(248 days)
Not Found
No
The document describes a peristaltic pump and a monitoring system for urodynamic procedures, with no mention of AI, ML, or related technologies.
No
The device is indicated for "urodynamic diagnostic procedures only" and is used to "pressurize the filling media during water cystometry diagnostic procedures." Its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only." and "The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures."
No
The device description explicitly states it is a "peristallic pump," which is a hardware component.
Based on the provided text, the Circon Endotek OM-4 Urodynamics Monitoring System and the Circon Endotek OM-4 H2O Cystometry Pump are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis.
- The description of these devices clearly states they are used for urodynamic diagnostic procedures. Urodynamics involves measuring pressures and flows within the urinary tract in vivo (within the living body).
- The cystometry pump is used to pressurize filling media during the procedure, not to analyze a sample after it's been removed.
Therefore, these devices are used for in vivo diagnostic procedures, not in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.
Product codes (comma separated list FDA assigned to the subject device)
78 FEN, 78 EXY
Device Description
The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
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.
K920451, K921047, K920992, K920575
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
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
K970595
P193
SUMMARY OF SAFETY AND EFFECTIVENESS Circon Endotek OM-4 Cystometry Pump
OCT 2 4 1997
Applicant's Name, Address and Establishment Registration Number: Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117-3019 Establishment Registration Number 2020483
Owner/Operator's Name, Address, and Establishment Registration Number: Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117-3019 Establishment Registration Number 2020483
Contact Person, Contact Person's Address and Telephone Number Todd J. Polk Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117-3019 Establishment Registration Number 2020483 Telephone (805) 961-3290
Manufacturing Site, Address and Establishment Registration Number: Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117-3019 Establishment Registration Number 2020483
Device Trade/Proprietary Name and Catalog Number:
| Catalog No. | Description |
|---|---|
| Not Assigned | Circon Endotek OM-4 H₂O Cystometry Pump |
| Not Assigned | H₂O Cystometry Pump Interconnecting Cable |
| 5290700 | Ultra Pump H₂O Infusion Set (10/case) |
1
Classification Name and Panel Classification Number:
| Product Nomenclature | Device, Cystometric, Hydraulic |
|---|---|
| Classification Name | Urodynamics Measurement |
| System | |
| Procode | 78 FEN |
| Regulation Number | 21 CFR § 876 |
| Classification | Class II (Special Controls) |
| Device Common or Usual Name | H2O Cystometry Pump |
8203
Performance Standards:
Performance Standards.
No applicable performance standards have been promulgated under Section 514 of No applicable pice Act for Cystometric Measuring Systems.
The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:
Marketed Devices Used for Substantial Equivalence
| Manufacturer | Model No. | Description | 510(k)
No. |
|----------------|--------------|---------------------------------|---------------|
| Circon Endotek | Ultra System | Cystometric
Measuring System | K920451 |
| Browne | MiniPro 8100 | Cystometric
Measuring System | K921047 |
| Browne | Profile Plus | Cystometric
Measuring System | K920992 |
| WIEST | MERKUR 4000 | Cystometric
Measuring System | K920575 |
Device Description and Intended Use of the Marketed Device
The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.
2
K970595P393
Indicated Use for the Proposed Device
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.
3
Image /page/3/Picture/0 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 coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Mr. Andrew D. Simon Vice President Secretary Circon Corporation 6500 Hollister Avenue Santa Barbara, California 93117-3019 Re: K970595
Circon Endotek OM-4 H2O Cystometry Pump Dated: August 15, 1997 Received: August 19, 1997 Regulatory class: II 21 CFR 8876.1620/Product code: 78 FEN 21 CFR §876.1800/Product code: 78 EXY
Dear Mr. Simon:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 (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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 thre 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/dsmamain.html".
Sincerely yours.
William Yu
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
4
Page 1 of 1
K970595 510(k) Number (if known): Not Assigned
Device Name: Circon Endotek OM-4 H2O Cystometry Pump
Indications For Use:
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.
Image /page/4/Picture/6 description: The image shows a thick, black line that is diagonally oriented. The line starts in the upper left corner and extends towards the lower right corner of the frame. The background is plain white, which allows the black line to stand out prominently.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | Robert R sthing /
(Division Sign-Off) |
|--------------------------------------------------------------------|------------------------------------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K970595 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
OR
| Over The Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |