(75 days)
The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the urinary tract during endoscopic surgical procedures in urology.
The Karl Storz Equimat is indicated for use in monitoring the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology
The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology.
This document is a 510(k) summary for the Karl Storz Equimat, a fluid monitoring system. It does not provide details of a clinical study with acceptance criteria and device performance as typically expected for complex AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design and intended use.
Therefore, many of the requested points regarding acceptance criteria, study details, and AI/ML specific information are not applicable or cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated as not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the 510(k) summary. The document focuses on "substantial equivalence" rather than presenting specific performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No specific test set or clinical study for performance evaluation is described. The submission relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study is mentioned. This device is a fluid monitoring system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a hardware device for fluid monitoring, not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable. No ground truth for device performance is described in the context of a study. The device's function is to directly monitor fluid, so its "ground truth" would inherently be its accurate measurement against a known standard, which would typically be part of design verification and validation, not necessarily a clinical study needing expert ground truth.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML model, no ground truth for it was established.
Summary from the provided document:
The Karl Storz Equimat is a fluid monitoring system designed to measure the inflow and outflow of irrigation fluid during endoscopic surgical procedures. The 510(k) submission primarily establishes substantial equivalence to existing predicate devices based on its basic features, design, and intended use. It explicitly states that "The minor differences between the Karl Storz Equimat 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 implies that extensive new performance data from a clinical study with defined acceptance criteria was not deemed necessary for this type of device and submission.
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AUG 1 2 1497
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 are accurate and complete to the best of KSEA's knowledge.
Karl Storz Endoscopy - America, Inc. Applicant: 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Kevin Kennan Contact: Regulatory Affairs Specialist
Common Name Device Identification: Fluid Monitoring System
Trade Name Karl Storz Model 203020 20 Equimat
Indication: The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the urinary tract during endoscopic surgical procedures in urology.
Device Description: The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology.
Substantial Equivalence: The Karl Storz model 203020 20 Equimat system for urology is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the Karl Storz Equimat 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.
Signed: Kevin Kennan
Regulatory Affairs Specialist
000084
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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 consists of a stylized eagle with three wing-like shapes, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1997
Mr. Kevin A. Kennan Requlatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600
Re: K971982 Karl Storz Equimat (model 203020 20) Dated: May 28, 1997 Received: May 29, 1997 Regulatory Class: Unclassified Product Code: 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, 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 requirement, as set forth in the Quality System Regulation (QS) 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 Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 (2) CFR Part 801 and additionally 809.10 for in yitte 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/dsmamain.html".
Sincerely yours,
h. William Yui
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
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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
510(k) Number (if known): Not yet assigned K971982
Device Name: Karl Storz Equimat
Indications for Use: The Karl Storz Equimat is indicated for use in monitoring the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Dmel XxC
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use: ﻻ
Over-The-Counter
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
000003
Use:
§ 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.