← Product Code [GCJ](/productcode/GCJ) · K120611

# SONY PVM-2551MD OLED MONITOR (K120611)

_Sony Electronics, Inc. · GCJ · Jun 28, 2012 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K120611

## Device Facts

- **Applicant:** Sony Electronics, Inc.
- **Product Code:** [GCJ](/productcode/GCJ.md)
- **Decision Date:** Jun 28, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.

## Device Story

The Sony PVM-2551MD is a 24.5-inch widescreen OLED color video monitor for medical environments. It accepts digital and analog video signals from surgical camera systems, converting analog to digital as needed. The device utilizes TRIMASTER technology and electroluminescence to provide high-definition (1920 x 1080) real-time imaging with high contrast and color accuracy. Used in ORs by surgeons and clinical staff during minimally invasive procedures (arthroscopy, laparoscopy, endoscopy, etc.), the monitor displays live surgical feeds to assist in visualization and clinical decision-making. It features two option slots for signal input/output expansion.

## Clinical Evidence

Bench testing only. Compliance with recognized standards for electromagnetic compatibility and electrical safety was demonstrated.

## Technological Characteristics

24.5-inch OLED flat-panel display; 1920 x 1080 resolution; 16:9 aspect ratio; electroluminescence-based light emission; accepts digital and analog video inputs; two built-in option slots for signal expansion; standalone medical monitor.

## Regulatory 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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- Stryker Vision Elect WHDTV ([K081995](/device/K081995.md))

## Submission Summary (Full Text)

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>
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# 510(k) Summary for Sony PVM-2551MD OLED Monitor (per 21 CFR 807.92)

JUN 2 8 2012

#### 1. APPLICANT / SPONSOR

Sony Electronics Inc. Sony Medical Systems Division 1 Sony Drive Park Ridge, NJ 07656

Contact Person: Ms. Aleta Moeller 201-358-4182 Telephone:

June 8, 2012 Date Prepared:

### 2. DEVICE NAME

Sony PVM-2551MD OLED Monitor Proprietary Name: Common/Usual Name: Monitor Endoscope and Accessories Classification Name:

### 3. PREDICATE DEVICE

- · Stryker Vision Elect WHDTV, Stryker Endoscopy, K081995
### 4. DEVICE DESCRIPTION

The Sony PVM-2551MD OLED Monitor is a color video monitor and is intended primarily for use in a medical environment for displaying images captured during minimally invasive and general surgical procedures. The monitor features a 24.5inch widescreen OLED panel and Sony's TRIMASTER™ technology, which has been developed to provide accurate color reproduction, precision imaging, and quality picture consistency. The monitor employs full high-definition (HD) performance with 1920 x 1080 pixels, an aspect ratio of 16:9, and a pixel efficiency of 99.99%.

OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric Being self-emitting, the strength of luminescence can be current is applied.

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Ki20611

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controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction.

In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals.

The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.

### 5. INTENDED USE

The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Sony PVM-2551MD OLED Monitor has the same overall purpose and function as the predicate device cited above. Both of the systems are intended to provide color video displays of images from surgical camera systems.

### 7. PERFORMANCE TESTING

Testing of the Sony PVM-2551MD OLED Monitor demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety.

### 8. CONCLUSION

Based on the similarities in overall purpose and function, the Sony PVM-2551MD OLED Monitor has demonstrated substantial equivalence to the cited predicate device and any differences do not affect the safety or effectiveness of the device.

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Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the people in the United States.

Public Health Service

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

JUN 2 8 2012

Sony Electronics, Incorporated % Aptiv Solutions Ms. Cynthia Sinclair Principal Consultant, Regulatory Services, Aptiv Solutions 49 Plain Street North Attleboro, Massachusetts 02760

Re: K120611

Trade/Device Name: Sony PVM-2551MD OLED Monitor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, FET Dated: June 08, 2012 Received: June 11, 2012

Dear Ms. Sinclair:

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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Cynthia Sinclair

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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

urs,

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

Enclosure

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K12.0611

## Indications for Use

510(k) Number (if known): K120611

Sony PVM-2551MD OLED Monitor Device Name:

Indications for Use:

The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.

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

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)

Neil R. Osher for mxm

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120611

---

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