(200 days)
Not Found
No
The summary describes a device for transmitting and receiving medical images over a network. There is no mention of image processing, AI, DNN, or ML in the description or performance studies.
No
The device is described as an "IP Converter" that distributes and transmits patient images. Its function is to facilitate image display and recording, not to provide therapy or directly treat a disease or condition.
No
The device is described as an "IP Converter" intended to "distribute patient images acquired from modalities" and send them to "displays or recording devices." Its function is image transmission and reception, not the analysis or interpretation of medical images for diagnostic purposes.
No
The device description explicitly states "The NU-IP3T/NU-IP3R IP converters are devices for the transmission/reception of 4K or HD images over a network..." and mentions connecting "multiple IP converters via a network switch," indicating physical hardware components are involved.
Based on the provided information, the Sony IP Converter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to distribute patient images acquired from modalities. This is a function related to image transmission and display, not the analysis of biological samples or the diagnosis of diseases based on in vitro testing.
- Device Description: The device description focuses on the technical aspects of transmitting and receiving image signals over a network. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD-Specific Information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims based on in vitro testing
- Performance metrics like sensitivity, specificity, PPV, NPV (which are relevant to diagnostic accuracy)
The device's function is purely related to the infrastructure for handling and displaying medical images, which falls under the category of medical imaging accessories or image management systems, not IVD.
N/A
Intended Use / Indications for Use
The Sony IP Converter's (PC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time. The IPC can send 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 NU-IP3T/NU-IP3R IP converters are devices for the transmission/reception of 4K or HD images over a network with low latency from devices equipped with 3G-SDI, HDMI, Display Port, or DVI image outputs.
Connecting multiple IP converters via a network switch allows you to construct a network video transmission system for medical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or clinical environment, medical procedure room or operating room
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 ES 60601-1 ●
- 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
January 9, 2020
Sony Electronics Inc. % Tomomichi Iwasaka Senior Manager of Regulatory Affairs section Sony Corporation, Atsugi Technology Center 4-14-1 Asahi-Cho Atsugi-Shi, Kanagawa, JAPAN 243-0014
Re: K191678
Trade/Device Name: Sony IP Converter NU-IP3T, Sony IP Converter NU-IP3R Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 17, 2019 Received: June 24, 2019
Dear Tomomichi Iwasaka:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191678
Device Name Sony IP Converter NU-IP3T Sony IP Converter NU-IP3R
Indications for Use (Describe)
The Sony IP Converter's (PC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time. The IPC can send 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Date of the summary prepared: June 17, 2019
510(k) Number: K191678
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.
1 Applicant Information
| Company Name and
Address: | Sony Electronics Inc.,
115 West Century Road
Suite 250
Paramus, NJ 07652
Phone Number: (201)358-4082
FAX Number: (201)930-6307 |
| ------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2 Application Correspondent / Contact
| Company Name and
Address: | Sony Corporation, Atsugi Technology Center
4-14-1 Asahi-Cho
Atsugi-Shi, Kanagawa, JAPAN 243-0014 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Phone Number: +81-50-3141-0325
FAX Number: +81-50-3141-2453
Contact E-mail Address: T.Iwasaka@sony.com
Contact Name: Tomomichi Iwasaka |
3 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: | Sony IP Converter NU-IP3T |
| Sony IP Converter NU-IP3R |
4
4 Predicate Device(s)
The legally marketed device to which substantial equivalence is being claimed is:
| 510(k) Number: | K161122 |
|---|---|
| Device Name: | Sony IP Converter NU-IP40S |
| Applicant: | SONY ELECTRONICS INC. |
| 1 SONY DRIVE | |
| park ridge, NJ 07656 | |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | II |
5 Device Description
The NU-IP3T/NU-IP3R IP converters are devices for the transmission/reception of 4K or HD images over a network with low latency from devices equipped with 3G-SDI, HDMI, Display Port, or DVI image outputs.
Connecting multiple IP converters via a network switch allows you to construct a network video transmission system for medical procedures.
6 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 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.
7 Technological Characteristics
The subject device compare to the legally marketed devices as follows:
| Device | Subject Device | Predicate Device(s) |
|---|---|---|
| Sony IP Converter NU-IP3T | ||
| Sony IP ConveterNU-IP3R | Sony IP Converter NU-IP40S | |
| Product | ||
| Configuration | Consists of: | |
| Internet protocol converter (mandatory) NU-IP3T (for Transmitter) NU-IP3R (for Receiver) Network System Manager (optional software) NU-NM30E A/V displays Not provided Exist inside and outside operating room | Consists of: | |
| Internet protocol converter (mandatory) NU-IP40S (for Transmitter and Receiver) Network System Manager (optional software) NU-NM10B A/V displays Not provided Exist inside and outside operating room | ||
| Device | Subject Device | Predicate Device(s) |
| Sony IP Converter NU-IP3T | Sony IP Converter NU-IP40S | |
| Sony IP ConveterNU-IP3R | ||
| Supported | HD-SDI | HD-SDI |
| Signal Formats | 3G-SDI | |
| ● | 3G-SDI | |
| ● | ||
| Quad Link 3G-SDI | ||
| ● | Quad Link 3G-SDI | |
| ● | ||
| Display Port 1.2 | ||
| ● | 3D | |
| ● | ||
| HDMI 2.0 | ||
| ● | ||
| DVI | ||
| ● | ||
| Analog RGB | ||
| Component | ||
| ● | ||
| Composite | ||
| ● | ||
| Supported Video | 640x480 | |
| ● | 1920x1080 | |
| ● | ||
| Resolution | 720x480 | |
| ● | 3840x2160 | |
| ● | ||
| 720x576 | ||
| ● | 4096x2160 | |
| ● | ||
| 800x600 | ||
| ● | ||
| 1024x768 | ||
| ● | ||
| 1280x720 | ||
| ● | ||
| 1280x768 | ||
| ● | ||
| 1280x1024 | ||
| ● | ||
| 1366x768 | ||
| 1920x1080 | ||
| 3840x2160 | ||
| ● | ||
| ● | ||
| 4096x2160 | ||
| Power | +24 V DC, 2 A, 38W (NU-IP3T) | |
| ● | +24 V DC, 1 A, 24W | |
| ● | ||
| Specifications | +24 V DC, 2 A, 42W (NU-IP3R) | |
| ● | ||
| Physical | Ordinary protection against harmful | |
| ● | Ordinary protection against harmful | |
| ● | ||
| Specifications | ingress of water | ingress of water |
| Approx. 1.0 kg (2 lb 3.2 oz) (NU-IP3T) | ||
| ● | Approx. 0.7 kg (1 lb. 8 oz.) | |
| ● | ||
| Approx. 1.2 kg (2 lb 10 oz) (NU-IP3R) | ||
| ● | VESA 100 compatible with adaptation | |
| ● | ||
| Adaptation plate (Back of the monitor) | ||
| ● | plate | |
| Software User | Optional accessory Network System | Optional accessory Network System |
| Interface | Manager (NSM) software allows control of | Manager (NSM) software allows control of |
| multiple IP converters and enables video | multiple IP converters and enables video | |
| switching from a server computer | switching from a server computer | |
| connected to the same network | connected to the same network | |
| Software Main | IP transmission of video signals | |
| ● | IP transmission of video signals | |
| ● | ||
| Function | Auto input signal detection | |
| ● | Auto input signal detection | |
| ● | ||
| Video signal codec | ||
| ● | Video signal codec | |
| ● | ||
| Thumbnail generation | ||
| ● | Thumbnail generation | |
| ● | ||
| IP reception of video signals | ||
| ● | IP reception of video signals | |
| ● | ||
| Video output | ||
| ● | Video output | |
| ● | ||
| Firmware update | ||
| ● | Firmware update | |
| ● | ||
| PiP/PaP | Switching of channels used for video | |
| ● | ||
| Still image create | ● | |
| signal transmission | ||
| ● | Redundant network transmission | |
| Still image display | ||
| ● | ● | |
| function | ||
| Direct video output | ||
| ● | ||
| RS232 serial control | ||
| ● | ||
| Distributes | Yes | Yes |
| Audio / Video | Video only | |
| Signals Inside | ||
| the Operating | ||
| Room? | ||
| Distributes | Yes | Yes |
| Audio / Video | Video only | |
| Signals Outside | ||
| the Operating | ||
| Room? | ||
| Device | Subject Device | Predicate Device(s) |
| Sony IP Converter NU-IP3T | ||
| Sony IP ConveterNU-IP3R | Sony IP Converter NU-IP40S | |
| Enables | ||
| Centralized | ||
| Management of | ||
| Audio / Video | ||
| Signals? | Yes | |
| Video only | Yes | |
| Performance | ||
| Standards | • ANSI/AAMI ES60601-1:2005(R), | |
| 2012 (IEC:3.1) | ||
| • IEC 60601-1-2:2014 | ||
| • IEC 62304:2006/A1:2015 | ||
| • ISO 14971:2007 | • ANSI/AAMI ES60601-1:2005 | |
| • IEC 60601-1-2:2007 | ||
| • IEC 62304:2006 | ||
| • ISO 14971:2007 |
5
6
K191678
8 Non-Clinical Performance Data
The subject devices demonstrate conformance with the following recognized standards:
- ANSI/AAMI ES 60601-1 ●
- IEC 60601-1-2 ●
- . IEC 62304
- . ISO 14971
9 Clinical Performance Data
No clinical study is included in this submission.
10 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.