DISPOSABLE SUCTION AND IRRIGATION SYSTEM

K093479 · Modern Medical Equipment Mfg., Ltd. · FHF · May 19, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093479
• Device Name: DISPOSABLE SUCTION AND IRRIGATION SYSTEM
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: FHF · Gastroenterology, Urology
• Decision Date: May 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4370
• Device Class: Class 2

Intended Use

The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

Device Story

Disposable Suction and Irrigation System; stainless steel probe connected to handle with two trumpet-type valves; PVC tubing connects to irrigation source (saline bag) and vacuum pump. Physician-operated during laparoscopic surgery; depressing one valve delivers irrigation fluid to surgical site; depressing second valve activates suction to remove blood, tissue debris, and smoke into waste container. Single-use device; facilitates site visualization and cleaning during minimally invasive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel suction/irrigation probe; PVC tubing; handle with two trumpet-type valves; single-use; manual operation; non-powered (requires external vacuum source).

Indications for Use

Indicated for use during laparoscopic surgical procedures to deliver sterile irrigation fluids and remove fluid waste, tissue debris, and smoke from the surgical site.

Regulatory Classification

Identification

A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

Special Controls

*Classification.* (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Predicate Devices

• Applied SI Suction Irrigator

Submission Summary (Full Text)

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# MAY 1 9 2010

Aedical Equipment Manufacturing Ltd

Gold King Ind Bldg 35 Tail in Pai Rd., Kv Tel: [phone].

### 510(k) Summa

Page 1 of 2.

Owner's name: Modern Medical Equipment Manufacturing Ltd Address: 5F,Gold King Ind.Bldg.,35 Tai Lin Pai Rd.. Kwai Chung, Hong Kong, China Phone number : [phone] , Fax number : [phone] Name of contact person: Eugene Yeung Date the summary was prepared: 19 October 2009 Name of the device: Disposable Suction And Irrigation System Trade or proprietary name: Disposable Suction And Irrigation System Common or usual name: Suction And Irrigation System Classification name: Laparoscope, General & Plastic Surgery Substantially equivalent device: Applied SI Suction Irrigator

#### Description of Device:

The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container.

The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.

#### Intended Use of Device:

The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

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093479

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# Aodern Medical Equipment Manufacturing Ltd

ld King Ind.Bldg. 35 Tai Lin Pai Rd.. Kwai Chung, Hong Ko Tel:[phone], Fax:[phone], Web address: www.modernmedical.com.hk

Page 282

The technological characteristics of The Disposable Suction System as compared to the predicate device - Applied SI Suction Irrigator, are found to be very similar. This device has the same technological characteristics in terms of design, structure, material composition, indication for use, intended use are similar as the predicate device. A summary of the technological characteristics of the new device in comparison to those of the predicate device was included in the main submission file.

### Conclusion:

It is demonstrated that the device Disposable Suction And Irrigation System is as safe, as effective, and performs very much the same way as the predicate device, Applied SI Suction Irrigator. It also has the same design, performance and structure as predicate device. Hence it is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is oriented towards the upper right. Surrounding the bird symbol is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY 1 9 2010

Modern Medical Equipment Manufacturing, Ltd. % Mr. Eugene Yeung Assistant Regulatory Manager 5F, Gold King Ind. Building 35 Tai Lin Pai Road Kwai Chung, Hong Kong, China

Re: K093479

Trade/Device Name: Disposable Suction and Irrigation System Regulation Number: 21 CFR 876.4370 Regulation Name: Gastroenterology-urology-urology evacuator Regulatory Class: Class II Product Code: FHF Dated: April 09, 2010 Received: April 13, 2010 -

Dear Mr. Yeung:

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

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Page 2 - Mr. Eugene Yeung

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 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,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use Statement

Applicant: Modern Medical Equipment Manufacturing Ltd. 510(k) Number Notassioned vet

Device Name:

Disposable Suction And Irrigation System

Indications For Use:

The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and moke from the surgical site.

Prescription Use V AND/OR (Part 21 CFR 801 sub-part D)

Over-The-Counter Use (Part 21 CFR 807 sub-part C)

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

Concurrence of CDRH, Office of Device Evaluation

Neil R. Oslen Lyman

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093479