(248 days)
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.
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.
The provided document is a 510(k) premarket notification for the Circon Endotek OM-4 Cystometry Pump. This type of submission is for establishing substantial equivalence to existing devices, not for demonstrating novel performance or conducting advanced clinical studies. Therefore, many of the requested elements for AI/ML device studies (like MRMC studies, specific performance metrics against an established ground truth, or details on sample sizes for training/test sets for AI models) are not applicable to this 1997 medical device submission.
This document describes a device used for measuring during cystometry, not an AI-powered diagnostic tool. The "performance criteria" described are typically related to the functional specifications and safety of the pump itself, rather than diagnostic accuracy metrics.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of specific numerical performance targets for diagnostic accuracy or device output error rates that would be typical for an AI/ML device.
Instead, the submission focuses on meeting voluntary standards and demonstrating substantial equivalence to predicate devices. The implicit "acceptance criteria" for a 510(k) of this nature are that the device is safe and effective for its intended use and performs comparably to legally marketed predicate devices.
The document states:
- "The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:" (However, the list of those standards is not provided in the excerpt.)
For this type of device, performance would typically relate to its ability to accurately pressurize the filling media, its flow rate, pressure consistency, safety features, and reliability. Specific numerical performance data for these aspects are not included in the provided excerpt.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) / Not Provided. This document describes a new hardware device (a pump) for cystometry, not an AI/ML diagnostic tool that would typically involve a "test set" of patient data in the modern sense. The submission would have involved engineering tests and perhaps a limited clinical evaluation for safety and basic functionality, but not "test sets" for diagnostic performance in the way AI/ML devices do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). As this is not an AI/ML diagnostic device, there would be no "ground truth for a test set" related to diagnostic outcomes or classifications.
4. Adjudication method for the test set
Not Applicable (N/A). See explanation for question 3.
5. 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
No. This device is a pump, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This is a hardware pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A). No "ground truth" as typically understood for AI/ML diagnostic performance was established for this pump. The device's performance would be evaluated against its technical specifications (e.g., pressure accuracy, flow rate stability) and safety standards.
8. The sample size for the training set
Not Applicable (N/A). This is a hardware device submission, not an AI/ML algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A). See explanation for question 8.
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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 MeasurementSystem |
| 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 | CystometricMeasuring System | K920451 |
| Browne | MiniPro 8100 | CystometricMeasuring System | K921047 |
| Browne | Profile Plus | CystometricMeasuring System | K920992 |
| WIEST | MERKUR 4000 | CystometricMeasuring 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.
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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.
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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
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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.
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(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) | |
|---|---|
| ----------------------------------------------- | -- |
§ 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.