(75 days)
Not Found
Not Found
No
The description focuses on microprocessor control for monitoring fluid volume, with no mention of AI, ML, image processing, or data training/testing.
No
The device is designed to monitor fluid inflow and outflow, not to treat a condition or restore function. It's a monitoring device used alongside surgical procedures, not a therapeutic one itself.
No
The device monitors the volume of irrigation fluid during surgical procedures, which is a real-time monitoring function for surgical support, not a diagnostic one.
No
The device description explicitly states it is a "microprocessor controlled monitoring device," indicating it includes hardware components beyond just software.
Based on the provided information, the Karl Storz model 203020 20 Equimat system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Equimat's function: The Equimat system monitors the flow of irrigation fluid during a surgical procedure within the body (in vivo), not on a sample taken from the body (in vitro).
- Intended Use/Indications: The description clearly states its use is for monitoring fluid flow during endoscopic surgical procedures in the urinary tract.
Therefore, the Equimat is a surgical device used for monitoring during a procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
78 LJH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
0
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
1
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
2
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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: