(54 days)
No
The description of the device's functionality, including the "SMART FLOW" feature, is based on detecting a drop in vacuum level and adjusting operation accordingly. This is a rule-based or algorithmic response, not indicative of AI/ML which typically involves learning from data to make predictions or decisions. There is no mention of training data, test data, or any AI/ML specific terms.
Yes
The device is designed for removing debris, secretions, blood, and other materials from a patient's airway or respiratory system, and for gastrointestinal and abdominal wound drainage, which are actions intended to restore or improve health.
No
This device is a suction device designed for removing debris, secretions, blood, and other materials from a patient's airway or for wound drainage. Its primary function is therapeutic/management, not diagnostic (i.e., it does not aim to identify a disease or condition).
No
The device description clearly states it is an electrically powered suction pump and mentions hardware components like LED lights and an internal rechargeable battery system. It also details electrical safety and EMC testing, which are relevant to hardware.
Based on the provided text, the ZOLL® Model 330 Multifunction Aspirator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a suction device for removing various substances from a patient's body (airway, respiratory system, surgical sites, etc.). This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The description reinforces its function as a suction pump for removing materials from the patient.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples outside the body.
- Providing information about a patient's health status based on the analysis of samples.
- Using reagents or other substances to perform tests on samples.
The device is clearly intended for direct patient care and procedural support, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
BTA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's airway or respiratory system
Indicated Patient Age Range
adult, pediatric
Intended User / Care Setting
by or on the order of a physician.
pre-hospital, mass casualty and transport environments, including aeromedical.
hospital, prehospital, field hospital, mass casualty and during ground or air transport settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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): Testing was conducted in accordance with the applicable requirements and specifications contained in IEC 60601-1-2:2014. Electrical safety testing was conducted in accordance with IEC 60601-1:2005+A1:2012.
Usability Testing: Usability testing was performed, where appropriate, to ensure that the proposed functionalities meet the user requirements and can be used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Model 326/326M Aspirator (K951423)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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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:
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
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.
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
Aspirator
(K951423) | Proposed Model 330
Multifunction
Aspirator | Substantial
Equivalence
Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 | Same |
| Classification | Class II | Class II | Same |
| Device | Model 326/326M
Aspirator
(K951423) | Proposed Model 330
Multifunction
Aspirator | Substantial
Equivalence
Discussion |
| Product Code | Pump, Portable,
Aspiration (Manual Or
Powered) | Pump, Portable,
Aspiration (Manual Or
Powered) | Same |
| Intended Use | The Impact Model
326/326M is a self-
contained, multipurpose,
suction apparatus
designed for removing
secretions from the upper
airway during
oropharyngeal,
nasopharyngeal and
tracheal suctioning
procedures;
programmable
gastrointestinal and
abdominal wound
drainage; or surgical site
debris in field hospitals.
The apparatus includes
EMI/RFI suppression
circuitry and is suitable
for use in the desert,
tropic, arctic or
aeromedical
environments.
Simultaneous operation
and battery recharge are
permitted from either
115/230 VAC, 50-400
Hz using the provided
AC-DC Power Supply or
12 VDC using the
provided Auto Power
Cable accessories.
Simultaneous operation
and/or recharge from
aircraft electrical systems
(24 to 28 VDC) is
permissible with an
appropriate cable. The
Model 326/326M is
designed to accept DC
power sources ranging
from 11 to 30 volts,
positive or negative
ground. | 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. | The Indications for
Use has been
revised for clarity. |
| Device | Model 326/326M
Aspirator
(K951423) | Proposed Model 330
Multifunction
Aspirator | Substantial
Equivalence
Discussion |
| Energy Used | AC, DC and Internal
Battery | AC, DC and Internal
Battery | Same |
| Input voltage | AC: 115/230 VAC
DC: 11 to 30 VDC | AC: 100 to 240 VAC
DC: 11.8 to 30 VDC | Slightly expanded
input power range. |
| Internal Battery | Sealed Lead Acid | Li-Ion | Li-Ion battery
reflects the more
modern and more
commonly used
technology. |
| Free Flow Rate | Continuous: Upto 30
LPM
Intermittent: 8 l/min | Continuous: Upto 30
LPM
Intermittent: 8 l/min | Same |
| Suction Pressure
Range in Continuous
Mode | 0 mmHg to 550 mmHg. | 10 mmHg to 550 mmHg | Pressure range
remains effectively
the same. |
| Suction Pressure
Range in Intermittent
Mode | 0 mmHg to 200 mmHg | 10 mmHg to 200 mmHg | Pressure range
remains effectively
the same. |
| Intermittent Controls:
ON Time
OFF Time | 5 to 40 sec
5 to 40 sec | 5 to 40 sec
5 to 40 sec | Same |
| Smart flow Feature | N/A | Yes | The feature is
introduced to allow
quieter operation of
the device when the
therapy is not being
applied. |
| Alarms | N/A | Visual: Yes
Audio: Yes | The proposed 330
Aspirator offers a
suite of alarms to
alert the user about
issues relating to
external power or
battery,
environmental
conditions that
could affect device
performance, and
device self-check
failures. |
| Device | Model 326/326M
Aspirator
(K951423) | Proposed Model 330
Multifunction
Aspirator | Substantial
Equivalence
Discussion |
| Smart Menu
Functionality | N/A | Yes | Start Menu
functionality is
developed that
allows the user to
select from a series
of preconfigured
options that are
appropriate for
different patient
groups. |
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.