(189 days)
970078, K936231
No
The device description and performance studies focus on mechanical and pressure-based fluid control, with no mention of AI or ML algorithms for decision-making or data analysis.
Yes
The device is intended to provide distention and irrigation of the uterus for diagnostic and/or operative hysteroscopy, which is a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended "for diagnostic and/or operative hysteroscopy."
No
The device description clearly outlines hardware components like a pump controller, tubing set, and pressure relief valve, indicating it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a system for pumping fluid into the uterus to improve visualization and clear debris during a surgical or diagnostic procedure. This is a therapeutic or procedural device, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing information about a patient's health status based on sample analysis
The device is clearly designed to facilitate a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIG
Device Description
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 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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HydroFlex™ HD Hysteroscopic Distention System (970078), Karl Storz Hamou Endomat (K936231)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 HydroFlex
HD (K970078) | Karl Storz Hamou
Endomat (K936231) |
|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Pressure Control: | Pressure selected
at electronic
Controller | Pressure selected
at electronic
Controller | Pressure selected
at electronic
Controller |
| Disposable
Supplied
Sterile: | Yes | Yes | Yes |
| Pressure
Monitor: | No | No | Yes |
| Flow
Monitor: | No | No | Yes |
| Volume
Monitor: | No | No | No |
| Alarm: | No | No | Yes |
| Reusable
Pump: | Yes | Yes | Yes |
| Reusable
Pump Supplied
Non-Sterile: | Yes | Yes | Yes |
| Reusable
Pump has
Multiple
Indications: | Yes | Yes | Yes |
7
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NOTE: The Hamou Endomat (K936231) is provided in this submission as an example of a 510(k) concurred multi-application pump which als
rovides flow rates of 600 ml/minute. Testing was performed and provided in the original HydroFlex HD 510(k) (K970078) which demonstrates -
maximum flow rate of 600 ml/min. Exhibit VIII of this submission contains the summary data from this testing. Maximum Pressure settings an
within the criteria set within the "Hyster
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BLOOLEST OF
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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