Karl Storz UROMAT E.A.S.I.

K162992 · Karl Storz Endoscopy America, Inc. · LJH · Jul 7, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162992
• Device Name: Karl Storz UROMAT E.A.S.I.
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Jul 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

Device Story

UROMAT E.A.S.I. is a microprocessor-controlled, peristaltic double-roller pump for irrigation and suction during endoscopic procedures. It provides continuous fluid flow for urological interventions or independent flow regulation for laparoscopic interventions. The device features a touch screen interface and digital display. It monitors pressure via a sensor at the pump output; software enforces a hardcoded 200 mm Hg pressure limit, with a hardware alarm triggered if pressure exceeds this by 40 mm Hg. Used in clinical settings by medical professionals, the device assists in maintaining visibility and managing fluids in the operating field. It benefits patients by enabling controlled irrigation and efficient suction during minimally invasive surgery.

Clinical Evidence

Bench testing only. Provided data includes electrical safety, electromagnetic compatibility (EMC), software verification and validation, usability testing, biocompatibility (cytotoxicity and leachables/extractability), and sterilization/shelf-life/packaging validation.

Technological Characteristics

Peristaltic double-roller pump; microprocessor-controlled; touch screen interface; pressure sensor at pump output; irrigation pressure 20-200 mm Hg; suction flow 100-1800 ml/min. Complies with federal and international safety/performance standards.

Indications for Use

Indicated for patients undergoing endoscopic interventions requiring irrigation and suction of fluids, secretions, and tissue.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Karl Storz Uropump (K981615)
• Karl Storz Universal Laparomat (K010569)

Reference Devices

• KS CALCUSON

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

July 7, 2017

KARL STORZ Endoscopy America, Inc. % Jack Rogers Consultant Safis Solutions LLC 303 N. Alabama, Suite 210 Indianapolis, IN 46204-2132

Re: K162992

> Trade/Device Name: Karl Storz UROMAT E.A.S.I. Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: LJH Dated: May 22, 2017 Received: May 24, 2017

Dear Jack Rogers:

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.

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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 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" (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,

Benjamin R. Fisher -S

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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# Indications for Use

510(k) Number (if known) K162992

Device Name Karl Storz UROMAT E.A.S.I

#### Indications for Use (Describe)

The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary

#### 1. Applicant Information

Karl Storz Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245

Contact Person: Serkan Sezer, VP Global Quality and Regulatory Phone: [phone]

Date Summary Prepared: September 22, 2016

#### 2. Device/Classification

| Device Trade Name: | Karl Storz Uromat E.A.S.I. |
|--------------------|----------------------------------------------------------------|
| Common Name: | System, Irrigation, Urological |
| Classification: | 21CFR 876.5130, Class 2<br>Urological catheter and accessories |
| Panel: | Gastroenterology/Urology |
| Product Code(s): | LJH |

#### 3. Predicate Devices

| 510(k) number: | K981615 | K010569 |
|--------------------|----------------------------------------------------------------|------------------------------------------------------|
| Device Trade Name: | Karl Storz Uropump | Karl Storz Universal Laparomat |
| Common Name: | System, Irrigation, Urological | Laparoscope, General & Plastic Surgery |
| Classification: | 21CFR 876.5130, Class 2<br>Urological catheter and accessories | 21CFR 876.1500, Class 2<br>Endoscope and accessories |
| Panel: | Gastroenterology/Urology | General & Plastic Surgery |
| Product Code(s): | LJH | GCJ |

#### 4. Device Description

The UROMAT E.A.S.I. is a peristaltic (double roller), microprocessor controlled, irrigation and suction pump with continuous fluid flow for urological interventions. Alternatively, the two pumps can be flowoperated independently of each other for flow regulation, e.g., for laparoscopic interventions.

#### 5. Intended Use / Indications for Use

The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

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| Device | Karl Storz<br>UROMAT E.A.S.I. | Karl Storz<br>UROPUMP | Karl Storz<br>Universal Laparomat |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Design | Peristaltic (double roller)<br>pump;<br>Microprocessor controlled | Peristaltic (single roller)<br>pump;<br>Microprocessor controlled | Gear pump;<br>microprocessor controlled |
| Selection of<br>Application(s) | Dual purpose pump for<br>irrigation and suction:<br>1) continuous flow for<br>urologic interventions;<br>including use in lithotripsy<br>(KS CALCUSON)<br>2) independent pump flow<br>and regulation for<br>laparoscopic interventions | Dual purpose pump for<br>irrigation and suction,<br>including when used in<br>lithotripsy (KS CALCUSON) | Single mode |
| Overpressure<br>Safety | Software does not allow<br>pressure over 200 mm Hg<br>(hardcode).<br>Hardware alarm is triggered<br>when the maximum pressure<br>of 200 mm Hg is exceeded by<br>40 mm Hg. | Software alarm triggered<br>when the present pressure<br>setpoint value is exceeded by<br>20 mmHg.<br>Hardware alarm is triggered<br>when the maximum pressure<br>of 200 mm Hg is exceeded by<br>40 mm Hg. | Electronic monitoring of<br>the maximum output<br>pressure via the torque of<br>the gear pump.<br>Double monitoring of the<br>suction pressure. |
| Primary<br>Pressure<br>Measurement | Pressure sensor at the<br>pressure dome measures the<br>pressure at the pump output. | Pressure sensor at the<br>pressure dome measures the<br>pressure at the pump output. | Electronic monitoring of<br>the maximum output<br>pressure via the torque of<br>the gear pump. |
| Irrigation<br>Pressure | 20...200mm Hg for<br>Continuous Flow (CF), Single<br>Flow (SF) | 0 – 200 mm Hg | 0 – 1800 mm Hg |
| Irrigation Flow | 10...250 ml/min for<br>Continuous Flow (CF) | 0 – 400 ml/min | 0 – 3000 ml/min (LAP) |
| Suction<br>Pressure | N/A | Max -0.75 bar | 0 – 800 mbar (LAP) |
| Suction Flow | 100...1800 ml/min for<br>Suction/Irrigation and<br>Lithotripsy | 0-1000 ml/min<br>Suction flow rate is adjustable<br>by the user and is preset<br>before Uropump is used.<br>Flow rate is key parameter for<br>suction. | 0 - (-)8 bar<br>Suction under pressure |
| User Interface | Touch screen, digital display | Keys and LED bar graphs | Bar graph display |

## 6. Comparison of Technological Characteristics with the Predicate Devices

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#### 7. Performance Data - Nonclinical testing

The following test data were provided in support of the substantial equivalence determination:

- o Uromat E.A.S.I.
- Electrical safety and electromagnetic compatibility (EMC ) o
- Software Verification and Validation Testing O
- O Usability
- Tubing sets:
- Biocompatibility including Cytotoxicity and Leachables/Extractability (Chemical Analysis) O
- Sterilization, shelf life and packaging verification and validation o

#### 8. Conclusion

The Karl Storz (KS) Uromat E.A.S.I. is substantially equivalent to the Karl Storz predicate devices.

The KS Uromat E.A.S.I. is substantially equivalent to the KS UROPUMP with regard to use and design characteristics. Both are used for irrigation and suction of fluids in ureteroscopic procedures.

The KS UROMAT E.A.S.I. is substantially equivalent to the KS KSEA Universal Laparomat with regard to use and design characteristics. Both are used for irrigation of fluids in laparoscopic procedures.

Minor technological differences between the new and predicate devices do not raise any new concerns of safety and effectiveness.

The new device has the same intended use and operating principles, with similar design features, and functional and performance characteristics as the predicate devices. Based upon the performance data, it has been demonstrated that the Uromat E.A.S.I. performs as intended in the specified use conditions. The device is designed to comply with relevant federal and international safety and performance standards.