Sony IP Converter NU-IP40S

K161122 · Sony Electronics, Inc. · GCJ · Jun 8, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161122
• Device Name: Sony IP Converter NU-IP40S
• Applicant: Sony Electronics, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Sony IP Converter's (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time. The IPC can send audio visuals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room. The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

Device Story

Sony IP Converter NU-IP40S transmits 4K/HD video and audio signals from endoscopes or other modalities with 3G/HD-SDI outputs over high-speed optical fiber networks. Device connects multiple converters via network switch to form a video transmission system for medical procedures. Used in hospitals/operating rooms by clinical staff. Optional Network System Manager (NSM) software allows centralized switching and control of images across the healthcare campus. Output is displayed on commercially available monitors or recording devices. Enables real-time image distribution and switching, facilitating clinical workflow and information sharing during procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

IP-based video converter; supports HD-SDI, 3G-SDI, Quad Link 3G-SDI, 3D signals; resolutions up to 4096x2160. Connectivity via high-speed optical fiber network. VESA 100 compatible. Power: +24 V DC. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 14971.

Indications for Use

Indicated for distribution of patient images and audio-visual signals from medical modalities (e.g., endoscopes) to displays or recording devices within hospital or clinical environments, including operating rooms.

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

• NEXXIS OR (K122167)
• BrainSUITE NET (K070556)
• Switchpoint Infinity Control System (K033132)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation.

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

June 8, 2016

Sony Electronics Inc. Mr. Amarjit Jowandha Head, Global Quality Assurance, Regulatory Affairs and Compliance 1 Sony Drive Park Ridge, New Jersey 07656

Re: K161122

Trade/Device Name: Sony IP Converter NU-IP40S Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 18, 2016 Received: April 21, 2016

Dear Mr. Jowandha:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161122

Device Name

Sony IP Converter NU-IP40S

Indications for Use (Describe)

The Sony IP Converter's (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time.

The IPC can send audio visuals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room.

The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

510(k) Number:

# 5.1 Applicant Information

| Date Prepared: | April 18, 2016 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and Address: | Sony Electronics, Inc.<br>Sony Medical Systems Division<br>1 Sony Drive, Mail Stop 2E2<br>Park Ridge, NJ 07656-8004<br>United States of America |
| Contact Person: | Mr. Amarjit "Andy" Jowandha<br>Head, Global Quality Assurance, Regulatory Affairs & Compliance<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

## 5.2 Device Information

| Device Type: | IP Converter |
|-------------------------|---------------------------|
| Regulation Description: | Endoscope and Accessories |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | II |
| Device Name: | NU-IP40S |

## 5.3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

| 510(k) Number: | K122167 | K070556 | K033132 |
|--------------------|-----------------|----------------------------------------|----------------------------------------|
| Applicant: | BARCO NV | BrainLAB AG | Stryker Communications<br>Corp. |
| Device Name: | NEXXIS OR | BrainSUITE NET | Switchpoint Infinity<br>Control System |
| Regulation Number: | 21 CFR 870.2450 | 21 CFR 876.1500 and 21<br>CFR 882.4560 | 21 CFR 876.1500 |
| Product Code: | DXJ | GCJ and HAW | GCJ |
| Device Class: | II | II | II |

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# 5.4 Device Description

The Sony IP Converter NU-IP40S is intended to transmit 4K or HD video and audio signals from endoscope system or other modalities equipped with 3G/HD-SDI video output via a high-speed optical fiber network with minimal delay.

Connecting multiple IP Converters via a network switch can construct a network video transmission system for medical procedures.

# 5.5 Intended Use/Indications for Use

The Sony IP Converter's (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real time.

The IPC can send audio visuals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room.

The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

# 5.6 Technological Characteristics

| | Subject Device | Predicate Devices | | |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | IP Converter NU-<br>IP40S | NEXXIS OR<br>(K122167) | BrainSUITE NET<br>(K070556) | Switchpoint<br>Infinity (K033132) |
| Classification<br>Regulation | 21 CFR 876.1500 | 21 CFR 870.2450 | 21 CFR 876.1500<br>21 CFR 882.4560 | 21 CFR 876.1500 |
| Product Codes | GCJ | DXJ | GCJ<br>HAW | GCJ |
| Class | II | II | II | II |
| Intended<br>Use/Indications<br>for Use | The Sony IP<br>Converter's (IPC)<br>intended use is to<br>distribute patient<br>images acquired<br>from modalities<br>within a hospital or<br>clinical environment<br>in almost real-time.<br><br>The IPC can send<br>audio visual signals<br>and medical images<br>to various<br>commercially<br>available products<br>such as displays or<br>recording devices<br>commonly used in a<br>medical procedure<br>room or operating<br>room. | The Barco Nexxis<br>OR system is<br>designed to allow<br>transfer, selection<br>and distribution of<br>A/V signals and<br>medical images<br>from various<br>commercially<br>available<br>instruments that are<br>commonly used in a<br>medical procedure<br>laboratory or<br>operating room.<br><br>The Barco Nexxis<br>OR system is also<br>designed for<br>transfer, selection<br>and distribution of<br>human interface<br>signals and control | BrainSUITE NET<br>from BrainLAB is a<br>platform for the<br>integration of<br>devices and for the<br>distribution of video<br>signals and<br>multimedia content.<br>lt is intended to be<br>used for<br>communication<br>between compatible<br>BrainLAB devices.<br><br>It provides<br>centralized access<br>for managing video<br>data, medical<br>images and patient<br>data.<br><br>BrainSUITE NET<br>can be used in the | The Switchpoint<br>Infinity Control<br>System is a medical<br>device that is<br>designed to allow<br>direct control of the<br>state, selection, and<br>settings of room<br>equipment, and<br>audio/video<br>equipment and<br>indirect control<br>through the Stryker<br>Endoscopy Sidne<br>System of the state,<br>selection, and<br>settings of surgical<br>equipment in the<br>operating room. The<br>Switchpoint Infinity<br>Control System is<br>also an integrated<br>voice, video, and |
| | Subject Device | | Predicate Devices | |
| Device | IP Converter NU-<br>IP40S | NEXXIS OR<br>(K122167) | BrainSUITE NET<br>(K070556) | Switchpoint<br>Infinity (K033132) |
| | The IPC allows for<br>the switching of<br>images easily<br>among devices<br>connected to an IPC<br>in the operating<br>room or throughout<br>a healthcare<br>campus. | signals of non-<br>medical room<br>equipment.<br>The Barco Nexxis<br>OR system allows<br>control and<br>selection of these<br>signals from a<br>central point.<br>The Barco Nexxis<br>OR system is not<br>intended to be used<br>for remote or<br>robotically-assisted<br>surgery.<br>The Barco Nexxis<br>OR system is not<br>intended to be used<br>in the vicinity of MRI<br>or other devices that<br>use strong magnetic<br>fields. | operating theater for<br>various surgical<br>procedures<br>involving video<br>processing, image<br>recording, patient<br>data viewing and<br>software application<br>control. | data router and<br>teleconferencing<br>interface for the<br>operating room. The<br>intent of the<br>Switchpoint Infinity<br>Control System is to<br>allow operating<br>room personnel a<br>center point for<br>controlling all<br>equipment and<br>communication in<br>surgery.<br>The Stryker<br>Switchpoint Infinity<br>Control System is<br>indicated for use<br>with the Stryker<br>Endoscopy Sidne<br>System [510(k) #<br>K022393] and Sidne<br>compatible<br>endoscopic and<br>general surgery<br>devices. The users<br>of Switchpoint<br>Infinity Control<br>System are general<br>surgeons,<br>gynecologists,<br>cardiac surgeons,<br>thoracic surgeons,<br>plastic surgeons,<br>orthopedic<br>surgeons, ENT<br>surgeons,<br>urologists,<br>radiologists, and<br>any other surgeon<br>whom requires the<br>use of voice, video,<br>or control in the<br>operating room or a<br>teleconferencing<br>interface. |
| | | | | interface. |
| Product<br>Configuration | Consists of:<br>• Internet<br>protocol<br>converter<br>(mandatory)<br>○ NU-IP40S<br>• Network<br>System<br>Manager | Consists of:<br>• Nexxis MNA<br>encoders and<br>decoders<br>(mandatory)<br>○ MNA-120<br>ENC<br>○ MNA-120<br>DEC | Consists of:<br>• Touchscreen<br>interface<br>• A/V displays<br>○ Not<br>provided<br>○ Exist inside<br>and<br>outside | Consists of:<br>• Media router<br>• Control system<br>• Touchscreen<br>interface<br>• A/V displays<br>○ Not<br>provided<br>○ Exist inside |
| | Subject Device | Predicate Devices | | |
| Device | IP Converter NU-<br>IP40S | NEXXIS OR<br>(K122167) | BrainSUITE NET<br>(K070556) | Switchpoint<br>Infinity (K033132) |
| | (optional)<br>• NU-<br>NM10B<br>• A/V displays<br>• Not<br>provided<br>• Exist inside<br>and<br>outside<br>operating<br>room | • Network<br>management<br>software<br>(mandatory)<br>• Nexxis OR<br>Management Suite<br>• Nexxis Network<br>Switch<br>• Extreme<br>network<br>switch<br>(optional)<br>• A/V displays<br>• Not<br>provided<br>• Exist inside<br>and<br>outside<br>operating<br>room | operating<br>room | and<br>outside<br>operating<br>room |
| Supported<br>Signal Formats | • HD-SDI<br>• 3G-SDI<br>• Quad Link 3G-<br>SDI<br>• 3D | • DVI-D<br>• SDI<br>• DP | Wide range per<br>K070556 510(k)<br>Summary | • S-Video<br>• Composite<br>• RGBHV<br>• 3G-SDI<br>• HD-SDI<br>• DVI |
| Supported Video<br>Resolution | • 1920x1080<br>• 3840x2160<br>• 4096x2160 | • 1920x1200<br>maximum | Unknown | • 1920x1080<br>• 1920x1200 |
| Power<br>Specifications | • +24 V DC, 1 A,<br>24 W | • 100-120, 200-<br>240 VAC,<br>50/60Hz, 30 W<br>max | Unknown | • 100-240 VAC,<br>50/60 Hz, 570<br>VA<br>(Media router)<br>• 120-240 VAC,<br>50/60 Hz, 400<br>VA<br>(Control<br>system) |
| Physical<br>Specifications | • Ordinary<br>protection<br>against harmful<br>ingress of water<br>• Approx. 0.7 kg<br>(1 lb. 8 oz.)<br>• VESA 100<br>compatible with<br>adaptation<br>plate | • IPX0<br>• 750 g<br>• VESA 100<br>compatible with<br>adaptation<br>plate | Unknown | • 34 kg, 24" H x<br>20.6" W x 17" D<br>(Media router)<br>• 4.08 kg, 2.6" H<br>x 12.6" W x 17"<br>D (Control<br>system) |
| Software User<br>Interface | Optional accessory<br>Network System<br>Manager (NSM)<br>software allows<br>control of multiple IP<br>converters and<br>enables video | Network<br>management<br>software<br>(mandatory)<br>provides software<br>control interface for<br>layout, status and | Single touchscreen<br>interface enables<br>full control of video<br>signals allowing<br>manipulation of<br>how/where<br>information is | Control system is an<br>integrated voice,<br>video, and data<br>router and<br>teleconferencing<br>interface for the<br>operating room |
| | Subject Device | Predicate Devices | | |
| Device | IP Converter NU-<br>IP40S | NEXXIS OR<br>(K122167) | BrainSUITE NET<br>(K070556) | Switchpoint<br>Infinity (K033132) |
| | switching from a<br>server computer<br>connected to the<br>same network | diagnosis, LED<br>indicators for power<br>supplies | displayed, such as<br>monitors in the<br>operating room or in<br>remote rooms | |
| Distributes<br>Audio / Video<br>Signals Inside<br>the Operating<br>Room? | Yes | Yes | Yes | Yes |
| Distributes<br>Audio / Video<br>Signals Outside<br>the Operating<br>Room? | Yes | Yes | Yes | No |
| Enables<br>Centralized<br>Management of<br>Audio / Video<br>Signals? | Yes | Yes | Yes | Yes |
| Performance<br>Standards | ● ANSI/AAMI<br>ES60601-1:2005<br>● IEC 60601-1-<br>2:2007<br>● IEC 62304:2006<br>● ISO 14971:2007 | ● IEC 60601-1<br>● IEC 60601-1-<br>2:2001<br>● ISO 14971 | ● IEC 60601-1-1<br>● IEC 60601-1-2 | ● UL 60601-1<br>● EN 60601-1-2 |

The subject device compares to the legally marketed devices as follows:

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## 5.7 Non-Clinical Performance Data

The subject devices demonstrate conformance with the following recognized standards:

- ANSI/AAMI ES60601-1 .
- . IEC 60601-1-2
- IEC 62304 .
- . ISO 14971

## 5.8 Clinical Performance Data

No clinical study is included in this submission.

## 5.9 Conclusions

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject devices are substantially equivalent to the predicate device identified in this submission.