Model 330 Multifunction Aspirator

K170533 · ZOLL Medical Corporation · BTA · Apr 18, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170533
• Device Name: Model 330 Multifunction Aspirator
• Applicant: ZOLL Medical Corporation
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Apr 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

Device Story

Portable, electrically powered suction pump; removes debris, secretions, blood, vomitus, tissue, and bodily fluids from airway/respiratory system; performs intermittent gastrointestinal/abdominal wound drainage. Operates via AC, DC, or internal Li-Ion battery. Features 'Start Menu' for patient-specific configurations (adult/pediatric/custom); 'SMART FLOW' technology reduces vacuum level when therapy is inactive to decrease noise; visual/audible alarm suite for power, battery, environmental, and self-check status. Used in hospital, pre-hospital, field, and transport (aeromedical) environments by physicians or under physician order. Output is vacuum-based suction; healthcare providers monitor via LED indicators and audible alerts to ensure safe operation and effective drainage.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software verification/validation, and safety testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-12, IEC 62304, IEC 62366-1, and ISO 10079-1.

Technological Characteristics

Portable suction pump; Li-Ion internal battery; AC/DC power input. Features SMART FLOW vacuum control and LED/audible alarm system. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-12, IEC 62304, IEC 62366-1, and ISO 10079-1. Software level of concern: minor.

Indications for Use

Indicated for patients requiring airway/respiratory debris removal, secretion/fluid suctioning, or gastrointestinal/abdominal wound drainage. Suitable for use in pre-hospital, hospital, mass casualty, and transport settings. Use restricted to physicians or by physician order.

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

• Model 326/326M Aspirator (K951423)

Submission Summary (Full Text)

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Public Health Service

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

April 18. 2017

ZOLL Medical Corporation Ms. Pooja Dalvi Regulatory Affairs Associate 269 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K170533

Trade/Device Name: Model 330 Multifunction Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: February 21, 2017 Received: February 23, 2017

Dear Ms. Dalvi:

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 device

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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 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.

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

510(k) Number (if known) K170533

Device Name Model 330 Multifunction Aspirator

#### Indications for Use (Describe)

The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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ZOLL , @ ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.

978-421-9655 978-421-0025 Main Fax

## 510(k) Summary

# Sponsor Information:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824

Contact Person: Pooja Dalvi Regulatory Affairs Associate Phone: [phone] Fax: [phone]

## Date of Summary: April 17, 2017

## Device Name and Classification:

Common Name: Aspirator

Device Name: Model 330 Multifunction Aspirator

Classification Name: Pump, Portable, Aspiration (Manual Or Powered) (21 CFR 878.4780)

Product Code: BTA

## Predicate Device:

Model 326/326M Aspirator (K951423)

## Device Description:

The ZOLL Model 330 Multifunction Aspirator is a product based on the currently marketed Model 326/326M Aspirator (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc., reviewed and cleared under K951423). Similar to the currently marketed 326

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Aspirator, the ZOLL 330 Aspirator is a small, durable, full-featured portable aspirator designed to operate in the hospital, prehospital, field hospital, mass casualty and during ground or air transport settings.

Like the predicate 326 Aspirator, the proposed 330 Aspirator is an electrically powered suction pump intended to remove debris from a patient's airway or respiratory system, secretions, blood, yomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Both the devices can also be used to perform programmable intermittent gastrointestinal and abdominal wound drainage.

Both Aspirators can be operated from an AC or DC external power source, or from an internal rechargeable battery system, and supports both aspiration modes: Continuous and Intermittent. The Continuous mode in the proposed 330 Aspirator is sub-divided into four procedure types: Surgical, Pharyngeal, Tracheal, and CASS (Continuous Aspiration of Subglottic Secretions). Each procedure has a pre-set pressure range under which the device can be operated. Additionally with the proposed device we have introduced the following functionality:

- . Start Menu Functionality: Start Menu functionality is developed that allows the user to select from a series of preconfigured options that are appropriate for different patient groups: adult, pediatric, the last device settings and a custom start configuration established by the user or their organization.
- SMART FLOW Functionality: The feature detects a drop in the measured vacuum level when the ● therapy is not being applied and in response allows the aspirator to reduce the applied vacuum thereby allowing quieter operation of the device in the continuous mode.
- . ALARMS: The 330 Aspirator offers a suite of visual alarm indicators by illuminating red, yellow and green LED lights, and audible alarm indicators, to alert the user about issues relating to external power or battery, environmental conditions that could affect device performance, and device selfcheck failures.

## Indications for Use:

The ZOLL Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

## Comparison of Technological Characteristics:

The Model 330 Multifunction Aspirator is substantially equivalent to the predicate device, the 326 Aspirator. The devices have the same intended use, operating mechanism, portability, and function. The minor differences between the subject and the proposed device are presented in the following table. These minor differences were appropriately assessed and do not raise new questions regarding safety or effectiveness. The comparison table is listed below,

| Device | Model 326/326M<br>Aspirator<br>(K951423) | Proposed Model 330<br>Multifunction<br>Aspirator | Substantial<br>Equivalence<br>Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 | Same |
| Classification | Class II | Class II | Same |
| Device | Model 326/326M<br>Aspirator<br>(K951423) | Proposed Model 330<br>Multifunction<br>Aspirator | Substantial<br>Equivalence<br>Discussion |
| Product Code | Pump, Portable,<br>Aspiration (Manual Or<br>Powered) | Pump, Portable,<br>Aspiration (Manual Or<br>Powered) | Same |
| Intended Use | The Impact Model<br>326/326M is a self-<br>contained, multipurpose,<br>suction apparatus<br>designed for removing<br>secretions from the upper<br>airway during<br>oropharyngeal,<br>nasopharyngeal and<br>tracheal suctioning<br>procedures;<br>programmable<br>gastrointestinal and<br>abdominal wound<br>drainage; or surgical site<br>debris in field hospitals.<br>The apparatus includes<br>EMI/RFI suppression<br>circuitry and is suitable<br>for use in the desert,<br>tropic, arctic or<br>aeromedical<br>environments.<br>Simultaneous operation<br>and battery recharge are<br>permitted from either<br>115/230 VAC, 50-400<br>Hz using the provided<br>AC-DC Power Supply or<br>12 VDC using the<br>provided Auto Power<br>Cable accessories.<br>Simultaneous operation<br>and/or recharge from<br>aircraft electrical systems<br>(24 to 28 VDC) is<br>permissible with an<br>appropriate cable. The<br>Model 326/326M is<br>designed to accept DC<br>power sources ranging<br>from 11 to 30 volts,<br>positive or negative<br>ground. | The ZOLL® Model 330<br>Multifunction Aspirator<br>is a self-contained<br>suction device designed<br>for removing debris from<br>a patient's airway or<br>respiratory system,<br>secretions, blood,<br>vomitus, surgical fluids,<br>tissue (including bone),<br>bodily fluids and<br>infectious materials<br>during surgery.<br>Programmable<br>intermittent<br>gastrointestinal and<br>abdominal wound<br>drainage can also be<br>performed with the<br>device. It is suitable for<br>use in pre-hospital,<br>hospital, mass casualty<br>and transport<br>environments, including<br>aeromedical. The Model<br>330 is only for use by or<br>on the order of a<br>physician. | The Indications for<br>Use has been<br>revised for clarity. |
| Device | Model 326/326M<br>Aspirator<br>(K951423) | Proposed Model 330<br>Multifunction<br>Aspirator | Substantial<br>Equivalence<br>Discussion |
| Energy Used | AC, DC and Internal<br>Battery | AC, DC and Internal<br>Battery | Same |
| Input voltage | AC: 115/230 VAC<br>DC: 11 to 30 VDC | AC: 100 to 240 VAC<br>DC: 11.8 to 30 VDC | Slightly expanded<br>input power range. |
| Internal Battery | Sealed Lead Acid | Li-Ion | Li-Ion battery<br>reflects the more<br>modern and more<br>commonly used<br>technology. |
| Free Flow Rate | Continuous: Upto 30<br>LPM<br>Intermittent: 8 l/min | Continuous: Upto 30<br>LPM<br>Intermittent: 8 l/min | Same |
| Suction Pressure<br>Range in Continuous<br>Mode | 0 mmHg to 550 mmHg. | 10 mmHg to 550 mmHg | Pressure range<br>remains effectively<br>the same. |
| Suction Pressure<br>Range in Intermittent<br>Mode | 0 mmHg to 200 mmHg | 10 mmHg to 200 mmHg | Pressure range<br>remains effectively<br>the same. |
| Intermittent Controls:<br>ON Time<br>OFF Time | 5 to 40 sec<br>5 to 40 sec | 5 to 40 sec<br>5 to 40 sec | Same |
| Smart flow Feature | N/A | Yes | The feature is<br>introduced to allow<br>quieter operation of<br>the device when the<br>therapy is not being<br>applied. |
| Alarms | N/A | Visual: Yes<br>Audio: Yes | The proposed 330<br>Aspirator offers a<br>suite of alarms to<br>alert the user about<br>issues relating to<br>external power or<br>battery,<br>environmental<br>conditions that<br>could affect device<br>performance, and<br>device self-check<br>failures. |
| Device | Model 326/326M<br>Aspirator<br>(K951423) | Proposed Model 330<br>Multifunction<br>Aspirator | Substantial<br>Equivalence<br>Discussion |
| Smart Menu<br>Functionality | N/A | Yes | Start Menu<br>functionality is<br>developed that<br>allows the user to<br>select from a series<br>of preconfigured<br>options that are<br>appropriate for<br>different patient<br>groups. |

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# Substantial Equivalence - Non-Clinical Evidence:

The following performance data were provided in support of substantial equivalence determination:

### Software Verification and System Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained Medical Devices". The software for this device was considered as a "minor" level of concern, since a failures or latent design flaws are unlikely to cause any injury to the patient or operator.

Extensive performance testing in the software verification and system level validation ensured that the 330 Aspirator performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications.

### Safety testing per the international recognized standards

The device was evaluated and found to be in compliance with IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 10079-1, IEC 60601-1-8, IEC 62304 and IEC 60601-1-12.

Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards.

## Electrical Safety and electromagnetic compatibility (EMC)

The proposed Model 330 Multifunction Aspirator has been subjected to extensive performance and safety testing. Testing for Electromagnetic Compatibility & Electrical Safety was conducted in accordance with the applicable requirements and specifications contained in IEC 60601-1-2:2014, Medical Electrical Equipment- Part 1-2: General Requirements for Safety; Electromagnetic Compatibility.

Electrical safety testing was conducted in accordance with IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for Safety and Essential Performance.

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### Usability Testing

Usability testing was performed, where appropriate, to ensure that the proposed functionalities meet the user requirements and can be used as intended.

# Substantial Equivalence -Clinical Evidence:

Clinical evidence was not necessary to show substantial equivalence.

# Conclusion:

The subject device has undergone the appropriate verification, validation and safety testing, all of which confirms that the device meets its design, performance, and safety specifications. Performance data demonstrates that the features and functions of the subject device is substantially equivalent to those of the indicated commercially distributed devices.