(63 days)
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.
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.
This document describes a 510(k) premarket notification for the Karl Storz Uropump, a suction/irrigation pump. The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, rather than proving independent performance against specific acceptance criteria through extensive clinical studies.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies as one would expect for a more rigorous performance study.
Here's why the requested information is absent based on the provided text:
- Nature of 510(k) Submission: A 510(k) submission focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design principles, materials, indications for use, energy used, and performance characteristics to show that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. It's not a de novo approval process requiring extensive clinical trials to establish new performance metrics.
- Device Type: The Karl Storz Uropump is a "roller type irrigation/aspiration pump." For this type of device, substantial equivalence often relies on engineering comparisons, bench testing to confirm fluid dynamics (flow rates, pressures, suction), and adherence to relevant standards, rather than clinical studies with "acceptance criteria" and "ground truth" derived from expert consensus on medical images or outcomes.
To directly address your request given the limitations of the provided text:
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A table of acceptance criteria and the reported device performance:
- N/A. The document states: "The Karl Storz Uropump system is substantially equivalent to the 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 issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement is the "performance acceptance" for a 510(k) – that its performance is equivalent to an already approved device. Specific numerical acceptance criteria against a defined "ground truth" are not provided.
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Sample size used for the test set and the data provenance:
- N/A. No formal "test set" in the context of clinical or diagnostic performance is mentioned. The equivalence is likely based on engineering specifications and bench testing comparing the Uropump to its predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No expert ground truth establishment for a test set is described.
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Adjudication method for the test set:
- N/A. No test set requiring adjudication is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a pump, not an AI-assisted diagnostic or imaging device. MRMC studies are irrelevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" for a device like this would be its functional specifications (e.g., accurate flow rate, reliable pressure, sufficient suction) as demonstrated through engineering tests, compared against the predicate device. These details are not in the summary.
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The sample size for the training set:
- N/A. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- N/A. Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Karl Storz Uropump to existing predicate devices. It explicitly states that "the basic features and intended uses are the same" and "minor differences... raise no new issues of safety and effectiveness... have no effect on the performance, function or intended use." This is the primary "proof" for this type of submission.
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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
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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
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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)
000003
§ 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.