core nova Complete Operating Room Endoscopy

K151282 · Richard Wolf Medical Instruments Corp. · ODA · Jan 12, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151282
• Device Name: core nova Complete Operating Room Endoscopy
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: ODA · Gastroenterology, Urology
• Decision Date: Jan 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.

Device Story

Network-based integrated operating room accessory; provides central control for Richard Wolf and third-party medical devices. System components include core.browser (control software), core.connect (hardware interface/drivers), IR Transceiver (infrared connectivity), core.media (video distribution/recording), and core.portal (HIS/PACS/billing integration). Operated by physicians/medical staff via touch-screen terminals in the OR. Enables remote control of device settings, parameter monitoring, and warning displays from a sterile area. Benefits include centralized workflow management and reduced need for manual adjustment of individual devices during procedures. No direct patient contact; reusable components.

Clinical Evidence

No clinical or animal studies performed. Evidence consists of bench testing, including electrical safety (IEC 60601-1, ANSI/AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2, EN 61000-3-2/3). Software verification and validation conducted per FDA guidance.

Technological Characteristics

Network-based central control unit; metal and plastic construction. Connectivity via LAN/Ethernet and IR Transceiver. Multi-master communication architecture. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Software-controlled via touch-screen terminals. No direct patient contact.

Indications for Use

Indicated for central control of integrated medical devices and accessories (e.g., OR-lamp, OR-camera, OR-table, insufflators, video/documentation systems) in the operating room for diagnostic and therapeutic medical conditions. Intended for use by qualified medical experts.

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.

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

• RIWO NET Operating Control System Model # 5590 (K020255)

Submission Summary (Full Text)

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

January 12, 2016

Richard Wolf Medical Instruments Corporation Ms. Lisa Williams Regulatory Affairs Assistant 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K151282

Trade/Device Name: core nova Complete Operating Room Endoscopy Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODA Dated: December 11, 2015 Received: December 15, 2015

Dear Ms. Williams:

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 (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 -S

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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# Indications for Use

510(k) Number (if known) K151282

#### Device Name

core nova Complete Operating Room Endoscopy

#### Indications for Use (Describe)

Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 5. 510(k) Summary

| Submitter: | Date of Preparation: |
|----------------------------------------|--------------------------------------------------|
| Company / Institution name: | May 01, 2015 Revised Jan. 07, 2016 |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: 14 184 79 |
| Division name (if applicable): | Phone number (include area code): |
| N.A. | ( 847 ) 913 1113 |
| Street address: | FAX number (include area code): |
| 353 Corporate Woods Parkway | ( 847 ) 913 0924 |
| City: | State/Province: |
| Vernon Hills | Illinois |
| Country: | ZIP / Postal Code: |
| USA | 60061 |
| Contact name: | Lisa Williams |
| Contact title: | Regulatory Affairs Assistant |

Parent Company:

| Company / Institution name: | FDA establishment registration number: |
|-----------------------------|----------------------------------------|
| Richard Wolf GmbH | 96 111 02 |
| Street address: | |
| Pforzheimer Str. 32 | |
| City: | State/Province: |
| Knittlingen | Baden-Württemberg |
| Country: | ZIP / Postal Code: |
| Germany | 75438 |

Product Information:

| Trade name: | Model numbers: |
|---------------------------------------------|-------------------------------------------------------------------------------------|
| core nova Complete Operating Room Endoscopy | 5592201, 5592501, 5592504, 55926xx, 5593001, and their accessories |
| Common name: | Classification name: |
| Endoscopic Central Control Unit | 876.1500; ODA Endoscopic Central Control Unit, Endoscope and accessories. Class II. |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|------------------------------------------------|--------------|
| K020255 | RIWO NET Operating Control System Model # 5590 | Richard Wolf |

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# 1.0 Description

The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area.

Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.

- · The software core.browser is used to control an OR system in conjunction with core nova.
- · The core.connect module is used for the connection of external medical devices to core nova and allows the triggering of predefined functions.
- · In conjunction with the core.connect hardware, the product-specific drivers are used for remote-controlling the specified devices within core nova.
- · The IR Transceiver infrared module serves to connect external medical devices equipped with an infrared interface to core nova in order to control predefined functions.
- The core.media device is designed for distributing and recording video signals and video data within core nova.
- · The core.portal is designed for exchange of information with hospital information systems (HIS), image archiving (PACS) and billing systems.

Devices which are integrated into the Richard Wolf core nova can be controlled via the core nova centrally from one or more work stations in the operating room via software installed on a control terminal. The connected devices can be controlled via the core nova. using: control terminals with touch screens, user presets, as well as the control options on the connected devices themselves.

Devices included in core nova devices are reusable and do not require sterilization because there is no direct / in-direct patient contact. For device operation, a short contact of the operator with control terminal interface (touchscreen) will occur. Methods of cleaning and disinfection are detailed in the Instruction for Use.

Core nova use is exclusively intended for use by medical experts and may only be used by adequately qualified and trained medial doctors.

# 2.0 Indications for Use

Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room.

In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp. OR-camera. OR-table, insufflators, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be controlled by control terminals (with touch screen), or the control mechanism on actual device.

WARNING! The safety and efficacy of the use of this system has not been evaluated along with the use of a robotic assisted surgical device in the OR environment.

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| Manufacturer | Richard Wolf | Richard Wolf | SE Decision |
|----------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|----------------------------------|
| Trade Name | Core Nova | RIWO-NET | N/A |
| 510(k) Number | | K020255 | N/A |
| Product Code | ODA | KOG | Equivalent |
| Regulation Number | 876.1500 | 876.1500 | Equivalent |
| Regulation Name | Endoscopic Central Control<br>Unit | Endoscope and/or Accessories | Equivalent |
| Indications for Use | Central control of devices<br>in the operating room | Central control of devices<br>in the operating room | Equivalent |
| Connection type | LAN/Ethernet | CAN-Bus | Equivalent,<br>See SE Discussion |
| Connection with | interface box core.connect | individual CAN interfaces | Equivalent, |
| foreign devices | 5592501 with drivers 55926xx | 5590.8xx | See SE Discussion |
| Material | Metal & plastics | Metal & plastics | Equivalent |
| AC Powered | yes | yes | Equivalent |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Equivalent |
| Testing | IEC601-1-2 | IEC601-1-2 | Equivalent |
| Show centrally<br>operating parameters<br>of connected devices | yes | yes | Equivalent |
| Show centrally<br>warnings of connected<br>devices | yes | yes | Equivalent |
| Designed for use in<br>ceiling supply units or<br>video cart | yes | yes | Equivalent |
| media management | core.media, inside the<br>operating room | outside operating room | Equivalent |
| Principle of operation | Multi-master communication | only one master possible | Equivalent |

## 3.0 Comparison of Technological Characteristics with the Predicate Devices

The main difference between predicate RIWO-NET and new core nova by Richard Wolf is the interconnection between the components, made via LAN (Ethernet) interface at the new core nova instead via CAN-bus interface before. The functionality is equivalent.

For the connection of equipments by foreign manufacturers interface boxes are also used in these systems, which are equivalent to Richard Wolf's interface box core.connect 5592501.

The differences between the above comparisons products and the core nova are mainly related to the following aspects:

- · The presentation mode at the appropriate monitor(s)
- · The kinds of functions for the remote control of the device models to be connected
- · The transfer type between the OR devices and the control computer

## 4.0 Substantial Equivalence Discussion

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-cleared devices sold by Richard Wolf (K020255).

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# 5.0 Performance Data

# Biocompatibility testing

There is no direct or indirect patient contact with core nova, Biocompatibility testing is not applicable.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the core nova devices

The components of core nova comply with the standards:

- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007): Medical electrical equipment ● Part 1: General requirements for basic safety and essential performance (3th edition)
- ANSI/AAMI ES60601-1 Medical electrical equipment- Part I: General requirements for basic safety and essential performance, C1: 2009, Amendment 2: 2010.
- . IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- EN 61000-3-2/ EN 61000-3-3 Electromagnetic compatibility (harmonics/ flicker) for limit class: A

## Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for these devices was considered as a "minor" level of concern, but components that control devices with a "moderate" level of concern were considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

# Animal Study or Clinical Studies

Preclinical laboratory studies, tissue or animal testing were not performed.

## 7.0 Conclusions

Core nova has the same Indications for use as the predicate devices The different technological characteristics are demonstrated to be substantially equivalent to the predicate devices by Richard Wolf, and the core nova components does not raise different questions regarding its safety and effectiveness as compared to the referenced predicate device.

Core nova devices were non-clinically tested to determine the safety and efficacy under the indications for use and meet aforementioned safety standards, same as the predicate device.

For these reasons, The Richard Wolf core nova is substantially equivalent to the existing 510(k) cleared devices sold devices sold by Richard Wolf (K020255).