. | |
| Characteristics: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
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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.
§ 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.