(48 days)
Not Found
No
The document describes a device for transmitting and distributing video and images, with no mention of AI, ML, or related concepts like deep learning or neural networks. The focus is on network connectivity and signal transmission.
No.
The device is described as an "IP Converter" intended to "distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time" and "transmit 4K or HD video and audio signals from endoscope system or other modalities." It primarily functions as a video and audio signal distribution system within a medical setting, rather than directly applying to the human body to diagnose, cure, mitigate, or treat disease or other conditions.
No
The device's intended use is to distribute and transmit images and video, not to perform diagnosis. It is a converter and network transmission system.
No
The device description explicitly states it transmits video and audio signals from modalities via a high-speed optical fiber network and connects multiple IP Converters via a network switch, indicating it is a hardware device.
Based on the provided information, the Sony IP Converter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the distribution and transmission of patient images and audio-visuals from medical modalities within a hospital or clinical environment. It facilitates the display and recording of these images.
- Device Description: The device description reinforces this by stating its purpose is to transmit video and audio signals from modalities.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or examination of biological samples (blood, tissue, etc.) to provide diagnostic information. IVDs are specifically designed for these purposes.
- No Mention of IVD-Specific Activities: The description doesn't include any activities typically associated with IVDs, such as sample preparation, reagent use, or the generation of diagnostic results.
- Predicate Devices: The predicate devices listed (BARCO NV NEXXIS OR, BrainLAB AG BrainSUITE NET, Stryker Communications Corp. Switchpoint Infinity Control System) are all systems for managing and distributing medical images and video within an operating room or clinical setting, not IVDs.
In summary, the Sony IP Converter is a medical device used for the infrastructure and management of medical imaging and video data, not for performing in vitro diagnostic tests.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscope system or other modalities equipped with 3G/HD-SDI video output
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or clinical environment, medical procedure room or operating room, healthcare campus.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Clinical Performance Data: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 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
2
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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
EF PSC Publishing Services (301) 443-6740
3
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. |
| Sony Medical Systems Division | |
| 1 Sony Drive, Mail Stop 2E2 | |
| Park Ridge, NJ 07656-8004 | |
| United States of America | |
| Contact Person: | Mr. Amarjit "Andy" Jowandha |
| Head, Global Quality Assurance, Regulatory Affairs & Compliance | |
| Phone: +1 (201) 930-6078 | |
| FAX: +1 (201) 930-6307 | |
| Email: Amarjit.Jowandha@am.sony.com |
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 |
| Corp. | |||
| Device Name: | NEXXIS OR | BrainSUITE NET | Switchpoint Infinity |
| Control System | |||
| Regulation Number: | 21 CFR 870.2450 | 21 CFR 876.1500 and 21 | |
| 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- | |||
| IP40S | NEXXIS OR | |||
| (K122167) | BrainSUITE NET | |||
| (K070556) | Switchpoint | |||
| Infinity (K033132) | ||||
| Classification | ||||
| Regulation | 21 CFR 876.1500 | 21 CFR 870.2450 | 21 CFR 876.1500 | |
| 21 CFR 882.4560 | 21 CFR 876.1500 | |||
| Product Codes | GCJ | DXJ | GCJ | |
| HAW | GCJ | |||
| Class | II | II | II | II |
| 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 visual signals
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 Barco Nexxis
OR system is
designed to allow
transfer, selection
and distribution of
A/V signals and
medical images
from various
commercially
available
instruments that are
commonly used in a
medical procedure
laboratory or
operating room.
The Barco Nexxis
OR system is also
designed for
transfer, selection
and distribution of
human interface
signals and control | BrainSUITE NET
from BrainLAB is a
platform for the
integration of
devices and for the
distribution of video
signals and
multimedia content.
lt is intended to be
used for
communication
between compatible
BrainLAB devices.
It provides
centralized access
for managing video
data, medical
images and patient
data.
BrainSUITE NET
can be used in the | The Switchpoint
Infinity Control
System is a medical
device that is
designed to allow
direct control of the
state, selection, and
settings of room
equipment, and
audio/video
equipment and
indirect control
through the Stryker
Endoscopy Sidne
System of the state,
selection, and
settings of surgical
equipment in the
operating room. The
Switchpoint Infinity
Control System is
also an integrated
voice, video, and |
| | Subject Device | | Predicate Devices | |
| Device | IP Converter NU-
IP40S | NEXXIS OR
(K122167) | BrainSUITE NET
(K070556) | Switchpoint
Infinity (K033132) |
| | The IPC allows for
the switching of
images easily
among devices
connected to an IPC
in the operating
room or throughout
a healthcare
campus. | signals of non-
medical room
equipment.
The Barco Nexxis
OR system allows
control and
selection of these
signals from a
central point.
The Barco Nexxis
OR system is not
intended to be used
for remote or
robotically-assisted
surgery.
The Barco Nexxis
OR system is not
intended to be used
in the vicinity of MRI
or other devices that
use strong magnetic
fields. | operating theater for
various surgical
procedures
involving video
processing, image
recording, patient
data viewing and
software application
control. | data router and
teleconferencing
interface for the
operating room. The
intent of the
Switchpoint Infinity
Control System is to
allow operating
room personnel a
center point for
controlling all
equipment and
communication in
surgery.
The Stryker
Switchpoint Infinity
Control System is
indicated for use
with the Stryker
Endoscopy Sidne
System [510(k) #
K022393] and Sidne
compatible
endoscopic and
general surgery
devices. The users
of Switchpoint
Infinity Control
System are general
surgeons,
gynecologists,
cardiac surgeons,
thoracic surgeons,
plastic surgeons,
orthopedic
surgeons, ENT
surgeons,
urologists,
radiologists, and
any other surgeon
whom requires the
use of voice, video,
or control in the
operating room or a
teleconferencing
interface. |
| | | | | interface. |
| Product
Configuration | Consists of:
• Internet
protocol
converter
(mandatory)
○ NU-IP40S
• Network
System
Manager | Consists of:
• Nexxis MNA
encoders and
decoders
(mandatory)
○ MNA-120
ENC
○ MNA-120
DEC | Consists of:
• Touchscreen
interface
• A/V displays
○ Not
provided
○ Exist inside
and
outside | Consists of:
• Media router
• Control system
• Touchscreen
interface
• A/V displays
○ Not
provided
○ Exist inside |
| | Subject Device | Predicate Devices | | |
| Device | IP Converter NU-
IP40S | NEXXIS OR
(K122167) | BrainSUITE NET
(K070556) | Switchpoint
Infinity (K033132) |
| | (optional)
• NU-
NM10B
• A/V displays
• Not
provided
• Exist inside
and
outside
operating
room | • Network
management
software
(mandatory)
• Nexxis OR
Management Suite
• Nexxis Network
Switch
• Extreme
network
switch
(optional)
• A/V displays
• Not
provided
• Exist inside
and
outside
operating
room | operating
room | and
outside
operating
room |
| Supported
Signal Formats | • HD-SDI
• 3G-SDI
• Quad Link 3G-
SDI
• 3D | • DVI-D
• SDI
• DP | Wide range per
K070556 510(k)
Summary | • S-Video
• Composite
• RGBHV
• 3G-SDI
• HD-SDI
• DVI |
| Supported Video
Resolution | • 1920x1080
• 3840x2160
• 4096x2160 | • 1920x1200
maximum | Unknown | • 1920x1080
• 1920x1200 |
| Power
Specifications | • +24 V DC, 1 A,
24 W | • 100-120, 200-
240 VAC,
50/60Hz, 30 W
max | Unknown | • 100-240 VAC,
50/60 Hz, 570
VA
(Media router)
• 120-240 VAC,
50/60 Hz, 400
VA
(Control
system) |
| Physical
Specifications | • Ordinary
protection
against harmful
ingress of water
• Approx. 0.7 kg
(1 lb. 8 oz.)
• VESA 100
compatible with
adaptation
plate | • IPX0
• 750 g
• VESA 100
compatible with
adaptation
plate | Unknown | • 34 kg, 24" H x
20.6" W x 17" D
(Media router)
• 4.08 kg, 2.6" H
x 12.6" W x 17"
D (Control
system) |
| Software User
Interface | Optional accessory
Network System
Manager (NSM)
software allows
control of multiple IP
converters and
enables video | Network
management
software
(mandatory)
provides software
control interface for
layout, status and | Single touchscreen
interface enables
full control of video
signals allowing
manipulation of
how/where
information is | Control system is an
integrated voice,
video, and data
router and
teleconferencing
interface for the
operating room |
| | Subject Device | Predicate Devices | | |
| Device | IP Converter NU-
IP40S | NEXXIS OR
(K122167) | BrainSUITE NET
(K070556) | Switchpoint
Infinity (K033132) |
| | switching from a
server computer
connected to the
same network | diagnosis, LED
indicators for power
supplies | displayed, such as
monitors in the
operating room or in
remote rooms | |
| Distributes
Audio / Video
Signals Inside
the Operating
Room? | Yes | Yes | Yes | Yes |
| Distributes
Audio / Video
Signals Outside
the Operating
Room? | Yes | Yes | Yes | No |
| Enables
Centralized
Management of
Audio / Video
Signals? | Yes | Yes | Yes | Yes |
| Performance
Standards | ● ANSI/AAMI
ES60601-1:2005
● IEC 60601-1-
2:2007
● IEC 62304:2006
● ISO 14971:2007 | ● IEC 60601-1
● IEC 60601-1-
2:2001
● ISO 14971 | ● IEC 60601-1-1
● IEC 60601-1-2 | ● UL 60601-1
● EN 60601-1-2 |
The subject device compares to the legally marketed devices as follows:
5
6
7
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.