(63 days)
No
The description focuses on the mechanical function of a roller pump with adjustable flow and pressure, with no mention of AI or ML terms or functionalities.
No
The device is used for irrigation and aspiration during surgical procedures, which are supportive functions rather than directly therapeutic. It does not treat or cure a disease or condition itself, but facilitates other therapeutic interventions (e.g., lithotripsy).
No
The device is described as an irrigation/aspiration pump used by surgeons for infusing solutions or as a suction pump during lithotripsy, which are procedural and therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "roller type irrigation/aspiration pump," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of sterile irrigation solution and suction within the ureter and upper urinary tract during surgical procedures. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The device is described as a roller type irrigation/aspiration pump. This is a mechanical device used to move fluids.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body for treatment or procedural support.
N/A
Intended Use / Indications for Use
The Karl Storz Uropump system is intended for use by qualified surgeons and is used Indication: for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.
These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.
Product codes
78 LJH
Device Description
The Karl Storz Uropump and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction flow rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and upper urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUL - 8 1998
P 1 All
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 KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. |
|---|---|
| 600 Corporate Pointe Drive | |
| Culver City, CA 90230 | |
| (310) 558-1500 | |
| Contact: | Kevin Kennan |
Senior Regulatory Affairs Specialist
Device Identification:
Common Name: Suction/irrigation Pump
Trade Name: (optional) Karl Storz Uropump
The Karl Storz Uropump system is intended for use by qualified surgeons and is used Indication: for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor ..
Device Description: The Karl Storz Uropump and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction flow rate.
The Karl Storz Uropump system is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are the same. The minor differences between the Karl Storz Uropump and the predicate devices raise no new jssues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Kennan
Regulatory Affairs Specialist
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K981615
Uropump Irrigation/Suction System Dated: May 1, 1998 Received: May 6, 1998 Unclassified/Procode: 78 LJH
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Feceral Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): Not yet assigned
Device Name: Uropump
Indications for Use: These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rater D. Stalling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K961611
Prescription Use:
(Per 21 CFR 801.109) OR Over-The-Counter Use:
(Optional Format 1-2-96)
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