(210 days)
Not Found
No
The description details a software pressure control algorithm for fluid management, which is a deterministic control system, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is intended for "cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device," which are therapeutic actions.
Yes
The device's intended use explicitly states "to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy," indicating its role in diagnostic procedures.
No
The device description explicitly lists multiple hardware components including a Controller, Footswitch, Fluid Management Accessories, and a Resecting Device. The software operates these hardware components.
Based on the provided information, the IOGYN System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for distending the uterus with saline to facilitate viewing with a hysteroscope and for cutting and coagulation of uterine tissue. This is a therapeutic and procedural device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a system with peristaltic pumps for fluid management and a bipolar radiofrequency device for tissue resection. These are all components of a surgical system, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on such analysis. The system facilitates a visual examination (hysteroscopy) and performs a therapeutic action (tissue removal).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The IOGYN System does not fit this definition.
N/A
Intended Use / Indications for Use
The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.
Product codes
PGT
Device Description
Device Model(s): FG-0200 (IOGYN Controller with Integrated Fluid Management), FG-0201 (Resecting Device), FG-0202(Fluid Management Accessories)
The IOGYN System is comprised of the following:
- IOGYN Controller with Integrated Fluid Management .
- o Footswitch
- o Fluid Management Accessories
- IOGYN Resecting Device .
The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intrauterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg.
The IOGYN System uses a closed loop fluid management system with a single 3-liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through a tissue catch and then a molecular filter to generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, Intrauterine
Indicated Patient Age Range
25 to 65 years
Intended User / Care Setting
Physicians trained in hysteroscopy and hysteroscopic surgery using powered instruments.
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)
Non-clinical/Bench Studies:
- Biocompatibility/Materials:
- Fluid Management Accessories (FMA) and filtrate: Patient-contacting materials and colorants identified for various FMA components. Biocompatibility testing performed according to ISO 10993-1-2009 for indirect tissue and blood contact of limited duration (
§ 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
(a)
Identification. A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.(b)
Classification. Class II (special controls). The special control(s) for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed.
(4) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 .(5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life.
(6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test.
(i) The following tests must be performed for the resection portion of the device:
(A) Mechanical testing to assess critical joint strength.
(B) Device electrode temperature testing.
(C) Coagulation depth testing.
(D) Simulated use testing.
(E) Device durability testing.
(ii) The following tests must be performed for the fluid management portion of the device:
(A) Mechanical testing to assess tensile strength of connections.
(B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements.
(C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level.
(D) Flow rate testing.
(E) Simulated use testing.
(F) Filtration testing.
(G) Blood filtration capacity testing.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk.
(7) Clinician labeling must include:
(i) Specific instructions and the clinical training needed for the safe use of the device.
(ii) Appropriate warnings, precautions, and information related to overpressurization.
(iii) Appropriate EMC information.
(iv) An expiration date/shelf life.
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DE NOVO CLASSIFICATION REQUEST FOR IOGYN SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Closed Loop Hysteroscopic Insufflator with Cutter-coagulator: A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.
NEW REGULATION NUMBER: 21 CFR 884.1710
CLASSIFICATION: CLASS II
PRODUCT CODE: PGT
BACKGROUND
DEVICE NAME: IOGYN SYSTEM
SUBMISSION NUMBER: K132695
DATE OF DE NOVO: SEPTEMBER 5, 2013
- CONTACT: MARY J. EDWARDS REGULATORY CONSULTANT IOGYN, Inc. 20195 Stevens Creek Blvd., Suite 120 Cupertino, CA 95014
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.
LIMITATIONS
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The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
The IOGYN System is to be used in conjunction with:
- . IOGYN Endoscope
- 3 Liter Irrigation USP Saline Bag (sodium chloride (0.9% w/v: 150mmol/1)) . Irrigation Solution (such as Baxter part#2B7477 or Hospira part#0409-7972-08)
- Light Sources and Flexible Light Cables ●
- . Endoscopic Accessories (light cable adapters, brushes)
Contraindications:
Pregnancy, genital tract infections, and known uterine cancer are contraindications to hysteroscopy.
Use of this device for intrauterine distension is contraindicated whenever hysteroscopy is contraindicated. See the operator's manual of your hysteroscope for absolute and relative contraindications.
The IOGYN System contains a large amount of metal components. Therefore it is MRI unsafe. Do not use the IOGYN System in conjunction with MRI, CT or RFID.
Warnings:
The IOGYN System should only be used by physicians trained in hysteroscopy and hysteroscopic surgery using powered instruments. Healthy tissue can be injured, e.g., perforation by improper use of the Resecting Device. Use every available means to avoid such injury.
The IOGYN closed loop system permits the operator to elect intrauterine pressure up to 125mm Hg. Clinicians using the IOGYN System should be aware of the 2013 AAGL practice guidelines regarding uterine cavity distension pressure (i.e. lowest pressure necessary to distend the uterine cavity and ideally should be maintained below the mean arterial pressure) when setting distension pressure on the IOGYN System.
Gas bubbles are a normal by-product of electrosurgical procedures performed in liquids. When bubbles occur in the uterus, care should be taken to manage the removal of air/gas bubbles to minimize the inherent risk of emboli. Bubbles produced during tissue vaporization may interrupt surgery by temporarily interfering with field of view and may also result in electrode overheating, causing damage to the electrode tip.
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Surgeon should avoid entry of air into uterus by:
- Carefully purging air from fluid inflow lines and hysteroscopic devices prior to use
- Following cervical dilation, care should be taken to minimize the exposure of the open cervix to room air
- Keeping an effective cervical seal during surgery as much as possible once the cervix is dilated
- Using active fluid outflow to effectively flush the uterus of bubbles and debris
- Minimizing the frequency of removal and reinsertion of hysteroscopic devices
If room air or gas embolism is suspected, surgeon should consider interrupting surgery, deflating the uterus, and removing sources of fluid and gas until the diagnosis and a management plan are clarified.
Do not use the IOGYN System with another fluid management system, endoscope, or controller. Use with another fluid management system, endoscope or controller may result in failure of the device to operate or lead to patient or physician injury.
Testing of the IOGYN System has not been confirmed in patients with hemoglobinopathies (e.g., Sickle Cell Disease, Beta Thalassemia) and therefore, the possible effects are unknown.
Hemolysis may occur during recirculation. If significant hemolysis occurs, this may result in electrolyte (e.g., increased serum potassium) changes or decrease in hemoglobin. Hemolysis may reveal red-tinged coloring of the recirculated fluid, but may not be visually apparent. Therefore, assessment of serum electrolytes and hemoglobin level after completion of the procedure is recommended.
Precautions:
USE ONE 3 LITER IRRIGATION USP SALINE BAG ONLY. DO NOT USE MULTIPLE SALINE BAGS. Use of multiple saline bags increases the chance of fluid overload.
Do not use the IOGYN System in patients where anatomy does not support an endoscopic procedure (i.e. cervical stenosis, existence of an IUD, or in conditions that limit access to the target tissue).
Use Resection and COAG with caution in the presence of any active implantable or body worn medical devices such as internal or external pacemakers or neurostimulators. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. The output of the IOGYN device might also affect other types of active devices such as implanted neurostimulator devices. Consult the active implantable device manufacturer (for implanted pacemakers and ICDs the hospital cardiology department might also be helpful) for further information when use of myomectomy or tissue coagulation is planned in patients with active implantable devices such as cardiac pacemakers.
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If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD manufacturer for instructions before performing myomectomy or tissue coagulation. Electrosurgery or tissue coagulation may cause multiple activations of ICDs.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
Device Model(s): FG-0200 (IOGYN Controller with Integrated Fluid Management), FG-0201 (Resecting Device), FG-0202(Fluid Management Accessories)
The IOGYN System is comprised of the following:
- IOGYN Controller with Integrated Fluid Management .
- o Footswitch
- o Fluid Management Accessories
- IOGYN Resecting Device .
The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intrauterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg.
The IOGYN System uses a closed loop fluid management system with a single 3-liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through a tissue catch and then a molecular filter to generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.
Components Description
The IOGYN System consists of the following components:
- IOGYN Controller (Figure 1) with Integrated Fluid Management
- Footswitch ●
- Fluid Management Accessories ●
- Resecting Device ●
The IOGYN Controller includes:
De Novo Summary (K132695)
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- A touch screen with an Graphical User Interface (GUI) including user-adjustable ● cavity pressure control;
- Radiofrequency (RF) cut and coagulation output for the IOGYN Resecting Device; ●
- Two pumps for the controlled infusion and aspiration of fluids and tissue; ●
- Accessories including a footswitch and Fluid Management Accessories
- An electrical connection for pressure sensor monitoring of the uterine cavity pressure;
- A footswitch connection with the IOGYN Controller for user activation of RF energy ● and aspiration; and
Image /page/4/Figure/6 description: The image shows a medical device with several labeled components. The device includes a touch screen for user interaction and two pumps: an infusion pump and an aspiration pump. Additionally, there are connectors for a footswitch, a resecting device, and a pressure sensor, indicating the device's functionality in a surgical or medical setting.
Figure 1: IOGYN Controller
The IOGYN Controller is provided non-sterile and is intended to be cleaned prior to use pursuant to provided instructions. (Figure 1).
Accessories to the IOGYN Controller consist of the (1) footswitch and (2) the Fluid Management Accessories.
The footswitch has a three button arrangement with individual pedals for cut, coagulation, and aspiration. When acted upon by the user, it communicates with the IOGYN Controller to perform the designated function. The footswitch connects to the foot switch connector on the front of the IOGYN Controller.
The Fluid Management Accessories to the IOGYN Controller consist of infusion and aspiration tubing sets. (Figures 2 and 3). The infusion tubing set consists of a pressure sensor, infusion tubing and a disposable introducer seal for the endoscope. The infusion tubing has a saline bag spike integrated with a float valve on the proximal end. The float valve prevents ingress of air into the infusion tubing and the uterine cavity when the bag
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is empty. The infusion tubing in conjunction with the infusion pump is responsible for insufflation of the uterine cavity via pressure feedback control from the pressure sensor to the IOGYN Controller. The aspiration tubing set consists of an aspiration tube, a container to collect tissue, a molecular filter and filter tubing. The molecular filter is a (b)(4) Trade Secret/CCI
The pore size is configured for the removal of most cellular materials including plasma proteins, cytokines, coagulation factors, and bacteria, viruses and endotoxins. The tube has a float valve to prevent back flow from the filter. The aspiration tubing set in conjunction with the aspiration pump is responsible for the aspiration and filtration of uterine outflow and the subsequent recirculation into the 3-liter saline bag. The Fluid Management Accessories are provided sterile, as a single-use disposable device.
Image /page/5/Figure/3 description: The image shows the title of a figure. The title is "Figure 2- Infusion Tubing Set". The title is written in a bold, sans-serif font.
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Figure 3- Aspiration Tubing Set
Image /page/6/Picture/1 description: The image shows a medical device with several components labeled. There is a molecular filter, an aspiration tube, and an aspiration valve. The device also includes a tissue catch tube, a tissue catch, a filter tube, and a saline spike.
The Resecting Device is a sterile, single use disposable bipolar radiofrequency device for the resection and coagulation of tissue in a saline-insufflated environment. (Figures 4 and 5). The Resecting Device features an outer tube and an internal reciprocating electrode. The IOGYN Controller provides bipolar radiofrequency output to the Resecting Device sufficient for the cutting and coagulation of tissue within the endoscopic environment. An internal full loop electrode reciprocates within the outer tube window, which is positioned at the distal tip of the device. When the RF Cut pedal is activated, the bipolar RF full-loop electrode moves distally to electrosurgically cut the tissue in the outer tube window. The resected tissue is simultaneously aspirated from the treatment site through the inner diameter of the full loop electrode, through the shaft and device handle area, and through the aspiration tube of the Fluid Management Accessories via the aspiration pump on the IOGYN Controller. When the RF Coagulation is activated, the bipolar RF full-loop electrode electro-surgically coagulates the tissue adjacent to the full loop electrode.
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Image /page/7/Figure/0 description: The image shows the title of a figure. The title is "Figure 4- Resecting Device". The text is in bold font.
Image /page/7/Figure/1 description: The image shows a medical device with three labeled parts. The first part is the device cable, which is on the left side of the image. The second part is the device handle, which is in the middle of the image and is gray and purple. The third part is the shaft, which is on the right side of the image and is a long, thin, gray rod.
Figure 5- Resecting Device Distal Tip
Image /page/7/Figure/3 description: The image shows a diagram of a device with several labeled components. The "Outer Tube (Return electrode)" is a long, cylindrical structure forming the outer layer of the device. An "Insulator" is positioned between the outer tube and the "Full Loop Electrode (Active electrode)", which appears to be a conductive element. Another "Insulator" is located beneath the active electrode, separating it from the underlying structure.
A depiction of the IOGYN System set-up when used with the currently cleared IOGYN Endoscope is shown in Figure 6.
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Image /page/8/Figure/0 description: The image shows the title of a figure. The title is "Figure 6- IOGYN Closed Loop System". The title is written in a bold, sans-serif font. The title is centered on the image.
Image /page/8/Figure/1 description: The image shows a diagram of a medical device setup. It includes a 3-liter saline bag connected to an infusion pump via tubing. The fluid flows through a filter and tissue catch before reaching a resecting device and an IOGYN endoscope, model K123330, which is equipped with a pressure sensor, and is used inside a cavity.
The IOGYN System operates under two modes: Diagnostic mode and Resection mode. In diagnostic mode, the infusion pump, aspiration pump and pressure monitoring are active. The Controller graphical user interface (GUI) touch screen has fluid control settings that can be adjusted by the user. The infusion pump can be toggled ON/OFF by pressing the infusion pump button on the GUI touch screen. The cavity pressure can be set by touching the up and/or down arrows on the touch screen. The pressure can be set from 30-125mmHg in 5 mmHg increments and can be adjusted at any time during the procedure. The user must first set a desired pressure in order for the system to start. Once the procedure starts, the rotational speed of the infusion pump is (b)(4) Trade Secret/CCI based on feedback from the pressure sensor which monitors the uterine pressure. The pressure control algorithm creates a (b)(4) Trade SeceetCC from the therefore, if the user selects (b)(4) Trade Secret/CCI the (6)(4) Trade Secretco will (b)(4) Trade Secret/CCI
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During diagnostic mode, fluid can also be aspirated from the cavity using the center button on the foot switch; this causes the aspiration pump to operate at a flow rate preset and fixed by the Controller. This results in a constant outflow from the cavity in which the pressure algorithm adjusts by increasing the flow rate of the infusion pump to maintain the pressure in the cavity. When aspirating from the cavity, the aspiration icon appears on the GUI. The user display includes information on the set pressure and the actual pressure.
In Resection mode, bipolar radiofrequency outputs for the IOGYN Resecting Device are active as well as the fluid management functions described in diagnostic mode. When switching from diagnostic mode to resection mode, the user detaches the aspiration tube from the introducer (attached to the endoscope) and connects the tube to the proximal end of the Resecting Device.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
There are two components of the IOGYN System that are patient contacting: Fluid Management Accessories (FMA) and Resection Device. Unique to this system is the recirculation of the hysteroscopic fluid. As a result, the biocompatibility of the filtrate also needs to be considered.
FMA and filtrate:
The patient contacting materials including colorants were identified for the following components of the FMA: aspiration tubing assembly; pressure sensor assembly; filter tubing assembly; tissue catch assembly; tissue catch tubing assembly; vacuum tubing assembly; introducer assembly; and filter assembly.
Biocompatibility testing was performed in accordance with ISO 10993-1-2009: Biological evaluation of medical devices, Part 1: Evaluation and Testing. The Fluid Management Accessories have indirect tissue and blood contact through the filtrate and can be generally classified as an external communicating device with mucosal tissue and indirect blood path contact of limited duration (