CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

K970595 · Circon Video · FEN · Oct 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970595
• Device Name: CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
• Applicant: Circon Video
• Product Code: FEN · Gastroenterology, Urology
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2

Intended Use

The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only by 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.

Device Story

Circon Endotek OM-4 H₂O Cystometry Pump is a peristaltic pump component of the OM-4 Urodynamic Monitoring System. Device pressurizes filling media (water) during cystometry diagnostic procedures. Operated by qualified physicians or trained personnel in clinical settings. Output is controlled fluid delivery for bladder pressure measurement. Benefits include standardized, controlled filling for accurate urodynamic assessment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Peristaltic pump mechanism. Electrical safety compliance: UL 2601, CSA 601, IEC 601-2. Spillage compliance: BSI. Package drop test: NSTA. System includes interconnecting cable and H₂O infusion set.

Indications for Use

Indicated for patients undergoing urodynamic diagnostic procedures requiring water cystometry. To be operated by qualified physicians or personnel under physician supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ultra System (K920451)
• MiniPro 8100 (K921047)
• Profile Plus (K920992)
• MERKUR 4000 (K920575)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness: Circon Endotek OM-4 H₂O Cystometry Pump
K970595
P173

# SUMMARY OF SAFETY AND EFFECTIVENESS
## Circon Endotek OM-4 Cystometry Pump

OCT 24 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 [phone]

**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) |

Page 1 of 3

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Summary of Safety and Effectiveness: Circon Endotek OM-4 H₂O Cystometry Pump
K970593
2073

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 |

Performance Standards:

No applicable performance standards have been promulgated under Section 514 of the Medical device Act for Cystometric Measuring Systems.

The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:

| Designed to Meet Following Safety Specifications | |
| --- | --- |
| Electrical | UL 2601, CSA 601, IEC 601-2 |
| Spillage | BSI |
| Package Drop Test | NSTA |

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 peristaltic pump used with the Circon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.

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Summary of Safety and Effectiveness: Circon Endotek OM-4 H₂O Cystometry Pump
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 by 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.

Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 24 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 §876.1620/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 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 II (Special Controls) or 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 submission does not affect any obligation you might have under sections 531 through 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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510(k) Number (if known): Not Assigned K970595

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 by 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.


(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Ntting
(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)