TACVAC

K153459 · Athena Gtx · BTA · Jan 28, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153459
• Device Name: TACVAC
• Applicant: Athena Gtx
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jan 28, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.

Device Story

TACVAC is a portable, battery-powered suction device for airway clearance. It consists of a reusable suction unit and disposable components (bottle, valve unit, suction tip). To operate, the user assembles the unit by locking the suction unit into the valve/bottle assembly via bayonet fittings. Upon activation, the diaphragm vacuum pump creates suction in the bottle; the user applies suction to the patient airway by depressing a button. The device must remain upright to prevent fluid overflow via an integrated float check valve. Used by EMTs, nurses, and doctors in field or hospital settings. After use, the valve, bottle, and tip are discarded; the suction unit is cleaned and disinfected. The device provides a portable, lightweight solution for clearing obstructions, potentially improving patient respiratory outcomes in emergency scenarios.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including vacuum/flow ratings, operational times, IPX4 fluid ingress protection, mechanical strength (drop testing), vibration/noise, and pharyngeal suction performance (simulated vomitus).

Technological Characteristics

Battery-powered portable suction; diaphragm vacuum pump; plastic enclosure; fixed medium vacuum setting; Lithium battery; reverse voltage protection circuit. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), ISO 10079-1 (Medical suction equipment). IPX4 rated.

Indications for Use

Indicated for adult patients requiring airway clearance of bodily fluids (blood, saliva, mucous, vomitus) and particulate matter (<2.50mm) by trained healthcare providers in pre-hospital, transport, or hospital 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

• S-SCORT... Jr® Quickdraw, Model 2400 (K041154)

Submission Summary (Full Text)

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

January 28, 2016

Athena GTX Mr. Sean Mahoney V.P. Regulatory Affairs 5900 NW 86th Street, Suite 300 Johnston, Iowa 50131

Re: K153459 Trade/Device Name: TACVACTM Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: November 25, 2015 Received: December 1, 2015

Dear Mr. Mahoney:

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 of medical devicerelated 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.

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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,

Jennifer R. Stevenson -S

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K153459

Device Name: TACVAC Portable Battery Powered Suction Device

Indications for Use:

The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Submitter: | Athena GTX<br>5900 NW 86th Street, Suite 300<br>Johnston, Iowa 50131<br>Ph.: 515.288.3360 Fax: [phone] |
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| Company Contact: | Sean Mahoney (VP of Regulatory Affairs)<br>Office Phone Number: 515.288.3360 x103<br>Email: [e-mail] |
| Date Prepared: | January 27, 2016 |
| Trade Name: | TACVAC™ |
| Common Name: | Portable Battery Powered Suction Device |
| Product Code: | BTA |
| Classification Regulation: | 21 CFR 878.4780 |
| Classification Name: | Powered Suction Pump |
| Device Class: | Class II |
| Basis for Submission: | New Device |
| Legally Marketed<br>(Predicate) Device: | S-SCORT... Jr® Quickdraw, Model 2400, (K041154) |

## 510(k) Summary of Safety and Effectiveness

Device Description:

The TACVAC™ portable battery powered suction device is designed for the same application and intended use as the SSCOR, Inc. Jr® Quickdraw, Model 2400 listed predicate device. The TACVAC™ portable battery powered suction device is capable of the same functions as have been provided by the predicate device referenced above. The TACVAC™ consist of both re-useable and disposable (one-time use components). The device is very light weight (8 ounces) and can be compactly stowed (7.25" x 7.38" x 3.0") by inserting the suction unit inside the bottle to reduce space required to carry the device to the point of injury. To assemble from the stowed condition the valve unit is simply removed (unscrewed from the bottle) and the suction unit is removed. Then the valve unit is replaced back on the bottle and the suction unit is inserted into the valve unit and locked in place by twisting to engage the bayonet fittings. The assembled size is 7.25" x 11.88" x 3.0". A third party suction tip is installed on the suction tubing and then the unit can be turned on/off with the power switch. Once the unit is switched on suction will build in the bottle. Suction is applied at the suction tip by depressing the

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suction button. The device must be kept upright during use to prevent the overfill float check valve from engaging and shutting off suction to the tip. Once the user has finished using the device on a particular patient the valve unit, bottle and suction tip are discarded. The Suction unit is to be cleaned and disinfected. New batteries are installed as required to ensure full suction and use time. A new valve unit, bottle and suction tip are needed for the next use of the device.

Device Indications for Use:

The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs. nurses, doctors, first responders, etc.). The patient population includes adults.

Differences in Intended Use between the Device and Predicate:

The TACVAC™ has a more detailed description of the types of fluids and particulate matter that can be suctioned by the device in the Indications for Use statement than the predicate. TACVAC™ also is more descriptive in the use environments and patient population. In all these cases the TACVAC™ provides additional information, but is inclusive of the predicate indications.

The predicate indications statement includes specific information on the device being non-sterile and a single use disposable canister with integrated suction tip. The TACVAC™ does not have non-sterile in the indications statement, but this information is included in the labeling.

These differences are not critical to the intended use and do not affect the safety and effectiveness of the device since they essentially provide more details on use or are the same and included in different locations (Indications Statement vs. Labeling).

Summary of Technological Characteristics:

- Similarities: The TACVAC™ portable battery powered suction device employs the same technology as the predicate device including: battery powered portable suction, hand held during operation, suction provided via a diaphragm vacuum pump, enclosures are constructed of plastic material, protection against fluid overflow, and electrical circuit protection.
- Differences: The differences between the TACVAC™ and predicate device include: the TACVAC™ uses a larger non-custom collection container and the predicate device uses a custom collection container, the TACVAC™ has a fixed vacuum setting (medium) and the predicate has two settings (high and low), the TACVAC™ is smaller and lighter than the predicate, the TACVAC™ has an additional reverse voltage protection circuit, the

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TACVAC™ uses a lower voltage Lithium based battery and the predicate uses a higher voltage sealed lead-acid or alkaline battery, and the TACVAC™ has a reported longer 200mL simulated vomitus suction time.

Summary of Non-Clinical Performance Testing:

The TACVAC™ portable battery powered suction device employs the substantially equivalent performance as the predicate device including: Vacuum and Flow rating, similar operational times, environmental ratings and the same IPX4 rating. Testing of the TACVAC™ Portable Battery Powered Suction Device has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device including:

IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and

IEC 60601-1-2 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.

Additionally the following tests per ISO 10079-1 were also performed: Mechanical strength (Drop height), vibration and noise, means to prevent inadvertent contamination of the pump, fluid ingress protection, environmental (temperature and humidity), medium vacuum, pharyngeal suction (simulated vomitus), and minimum battery life test.

Summary of Clinical Performance Testing: (none)

Conclusion:

Based on the results for all safety and compliance testing performed. it is the opinion of Athena GTX the TACVAC™ Portable Battery Powered Suction Device is safe and effective, and is substantially equivalent to the above listed predicate device.