PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)

K141551 · Stryker Corporate · PGW · Sep 8, 2014 · Neurology

Device Facts

• Record ID: K141551
• Device Name: PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
• Applicant: Stryker Corporate
• Product Code: PGW · Neurology
• Decision Date: Sep 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Device Story

The Stryker PROFESS System is an intraoperative image-guided surgery (IGS) navigation system for intranasal and sinus procedures. It utilizes a computer workstation (Stryker ADAPT, Nav3, or Nav3i) running navigation software. The system takes pre-operative CT images as input. During surgery, a miniature video camera mounted on navigated surgical instruments (suction tools, sinus seekers) captures live video of the surgical field. The software processes these video images to track the instrument's position relative to a patient-mounted tracker (PROFESS Patient Tracker) and the pre-operative CT scan. The system displays the instrument's real-time location on a monitor via multiplanar reconstruction (sagittal, coronal, axial views) with superimposed cross-hairs. This guidance assists surgeons in navigating complex sinus anatomy. The system is intended for use by trained surgeons and clinical staff in an operating room environment.

Clinical Evidence

No clinical testing was conducted. Evidence is based on bench testing, including accuracy verification (± 2 mm per ASTM F2554:2010), phantom and cadaver studies, biocompatibility (ISO 10993-1), electrical safety (ANSI/AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software validation (IEC 62304).

Technological Characteristics

System components include PROFESS software, navigated surgical instruments (AISI 301/304 stainless steel), patient tracker (ABS/TPE), and registration stickers. Navigation uses video-based localization. Connectivity via USB 2.0. Sterilization of single-use components via Ethylene Oxide (EO) per ISO 11135-1. Software operates on Stryker SPC-3 workstation running Windows XP.

Indications for Use

Indicated for intranasal and sinus surgery in which computer-assisted surgery is appropriate and a CT image of the patient is available. Supports endoscopic sinus surgery and intranasal procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Stryker Navigation System – ENT Module (K002732)
• Stryker Navigation System – Cranial Module (K062640)
• Stryker NAV3i Platform (K130874)

Submission Summary (Full Text)

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

September 8, 2014

Stryker IMT Ms. Becky Ditty Sr. Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, MI 49001

Re: K141551

Trade/Device Name: Stryker PROFESS System Regulation Number: 21 CFR 882.4560 Regulation Name: Ear, Nose, and Throat Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: June 10, 2014 Received: June 11, 2014

Dear Ms. Ditty:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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/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,

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

Stryker PROFESS™ System

#### Indications for Use (Describe)

The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intransal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures:

• Endoscopic sinus surgery

• Intranasal procedures

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Eric A. Mann -S 2014.09.08 17:23:26 -04'00'

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# Section 5. 510(k) Summary

This section provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG – Navigation<br>Boetzinger Str. 41<br>D-79111 Freiburg, GERMANY<br>(p) [phone]<br>(f) [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Becky Ditty<br>Sr. Staff Regulatory Affairs Specialist<br>4100 E. Milham Ave<br>Kalamazoo, MI 49002<br>[e-mail] |
| Registration No.: | 8010177 |
| Trade Name: | Stryker PROFESS™ System |
| Common Name: | Navigation System |
| Classification Name: | Ear, Nose, and Throat Stereotaxic Instrument |
| Regulation Number: | 882.4560 |
| Product Code: | PGW |
| Device Description: | The PROFESS™ System, consisting of a computer<br>platform, software and sterile single-use accessories, is<br>designed to enable image guided surgery in intranasal and<br>sinus surgery. Specifically, the system tracks and displays<br>to the surgeon the intraoperative location of navigated<br>surgical instruments, for example suction tools, relative to a<br>CT image.<br>The PROFESS™ System is based on the use of live video<br>images captured by the miniature video camera mounted<br>on the PROFESS™ Navigated Surgical Instruments. The |

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captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image.

The following are the PROFESS™ System components:

- PROFESS™ Software ●
- PROFESS™ Navigated Surgical Instruments: ●
- PROFESS™ Straight Suction
- PROFESS™ Curved 70°Suction
- PROFESS™ Curved 90° Suction
- PROFESS™ Frontal Sinus Seeker
- PROFESS™ Registration Stickers ●
- PROFESS™ Patient Tracker ●
- PROFESS™ Adaptor Cable .
- Computer platform containing an SPC-3 Workstation . and IO-Tablet, one of:
- Stryker ADAPT® Platform
- Stryker Nav3® Platform
- o Stryker Nav3i™ Platform
- The Stryker PROFESS™ system is a navigation surgical Indications for Use: software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative quidance system to enable intranasal and sinus computer assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.

The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available.

The Stryker PROFESS™ system supports the following surqical procedures:

- Endoscopic sinus surgery .

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Image /page/5/Picture/0 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is in all lowercase letters except for the first letter, which is capitalized. A registered trademark symbol is located to the right of the word. The word is black and the background is white.

- Intranasal procedures
The PROFESS™ System has the same intended use and Predicate Devices: technological characteristics as the predicate devices shown in the following tables:

| Predicate Device | 510(k)<br>Number | Clearance<br>Date | Predicate Substantial<br>Equivalence Characteristic | Feature | Subject Device | Predicate Devices |
|-----------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stryker Navigation System – ENT<br>Module | K002732 | 10/01/2000 | Navigated Surgical Instruments | Indications for<br>Use | The Stryker PROFESS™ system is a navigation surgical software module that,<br>when used with a specific Stryker computer workstation, is intended as an<br>intraoperative guidance system to enable intranasal and sinus computer-<br>assisted surgery. The system tracks and displays the intraoperative location of<br>navigated surgical instruments relative to a CT image. The system can be used<br>for intraoperative guidance where a reference to a rigid anatomical structure can<br>be identified. | K002732, Stryker Navigation System - ENT Module<br>The Stryker Navigation System - ENT Module is intended as a planning and<br>intraoperative guidance system to enable open or percutaneous image guided<br>surgery. The system is indicated for any medical condition in which the use of<br>image guided surgery may be appropriate, and where a reference to a rigid<br>anatomical structure can be identified relative to medical images. The ENT<br>Module is also indicated for intranasal or sinus use. |
| Stryker Navigation System – Cranial<br>Module | K062640 | 12/14/2006 | Application Software<br>Patient Reference Localizer<br>Registration Accessories | | The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in<br>which the use of computer-assisted surgery is appropriate and for which a CT<br>image of the patient in accordance with the imaging protocol is available.<br>The Stryker PROFESS™ system supports the following surgical procedures:<br>• Endoscopic sinus surgery<br>• Intranasal procedures | K062640, Stryker Navigation System - Cranial Module (iNtellect)<br>The Stryker Navigation System - Cranial Module is intended as a planning<br>and intraoperative guidance system to enable open or percutaneous computer<br>assisted surgery. The system is indicated for any medical condition in which<br>the use of computer assisted planning and surgery may be appropriate. The<br>system can be used for intra-operative guidance where a reference to a rigid<br>anatomical structure can be identified. |
| Stryker NAV3i Platform | K130874 | 09/27/2013 | Computer Platform | | | The system should be operated only by trained personnel such as surgeons and<br>clinic staff. The Cranial Navigation system supports, but is not limited to, the<br>following surgical procedures: |
| | | ENT/Neuro Procedures<br>• Endoscopic Sinus Surgery (ESS)<br>• Intranasal procedures<br>• Ear implant procedures | | | | |
| | | Neuro Procedures<br>• Cranial biopsies<br>• Puncture of abscesses<br>• Craniotomies<br>• Craniectomies<br>• Resection of tumors and other lesions<br>• Removal of foreign objects<br>• Skull base procedures<br>• Transnasal neurosurgical procedures<br>• Transphenoidal pituitary surgery<br>• Shunt placement, including pediatric shunt placement<br>• Placement of electrodes for recording, stimulation and lesion generation<br>• Craniofacial procedures<br>• Skull reconstruction procedures<br>• Orbital cavity reconstruction procedures<br>• Placement of patient specific implants | | | | |

TABLE 5-1 PREDICATE DEVICES

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| Feature | Subject Device | Predicate Devices |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use (continued) | | K130874, Stryker NAV3i Platform<br>The NAV3i platform is a computer workstation that, when used with specific<br>Stryker Navigation surgical software, displays patient specific images and/or<br>patient specific anatomical landmark information and tracks the position and<br>movement of surgical instruments in relation to a target anatomical site on a<br>patient.<br>The clinical setting and target population for the NAV3i Platform is that of a<br>patient undergoing a surgical procedure using stereotactic techniques.<br>Equivalent |
| Components | • PROFESS™ Software<br>• PROFESS™ Navigated Surgical Instruments<br>• PROFESS™ Registration • Stickers<br>• PROFESS™ Patient Tracker<br>• PROFESS™ Adaptor Cable<br>• Computer platform, one of:<br>o Stryker ADAPT® Platform<br>o Stryker Nav3® Platform<br>o Stryker Nav3i™ Platform | K002732, Stryker Navigation System - ENT Module<br>• ENT Software<br>• Navigated Surgical Instruments<br>• Instrument Battery<br>• Patient Tracking System<br>• Computer Platform:<br>o Stryker Navigation System I - Cart<br>K062640, Stryker Navigation System - Cranial Module<br>• iNtellect Software<br>• Navigated Surgical Instruments<br>• Instrument Battery<br>• Patient Registration Mask<br>• Computer Platform, one of:<br>o Stryker Navigation System II - Cart<br>o Stryker eNlite<br>Equivalent |
| Stryker ADAPT® Platform | | |
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i Platform<br>Stryker PC-3 (SPC-3)<br>Equivalent |
| Operating<br>System | Windows XP | K130874, Stryker NAV3i Platform<br>Windows XP<br>Equivalent |
| User Interface | • IO-Tablet Touchscreen with virtual keyboard<br>• Mouse | K130874, Stryker NAV3i Platform<br>• IO-Tablet Touchscreen with virtual keyboard<br>• Mouse<br>Equivalent |
| Feature | Subject Device | Predicate Devices |
| Main Monitor | 24" | K130874, Stryker NAV3i Platform<br>32"<br>Equivalent |
| Main Monitor<br>Position | Fixed position facing surgical field | K130874, Stryker NAV3i Platform<br>Mounted on articulated arm for flexible positioning<br>Equivalent |
| Localizer | N/A | K130874, Stryker NAV3i Platform<br>Infrared optical localizer Navigation System II Camera<br>Equivalent |
| Interfaces | • USB<br>• CD/DVD<br>• Equipotentially Connector<br>Additional interfaces, not used by PROFESS™ System:<br>• LAN<br>• BNC<br>• S-Video | K130874, Stryker NAV3i Platform<br>• USB<br>• CD/DVD<br>• Equipotentially Connector<br>Additional interfaces, not used by PROFESS™ System:<br>• LAN<br>• BNC<br>• S-Video<br>• HDMI<br>• DVI<br>• VGA<br>• FireWire<br>• Microscope (Optional Accessory)<br>Equivalent |
| RFID Reader | Deactivated by default, can be activated with an optional RFID Activation Kit | K130874, Stryker NAV3i Platform<br>Deactivated by default, can be activated with an optional RFID Activation Kit<br>Equivalent |
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i Platform<br>Deactivated by default, can be activated with an optional WLAN Activation Kit<br>Equivalent |
| Uninterruptible<br>Power Supply | N/A | K130874, Stryker NAV3i Platform<br>Yes<br>Equivalent |
| Feature | Subject Device | Predicate Devices |
| Stryker Nav3® Platform | | |
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i Platform<br>Stryker PC-3 (SPC-3)<br>Equivalent |
| Operating<br>System | Windows XP | K130874, Stryker NAV3i Platform<br>Windows XP<br>Equivalent |
| User Interface | • IO-Tablet Touchscreen with virtual keyboard<br>• Mouse | K130874, Stryker NAV3i Platform<br>• IO-Tablet Touchscreen with virtual keyboard<br>• Mouse<br>Equivalent |
| Main Monitor | 24" | K130874, Stryker NAV3i Platform<br>32"<br>Equivalent |
| Main Monitor<br>Position | Fixed position facing surgical field | K130874, Stryker NAV3i Platform<br>Mounted on articulated arm for flexible positioning<br>Equivalent |
| Localizer | Infrared optical localizer Navigation System II Camera | K130874, Stryker NAV3i Platform<br>Infrared optical localizer Navigation System II Camera<br>Equivalent |
| Interfaces | • USB<br>• CD/DVD<br>• Equipotentially Connector<br>Additional interfaces, not used by PROFESS™ System:<br>• LAN<br>• BNC<br>• S-Video | K130874, Stryker NAV3i Platform<br>• USB<br>• CD/DVD<br>• Equipotentially Connector<br>Additional interfaces, not used by PROFESS™ System:<br>• LAN<br>• BNC<br>• S-Video<br>• HDMI<br>• DVI<br>• VGA<br>• FireWire<br>• Microscope (Optional Accessory) |
| Feature | Subject Device | Predicate Devices |
| RFID Reader | Deactivated by default, can be activated with an optional RFID Activation Kit | K130874, Stryker NAV3i Platform<br>Deactivated by default, can be activated with an optional RFID Activation Kit<br>Equivalent |
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i Platform<br>Deactivated by default, can be activated with an optional WLAN Activation Kit<br>Equivalent |
| Uninterruptible<br>Power Supply | N/A | K130874, Stryker NAV3i Platform<br>Yes<br>Equivalent |
| PROFESS™ Software | | |
| Operating<br>Principle | The PROFESS™ Software is installed on the computer platform. Images are<br>imported in DICOM format. The software displays the anatomical images on a<br>monitor facing the surgeon and provides the navigational information. | K062640, Stryker Navigation System - Cranial Module<br>The iNtellect software is installed on the computer platform. Images are<br>imported in DICOM format. The software displays the anatomical and functional<br>images and planned items on a monitor facing the surgeon and provides the<br>navigational information.<br>Equivalent |
| Modes of<br>Operation | • Data Import<br>• System Setup<br>• Registration<br>• Navigation | K062640, Stryker Navigation System - Cranial Module<br>• Data Import<br>• Planning<br>• System Setup<br>• Registration<br>• Navigation<br>Equivalent |
| Control<br>Mechanism | The software is controlled using:<br>• Mouse<br>• Touchscreen<br>• Keyboard<br>• via buttons on the sterile navigated surgical instruments | K062640, Stryker Navigation System - Cranial Module<br>The software is controlled using:<br>• Mouse<br>• Keyboard<br>• via buttons on the sterile navigated surgical instruments<br>Equivalent |
| Localization and<br>Tracking<br>Technology | Video localization and tracking technology: A miniature video camera mounted<br>on the PROFESS™ Navigated Surgical Instruments captures live video images<br>which can be processed by the PROFESS™ Software for localization and<br>tracking of the PROFESS™ Navigated Surgical Instrument relative to the<br>PROFESS™ Patient Tracker | K062640, Stryker Navigation System - Cranial Module<br>Infrared optical active sensing technology: Infrared light emitted by diodes<br>placed in a known fashion on navigated surgical instruments is sensed by a<br>camera array (Navigation Camera) on the computer platform, thus allowing for<br>computation of the spatial information.<br>Equivalent |
| Feature | Subject Device | Predicate Devices |
| System Accuracy<br>Statement | Within the nasal cavities the system has a mean accuracy of 2 mm | K062640, Stryker Navigation System - Cranial Module<br>Within the camera working space, the system has a mean accuracy of 2 mm for<br>translation and 2° for rotation<br>Equivalent |
| Supported Image<br>Modalities | • CT | K062640, Stryker Navigation System - Cranial Module<br>• CT<br>• CTA<br>• MR<br>• MRA<br>• fMRI<br>• PET<br>• SPECT<br>Equivalent |
| Scanner<br>Interfaces | • CD/DVD<br>• USB | K062640, Stryker Navigation System - Cranial Module<br>• CD/DVD<br>• USB<br>• Network connectivity<br>• Magneto Optical Disk<br>Equivalent…