(181 days)
No
The description focuses on fluid management, temperature control, and suction, with no mention of AI or ML terms or functionalities.
No.
The device facilitates surgical procedures by managing fluids and maintaining visibility, but it does not directly treat a disease or condition.
No
Explanation: The device is described as an "Irrigation, Warming and Suction System" used to "fill and/or wash different operating cavities" and "control of the Irrigation, the temperature of the fluid and the suction." Its purpose is to manage fluids during surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states that the ENDOFLOW® II System includes an "electro medical device" and "disposables," indicating it is a hardware system with associated software, not a software-only device.
Based on the provided information, the ENDOFLOW® II Irrigation, Warming and Suction System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ENDOFLOW® II Function: The ENDOFLOW® II system is used during surgical procedures (endo-urology, hysteroscopy, and laparoscopy) to manage fluids within the operating cavity. It irrigates, warms, and suctions. It does not analyze samples taken from the body to provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is to "fill and/or wash different operating cavities" during procedures, not to perform diagnostic tests on patient samples.
Therefore, the ENDOFLOW® II is a surgical device used for fluid management during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endo-urology, hysteroscopy and laparoscopy procedures to fill and/or wash different operating cavities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician during endo-urology, hysteroscopy and laparoscopy procedures in medical facilities.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
:
510 (k) Summary
A. Submitter Information
| Submitter's Name: | PROMEPLA SAM | |
|---|---|---|
| Address | 9 Avenue Prince Albert II | |
| 98000 Monaco | ||
| MONACO (Principality of) | ||
| Contact Person | Alexandre Bareille | |
| Contact Person's email: | alb@promepla.com | |
| 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) |
| 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 |
.
4
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.
5
G. Substantial Equivalence:
| Product Name | ENDOFLOW II
Irrigation, Warming
and Suction System
Models MEN01US
& MEN02PUS | NORMOFLO
IRRIGATION FLUID
WARMER,
MODEL H-1129 | ENDOGATOR
ADVANTAGE
IRRIGATION PUMP
MODEL EGA-500 | FMS DUO® |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | OCX | K072080 | K113119 | K954465 |
| Product Code | OCX | LGZ | OCX | HRX |
| Classification Name | Endoscopic
Irrigation/Suction
System | Warmer, Thermal,
Infusion Fluid | Endoscopic
Irrigation/Suction
System | Arthroscopy |
| Manufacturer | PROMEPLA SAM | SMITHS MEDICAL
ASD, INC. | BYRNE MEDICAL,
INC. | FUTURE MEDICAL
SYSTEMS, INC |
| 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. | NORMOFLO
Irrigation Fluid
Warmer
NORMOFLO
Irrigation Fluid
Warmer
The Level 1
NORMOFLO®
Irrigation Fluid
Warmer is designed
for use by trained
medical personnel
for in-line warming
of irrigation fluids. | The EndoGator
Advantage
Irrigation Pump
EGA-500 is
indicated for
endoscopic
irrigation for use
with washing
catheters, integra
endoscope water jet
channels and
endoscope working
channels. | The FMS DUO®+ is
intended to be used
in arthroscopic
surgery in the
following joints:
shoulder, knee,
ankle, elbow, wrist,
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.
6
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.