IOGYN SYSTEM

K141848 · Iogyn, Inc. · PGT · Aug 29, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141848
• Device Name: IOGYN SYSTEM
• Applicant: Iogyn, Inc.
• Product Code: PGT · Obstetrics/Gynecology
• Decision Date: Aug 29, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1710
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

IOGYN System is a closed-loop hysteroscopic insufflator and cutter-coagulator. It uses a controller with two peristaltic pumps to manage saline infusion and aspiration, maintaining intra-uterine pressure (30-125 mmHg) via a pressure sensor feedback loop. A bipolar radiofrequency (RF) resecting device, operated via footswitch, performs tissue resection and coagulation. Resected tissue is aspirated through the device, filtered (removing particles, cellular material, proteins, and pathogens), and recirculated into a 3-liter saline bag. Used in clinical settings by physicians, the system provides real-time fluid management and visualization. The controller features a GUI for pressure settings and RF output control. Benefits include continuous, optically clear visualization and efficient tissue removal during hysteroscopic procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), sterility (ANSI/AAMI/ISO 11137-2), shelf-life (ASTM F1980), transit (ASTM D4169), and performance testing (simulated use, durability, hi-pot, tensile strength, flow rate, pressure testing, and dead volume). Results demonstrated that modified components meet design specifications and are suitable for intended use.

Technological Characteristics

System includes controller, footswitch, fluid management accessories (tubing/filters), and bipolar RF resecting device. Materials: Polyester and Parylene C (insulation), PVC (tubing). Energy: Bipolar RF. Connectivity: Electrical pressure sensor monitoring. Sterilization: Sterile single-use disposables. Software: Pressure control algorithm for peristaltic pumps.

Indications for Use

Indicated for patients undergoing diagnostic or operative hysteroscopy requiring uterine distension and resection/coagulation of intrauterine tissue (e.g., polyps, myomas).

Regulatory Classification

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.

Special Controls

In combination with the general controls of the Food, Drug & Cosmetic Act, the Closed Loop Hysteroscopic Insufflator with Cutter-coagulator is subject to the following special controls:

*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.

Predicate Devices

• IOGYN System (K132695)

Submission Summary (Full Text)

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

Iogyn, Inc. Rich Christensen Chief Operating Officer 20195 Stevens Creek Boulevard, Suite 120 Cupertino, CA 95014

Re: K141848 Trade/Device Name: Iogyn System Regulation Number: 21 CFR§ 884.1710 Regulation Name: Closed Loop Hysteroscope Insufflator with Cutter-coagulator Regulatory Class: II Product Code: PGT Dated: August 15, 2014 Received: August 18, 2014

Dear Rich Christensen,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 7.0 INDICATIONS FOR USE STATEMENT

# Indications for Use Statement

| 510(k)<br>Number | To be determined. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IOGYN System |
| Indications<br>For Use | The IOGYN System is intended to distend the uterus by filling it<br>with saline to facilitate viewing with a hysteroscope during<br>diagnostic and operative hysteroscopy and provide fluid<br>management through the closed-loop recirculation of filtered<br>distension fluid. It is also intended for cutting and coagulation of<br>uterine tissue such as intrauterine polyps and myomas using a<br>bipolar resecting device. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter

Use

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) SUMMARY

## 510(k) Summary for IOGYN System

#### A. Sponsor

IOGYN, Inc.

#### B. Contact

Rich Christensen Chief Operating Officer IOGYN, Inc 20195 Stevens Creek Blvd., Suite 120 Cupertino, CA 95014

Date Prepared: July 16, 2014

#### C. Device Name

| Trade name: | IOGYN System |
|----------------------|------------------------------------------------------------------|
| Common/usual Name: | Closed Loop Hysteroscopic Insufflator with Cutter-<br>coagulator |
| Classification Name: | Closed Loop Hysteroscopic Insufflator with Cutter-<br>coagulator |

#### D. Predicate Device(s)

| Trade name: | IOGYN System |
|-------------------------|------------------------------------------------------------------|
| Common/usual Name: | Closed Loop Hysteroscopic Insufflator with Cutter-<br>coagulator |
| Classification Name: | Closed Loop Hysteroscopic Insufflator with Cutter-<br>coagulator |
| Premarket Notification: | K132695 |

#### E. Device Description

Device Name: IOGYN System

The IOGYN System is comprised of the following:

- IOGYN Controller with Integrated Fluid Management .
- Footswitch O
- Fluid Management Accessories o
- IOGYN Resecting Device ●

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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 intra-uterine 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 3liter 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 two levels of filtration - the first level of filtration removes resected tissue and bulk particles; the second level of filtration removes cellular materials, hemoglobin, plasma proteins, cytokines, coagulation factors, bacteria and viruses. These two levels of filtration 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:

- o Component 1: IOGYN controller with Integrated Fluid Management
- Component 1a: Footswitch 0
- Component 1b: Fluid Management Accessories 0
- Component 2: Resecting Device ●

The IOGYN System is for use with the IOGYN Endoscope. Refer to IOGYN Endoscope Instructions.

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Image /page/5/Figure/1 description: This image is labeled Figure 1: IOGYN System Components and IOGYN Endoscope. The image shows the IOGYN Controller with Integrated Fluid Management Component 1, Fluid Management Accessories Component 1b, FootSwitch Component 1a, Resecting Device Component 2, and the IOGYN Endoscope. All of these components are laid out on a white surface.

## The IOGYN Controller includes:

- A touch screen with an intuitive Graphical User Interface (GUI) including . user-adjustable cavity pressure control;
- RF cut and coagulation output for the IOGYN Resecting Device;
- o Two pumps for the controlled infusion and aspiration of fluids and tissue;
- o 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 Accessories (footswitch, Fluid Management Accessories):

Image /page/5/Figure/8 description: This image is titled "Figure 2: IOGYN Controller with Integrated Fluid Management". The image is split into two sections, the left side shows the IOGYN Controller, which includes a touch screen, infusion pump, aspiration pump, footswitch connector, resecting device connector, and pressure sensor connector. The right side of the image shows the footswitch, which includes the CUT pedal, COAG pedal, and aspiration button.

Component 1: The IOGYN Controller is provided non-sterile and is intended to be cleaned prior to use pursuant to provided instructions. (Figure 2).

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Accessories to the IOGYN Controller consist of the (1) Footswitch and (2) the Fluid Management Accessories.

Component 1a: The Footswitch has a three button arrangement with individual pedals for cut, coagulation, and aspiration. (Figure 2). 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.

Component 1b: The Fluid Management Accessories to the IOGYN Controller consist of infusion and aspiration tubing sets. (Figure 3). The infusion tubing set consists of a pressure sensor, an infusion tube and a disposable introducer seal for the endoscope. The infusion tube 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 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/6/Figure/4 description: This image is titled "Figure 3: Fluid Management Accessories" and shows two different fluid management accessories. On the left is the Fluid Management Accessories Infusion Tubing Set, which includes a pressure sensor, pressure sensor connector, saline spike with integrated float valve, introducer, luer connection for endoscope, and infusion tube. On the right is the Fluid Management Accessories Aspiration Tubing Set, which includes an aspiration tube, molecular filter, tissue catch tube, aspiration valve, tissue catch, filter tube, and saline spike.

Component 2: The Resecting Device is a sterile, single use disposable bipolar radiofrequency device for the resection and coagulation of tissue in a salineinsufflated environment. (Figure 4). 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

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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 fullloop electrode moves distally to electro-surgically 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.

The Resecting Device is provided sterile, as a single-use disposable device.

Image /page/7/Figure/3 description: This image is labeled Figure 4: Resecting Device and shows two different views of the device. The left side of the image shows the resecting device with labels pointing to the device cable, device handle, and shaft. The right side of the image shows the resecting device distal tip with labels pointing to the outer tube, insulator, and full loop electrode.

The device description for the modified device is identical to the device description of the Predicate Device cleared per K132695 with the exception of the following modifications:

- 1. Resecting Device:
- · The Inner Tube Electrical Insulation material is being changed from FEP (Fluorinated Ethylene Propylene) to Polyester. The material change is being made to improve manufacturing reliability by use of a material that is stiffer and shrinks at a lower minimum temperature than FEP.
- · The Outer Tube Electrical Insulation material is being changed from Aesno Med and Trogamid (Nylon/Polyamide) to Parylene C. The material change is being made to increase manufacturing reliability by reducing a multi-component assembly of two insulation materials to a single vapor deposited conformal coating.
- 2. Fluid Management Accessories:
- · The Infusion Tube material and dimensions are being changed from AdvantPure AdvantaFlex (OD: 5/16" ID: 3/16") to polyvinyl chloride (PVC) (OD: .355" ID: 1/4") and the Aspiration Tube material and dimensions are being changed from PureWeld XL Thermoplastic Elastomer (TPE) (OD: 5/16" ID: 3/16") to polyvinyl chloride (PVC) (OD: .355" ID: 1/4"). The PVC tubing also contains two colorants: Ultramarine

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Blue and Ultramarine Violet. The material changes are being made to reduce supply chain risk associated with use of multiple vendors and to optimize cost structure.

#### F. Intended 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 distention fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

#### G. Technological Characteristics

The proposed Resecting Device and the Fluid Management Accessories (components of the IOGYN System) have the same fundamental design, operating principles and the intended/indications for use as the predicate device (K132695). The proposed device has differences in materials and dimensions when compared to the cleared device (K132695).

#### H. Substantial Equivalence

The indications for use, technology and principles of operation of the IOGYN System remain unchanged when compared to the IOGYN System cleared per K132695. Modifications described above were confirmed to be acceptable by means of biocompatibility evaluation and appropriate bench/performance testing. The modified device is substantially equivalent to the predicate device.

#### I. Performance Testing (Bench Evaluation)

As a part of the design control and material change process, Fluid Management Accessories and Resecting Device test samples assembled with the material changes were subjected to extensive testing at the system, component, and subassembly levels to ensure that the material changes did not alter device, component or system performance and that the IOGYN System met its performance specifications. The following testing was complete to evaluate the effects of the design change:

- o Biocompatibility testing per ISO 10993-1:2009 and FDA #G95-1
- Sterility testing per ANSI/AAMI/ISO 11137-2:2006(R)2010 and AAMI . TIR33:2005.
- Shelf Life Testing ASTMF1980-07(2011)
- Transit Testing per ASTM D4169(2009) ●
- Performance Testing ●
- Simulated Use O
- Durability Testing O

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- Hi Pot Testing O
- Tensile Strength O
- Flow Rate O
- Pressure Testing O
- O System undeliverable volume (dead volume)

#### J. Conclusion

Biocompatibility test results were deemed acceptable for the intended use and the devices were considered biocompatible.

All device bench test results were acceptable. Data demonstrate that the Resecting Device and the Fluid Management Accessories meet design specifications and are suitable for the intended use and labeled shelf-life.

IOGYN, Inc. has demonstrated that the proposed modifications to the IOGYN System components are substantially equivalent to their predicate in IOGYN System (K132695).