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 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 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the ZOLL Model 330 Multifunction Aspirator. This device is a powered suction pump and the submission focuses on demonstrating its substantial equivalence to a predicate device (Model 326/326M Aspirator).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Key Takeaway: This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies or extensive statistical evaluations of diagnostic performance. The device is a physical medical device, not an AI or imaging diagnostic tool, so the typical AI/ML-specific criteria requested in the prompt (like multi-reader studies, ground truth for training data, etc.) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's overall performance. Instead, it demonstrates compliance with recognized standards and verifies specific performance parameters through testing. The "reported device performance" is largely described by meeting these standards and verifying functional requirements.

Category	Acceptance Criteria (Implied/Standard)	Reported Device Performance (Summary)
Software	Compliance with FDA's "Guidance for the Content of Premarket Submission for Software Contained Medical Devices" (minor level of concern)	Software verification and validation testing conducted; documentation provided; ensured 330 Aspirator performs as well as predicate and met all functional requirements/performance specifications.
Safety Testing	Compliance with recognized international standards: IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 10079-1, IEC 60601-1-8, IEC 62304, IEC 60601-1-12	Device evaluated and found in compliance with all listed standards based on extensive performance and safety testing.
Electrical Safety & EMC	Compliance with IEC 60601-1-2:2014 (EMC) and IEC 60601-1:2005+A1:2012 (Electrical Safety)	Testing for Electromagnetic Compatibility & Electrical Safety was conducted and found to be in accordance with the applicable requirements and specifications of these standards.
Usability	Meet user requirements and be usable as intended.	Usability testing was performed, "where appropriate," to ensure proposed functionalities meet user requirements and can be used as intended.
Functional Equivalence to Predicate	Maintain or improve upon key functional characteristics of the predicate device (Model 326/326M Aspirator).	Input voltage: Expanded range (AC: 100-240V, DC: 11.8-30V) from predicate.Internal Battery: Li-Ion (modern, commonly used) from Sealed Lead Acid.Free Flow Rate: Continuous: Up to 30 LPM, Intermittent: 8 l/min (Same as predicate).Suction Pressure Range: 10-550 mmHg (continuous), 10-200 mmHg (intermittent) (Effectively same range as predicate, just a slightly different lower bound of 10 mmHg instead of 0 mmHg for clarification).Intermittent Controls: ON/OFF Time 5-40 sec (Same as predicate).Smart Flow Feature: Added feature for quieter operation. Alarms: Added visual and audio alarms. Smart Menu Functionality: Added for preconfigured options.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation, as this is not a diagnostic device involving patient data samples. The testing described (software V&V, safety, EMC, usability) refers to engineering and functional tests on the device hardware and software. There is no information about a "test set" in the context of patient data.
Data Provenance: Not applicable. The "data" here refers to test results from engineering and functional evaluations of the device, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For a physical medical device like an aspirator, "ground truth" is established by engineering specifications, safety standards, and functional requirements. Expert review likely occurred in the design, testing, and regulatory submission process by engineers and regulatory specialists, but not in the sense of physicians establishing ground truth for a diagnostic test.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No "test set" of cases requiring adjudication for diagnostic accuracy is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is not an AI/ML diagnostic device, so a MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical aspirator device, not an algorithm. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

Type of Ground Truth: For a physical medical device like the Model 330 Multifunction Aspirator, the "ground truth" for demonstrating performance and safety is derived from:
- Engineering Specifications: The device must perform according to its design specifications (e.g., free flow rate, suction pressure range).
- International Consensus Standards: Compliance with established safety (e.g., IEC 60601-1) and performance (e.g., ISO 10079-1 for suction equipment) standards serves as the ground truth for safety and baseline functionality.
- Predicate Device Performance: The device's ability to operate with similar, or improved, functional characteristics compared to its legally marketed predicate device (Model 326/326M Aspirator) is a key "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with a human profile in the center.

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

{1}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170533

Device Name Model 330 Multifunction Aspirator

Indications for Use (Describe)

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)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: (978) 805-6293 Fax: (978) 421-0010

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:

{4}------------------------------------------------

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.

. 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 326/326MAspirator(K951423)	Proposed Model 330MultifunctionAspirator	SubstantialEquivalenceDiscussion
Regulation	21 CFR 878.4780	21 CFR 878.4780	Same
Classification	Class II	Class II	Same
Device	Model 326/326MAspirator(K951423)	Proposed Model 330MultifunctionAspirator	SubstantialEquivalenceDiscussion
Product Code	Pump, Portable,Aspiration (Manual OrPowered)	Pump, Portable,Aspiration (Manual OrPowered)	Same
Intended Use	The Impact Model326/326M is a self-contained, multipurpose,suction apparatusdesigned for removingsecretions from the upperairway duringoropharyngeal,nasopharyngeal andtracheal suctioningprocedures;programmablegastrointestinal andabdominal wounddrainage; or surgical sitedebris in field hospitals.The apparatus includesEMI/RFI suppressioncircuitry and is suitablefor use in the desert,tropic, arctic oraeromedicalenvironments.Simultaneous operationand battery recharge arepermitted from either115/230 VAC, 50-400Hz using the providedAC-DC Power Supply or12 VDC using theprovided Auto PowerCable accessories.Simultaneous operationand/or recharge fromaircraft electrical systems(24 to 28 VDC) ispermissible with anappropriate cable. TheModel 326/326M isdesigned to accept DCpower sources rangingfrom 11 to 30 volts,positive or negativeground.	The ZOLL® Model 330Multifunction Aspiratoris a self-containedsuction device designedfor removing debris froma patient's airway orrespiratory system,secretions, blood,vomitus, surgical fluids,tissue (including bone),bodily fluids andinfectious materialsduring surgery.Programmableintermittentgastrointestinal andabdominal wounddrainage can also beperformed with thedevice. It is suitable foruse in pre-hospital,hospital, mass casualtyand transportenvironments, includingaeromedical. The Model330 is only for use by oron the order of aphysician.	The Indications forUse has beenrevised for clarity.
Device	Model 326/326MAspirator(K951423)	Proposed Model 330MultifunctionAspirator	SubstantialEquivalenceDiscussion
Energy Used	AC, DC and InternalBattery	AC, DC and InternalBattery	Same
Input voltage	AC: 115/230 VACDC: 11 to 30 VDC	AC: 100 to 240 VACDC: 11.8 to 30 VDC	Slightly expandedinput power range.
Internal Battery	Sealed Lead Acid	Li-Ion	Li-Ion batteryreflects the moremodern and morecommonly usedtechnology.
Free Flow Rate	Continuous: Upto 30LPMIntermittent: 8 l/min	Continuous: Upto 30LPMIntermittent: 8 l/min	Same
Suction PressureRange in ContinuousMode	0 mmHg to 550 mmHg.	10 mmHg to 550 mmHg	Pressure rangeremains effectivelythe same.
Suction PressureRange in IntermittentMode	0 mmHg to 200 mmHg	10 mmHg to 200 mmHg	Pressure rangeremains effectivelythe same.
Intermittent Controls:ON TimeOFF Time	5 to 40 sec5 to 40 sec	5 to 40 sec5 to 40 sec	Same
Smart flow Feature	N/A	Yes	The feature isintroduced to allowquieter operation ofthe device when thetherapy is not beingapplied.
Alarms	N/A	Visual: YesAudio: Yes	The proposed 330Aspirator offers asuite of alarms toalert the user aboutissues relating toexternal power orbattery,environmentalconditions thatcould affect deviceperformance, anddevice self-checkfailures.
Device	Model 326/326MAspirator(K951423)	Proposed Model 330MultifunctionAspirator	SubstantialEquivalenceDiscussion
Smart MenuFunctionality	N/A	Yes	Start Menufunctionality isdeveloped thatallows the user toselect from a seriesof preconfiguredoptions that areappropriate fordifferent patientgroups.

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.