IUR FLUID MANAGEMENT SYSTEM

K031616 · W.O.M. World of Medicine AG · HIG · Aug 13, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031616
• Device Name: IUR FLUID MANAGEMENT SYSTEM
• Applicant: W.O.M. World of Medicine AG
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1700
• Device Class: Class 2

Intended Use

The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

Device Story

IUR Fluid Management System provides uterine distension and monitors irrigation fluid loss during hysteroscopy. System comprises microprocessor-controlled peristaltic pump and fluid monitoring unit. Pump utilizes roller wheel and dual pressure sensors for redundant measurement; software-controlled active pressure reduction maintains preset nominal pressure; includes overpressure alarms. Monitoring unit uses volume differential measurement via weighing unit to track fluid loss; operator-selectable deficit threshold alarm (0-2000 ml). Used in clinical settings by healthcare professionals. System functionality requires connection of monitoring unit, pump unit, and resectoscope. Output displayed to operator to inform clinical decisions regarding fluid management and patient safety.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).

Technological Characteristics

Microprocessor-controlled peristaltic pump; dual pressure sensors for redundant measurement; weighing unit for volume differential monitoring; operator-selectable alarm thresholds. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients undergoing diagnostic or operative hysteroscopy requiring uterine distension and fluid loss monitoring.

Regulatory Classification

Identification

A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

Predicate Devices

• Hysteroscopy Pump HM4 (K022449)
• Flo-Stat Fluid Monitoring System (K954775)

Submission Summary (Full Text)

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AUG 1 3 2003

K031616
page 1 of 2

## 510(K) SUMMARY IUR Fluid Management System

### I. Applicant:

W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany

### II. Device Names:

- Classification Name: 1.
Proprietary Name:

- Common or Usual Name: 2.
Hysteroscopic Insufflator and Accessories Hysteroscopic Insufflator, Fluid Monitoring System and Tubing Sets IUR Fluid Management System

### III. Classification:

3.

Class II. This device is described in 21 C.F.R. § 884.1700. The product code for the device is HIG.

### IV. Predicate Devices:

- Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Flo-Stat Fluid Monitoring System (K954775) manufactured by Gynecare ● Innovation Center.

### V. Intended Use:

The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

### Device Description: VI.

The IUR Fluid Management System consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures.

The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to

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K031616
Page 2 of 2

### 510(K) SUMMARY Page -2- / -2-

perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0-2000 ml.

The IUR Fluid Management System is only functional if the monitoring unit is connected to the pump unit and a specific resectoscope is attached.

### VII. Substantial Equivalence:

The IUR Fluid Management System described in this notification is similar in design and technological characteristics to the Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD OF MEDICINE AG and to the Flo-Stat Fluid Monitoring System (K954775) manufactured by Gynecare Innovation Center.

In addition, both the IUR Fluid Management System and the predicate devices are intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and/or to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The differences between the IUR Fluid Management System and the predicate devices are minor and raise no new questions of safety and effectiveness.

Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the IUR Fluid Management System is substantially equivalent to the predicate devices currently on the market.

### VIII. Performance Data:

The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).

Signed:

S. Roals

Susanne Raab Official Correspondent

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal features a stylized eagle with three lines emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W.O.M. World of Medicine % Ms. Susanne Raab Official Correspondent 320 North Columbus Street ALEXANDRIA VA 22314 Re: K031616

Trade/Device Name: IUR Fluid Management System Hysteroscopy Pump HM4 Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopy insufflator Regulatory Class: II Product Code: 85 HIG Dated: May 7, 2003 Received: July 14, 2003

Dear Ms. Raab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATION FOR USE STATEMENT

510(k) Number (if known): 4031616

Device Name: IUR Fluid Management System

Indications for Use:

The IUR Fluid Management System is a device intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use ***_*** (Per 21 C.F.R. 801.109)

OR

Over-The-Counter

Nancy Brogdon
Division Sign-Off

(Division Sign-Off (Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

(Optional Format 3-10-98)

10-1