EASY GO VAC

K140179 · Precision Medical, Inc. · BTA · Apr 25, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140179
• Device Name: EASY GO VAC
• Applicant: Precision Medical, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Easy Go Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / health care environments.

Device Story

Easy Go Vac (PM66) is a portable medical suction device; consists of a DC motor powering a suction pump; vacuum level monitored by a gauge and set by a clinician up to 21 inches of mercury. Three models: PM66LI (internal Lithium battery, internal charger), PM66S (internal lead-acid battery, internal charger), and PM66AC (AC power only). Features include battery level and charge status indicators; choice of reusable or disposable waste containers. Used in homecare and healthcare settings by clinicians or patients. Provides vacuum source for aspiration; enhances operational ease compared to predicate. Benefits include extended run time (Lithium model) and simplified operation (AC model).

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered suction pump; DC motor; vacuum gauge. Models: PM66LI (Lithium battery), PM66S (lead-acid battery), PM66AC (AC power). Internal charger/power supply. Standards: ISO 15223-1, BS EN 1041, EN ISO 10079-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, EN ISO 14971, ISO 13485.

Indications for Use

Indicated for use as a portable, AC/DC powered medical vacuum source in homecare and healthcare environments.

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

• Precision Medical Inc Portable aspirator Model # pm 65 (K971749)

Submission Summary (Full Text)

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# APR 2 5 2014

# 510(k) Summary

Special 510K

# Precision Medical, Inc. Easy Go Aspirator.

# Submitter Information

Submitter

Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067 2523148

Facility Registration #

# Contact

Tel:

Fax:

James Parker Quality Assurance Manager (610)-262-6090 Extensions 228 (610)-262-6080 January 20, 2014

# Device Name

Preparation Date:

Proprietary Name: Model number Common Name: Classification Name: Classification Product Code: Regulation number: Regulatory Status

Easy Go Vac PM66 Aspirator Pump, Portable,Aspiration BTA 878.4780 Class II

# Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Precision Medical Inc Portable aspirator Model # pm 65 510Knumber K971749 Manufactured by: Precision Medical Inc. 300 Held Drive Northampton Pa 18067

# Device Descriptions ;

# Predicate Device (PM65)

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses a internal12 volt lead acid battery, with external charger/power supply.

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New Device PM66 (3 models)

# General description:

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal battery, with internal charger/power supply, on two models, and AC only on the third model.

# PM66LI model

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal Lithium battery, with internal charger/power supply. (charge status indicator along with a battery level indicator, disposable or reusable waste container)

# PM66AC

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses AC 100-240 volts power only.

#### PM66S

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal lead acid battery, with internal charger/power supply. (charge status indicator along with a battery level indicator, disposable or reusable waste container)

Differences from the new devices to the Predicate device

- Battery charger is internal on new devices for PM66LI and PM66S .
- Lithium battery on the PM66LI model ●
- . AC only Model
- . Addition of the charge indicator
- Addition of the battery level indicator .
- Choice of reusable or disposable waste container .

#### Conclusion:

The new devices are adding features that enhance the operation,

The lithium battery extends battery run time.

The AC model simplifies the device, for operators that do not need a portable device but want a simple small, easy to use device.

The lead acid battery model is the same as the predicate, with the added features of optional containers, a battery status indicator and the charge indicator.

The safety and effectiveness of the new devices compared to the predicate are substantially equivalent, with added features that ease, and enhance the operation.

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# Intended Use

ﺮ

The Easy Go Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / health care environments.

#### Applied Standards;

ISO 15223-1:2012 BS EN 1041:2008 EN ISO 10079-1:2009 IEC 60601-1:2005 ed3.1 Consol. with am1 IEC 60601-1-2:2007 IEC 60601-1-6:2007 IEC 60601-1-11:2010 EN ISO 14971:2012 ISO 13485:2012

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ci609 Silver Spring, MD 20993-0002

April 25, 2014

Precision Medical Incorporated Mr. James Parker Quality Assurance Manager 300 Held Drive Northampton, Pennsylvania 18067

Re: K140179

Trade/Device Name: Easy Go Vac Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Codc: BTA Dated: April 11, 2014 Received: April 14. 2014

Dear Mr. Parker:

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 for use stated in the energy to regard in the Medical Device Amendments. or to commerce provide to may 2014 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). and Cosmetic 71ct (71ct) that do not required to the general controls provisions of the Act. The I ou may, merelore, manust the Act include requirements for annual registration, listing of general controls provisions or active, labeling, and prohibitions against misbranding and advices: good manifacturing 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 If your device is classince (see above) inte time major regulations affecting your device can be finay be subject to acentral 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 Ficase of advised that + Dr. 3 issual.ib ever device complies with other requirements of the Act that 1 DA has made a doved regulations administered by other Federal agencies. You must or any it cather statures and registents including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Part 807), labering (21 CFR 803); good manufacturing practice requirements as sct

. - 9

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Page 2 - Mr. James Parker

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 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" (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 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,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K140179

Device Name

Precision Medical Easy Go Vac (PM66)

#### Indications for Use (Describe)

The Easy Go Vac Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / healthcare enviroments.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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