Endomat Select

K180735 · Karl Storz SE & CO. KG · HIG · Oct 31, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180735
• Device Name: Endomat Select
• Applicant: Karl Storz SE & CO. KG
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Oct 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Suction/irrigation pumps and their accessories are used for the introduction of irrigation fluids into organs, joints and operating fields as well as the suctioning off of irrigation fluids and bodily fluids, secretions, tissue and gas during diagnostic or therapeutic interventions.

Device Story

Endomat Select (UP210) is a multi-functional, pressure-controlled, combined irrigation and suction pump for endoscopic/surgical procedures. Device inputs include user settings via LCD touch screen and encoded tubing sets that automatically configure operating modes. It utilizes a microprocessor-controlled peristaltic pump to deliver or suction fluids. Used in ORs by surgeons/staff; integrates with other Karl Storz devices via Storz Control Bus (SCB). Software monitors pressure; stops actuator and reverses pump direction if pressure exceeds limits; provides high-pressure alarms. User must confirm pressures >100mmHg. Benefits include maintained visualization, controlled distention, and automated overpressure protection, reducing risk of tissue damage.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including verification of pressure control, flow limitation, flow control, pressure limitation, suction control, and overpressure safety alarms/relief mechanisms.

Technological Characteristics

Microprocessor-controlled peristaltic pump; LCD touch screen interface; dual pressure sensors at pump head; SCB connectivity. Software-based overpressure protection (pump reversal). Tubing sets are encoded for automatic mode selection. Electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, alarm systems per IEC 60601-1-8.

Indications for Use

Indicated for: infusion of sterile irrigant solutions into ureter/upper urinary tract and suctioning of fluids/tissue/gas during urological endoscopic procedures; liquid distention of uterus for diagnostic/operative hysteroscopy; infusion of sterile irrigant solutions into organs/operating fields during laparoscopic and open general surgery; sustained liquid irrigation/distention of joint/intra-articular spaces during arthroscopic surgery; infusion of sterile irrigant solutions for lens cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and transnasal pituitary gland surgery.

Regulatory Classification

Identification

A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

Predicate Devices

• World of Medicine AQUILEX FLUID CONTROL SYSTEM H112 (K112624)
• Applied Medical EPIX (K122619)
• World of Medicine Uro Pro (K042457)
• Karl Storz Endomat LC (K031457)
• Atherex Dual Wave Arthroscopy Pump (K083707)
• Karl Storz ClearVision (K072410)
• Karl Storz Clear Vision (K013838)

Submission Summary (Full Text)

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October 31, 2018

Karl Storz SE & Co. KG Nina Dusper Regulatory Affairs Manager Dr.-Karl-Storz-StraBe 34 Tuttlingen, 78532 Germany

Re: K180735

> Trade/Device Name: Endomat Select (Model Number: UP210) Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG. BTA. LJH. OCX. HRX. GWG. EOB Dated: July 30, 2018 Received: August 2, 2018

Dear Nina Dusper:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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

510(k) Number (if known) K180735

Device Name

Endomat Select (Model Number: UP210)

Indications for Use (Describe)

Endomat Select is intended to:

· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures

· provide liquid distention of the uterus for diagnostic and operative hysteroscopy

· provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery

· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery

· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

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)

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KARL STORZ`s knowledge.

| Applicant: | KARL STORZ SE & Co. KG<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen<br>Baden-Württemberg, GERMANY |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nina Dusper<br>Regulatory Affairs Manager<br>[phone]<br>[phone] |
| Date of Preparation: | 1st February 2018 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: Endomat Select (Model Number: UP210)<br>Common Name: Suction Irrigation Pump |
| Regulation: | 21 CFR 884.1700 (Hysteroscopic Insufflator) |
| Class: | II |
| Product Code: | HIG: Hysteroscopic Insufflator |
| Additional Product Codes: | BTA: Pump, Portable, Aspiration (Manual or Powered)<br>LJH: System, Irrigation, Urological<br>OCX: Endoscopic Irrigation/Suction System<br>HRX: Arthroscope |

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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

| GWG: Endoscope, neurological | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EOB: Nasopharyngoscope (flexible or rigid) | |
| Predicate Device(s): | World of Medicine AQUILEX FLUID CONTROL SYSTEM<br>H112 (K112624),<br>Applied Medical EPIX (K122619),<br>World of Medicine Uro Pro (K042457),<br>Karl Storz Endomat LC (K031457),<br>Atherex Dual Wave Arthroscopy Pump (K083707),<br>Karl Storz ClearVision (K072410),<br>Karl Storz Clear Vision (K013838)<br>**The above predicates have not been subject to any recall** |
| Device Description: | The Endomat Select is a multi-functional, pressure-<br>controlled, combined irrigation and suction pump. It can be<br>used for irrigation and, where appropriate dilation, during<br>Hysteroscopic (HYS), Arthroscopic (ART), Urological<br>(URO) and General Surgical or Laparoscopic (SURG)<br>interventions. The device can be used for suction during<br>Urological (URO) interventions. In addition the device can<br>function in an oscillatory mode (ENT/Neuro) providing a<br>fluid means to maintain lens clarity during use in Transnasal<br>procedures. The device has a modern LCD display with<br>touch screen user interface. The tubing sets are encoded so<br>that they can be identified by the device, which selects the<br>appropriate operating modes based on the tubing set<br>connected. The device can also be connected to other Karl<br>Storz devices using the proprietary Storz Control Bus (SCB)<br>[K994348].<br>The device protects the patient from overpressure via<br>software means. The software controlled pressure<br>measurement system can stop the actuator (roller pump)<br>should the pressure rise beyond the pre-determined limit and |

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will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

| Accessory description | Part number | Marketing Status |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Suction bottle, 5 1, sterilizable | 20300050 | Class II<br>510(k) Exempt |
| Cap for suction bottle 20 3000<br>50, 5 1 sterilizable | 20300034 | Class II<br>510(k) Exempt |
| Metal filter | 20300038 | Class II<br>510(k) Exempt |
| Bottle stand for suction bottle,<br>5 I | 20300032 | Class II<br>510(k) Exempt |
| Bottle stand holder | 20300033 | Class II<br>510(k) Exempt |
| Suction bottle, 0,5 I, sterilizable | 20300051 | Class II<br>510(k) Exempt |
| Cap, for suction bottle | 20300039 | Class II<br>510(k) Exempt |
| Bottle stand, for suction bottle | 20300231 | Class II<br>510(k) Exempt |
| Control cable | 20701070 | Class II<br>K973251 |
| Single pedal footswitch | 20014130 | Class II<br>K072410 |
| SCB connecting cord, length 100<br>cm | 20090170 | Class II<br>K994348 |
| Tubing Set, Irrigation, PC, for<br>single use, sterile, package of 10 | 031523-10 | Class I |
| Tubing Set, Suction, BS, for | 031647-10 | Class I |
| | single use, sterile, package of 10 | |
| Tubing Set, Suction, OS, for single use, sterile, package of 10 | 030647-10 | Class I |
| Tubing Set, Irrigation, FC, for single use, sterile, package of 10 | 031524-10 | Class I |
| Tubing Set, Irrigation, CV, for single use, sterile, package of 10 | 031529-10 | Class I |
| Intended Use: | Suction/irrigation pumps and their accessories are used for the introduction of irrigation fluids into organs, joints and operating fields as well as the suctioning off of irrigation fluids and bodily fluids, secretions, tissue and gas during diagnostic or therapeutic interventions. | |
| Indications for Use | Endomat Select is intended to:<br>• provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures<br>• provide liquid distention of the uterus for diagnostic and operative hysteroscopy<br>• provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery<br>• provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery<br>• provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically | |

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Image /page/6/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters.

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Image /page/7/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters on the bottom line.

| | | assisted transnasal pituitary gland surgery | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | ** The above Indications for Use represent a combination of the<br>indications for the cited predicate devices and therefore there is no new<br>intended use. ** | |
| Technological<br>Characteristics: | The proposed subject device is a multifunctional design that<br>incorporates the functionality of multiple predicate devices.<br>The technological differences between each of the subject<br>device's functions and the respective predicate devices are<br>summarized in the Table 1.1. below, and they do not raise<br>any different issues of safety and effectiveness. | | |
| Non-Clinical<br>Performance Data: | The Endomat Select follows the FDA recognized consensus<br>standards and is tested according to the following standards<br>and FDA Guidances:<br>Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-1-8 Software Verification and Validation Testing Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices issued on May 11, 2005 Level of Concern: Major Summative Usability Testing IEC 62366 Performance Testing Hysteroscopic and Laparoscopic Insufflators:<br>Submission Guidance For A 510(K) issued on<br>August 1, 1995 for Product Code HIG Performance tests of pressure controlled<br>irrigation mode | | |

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| Performance tests of intrauterine pressure | |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional bench testing was performed to ensure the device | |
| met its design specifications. | |
| Verification Test | Conclusion |
| Performance:<br>Pressure Control | Pass |
| Performance:<br>Flow Limitation | Pass |
| Performance:<br>Flow Control | Pass |
| Performance:<br>Pressure Limitation | Pass |
| Performance:<br>Suction Control | Pass |
| Safety:<br>Overpressure Warning (in pressure relevant<br>GYN and URO interventions) | Pass |
| Safety:<br>Overpressure Warning (in pressure relevant<br>ARTHRO interventions) | Pass |
| Safety:<br>Overpressure Alarm<br>(in pressure relevant GYN and URO<br>interventions) | Pass |
| Safety:<br>Pressure Relief<br>(in pressure relevant GYN and URO<br>interventions) | Pass |
| The bench testing performed verified and validated that the<br>Endomat Select has met all its design specification and is | |
| substantially equivalent to its predicate devices. | |
| Clinical Performance Data: | Clinical testing was not required to demonstrate the<br>substantial equivalence to the predicate devices. Non-clinical<br>bench testing was sufficient to assess safety and effectiveness<br>and to establish the substantial equivalence. |
| Conclusion: | The non-clinical testing demonstrates that the device is as<br>safe, as effective and performs as well as or better than the<br>legally marketed predicate devices. |

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Image /page/9/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

## Table 1.1. Comparison of Technological Characteristics

| | Subject Device | Predicate Devices by application | | | | | | |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Karl Storz | Applied Medical | World of Medicine | World of Medicine | Karl Storz | Artherex | Karl Storz | Karl Storz |
| | Endomat Select | EPIX | AQUILEX FLUID<br>CONTROL SYSTEM<br>H112 | Uro Pro | Endomat LC | Dual Wave Arthroscopy<br>Pump | Clearvision | Clearvision<br>Lens Irrigation System |
| Application | Multi | Surgery<br>( Laparoscopy ) | Hysteroscopic | Urological | Urological Suction | Arthroscopic | Lens Cleaning | Lens Cleaning |
| | | | | | | | | |
| Design | Microprocessor<br>controlled, pressure<br>monitoring peristaltic<br>Pump for irrigation or<br>suction. | Microprocessor<br>controlled, peristaltic<br>pump for irrigation<br>with conduit for<br>external suction. | Microprocessor<br>controlled, pressure<br>monitoring peristaltic<br>pump for irrigation<br>and/or suction. | Microprocessor controlled,<br>pressure monitoring<br>peristaltic pump for<br>irrigation or suction. | Microprocessor<br>controlled, peristaltic<br>pump for suction. | Microprocessor<br>controlled, pressure<br>monitoring peristaltic<br>pump for irrigation and<br>suction. | Microprocessor<br>controlled, oscillatory<br>peristaltic pump | Microprocessor<br>controlled, oscillatory<br>peristaltic pump |
| Intended Use | Suction/irrigation<br>pumps and their<br>accessories are used<br>for the introduction of<br>irrigation fluids into<br>organs, joints and<br>operating fields as wel<br>as the suctioning off of<br>irrigation fluids and<br>bodily fluids,<br>secretions, tissue and<br>gas during diagnostic<br>or therapeutic<br>interventions. | The Epix® Suction<br>Irrigation System is<br>intended as a general<br>purpose suction<br>and/or irrigation<br>device for use in<br>laparoscopic and open<br>general surgery,<br>laparoscopic and oper<br>gynecological surgery,<br>laparoscopic and open<br>urologic surgery. This<br>device delivers sterile<br>irrigant solution and<br>serves as a conduit for<br>suction. | Aquilex™ Fluid Control<br>System is intended to<br>provide liquid<br>distension of the<br>uterus during<br>diagnostic and<br>operative<br>hysteroscopy, and to<br>monitor the volume<br>differential between<br>the irrigation fluid<br>flowing into and out of<br>the uterus. | The URO Pro is an irrigation<br>roller pump intended for<br>the infusion of sterile<br>solutions into the ureter<br>and upper urinary tract<br>during diagnostic and/or<br>therapeutic endoscopic<br>urologic procedures. It is<br>indicated for the infusion of<br>sterile solutions through an<br>endoscope into the<br>urogenital tract to irrigate<br>the ureter or upper urinary<br>tract in a controlled<br>manner and to improve<br>visibility of the surgical<br>field during urologic<br>procedures. | Suction/irrigation pumps<br>and their accessories are<br>used for the introduction<br>of irrigation fluids into<br>organs, joints and<br>operating fields as well<br>as the suctioning off of<br>irrigation fluids and<br>bodily fluids, secretions,<br>tissue and gas during<br>diagnostic or therapeutic<br>interventions. | The AR-6480 is intended<br>to provide continuous<br>pulse-free flow that<br>reacts immediately to<br>changes in the intra-<br>articular pressure so that<br>joint distention can be<br>sustained even under<br>high shaver extraction<br>volumes or secondary<br>outflow. | Irrigation pumps and<br>their accessories are<br>used for the introduction<br>of irrigation fluids into<br>organs and operating<br>fields during endoscopic<br>interventions. The<br>clearvision is a lens<br>irrigation pump for the<br>fields of ENT and<br>Neurosurgery. | The KSEA Clearvision is<br>a lens irrogation system<br>for cleaning the lens<br>and maintaining clear<br>visualization without<br>removing the scope<br>from<br>the surgical site during<br>sinus surgery. |

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KARL STORZ Premarket Notification

Endomat Select

Summary of Safety and Effectiveness

| | HIG, BTA, LJH, OCX,<br>HRX, GWG, EOB | BTA | HIG | LJH | OCX | HRX | GWG | EOB |
|-----------------------------------------------|---------------------------------------------------|-----------------------------------------------------|-----------------------------------------------|------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------|----------------------------|----------------------------|
| Procode | | | | | | | | |
| Pressure<br>measurement<br>location and | Yes, dual pressure<br>sensors at the pump<br>head | No pressure<br>measurement | Yes, single transducer<br>at the pump head | Yes, dual pressure sensors<br>at the pump head | No pressure<br>measurement | Yes, dual sensor | No pressure<br>measurement | No pressure<br>measurement |
| User<br>interface/Selection<br>of Application | LCD touch screen | Digital flowrate display<br>and membrane<br>buttons | Digital display and button | Digital display and<br>membrane buttons | Digital flowrate display<br>and membrane buttons | LCD touch screen | On/Off | On/Off |
| Overpressure<br>Safety | Yes, using software<br>and roll pump reversal | No | Yes, using software<br>and roll pump reversal | Yes, using software and roll<br>pump reversal | N/A | Software controlled<br>pump stops at<br>>300mmHg (IFU<br>recommends manual | N/A | N/A |
| Features | | | | | | | | |
| Indicates<br>Operating | Yes | No | Intrauterine | Yes | No | Yes | No | No |
| Alarm for over<br>Pressure | Yes | No | Yes | Yes | No | Yes | No | No |
| Volume difference<br>monitor | No | No | Yes | No | No | No | No | No |
| Indicates<br>Operating Fluid<br>Flow | Yes | Yes | No | Yes, nominal set point | No | No | No | No |
| Alarm for over<br>Fluid Flow | Yes | No | Yes | Yes | No | No | No | No |
| Indicates<br>Maximum Suction<br>Pressure | No | No | No | No | No | No | No | No |
| Alarm for over<br>Suction Pressure | No | No | No | No | No | No | No | No |
| Accessories | | | | | | | | |
| Foot Switch | Yes | No | No | No | Yes | Yes | Yes | Yes |
| Tubing Sets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| External pressure<br>sensor (optional) | No | No | No | No | No | No | No | No |

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Summary of Safety and Effectiveness

| Performance | | | | | | | | |
|----------------------|---------------------------|-----------------|-------------|-------------|------------------------|------------------|-----------|-----------|
| Irrigation Pressure | | | | | | | | |
| Lap/Surgical | 100,300 and 500mmHg | Not Given | | | | | | |
| Hysteroscopic | 20-150mmHg | | 40-150 mmHg | | | | | |
| Urological | 20-150mmHg | | | 15-150 mmHg | | | | |
| Urological suction | N/A | | | | N/A | | | |
| Arthroscopy | 20-150mmHg | | | | | 10-120 mmHg | | |
| Clearvision | N/A | | | | | | N/A | |
| Clearvision | N/A | | | | | | | N/A |
| Irrigation Flow | | | | | |…