(253 days)
Not Found
No
The description mentions a "microprocessor controlled" pump, which is standard for many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML components.
No
The device is used for introducing and suctioning fluids during endoscopic interventions, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as an irrigation and suction pump used for introducing and removing fluids during endoscopic interventions. Its function is to manage fluids in a surgical setting, not to diagnose conditions or diseases.
No
The device description explicitly states it is a "peristaltic (double roller), microprocessor controlled, irrigation and suction pump," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the UROMAT E.A.S.I. is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a peristaltic pump for fluid management during procedures. This aligns with the intended use and does not suggest any diagnostic testing capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on the fluids or tissues handled.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The UROMAT E.A.S.I.'s function is purely procedural – managing fluids during surgery.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LJH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing for Uromat E.A.S.I. included Electrical safety and electromagnetic compatibility (EMC), Software Verification and Validation Testing, and Usability. For Tubing sets, biocompatibility including Cytotoxicity and Leachables/Extractability (Chemical Analysis), Sterilization, shelf life and packaging verification and validation were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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: 424-218-8201
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 |
| 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 | |
| Urological catheter and accessories | 21CFR 876.1500, Class 2 | |
| 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.
4
| Device | Karl Storz
UROMAT E.A.S.I. | Karl Storz
UROPUMP | Karl Storz
Universal Laparomat |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Design | Peristaltic (double roller)
pump;
Microprocessor controlled | Peristaltic (single roller)
pump;
Microprocessor controlled | Gear pump;
microprocessor controlled |
| Selection of
Application(s) | Dual purpose pump for
irrigation and suction:
- continuous flow for
urologic interventions;
including use in lithotripsy
(KS CALCUSON) - independent pump flow
and regulation for
laparoscopic interventions | Dual purpose pump for
irrigation and suction,
including when used in
lithotripsy (KS CALCUSON) | Single mode |
| Overpressure
Safety | Software does not allow
pressure over 200 mm Hg
(hardcode).
Hardware alarm is triggered
when the maximum pressure
of 200 mm Hg is exceeded by
40 mm Hg. | Software alarm triggered
when the present pressure
setpoint value is exceeded by
20 mmHg.
Hardware alarm is triggered
when the maximum pressure
of 200 mm Hg is exceeded by
40 mm Hg. | Electronic monitoring of
the maximum output
pressure via the torque of
the gear pump.
Double monitoring of the
suction pressure. |
| Primary
Pressure
Measurement | Pressure sensor at the
pressure dome measures the
pressure at the pump output. | Pressure sensor at the
pressure dome measures the
pressure at the pump output. | Electronic monitoring of
the maximum output
pressure via the torque of
the gear pump. |
| Irrigation
Pressure | 20...200mm Hg for
Continuous Flow (CF), Single
Flow (SF) | 0 – 200 mm Hg | 0 – 1800 mm Hg |
| Irrigation Flow | 10...250 ml/min for
Continuous Flow (CF) | 0 – 400 ml/min | 0 – 3000 ml/min (LAP) |
| Suction
Pressure | N/A | Max -0.75 bar | 0 – 800 mbar (LAP) |
| Suction Flow | 100...1800 ml/min for
Suction/Irrigation and
Lithotripsy | 0-1000 ml/min
Suction flow rate is adjustable
by the user and is preset
before Uropump is used.
Flow rate is key parameter for
suction. | 0 - (-)8 bar
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
5
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.