(48 days)
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.
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.
The provided document is a 510(k) summary for the Sony IP Converter NU-IP40S. This device is an "IP Converter" used for distributing patient images and audio-visuals within a hospital or clinical environment. It is classified as an "Endoscope and accessories" under regulation 21 CFR 876.1500.
The document states that no clinical study was included in the submission. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of clinical outcomes or human reader improvement, as this device primarily deals with technical image and audio-visual distribution.
However, the document does report on non-clinical performance data, which demonstrates the device's conformance to recognized technical safety and electromagnetic compatibility standards. These standards serve as the "acceptance criteria" for the non-clinical performance aspects of this device.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance (Conformance) |
|---|---|
| ANSI/AAMI ES60601-1:2005 | Conforms to standard |
| IEC 60601-1-2:2007 | Conforms to standard |
| IEC 62304:2006 | Conforms to standard |
| ISO 14971:2007 | Conforms to standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical samples or data. The testing mentioned relates to non-clinical performance (conformance to standards). For such testing, a sample size typically refers to the number of device units tested, but this detail is not provided. Data provenance is also not applicable in this context as it refers to technical performance rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The non-clinical performance data involves testing against established technical standards, not expert-derived ground truth on clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "No clinical study is included in this submission." This device is an IP converter for image/audio distribution, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a hardware IP converter for signal distribution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For non-clinical performance testing against technical standards, the "ground truth" is the specifications and requirements defined by those standards.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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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 (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
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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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (8/14)
EF PSC Publishing Services (301) 443-6740
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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.Sony Medical Systems Division1 Sony Drive, Mail Stop 2E2Park Ridge, NJ 07656-8004United States of America |
| Contact Person: | Mr. Amarjit "Andy" JowandhaHead, Global Quality Assurance, Regulatory Affairs & CompliancePhone: +1 (201) 930-6078FAX: +1 (201) 930-6307Email: 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 CommunicationsCorp. |
| Device Name: | NEXXIS OR | BrainSUITE NET | Switchpoint InfinityControl System |
| Regulation Number: | 21 CFR 870.2450 | 21 CFR 876.1500 and 21CFR 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) | SwitchpointInfinity (K033132) |
| ClassificationRegulation | 21 CFR 876.1500 | 21 CFR 870.2450 | 21 CFR 876.150021 CFR 882.4560 | 21 CFR 876.1500 |
| Product Codes | GCJ | DXJ | GCJHAW | GCJ |
| Class | II | II | II | II |
| IntendedUse/Indicationsfor Use | The Sony IPConverter's (IPC)intended use is todistribute patientimages acquiredfrom modalitieswithin a hospital orclinical environmentin almost real-time.The IPC can sendaudio visual signalsand medical imagesto variouscommerciallyavailable productssuch as displays orrecording devicescommonly used in amedical procedureroom or operatingroom. | The Barco NexxisOR system isdesigned to allowtransfer, selectionand distribution ofA/V signals andmedical imagesfrom variouscommerciallyavailableinstruments that arecommonly used in amedical procedurelaboratory oroperating room.The Barco NexxisOR system is alsodesigned fortransfer, selectionand distribution ofhuman interfacesignals and control | BrainSUITE NETfrom BrainLAB is aplatform for theintegration ofdevices and for thedistribution of videosignals andmultimedia content.lt is intended to beused forcommunicationbetween compatibleBrainLAB devices.It providescentralized accessfor managing videodata, medicalimages and patientdata.BrainSUITE NETcan be used in the | The SwitchpointInfinity ControlSystem is a medicaldevice that isdesigned to allowdirect control of thestate, selection, andsettings of roomequipment, andaudio/videoequipment andindirect controlthrough the StrykerEndoscopy SidneSystem of the state,selection, andsettings of surgicalequipment in theoperating room. TheSwitchpoint InfinityControl System isalso an integratedvoice, video, and |
| Subject Device | Predicate Devices | |||
| Device | IP Converter NU-IP40S | NEXXIS OR(K122167) | BrainSUITE NET(K070556) | SwitchpointInfinity (K033132) |
| The IPC allows forthe switching ofimages easilyamong devicesconnected to an IPCin the operatingroom or throughouta healthcarecampus. | signals of non-medical roomequipment.The Barco NexxisOR system allowscontrol andselection of thesesignals from acentral point.The Barco NexxisOR system is notintended to be usedfor remote orrobotically-assistedsurgery.The Barco NexxisOR system is notintended to be usedin the vicinity of MRIor other devices thatuse strong magneticfields. | operating theater forvarious surgicalproceduresinvolving videoprocessing, imagerecording, patientdata viewing andsoftware applicationcontrol. | data router andteleconferencinginterface for theoperating room. Theintent of theSwitchpoint InfinityControl System is toallow operatingroom personnel acenter point forcontrolling allequipment andcommunication insurgery.The StrykerSwitchpoint InfinityControl System isindicated for usewith the StrykerEndoscopy SidneSystem [510(k) #K022393] and Sidnecompatibleendoscopic andgeneral surgerydevices. The usersof SwitchpointInfinity ControlSystem are generalsurgeons,gynecologists,cardiac surgeons,thoracic surgeons,plastic surgeons,orthopedicsurgeons, ENTsurgeons,urologists,radiologists, andany other surgeonwhom requires theuse of voice, video,or control in theoperating room or ateleconferencinginterface. | |
| interface. | ||||
| ProductConfiguration | Consists of:• Internetprotocolconverter(mandatory)○ NU-IP40S• NetworkSystemManager | Consists of:• Nexxis MNAencoders anddecoders(mandatory)○ MNA-120ENC○ MNA-120DEC | Consists of:• Touchscreeninterface• A/V displays○ Notprovided○ Exist insideandoutside | Consists of:• Media router• Control system• Touchscreeninterface• A/V displays○ Notprovided○ Exist inside |
| Subject Device | Predicate Devices | |||
| Device | IP Converter NU-IP40S | NEXXIS OR(K122167) | BrainSUITE NET(K070556) | SwitchpointInfinity (K033132) |
| (optional)• NU-NM10B• A/V displays• Notprovided• Exist insideandoutsideoperatingroom | • Networkmanagementsoftware(mandatory)• Nexxis ORManagement Suite• Nexxis NetworkSwitch• Extremenetworkswitch(optional)• A/V displays• Notprovided• Exist insideandoutsideoperatingroom | operatingroom | andoutsideoperatingroom | |
| SupportedSignal Formats | • HD-SDI• 3G-SDI• Quad Link 3G-SDI• 3D | • DVI-D• SDI• DP | Wide range perK070556 510(k)Summary | • S-Video• Composite• RGBHV• 3G-SDI• HD-SDI• DVI |
| Supported VideoResolution | • 1920x1080• 3840x2160• 4096x2160 | • 1920x1200maximum | Unknown | • 1920x1080• 1920x1200 |
| PowerSpecifications | • +24 V DC, 1 A,24 W | • 100-120, 200-240 VAC,50/60Hz, 30 Wmax | Unknown | • 100-240 VAC,50/60 Hz, 570VA(Media router)• 120-240 VAC,50/60 Hz, 400VA(Controlsystem) |
| PhysicalSpecifications | • Ordinaryprotectionagainst harmfulingress of water• Approx. 0.7 kg(1 lb. 8 oz.)• VESA 100compatible withadaptationplate | • IPX0• 750 g• VESA 100compatible withadaptationplate | Unknown | • 34 kg, 24" H x20.6" W x 17" D(Media router)• 4.08 kg, 2.6" Hx 12.6" W x 17"D (Controlsystem) |
| Software UserInterface | Optional accessoryNetwork SystemManager (NSM)software allowscontrol of multiple IPconverters andenables video | Networkmanagementsoftware(mandatory)provides softwarecontrol interface forlayout, status and | Single touchscreeninterface enablesfull control of videosignals allowingmanipulation ofhow/whereinformation is | Control system is anintegrated voice,video, and datarouter andteleconferencinginterface for theoperating room |
| Subject Device | Predicate Devices | |||
| Device | IP Converter NU-IP40S | NEXXIS OR(K122167) | BrainSUITE NET(K070556) | SwitchpointInfinity (K033132) |
| switching from aserver computerconnected to thesame network | diagnosis, LEDindicators for powersupplies | displayed, such asmonitors in theoperating room or inremote rooms | ||
| DistributesAudio / VideoSignals Insidethe OperatingRoom? | Yes | Yes | Yes | Yes |
| DistributesAudio / VideoSignals Outsidethe OperatingRoom? | Yes | Yes | Yes | No |
| EnablesCentralizedManagement ofAudio / VideoSignals? | Yes | Yes | Yes | Yes |
| PerformanceStandards | ● ANSI/AAMIES60601-1:2005● 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:
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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.
§ 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.