WIS1000

K112621 · Foreseeson Custom Displays, Inc. · GCJ · May 30, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112621
• Device Name: WIS1000
• Applicant: Foreseeson Custom Displays, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 30, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.

Device Story

WIS1000 is a wireless transmitter and receiver pair for hospital environments; transmits high-definition (up to 1080p/60Hz) audio and video signals from surgical video sources to secondary displays. Operates via 60GHz radio-frequency link. Up to six pairs can operate in a single room. Used in ORs during endoscopic and surgical procedures; operated by clinical staff. Sources are hardwired to the transmitter; secondary displays are hardwired to the receiver. Facilitates visualization for surgical teams by enabling remote display of primary surgical video feeds. Non-sterile, reusable device.

Clinical Evidence

Bench testing only. Compliance demonstrated with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and FCC 47 CFR Part 15. Additional testing verified wireless performance, including coexistence, quality of service, and security.

Technological Characteristics

Wireless transmitter/receiver pair; 60GHz RF transmission; supports up to 1080p/60Hz video. Reusable, non-sterile form factor. Compliant with IEC 60601-1, IEC 60601-1-2, and FCC 47 CFR Part 15.

Indications for Use

Indicated for patients undergoing endoscopic and surgical procedures, including arthroscopy, laparoscopy, thorascopy, and general surgery, requiring wireless transmission of high-definition video to secondary displays. 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

• Stryker Vision Elect Wireless High Definition Television (K081995)
• ZeroWire Duo Wireless HD Video Transfer System (K100195)

Submission Summary (Full Text)

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MAY 3 0 2012

Image /page/0/Picture/1 description: The image shows a logo for a company called "FORESEEON Custom Displays". The logo features the company name in a bold, stylized font, with the letters "SEE" appearing within a black circle. Below the company name, the words "Custom Displays" are printed in a smaller font. A horizontal line is present below the text.

WIS1000 System Traditional Premarket Notification (KI12621)

K/126z/

### Section 5: 510(k) Summary Device Information:

| Category | Comments |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Company: Foreseeson Custom Display<br>Address: 2210 E. Winston Road<br>Anaheim, CA 92806<br>Phone: [phone]<br>Fax: [phone] |
| Correspondent Contact<br>Information: | Daniel Tomlinson<br>Foreseeson<br>Phone: [phone]<br>Fax: [phone] |
| Device Common Name: | Endoscope and accessories. |
| Device Classification Number: | 21 CFR 876.1500 |
| Device Classification &<br>Product Code: | Class II,<br>GCJ |
| Device Proprietary Name: | WIS1000 |

# Predicate Device Information:

| Predicate Device: | Stryker Vision Elect Wireless High<br>Definition Television (Stryker VE<br>WHDTV) |
|----------------------------------------------------|-----------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | Stryker |
| Predicate Device Common Name: | Endoscope and accessories. |
| Predicate Device Premarket Notification #: | K081995 |
| Predicate Device Classification: | 21 CFR 876.1500 |
| Predicate Device Classification &<br>Product Code: | Class II,<br>GCJ |

| Predicate Device: | ZeroWire Duo Wireless HD Video<br>Transfer System | |
|----------------------------------------------------|---------------------------------------------------|--|
| Predicate Device Manufacturer: | NDSsi | |
| Predicate Device Common Name: | Endoscope and accessories. | |
| Predicate Device Premarket Notification #: | K100195 | |
| Predicate Device Classification: | 21 CFR 876.1500 | |
| Predicate Device Classification &<br>Product Code: | Class II,<br>GCJ | |

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# b. Date Summary Prepared

24 May 2012

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Image /page/1/Picture/0 description: The image shows the logo for FORESEESON Custom Displays. The logo is in black and white and features the word "FORESEESON" in a bold, stylized font. The letters "EE" are inside of a circle. Below the word "FORESEESON" is the phrase "Custom Displays" in a smaller font.

## c. Description of Device

The WIS1000 System is a wireless transmitter and receiver pair which allows delivery of High Definition (HD) video from a wide range of video sources common in a hospital environment to a secondary video display.

Image /page/1/Figure/4 description: The image shows a diagram of a 60GHz wireless HD system for medical displays. The system consists of a laptop, a medical cart with a monitor, a 60GHz wireless HD transmitter, a 60GHz wireless HD receiver, and a medical display. The laptop and medical cart are connected to the transmitter, which wirelessly transmits the video signal to the receiver, which then displays the video on the medical display.

## Typical layout of the WIS1000 System: Sources are hardwired to the Transmitter, the secondary display is hardwired to the Receiver.

Up to six pairs of WIS1000 Transmitters and Receivers can be paired together in a single room.

### d. Indications for Use

The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.

#### e. Comparison to Predicate Device

The Foreseeson Custom Display WIS1000 is substantially equivalent in Intended Use, Indications for Use and technology as the predicate Stryker Vision Elect Wireless High Definition Television (K081995) and the NDSsi ZeroWire Duo Wireless HD Video Transfer System (K100195).

All of the device are combinations of wireless paired transmitters and receivers, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. They are all intended to supply images from primary displays to secondary monitors.

All of these wireless devices are reusable and non-sterile. They are not intended for use in the sterile field.

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Image /page/2/Picture/0 description: The image shows the logo for "FORESEESON Custom Displays". The word "FORESEESON" is in a bold, stylized font, with a circular graphic behind the letters "SEE". Below the main text, the words "Custom Displays" are printed in a smaller, simpler font.

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

Foreseeson concludes that the devices are substantially equivalent.

#### f. Summary of Supporting Data

Bench testing has demonstrated that the device is in compliance with IEC 60601-1, IEC 60601-1-2, FCC 47 CFR Part 15, the expectations of the medical community and the product labeling.

Additional compatibility testing was performed to verify that wireless capabilities such as functions, coexistence, quality of service, and security met essential performances.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

MAY 3 0 2012

Foreseeson Custom Displays, Inc. Mr. Daniel Tomlinson Director, Sales/Marketing /Engineering 2210 E. Winston Road Anaheim, California 92806

Re: K112621

Trade/Device Name: WIS1000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 03, 2012 Received: May 07, 2012

Dear Mr. Tomlinson:

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

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Page 2 – Mr. Daniel Tomlinson

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

For Mother
Orpicia
Diaz

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for "FORESESSION Custom Displays". The word "FORESESSION" is in bold, sans-serif font, with the letters "SS" inside of a black circle. Below the main text is the phrase "Custom Displays" in a smaller font.

# Section 4: Indications for Use Statement

510(k) Number (if known): K112621

Foreseeson Custom Display WIS1000 Device Name:

Indications For Use:

The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------------------------|-------------|
| (Division Sign-Off)<br>Division of Surgical, Orthopedic,<br>and Restorative Devices | Page 1 of 1 |
| 510(k) Number | K112621 |

Section 4, Page 1