(189 days)
The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.
The modified HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The modified HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure. Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.
The provided text describes modifications to the Davol HydroFlex™ HD System, a hysteroscopic distention and irrigation system. The 510(k) submission aims to demonstrate substantial equivalence to previous versions and predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Parameter | Acceptance Criteria (based on predicate or guidance) | Reported Device Performance (Modified HydroFlex HD) | Equivalence Demonstrated? |
|---|---|---|---|
| Maximum Static Intrauterine Pressure | Below 150 mmHg (based on "Draft Submission Guidance for a 510(k), Hysteroscopic and Laparoscopic Insufflators" dated Aug 1, 1995) | Below 150 mmHg (same as original HydroFlex HD, also stated as "approximately 100mmHg or 2.0 psig" by the main controller in the description) | Yes |
| Irrigation Flow Rate | At least 600 ml/minute (based on Hamou Endomat predicate) | Up to 600 ml/min or 630 ml/minute (higher than original HydroFlex HD, substantially equivalent to Hamou Endomat) | Yes |
| Pressure Relief Valve (PRV) Functionality | To relieve static pressures to below 150 mmHg (same as original HydroFlex HD PRV) | Relieves pressures to an acceptable level for hysteroscopic distention procedures, equivalent to the original HydroFlex HD PRV | Yes |
| Biocompatibility of Materials in Fluid Path | Materials suitable for externally communicating devices with limited duration tissue contact (Guidance: FDA General Program Memorandum #G9S-1) | Materials shown to be suitable | Yes |
| Electrical Safety Standards | Conformance to UL 2601-1 and ANSI/AAMI ES1-1993: Safe Current Limits for Electromechanical Apparatus (same as original HydroFlex HD Controller) | Conforms (no changes to controller, so original test results apply) | Yes |
| Electromagnetic Compatibility Standards | Conformance to IEC 601-1-2 (same as original HydroFlex HD Controller) | Conforms (no changes to controller, so original test results apply) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices or test runs) used for the performance testing. It refers to "testing was performed to evaluate the effect of the modifications on performance."
The data provenance is for a medical device manufactured by Davol Inc. in Cranston, RI, USA. The testing appears to be prospective testing conducted specifically for this 510(k) submission to demonstrate the performance of the modified device in comparison to its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a fluid management system, and its performance is evaluated through engineering and functional testing against specified parameters (e.g., pressure, flow rate). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes in the context of this device's performance claims.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication. Performance is measured objectively.
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 devices that involve human interpretation of medical images or data. The HydroFlex HD System is an accessory device that provides mechanical functions (distention and irrigation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The HydroFlex HD System is a physical device, not an algorithm. Its performance is inherent to its design and functionality, which is what the testing evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing in this submission is established through objective engineering measurements (e.g., pressure gauges, flow meters) against pre-defined specifications and regulatory guidance. For biocompatibility, the ground truth is adherence to established standards and guidelines (e.g., FDA General Program Memorandum #G9S-1).
8. The Sample Size for the Training Set
This is not applicable. The device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
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510(k) Summary of Safety and Effectiveness Information for the modified Davol HydroFlex™ HD System
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
1) Submitter Information:
Submitter's Name: Robin M. Drago Address: Davol Inc. 100 Sockanossett Crossroad Cranston, RI 02920 Phone #: 401-463-7000 Fax #: 401-463-3845 Contact Person: Robin M. Drago Date Of Preparation: February 15, 1999
2) Device Name:
Trade Name: HydroFlex™ HD Hysteroscopic Distention and Irrigation System Common/Usual Name: Hysteroscopic Distention System Classification Name: Hysteroscopic Insufflator. Obstetrics & Gynecology
3) Predicate Device:
- HydroFlex™ HD Hysteroscopic Distention System (970078) - Karl Storz Hamou Endomat (K936231)
The modified HydroFlex HD system described in this submission is substantially equivalent to the original HydroFlex HD system (K970078) and the Karl Storz Hamou Endomat (K936231). All of these devices are designed to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy. A comparison chart is provided which summarizes the similarities and differences in intended use, design and performance between the three systems (ref. Attachment 1 of this section).
Description and Intended Use of the Device: 4)
The modified HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system
{1}------------------------------------------------
. . - -
distends the uterus for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site.
The modified HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure.
Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.
Summary_of_Similarities_and_Differences_in_Technological_Characteristics, ર) Performance and Intended use:
A comparison chart is provided which summarizes the similarities and differences in intended use, technological characteristics and performance between the three systems (ref. Attachment 1 of this section).
The SIO(k) "Substantial Equivalence Decision Making Process (Detailed)" decision tree was utilized to make a determination of substantial equivalence. The answers to the decision tree questions lead to a determination of substantial equivalence.
Does the New Device Have the Same Indication Statement? 1.
Yes. The modified Davol HydroFlex HD system, the original HydroFlex HD system, and the Karl Storz Hamou Endomat are intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy. The devices distend the uterus for better visualization during hysteroscopic procedures and flush blood and tissue debris from the operative site.
2. Does the New Device Have the Same Technological Characteristics, e.g. Design, Materials, etc.?
Yes. The modified HydroFlex HD system and the original HydroFlex HD system have the same technological characteristics and fundamental scientific technology. The modified HydroFlex HD system (as well as the original HydroFlex HD system)
{2}------------------------------------------------
is driven by an impeller pump which is powered by an electronic Controller. The input pressure is determined by the user selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant and determines the resultant static pressure. .
Both the modified HydroFlex HD and the original HydroFlex HD system contain a Pressure Relief Valve (PRV) which limits the maximum intrauterine static pressure by releasing fluid through the valve and drain tube. The modified and original HydroFlex HD systems PRV relieves static pressures to below 150mmHg.
In addition, the design of the HydroFlex system reusable main Controller is such that it can be used as a multi-purpose fluid irrigation system (dependent on the disposable Pump Tubing set used with the Controller) as was described in the original HydroFlex HD system 510(k). There have been no modifications to the reusable Controller to allow for it's use with the modified HydroFlex HD system.
There are some minor material differences but all materials are biocompatible. Both systems are used only with low viscosity fluids for distention and inrigation of the uterine cavity.
3. Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?
No. Although the modified HydroFlex HD system and the original HydroFlex HD aystem have the same intended use and technological characteristics there has been a change to increase the flow rate of the modified HydroFlex HD system. The increased flow rate allows for better distention and visualization of the uterus when higher levels of outflow are being utilized with the hysteroscope outflow port. In this manner, distention is maintained under higher levels of outflow while the maximum static pressure reached within the uterus is the same as with the original HydroFlex HD system.
The change made to increase the flow rate of the modified HydroFlex HD raises a question regarding the ability of the system to meet the higher flow requirement and to continue to maintain static intrauterine pressures at the same levels as the original HydroFlex HD system.
In order to highlight the importance of fluid monitoring a new Warning has been added to the Instructions For Use provided with the modified HydroFlex HD system. This Warning states the following:
"Warning: the HydroFlex HD Hysteroscopic Distention System is a high flow system capable of delivering up to 600 ml/min., depending on the size of the sheath and scope. Under high flow conditions, fluid absorption and its consequent problems can be accelerated. It is important to carefully monitor the fluid-in/fluid-out difference,
{3}------------------------------------------------
and you may wish to consider use of an automated monitoring system, such as the AquaSens™ Fluid Monitoring System (Davol product code #0025333)."
Material changes made also required additional testing be performed to assure the new materials were biocompatible.
বঁ Are Performance Data Available to Assess Equivalence?
Yes. Testing was performed to evaluate the effect of the modifications on performance of the modified HydroFlex HD as compared to the data obtained for the original HydroFlex HD system. This testing included:
-
- measurement of maximum static pressure for each of the three devices to ensure equivalence
- irrigation flow rates obtainable out the distal end of the device with and 2) without hysteroscopes attached were measured to ensure equivalence
-
- fluid relief pressure testing of the Pressure Relief Valve (PRV) was measured to document the pressure at which the valve relieves to ensure equivalence to the original HydroFlex HD PRV
In addition, testing was performed on the modified HydroFlex HD system to assess the effects on pressure and flow rate of raising or lowering the fluid irrigation bags beyond the recommend height of 16". Testing was also performed to document the ability of the modified HydroFlex HD system to continue functioning with out loss of performance when the PRV is dripping and not releasing fluid in a steady stream mode.
Testing which was performed on the Hamou Endomat system (K936231), and had been provided in the original HydroFlex HD 510(k) (K970078), is provided for comparison purposes in Exhibit VIII of this submission.
Biocompatibility testing, performed in accordance with the FDA General Program Memorandum #G9S-1, has been conducted on all materials utilized in the fluid path of the modified HydroFlex HD system.
The HydroFlex Controller conforms to the applicable safety electrical standards (UL 2601-1 and ANSI/AAMI ES1-1993: Safe Current Limits for Electromechanical Apparatus) as well as applicable electromagnetic compatibility standards (IEC 601-1-Test results were provided in the original HydroFlex HD 510(k) submission 2). (K970078). Since no changes have been made to the HydroFlex Controller this data continues to be applicable.
5. Performance Data Demonstrate Equivalence?
{4}------------------------------------------------
Yes. The results of the testing performed demonstrates that the Static Pressure of the modified HydroFlex HD system is substantially equivalent to the original HydroFlex HD system. Both systems tested are below the maximum static pressure of 150mmHg which is described as the maximum pressure which should not be exceeded in the August 1, 1995 "Draft Submission Guidance for a 510(k), Hysteroscopic and Laparoscopic Insufflators".
The results of the flow rate testing demonstrate that the modified HydroFlex HD system is able to provided a higher flow rate than the original HydroFlex HD system and also provides a substantially equivalent flow rate as compared to the Hamou Endomat system.
The results of the Pressure Relief Valve (PRV) testing demonstrates the ability of the modified HydroFlex PRV to relieve pressures to an acceptable level for hysteroscopic distention procedures and is equivalent to the original HvdroFlex HD system PRV.
Results from the biocompatibility testing have shown that the materials to be used for the manufacture of the modified HydroFlex HD system are suitable for externally communicating devices with limited duration tissue contact.
CONCLUSION:
Based upon the above information, the modified Davol HydroFlex HD system is substantially equivalent to the original HydroFlex HD system and the Karl Storz Hamou Endomat system. Data generated from the testing of the devices demonstrates substantial equivalence.
Rubin m. Diaz
Manager of Regulatory and Clinical Affairs
HydroFlex is a trademark of C.R. Bard, Inc. or an affiliate
{5}------------------------------------------------
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{6}------------------------------------------------
| Feature | Proposed HydroFlex HD(Current Submission) | Original HydroFlexHD (K970078) | Karl Storz HamouEndomat (K936231) |
|---|---|---|---|
| Pressure Control: | Pressure selectedat electronicController | Pressure selectedat electronicController | Pressure selectedat electronicController |
| DisposableSuppliedSterile: | Yes | Yes | Yes |
| PressureMonitor: | No | No | Yes |
| FlowMonitor: | No | No | Yes |
| VolumeMonitor: | No | No | No |
| Alarm: | No | No | Yes |
| ReusablePump: | Yes | Yes | Yes |
| ReusablePump SuppliedNon-Sterile: | Yes | Yes | Yes |
| ReusablePump hasMultipleIndications: | Yes | Yes | Yes |
{7}------------------------------------------------
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{8}------------------------------------------------
Image /page/8/Picture/0 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 a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1000
Ms. Robin M. Drago Manager of Regulatory and Clinical Affairs Davol, Inc. Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920
Re: K982867 Hydroflex HD Hysteroscopic Distention System - Modified Dated: December 15, 1998 Received: December 16, 1998 Regulatory Class: II 21 CFR 884.1700/Procode: 85 HIG
Dear Ms. Drago:
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 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). 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 requirements, 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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Section I - D
:
510(K) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: PROPOSED DAVOL HD HYSTEROSCOPIC DISTENTION SYSTEM
Indications for Use: The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ U (Per 21 CFR 801.109)
Or
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 992847 510(k) Number_
Over-The-Counter Use_
(Optional Format 1-2-96)
0.10
§ 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.