AQUASENS FLUID MONITORING SYSTEM

K031213 · Davol, Inc. · HIG · Apr 30, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031213
• Device Name: AQUASENS FLUID MONITORING SYSTEM
• Applicant: Davol, Inc.
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Apr 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Davol AquaSens Fluid Monitoring System 4000 is intended for use in gynecological surgical and diagnostic procedures. The system consolidates the supply and collection of irrigation fluids used during hysteroscopic procedures to distend the uterus and to clear the operative site of blood and debris. The system monitors irrigation fluid losses and indicates when such losses exceed a level pre-set by the surgeon.

Device Story

AquaSens FMS 4000 monitors irrigation fluid during hysteroscopic procedures. System comprises load cell assembly with IV pole for irrigation bags/suction canisters and Electronic Control Unit (ECU). Device measures total weight changes to calculate fluid loss/gain; compares results against surgeon-defined thresholds; provides alerts when losses exceed pre-set levels. Operated by clinical staff in surgical settings. Power source includes battery or AC electricity. User interface features membrane buttons for PAUSE/RUN mode selection. Output allows surgeons to track fluid balance, aiding in management of uterine distension and operative site clearance.

Clinical Evidence

Bench testing only. Comparative weight loss testing performed on subject and predicate devices in AC, DC, and low battery modes. Testing confirmed performance within specifications. Compliance with UL 2601-1 standard for medical electrical equipment required.

Technological Characteristics

System includes load cell assembly and Electronic Control Unit (ECU). Powered by AC or battery. User interface utilizes membrane buttons for mode control. Designed for compliance with UL 2601-1 safety standards.

Indications for Use

Indicated for patients undergoing gynecological surgical and diagnostic hysteroscopic procedures requiring uterine distension and irrigation fluid management.

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

• AquaSens Fluid Monitoring System 3000

Submission Summary (Full Text)

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K031213

Subsidiary of C. R. Bard, Inc 100 Sockanossett Crossroad P.O. Box 8500 Cranston, RI 02920 401 463-7000

APR 3 0 2003

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Section 7.0 SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE AQUASENS FLUID MONITORING SYSTEM 4000

| A. Submitter's Name: | Davol, Inc. |
|----------------------|----------------------------------------------------------------------------------|
| Address: | Subsidiary of C.R. Bard Inc.<br>100 Sockanossett Crossroad<br>Cranston, RI 02920 |
| Telephone: | 401/463-7000 x 2642 |
| Fax: | 401/463-3845 |
| Contact Person: | Brian A. Kanerviko |
| Date of Preparation: | February 18, 2003 |

- B. 1. Trade Name: AquaSens Fluid Monitoring System 4000
- 2. Common Name: Hysteroscopic Fluid Monitoring Systems
- 3. Classification Name: Insufflator. Hysteroscopic: Fluid Monitoring Accessory (per CFR 884.1700)
- C. Predicate Device Name AquaSens Fluid Monitoring System 3000

## D. Device Description

The major components of the AquaSens FMS 4000 are a load cell assembly which includes an IV pole structure for supporting irrigation bags and fluid suction canisters and an Electronic Control Unit (ECU) that acquires information from the load cell assembly to calculate and display fluid loss/gain based on changes in total weight after the system is initialized.

- E. Intended Use
The Davol AquaSens Fluid Monitoring System 4000 is intended for use in gynecological surgical and diagnostic procedures. The system consolidates the supply and collection of irrigation fluids used during hysteroscopic procedures to distend the uterus and to clear the operative site of blood and debris. The system monitors irrigation fluid losses and indicates when such losses exceed a level pre-set by the surgeon.

F. Summary of Similarities and Differences in Technological Characteristics.

The predicate and proposed devices are designed to detect the loss of fluid weight by identifying discrepancies between fluid input and output by tracking changes in total

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system fluid weight, then converting the information for display through the Electronic Control Unit. However, the predicate device is battery powered, whereas the proposed device is powered by either battery or electricity.

The proposed device has a re-designed way the user changes between the PAUSE and RUN modes. The predicate device utilized a single toggle bar on the top-rear of the Electronic Control Unit to change modes. In the proposed device this toggle bar is eliminated and replaced with two membrane buttons located on the front of the Electronic Control Unit labeled PAUSE and RUN. The proposed device will now allow the user to push the button to select the mode.

## G. Performance Data

Laboratory testing was conducted to compare the proposed device to the predicate device. This testing consisted of a weight loss test in the AC, DC and low battery modes and switching characteristics of modes.

Underwriter Laboratories is currently conducting the necessary tests to ensure that this product will comply with the internationally harmonized standard UL 2601-1 for Medical Electrical Equipment. The test results from UL are currently pending, however the proposed device will not be marketed until all necessary test requirements under UL 2601-1 "General Electrical Requirement-Part 1: General Requirements for Safety" are satisfied.

## H. Conclusion

Laboratory testing was conducted to compare the proposed device to the predicate device. This testing consisted of a weight loss test in the AC, DC and low battery modes. The test results indicated that both the proposed and predicate device performed within the given specifications under the same test conditions. Based on the above information it can be stated that the proposed AquaSens FMS 4000 is substantially equivalent to the predicate AquaSens FMS 3000.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2003

C.R. Bard, Inc., Davol Division % Mr. Robert Mosenkis President CITECH Medical Device Testing and Consulting 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K031213 Trade/Device Name: Davol AquaSens Fluid Monitoring System 4000 Regulation Number: 21 CFR 884.1700 Regulation Name: Hysterscopic insufflator Regulatory Class: II Product Code: 85 HIG Dated: April 16, 2003 Received: April 17, 2003

Dear Mr. Mosenkis:

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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KO31213

Device Name:

Davol AquaSens Fluid Monitoring System 4000

Indications for Use:

The Davol AquaSens Fluid Monitoring System 4000 is intended for use in gynecological surgical and diagnostic procedures. The system consolidates the supply and collection of irrigation fluids used during hysteroscopic procedures to distend the uterus and to clear the operative site of blood and debris. The system monitors irrigation fluid losses/gains and indicates when such losses/gains exceed a level pre-set by the surgeon.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Or

Over-The-Counter Use

(Optional Format 1-2-96)

David R. Ingram

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