PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES

K120065 · Plaxtron Industrial (M) Sdn. Bhd. · JCX · Apr 3, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120065
• Device Name: PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
• Applicant: Plaxtron Industrial (M) Sdn. Bhd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Apr 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).

Device Story

Plaxtron Suction Unit (Model 88AA51/88AA61) is a portable, AC-powered suction pump. Device generates negative pressure (vacuum) to aspirate fluids from patient airways or respiratory support systems. System consists of pump, disposable tubing, and collection canister. Operated by physicians or licensed practitioners (e.g., EMTs) in clinical or field environments. Vacuum draws fluids through tubing into collection canister for containment. Device assists in airway management by clearing obstructions, potentially improving patient respiratory function.

Clinical Evidence

Bench testing only. Device performance verified against ISO 10079-1:2009 standards for powered suction equipment.

Technological Characteristics

Portable, AC-powered suction pump. Class II device (Product Code JCX). Complies with ISO 10079-1:2009 performance standards. System includes pump, disposable tubing, and collection canister. No software or complex algorithms described.

Indications for Use

Indicated for removal of fluids from the airway or respiratory support system. For use by physicians or licensed practitioners (e.g., EMTs) in clinical or field settings.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• DeVilbiss Suction Unit, Model 88 00 50 & 88 00 60, marketed name: Laerdal Compact Suction Unit (LCSU 3) (K982304)

Submission Summary (Full Text)

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K120065

## PLAXTRON INDUSTRIAL (M) SDN. BHD.

APR - 3 2012

A107

## 510 (K) Summary

| 5.1 Device Trade Name: | Plaxtron Suction Unit, Model 88AA51/88AA61 series |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 Named and Address of<br>Manufacturer: | PLAXTRON INDUSTRIAL (M) SDN. BHD.<br>plot 28, kawasan perusahaan, jelapang 2, ftz,<br>ipoh, MALAYSIA 30020 |
| Establishment<br>Registration Number: | 8044169 |
| Contact Person: | Doris Yang<br>Engineering / Regulatory Affairs Manager |
| | Or |
| | Leo Chien<br>General Manager |
| | Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 5.3 Device Classification<br>Names: | 1) apparatus, suction, ward use, portable, ac-powered |
| Regulation Description: | Powered Suction Pump |
| Review Panel: | General & Plastic Surgery, |
| Regulation Number: | §878.4780 |
| Classification: | Class II |
| Product Code: | 1) JCX |
| Recognized Performance<br>Standard | ISO 10079-1:2009 (JCX) |
| 5.4 Predicate Devices: | (a) DeVilbiss Suction Unit. Model 88 00 50 & 88 00 60,<br>marketed name: Laerdal Compact Suction Unit (LCSU<br>3). 510(k) Number: K982304 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Plaxtron Industrial (M) SDN, BHD % Sen Mu Technology Co., Ltd Ming-Yie Jan, Ph.D. No.15-2. Lane 26, Mincyuan 15t Road Lingya District, Kaohsiung City Taiwan 802

Re: K120065

Trade/Device Name: Plaxtron Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: March 13, 2012 Received: March 21, 2012

Dear Dr. Ming-Yie Jan:

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

APR - 3 2012

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Page 2 - Ming- Yie Jan, Ph.D.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set . forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/Resourcesfor.You/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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## Indications for use

510(k) Number (if known): ___K120065

Device Name: Plaxtron Suction Unit

Indications for Use:

The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).

Prescription Use _X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 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)

Richard T. Fisher for Ned Oeylon
(Division Sign-Off)

(Division Sign-C)) Division of Surg. al. Orthopedic, and Restorative Jevices

510(k) Number_< 12 00G

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