ENDOFLOW II - Irrigation, Warming and Suction System

K152278 · Promepla Sam · OCX · Feb 9, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152278
• Device Name: ENDOFLOW II - Irrigation, Warming and Suction System
• Applicant: Promepla Sam
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOFLOW® II Irrigation, Warming and Suction System intended to be used in medical facilities under direction of a trained physician during endo-urology, hysterocopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

Device Story

ENDOFLOW II is a fluid management system for endo-urology, hysteroscopy, and laparoscopy. It provides continuous, non-pulsating irrigation, fluid warming, and suction. The device uses compressed medical air to pressurize liquid bags in a closed tank, ensuring cavity pressure matches machine settings. A thermostatic heater maintains fluid at 38°C to support patient temperature and reduce endoscope condensation. The double-chamber model (MEN02PUS) includes a peristaltic-roller pump for suction. Operated by physicians or trained staff in medical facilities via touchscreen or footswitch. RFID technology identifies disposables to preselect parameters and prevent reuse. Output allows surgeons to inflate and clean the surgical field, improving visibility during procedures.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to establish performance and safety characteristics, demonstrating the device is safe and effective for its intended use.

Technological Characteristics

System uses compressed medical air for irrigation via closed-tank pressurization. Includes thermostatic heater (38°C) and peristaltic-roller pump for suction (MEN02PUS model). Features RFID technology for disposable identification and parameter selection. Operates on 120V/100V AC. Touchscreen interface and footswitch control. Designed for endo-urology, hysteroscopy, and laparoscopy.

Indications for Use

Indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy, and laparoscopy procedures to fill and/or wash operating cavities.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ENDOGATOR ADVANTAGE IRRIGATION PUMP (K113119)
• NORMOFLO IRRIGATION FLUID WARMER (K072080)
• FMS DUO® (K954465)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

February 9, 2016

Promepla SAM Alexandre Bareille Asst. Quality Manager - Regulatory Affairs 9 Avenue Prince Albert II 98000 Monaco

Re: K152278 Trade/Device Name: ENDOFLOW II - Irrigation, Warming and Suction System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: December 22, 2015 Received: December 28, 2015

Dear Alexandre Bareille,

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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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# Indications for Use

510(k) Number (if known) K152278

## Device Name

ENDOFLOW II - Irrigation, Warning and Suction System

Indications for Use (Describe)

The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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:

# 510 (k) Summary

## A. Submitter Information

| Submitter's Name: | PROMEPLA SAM | |
|-------------------------|-----------------------------------------------------------------------|--|
| Address | 9 Avenue Prince Albert II<br>98000 Monaco<br>MONACO (Principality of) | |
| Contact Person | Alexandre Bareille | |
| Contact Person's email: | [e-mail] | |
| Contact Person's Number | (377) 97984244 | |
| Contact Person's Fax | (377) 92056150 | |
| Submission date | August 05, 2015 | |

:

## B. Device Name

| Trade Name of the Device: | ENDOFLOW II – Irrigation, Warming and Suction System |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models: | MEN01US: ENDOFLOW® II single chamber (120V 60Hz, 100V 50/60Hz)<br>MEN02PUS: ENDOFLOW® II double chamber with aspiration pump (120V 60Hz, 100V 50/60Hz) |
| Common Name: | ENDOFLOW II |
| Device Class: | 2 |
| Classification Name(s): | Gastroenterology/Urology |
| Product Code: | OCX |
| Classification Regulation: | 21 CFR 876.1500 |
| Official Contact Person: | Alexandre Bareille |

## C. Predicates Devices

| N° | Product name | Manufacturer |
|----|-------------------------------------|-----------------------------|
| 1 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | BYRNE MEDICAL, INC. |
| 2 | NORMOFLO IRRIGATION FLUID WARMER | SMITHS MEDICAL ASD, INC. |
| 3 | FMS DUO® | FUTURE MEDICAL SYSTEMS, INC |

.

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## D. Device Description:

The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv.

The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction.

The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity.

The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function.

The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.

#### E. Intended Use:

The ENDOFLOW® II Irrigation, Warming and Suction System intended to be used in medical facilities under direction of a trained physician during endo-urology, hysterocopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

#### F. Technological Characteristics Summary:

Irrigation is obtained by compressed medical air that permits to pressurize the liquid bag. The pressurization is conducted in a closed tank exposing the liquid bag to an adjusted air pressure.

The ENDOFLOW® 11 includes a thermostatic heater that maintains the liguid bag to 38°C during the procedure. It permits to maintain the patient's body temperature during the procedure. It also reduces the condensation effect in the endoscope. The user can disable this function by the touch screen.

On the double chambers MEN02PUS, the aspiration system is performed by a peristallic-roller pump. The system is directly managed by the user with the touch screen and/or the footswitch.

The requirements for fluid management are adapted to the types of surgical procedures (Endourology, Hysteroscopy and Laparoscopy).

ENDFOLOW® II includes RFID technology that helps the user preselecting the appropriated parameters when the disposable is detected by the electro-medical device and preventing any reuse of the disposable. There is a range of disposables dedicated to each different intended surgical application.

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# G. Substantial Equivalence:

| Product Name | ENDOFLOW II<br>Irrigation, Warming<br>and Suction System<br>Models MEN01US<br>& MEN02PUS | NORMOFLO<br>IRRIGATION FLUID<br>WARMER,<br>MODEL H-1129 | ENDOGATOR<br>ADVANTAGE<br>IRRIGATION PUMP<br>MODEL EGA-500 | FMS DUO® |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | OCX | K072080 | K113119 | K954465 |
| Product Code | OCX | LGZ | OCX | HRX |
| Classification Name | Endoscopic<br>Irrigation/Suction<br>System | Warmer, Thermal,<br>Infusion Fluid | Endoscopic<br>Irrigation/Suction<br>System | Arthroscopy |
| Manufacturer | PROMEPLA SAM | SMITHS MEDICAL<br>ASD, INC. | BYRNE MEDICAL,<br>INC. | FUTURE MEDICAL<br>SYSTEMS, INC |
| Intended Use | The ENDOFLOW® II<br>Irrigation, Warming<br>and Suction<br>System intended to<br>be used in medical<br>facilities under<br>direction of a trained<br>physician during<br>endo-urology,<br>hysterocopy and<br>laparoscopy<br>procedures in order<br>to fill and/or wash<br>different operating<br>cavities. | NORMOFLO<br>Irrigation Fluid<br>Warmer<br>NORMOFLO<br>Irrigation Fluid<br>Warmer<br>The Level 1<br>NORMOFLO®<br>Irrigation Fluid<br>Warmer is designed<br>for use by trained<br>medical personnel<br>for in-line warming<br>of irrigation fluids. | The EndoGator<br>Advantage<br>Irrigation Pump<br>EGA-500 is<br>indicated for<br>endoscopic<br>irrigation for use<br>with washing<br>catheters, integra<br>endoscope water jet<br>channels and<br>endoscope working<br>channels. | The FMS DUO®+ is<br>intended to be used<br>in arthroscopic<br>surgery in the<br>following joints:<br>shoulder, knee,<br>ankle, elbow, wrist,<br>hip. |
| Main Functions | Irrigation | Similar | Different | Different |
| | Warming | Different | Similar | N/A |
| | Suction | Different | N/A | Similar |

ENDOFLOW® II is substantially equivalent to the predicate devices since the basic features and intended uses are the same.

The minor differences between ENDOFLOW® II and the predicate devices raise no new issues of safety and effectiveness.

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### H. Performance Data:

Performance testing have been executed to validate the performance and safety of the devices.

Verification and validation activities were conducted to establish the performance and safety characteristics of the ENDOFLOW® II. The results of these activities demonstrate that the ENDOFLOW® II is safe and effective when used in accordance with its intended use and labeling.