AQUASENS FLUID MONITORING SYSTEM by DAVOL, INC.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study findings for the AquaSens Fluid Monitoring System 4000, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on a comparison to a predicate device. The implied acceptance criterion is that the new device performs "within the given specifications" and demonstrates "substantially equivalent" performance to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device: To detect loss of fluid weight by identifying discrepancies between fluid input and output by tracking changes in total system fluid weight, then converting the information for display through the Electronic Control Unit.	The proposed device (AquaSens FMS 4000) maintains this core functionality.
Accuracy in Weight Loss Measurement: Performance in 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." (This implies the AquaSens FMS 4000 met the same performance standards as the AquaSens FMS 3000 in these modes, though specific thresholds are not provided).
Switching Characteristics of Modes: User interface for changing between PAUSE and RUN modes.	The proposed device has a re-designed interface for changing between PAUSE and RUN modes (eliminating a toggle bar and replacing it with two membrane buttons). The performance data states that "switching characteristics of modes" was tested, and the conclusion is substantial equivalence, suggesting the new interface performs acceptably.
Compliance with UL 2601-1 (International Harmonized Standard for Medical Electrical Equipment): (Implicit regulatory and safety requirement)	Underwriter Laboratories was "currently conducting the necessary tests," and the device would "not be marketed until all necessary test requirements under UL 2601-1... are satisfied."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document refers to "laboratory testing" conducted to compare the devices.
Data Provenance: The testing was conducted internally by Davol, Inc. ("Laboratory testing was conducted to compare the proposed device to the predicate device."). There is no mention of country of origin for the data or whether it was retrospective or prospective. It appears to be prospective lab testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a fluid monitoring system, not an AI or diagnostic imaging device that relies on expert interpretation of data to establish ground truth. The "ground truth" for its performance would be highly accurate weight measurements and electrical/mechanical performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this isn't a study involving human interpretation. The testing involved direct measurement and comparison to specifications of a mechanical/electronic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation plays a role.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance study effectively constitutes a standalone evaluation. The "laboratory testing" assesses the device's intrinsic ability to measure weight loss and manage modes, independent of a human operator's influence on its core measurement function. While a human interacts with the device (e.g., initiating PAUSE/RUN), the performance data focuses on the device's mechanical and electronic accuracy in response to these inputs and fluid changes.

7. The Type of Ground Truth Used

The ground truth used for this type of device would be:

Accurate Weight Measurements: Using calibrated scales or industrial standards to verify the device's ability to accurately measure fluid weight changes.
Electrical and Mechanical Specifications: Compliance with engineering specifications for power modes (AC, DC, low battery) and button functionality.

8. The Sample Size for the Training Set

Not applicable. This device is a fluid monitoring system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physical principles (weight measurement) and electronic design, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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

Image /page/0/Picture/3 description: The image shows a logo with the word "DAVOL" written in capital letters inside an oval shape. The oval is white with a thick black border. The word "DAVOL" is written in a simple, sans-serif font.

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.100 Sockanossett CrossroadCranston, 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
- 1. Classification Name: Insufflator. Hysteroscopic: Fluid Monitoring Accessory (per CFR 884.1700)
C. Predicate Device Name AquaSens Fluid Monitoring System 3000

D. Device Description

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

Image /page/0/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.

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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, composed of three curved lines that suggest the head and wings.

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (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 (800) 638-2041 or (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 884.1700 Hysteroscopic insufflator.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.