K Number
K221700
Device Name
AutoPulse NXT Resuscitation System
Date Cleared
2023-03-09

(269 days)

Product Code
Regulation Number
870.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient. The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
Device Description
The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles. The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger). The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use. The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use. The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits. The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways. The AutoPulse® NXT System comprises the subject devices included in this 510(k).
More Information

Not Found

No
The summary describes a mechanical chest compression device with a control system and software, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software mentioned appears to be for controlling the mechanical motion and user interface, not for learning or adapting based on data.

Yes
The device description states it provides "mechanical chest compressions" to aid blood flow during cardiac arrest and is an "adjunct to manual CPR," which are interventions directly aimed at treating a medical condition.

No

The device is an automatic chest compressor used as an adjunct to manual CPR. Its purpose is to deliver mechanical chest compressions, not to diagnose medical conditions or provide diagnostic information.

No

The device description clearly outlines multiple hardware components including a platform, band, battery, and charger, in addition to the software.

Based on the provided text, the AutoPulse NXT Resuscitation System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • AutoPulse NXT Function: The AutoPulse NXT System is a mechanical device that performs chest compressions on a patient's body. It does not analyze any biological samples.
  • Intended Use: The intended use clearly states it's an "adjunct to manual CPR" for adult patients in cases of clinical death, focusing on providing mechanical chest compressions.
  • Device Description: The description details the mechanical components and their function in applying external pressure to the chest.

Therefore, the AutoPulse NXT Resuscitation System falls under the category of a therapeutic or life-support device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.

The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Product codes

DRM

Device Description

The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles.

The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger).

The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use.

The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use.

The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits.

The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Chest

Indicated Patient Age Range

Adults only

Intended User / Care Setting

Point of Rescue, Ambulance, Hospital, Nursing home, Health Care Facility

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 Validation: Software verification and validation testing was conducted. The software for this device was considered as a "Major" level of concern. Extensive performance testing in the form of the software verification and system level validation ensured that the AutoPulse® NXT System performs as well as the indicated predicate device and met all of its functional requirements and performance specifications.

Safety testing per international recognized standards: The device was evaluated and found to be in compliance with various standards listed in Table 5-2. Applicable testing was completed to provide objective evidence of compliance to the aforementioned standards.

Usability Testing: Formative and summative human factors analyses were conducted. Key findings from preliminary analyses and formative evaluations were incorporated into the design. The final outcome of Summative Usability Testing indicated the AutoPulse® NXT System (AP 200) was found to be safe and effective for the intended users, uses, and use environments with acceptable risk. This determination was based on application of human factors and usability engineering processes, use-related risk-based comparison of the predicate device user interface to the proposed device, results of HF validation testing, and cross-functional risk-based review of use-related hazards. All identified risks have been reduced as far as possible (RAFAP), and the overall residual risk is acceptable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112998

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.5200 External cardiac compressor.

(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.

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March 9, 2023

ZOLL Circulation, Inc. Elizabeth Haines Senior Director, Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131

Re: K221700

Trade/Device Name: AutoPulse NXT Resuscitation System Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II Product Code: DRM Dated: February 6, 2023 Received: February 7, 2023

Dear Elizabeth Haines:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Kathleen
M.
Grunder -SDigitally signed
by Kathleen M.
Grunder -S
Date: 2023.03.09
16:47:19 -05'00'

for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K221700

Device Name AutoPulse NXT Resuscitation System

Indications for Use (Describe)

The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.

The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the ZOLL Medical Corporation logo. The word "ZOLL" is written in large, blue, sans-serif font. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller, black, sans-serif font.

K221700 ZOLL Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131 Phone: 408-419-2950 Fax: 408-541-1030 zoll.com

510(k) Summary

Sponsor Information:

ZOLL Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131

Contact Person:

Brian Robey Vice President, Advanced Development & Design Quality Assurance Phone: (978)-805-9015 E-mail: brobey@zoll.com

Date of Summary:

March 9, 2023

Device Name and Classification:

Trade/Proprietary Name:AutoPulse® NXT Resuscitation System
Common Name:Automatic Mechanical Chest Compressor
Regulatory Class:Class II
Classification Name:External Cardiac Compressor (21 CFR 870.5200)
Product Code:DRM

Predicate Device(s):

Trade/Proprietary Name:AutoPulse® Resuscitation System Model 100
Common Name:Automatic Mechanical Chest Compressor
Regulatory Class:Class II
Classification Name:External Cardiac Compressor (21 CFR 870.5200)
Product Code:DRM
510(k) Number:K112998 (Cleared: March 15, 2012)

Device Description

The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles.

The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists Page 1 of 9

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of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger).

The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use.

The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use.

The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits.

The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways.

The AutoPulse® NXT System comprises the subject devices included in this 510(k).

Indications for Use

The AutoPulse® NXT System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The system must be used only in cases where chest compressions are likely to help the patient.

The system is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (such as during patient transport or extended CPR when fatigue may prohibit the delivery of effective or consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Comparison of Technological Characteristics

The AutoPulse® NXT System is a battery-powered external chest compressor that utilizes a load- distributing compression band to circumferentially compress the entire thorax to provide blood flow during cardiac arrest. The principles of operation are substantially equivalent between the predicate AutoPulse® Resuscitation System Model 100 and subject device, AutoPulse® NXT System. A high-level comparison of technological characteristics is provided in Table 5-1.

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Image /page/5/Picture/0 description: The image features the logo for ZOLL Medical Corporation. The word "ZOLL" is written in large, bold, blue letters. Below the company name, in smaller black font, is the text "an Asahi Kasei company", indicating that ZOLL is a subsidiary of Asahi Kasei.

K221700 ZOLL Circulation, Inc.
2000 Ringwood Averilian 2000 Ringwood Alings 2000 Ringwood 2000 Ringson 2000 Rings 2000 Single 2008 - 10000
Pax: 408-3411-12030
Fax: 408-3411-

Table 5-1: Comparison of Technological Characteristics
Features/FunctionalitiesPredicate Device
AutoPulse® Resuscitation System
Model 100Proposed Device
AutoPulse® NXT System
510(k) NumberK112998K221700
Device ClassIISame
Classification Regulation21 CFR 870.5200 – External Cardiac
CompressorSame
Product CodeDRMSame
Indications for UseThe AutoPulse® Resuscitation System
Model 100 is intended to be used as an
adjunct to manual CPR, on adult
patients only, in cases of clinical death
as defined by lack of spontaneous
breathing and pulse.The AutoPulse® NXT System is
intended to be used as an adjunct to
manual CPR, on adult patients only,
in cases of clinical death as defined
by a lack of spontaneous breathing
and pulse. The system must be used
only in cases where chest
compressions are likely to help the
patient.
The AutoPulse® NXT System is
intended for use as an adjunct to
manual CPR when effective manual
CPR is not possible (e.g., during
patient transport or extended CPR
when fatigue may prohibit the
delivery of effective or consistent
compressions to the victim, or when
insufficient EMS personnel are
available to provide effective CPR).
Target Patient PopulationClinically dead adults as defined by a
lack of spontaneous breathing and
pulse.Same
Min. Patient Chest Width9.8"Same
Patient Chest CircumferenceMinimum: 30"
Maximum: 51.2"Minimum: Same
Maximum: 56"
Maximum Patient Weight300 lbs.400 lbs.
Intended EnvironmentPoint of Rescue, Ambulance, Hospital,
Nursing home, Health Care FacilitySame
Operating TemperatureTemperature: 0 – 40° C
Relative Humidity: 5 – 95% non-
condensing relative humidityTemperature: 0 – 45° C
Relative Humidity: 15 – 95% non-
condensing relative humidity
System ComponentsPlatform, Band, Battery, Battery
ChargerSame
Single-Use/ReusablePlatform: Reusable
Band: Single-Use
Same
Table 5-1: Comparison of Technological Characteristics
Features/FunctionalitiesPredicate Device
AutoPulse® Resuscitation System Model 100Proposed Device
AutoPulse® NXT System
Battery: Reusable Battery Charger: Reusable
SterilityNon-sterileSame
Prescription Use OnlyYesSame
Energy SourcePlatform: Battery-powered Band: N/A - non-active Battery: A/C Mains Battery Charger: A/C MainsSame
Patient ContactPlatform: Direct (limited) Band: Direct (limited) Battery: None Battery Charger: NoneSame
Patient Contact MaterialsPlatform: Thermoplastics Band: Tyvek, thermoplasticPlatform: Thermoplastics Band: Tyvek, thermoplastic There are some differences in the type of thermoplastics utilized for the proposed device. The change in materials was sought to aide improvements in manufacturability for the proposed design. Materials used in the manufacture of both devices have been used in numerous medical applications and have well-established material safety profiles. In addition, 10993-1 testing confirms that the proposed device materials are biocompatible.
Fundamental Technological
CharacteristicsCompression Frequency: 80 $\pm$ 5 compressions per minuteSame
Compression Depth: Chest displacement during chest compression equal to 20% reduction in anterior-posterior chest depth for each patient, +0.25/-0.5 inches.Compression Depth: Chest displacement during chest compression equal to 20%, up to 2.1 +0.25/-0.5 inches reduction in anterior-posterior chest depth for each patient.
Compression Modes: 30:2; 15:2; ContinuousCompression Modes: 30:2; Continuous
Physiologic Duty Cycle: 50 $\pm$ 5%Same
PlatformThe platform contains the drive mechanism, electronics, sensors, and support means for the patient.Same
Compressions are provided by tightening and releasing the band across the patient's sternumSame
Table 5-1: Comparison of Technological Characteristics
Features/FunctionalitiesPredicate DeviceProposed Device
AutoPulse® Resuscitation System
Model 100AutoPulse® NXT System
Patient baseline and compression depth
is determined and controlled via load
cell.Patient baseline and compression
depth is determined and controlled
via motor current.
User Control Panel:
Panel type: LCD screen with
several buttons and prompts
available to user to operate the
system.Quantity: One (1) control
panel placed on the side of the
device.User Control Panel:
Panel type: Simple non-
LCD user interface designed
to be glanceable and
intuitive, minimizing the
physical, cognitive, and
visual workload on users.Quantity: Two (2) identical
user control panels added to
both sides of the platform to
provide users access from
either side of the patient.
BandSingle-use, non-sterile band that
provides the mechanism of applying
compressions to the chest and consists
of a compression band and straps.Same
Patient position when changing band:
Patient must be off the platform.Patient position when changing band:
Patient can be either on or off the
platform.
BatteryRechargeable Lithium-Ion batterySame
Battery ChargerCapable of charging both the original
cleared nickel metal hydride (NiMH)
battery and the Li-Ion Battery.Capable of charging only the
proposed Li-Ion Battery.

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Image /page/6/Picture/0 description: The image features the logo for ZOLL Medical Corporation. The word "ZOLL" is written in large, bold, blue letters. Below the company name, in a smaller font, is the text "an Asahi Kasei company", indicating that ZOLL is a subsidiary of Asahi Kasei.

K221700 ZOLL Circulation, Inc.
2000 Ringwood Averilian 2000 Ringwood Alings 2000 Ringwood 2000 Ringson 2000 Rings 2000 Single 2008 - 10000
Pax: 408-3411-12030
Fax: 408-3411-

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Image /page/7/Picture/0 description: The image shows the ZOLL Medical Corporation logo. The word "ZOLL" is written in large, blue, sans-serif font. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller, black, sans-serif font. The logo is simple and modern, and the colors are bright and eye-catching.

K221700 ZOLL Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131 Phone: 408-419-2950 Fax: 408-541-1030 zoll.com

Substantial Equivalence - Non-Clinical Evidence:

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

Software Verification and Validation

Software verification and validation testing was 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, published on May 11, 2005. The software for this device was considered as a "Major" level of concern, as a failure or latent flaw in the software could result in serious injury or death to the patient. Extensive performance testing in the form of the software verification and system level validation ensured that the AutoPulse® NXT System performs as well as the indicated predicate device and met all of its functional requirements and performance specifications.

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Image /page/8/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo consists of the word "ZOLL" in large, blue, sans-serif font. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller, sans-serif font.

Software verification protocols were created to verify each requirement in the Software Requirements Specification (SRS) document. Protocols may use test, analysis, or inspection as acceptable methods of requirements verification.

Safety testing per the international recognized standards

The device was evaluated and found to be in compliance with the standards identified in Table 5-2.

Table 5-2: AutoPulse® NXT System Standards
Standard DesignationFDA Recognized Consensus Number
General Medical Device
ISO 13485:2012 EditionNot Recognized (N/R)
ANSI AAMI ISO 14971:2007/(R)20165-40
IEC 60812 Edition 2.0N/R
EN 1789:2020N/R
Transport, Environmental, and Storage
IEC 60068-2-1 Edition 6.0N/R
IEC 60068-2-2 Edition 5.0N/R
IEC 60068-2-6 Edition 7.0N/R
IEC 60068-2-13:1983N/R
IEC 60068-2-27 Edition 4.0N/R
IEC 60068-2-30 Edition 3.0N/R
IEC 60068-2-31 Edition 2.0N/R
IEC 60068-2-47 Edition 3.0N/R
IEC 60068-2-78 Edition 2.0N/R
IEC 60068-2-64 Edition 2.1N/R
IEC 60529 Edition 2.2N/R
UN3480:2014N/R
Electrical and Battery
EN 61959:2004N/R
IEC 62133-2 Edition 2.0 (2012-12)19-13
UN38.3 Edition 7.0N/R
EN 55011 CISPR-11:2009N/R
CISPR-14-1:2005N/R
CISPR-16-1-1 Edition 5.0N/R
CISPR-16-1-2 (2003+2004+2006 Edition 2.1)N/R
IEC 60073 Edition 6.0N/R
ANSI AAMI ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012 and A2:2010/
(R)201219-4
IEC-60601-1-2:2014 Edition 4.019-8
EN 301 489-1 V2.2.3N/R
EN 301 489-17 V3.2.4N/R
AIM Standard 7351731 Rev. 2.00 (2017-02-23)19-30
AAMI TIR69: 2017/(R2020)19-22
Table 5-2: AutoPulse® NXT System Standards
Standard DesignationFDA Recognized Consensus Number
IEC 60601-1-6 Edition 3.1 (2013-10)5-89
IEC 60601-1-9 Edition 1.1N/R
IEC 60601-2-2 Edition 5.0N/R
IEC 60601-2-4 Edition 3.1 (2018-02)3-169
IEC 60601-2-27 Edition 3.0 (2011-03)3-126
IEC 60601-2-47 Edition 2.0 (2012-02)3-155
IEC 60601-2-49 Edition 2.0N/R
IEC 61000-3-2 Edition 3.2N/R
IEC 61000-4-11 Edition 2.0N/R
IEC 61000-4-2 Edition 2.0N/R
IEC 61000-4-3 Edition 3.2N/R
IEC 61000-4-4 Edition 3.0N/R
IEC 61000-4-5 Edition 3.0N/R
IEC 61000-4-6 Edition 4.0N/R
IEC 61000-4-8 Edition 2.0N/R
IEC 61960:2011N/R
IEC 62281 Edition 2.0N/R
IEC 62353 Edition 2.0N/R
Materials
ANSI AAMI ISO-10993-1:20182-258
IEC 60085:2007N/R
Human Factors/Usability
ANSI AAMI IEC 62366:20155-114
ISO/TR 7250-1:2008N/R
ISO/TR 7250-2:2010N/R
Software
ANSI AAMI IEC 62304:2006/A1:201613-79
Labeling
ISO 20417 First edition (2021-04)15-135
ANSI AAMI ISO 15223-1:20165-117
IEC/TR 60878 Ed. 3.0 b:20155-104
Table 5-2: AutoPulse® NXT System Standards
Standard DesignationFDA Recognized Consensus Number
IEC 60417:2002 DB5-102

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Image /page/9/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo is in blue and consists of the word "ZOLL" in large, bold letters. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller font.

K221700 ZOLL Circulation, Inc.
2000 Ringwood Averilian 2000 Ringwood Alings 2000 Ringwood 2000 Ringson 2000 Rings 2000 Single 2008 - 10000
Pax: 408-3411-12030
Fax: 408-3411-

10

Image /page/10/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The word "ZOLL" is written in large, blue, sans-serif font. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller, dark gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards. Applicable testing was completed to provide objective evidence of compliance to the aforementioned standards.

Usability Testing

Formative and summative human factors analyses were conducted for the proposed AutoPulse® NXT System. The testing demonstrates the results of Human Factors Engineering (HFE) and Usability Engineering (UE). This report discusses key findings from preliminary analyses and formative evaluations and how they were incorporated into the design, as well the final outcome of Summative Usability Testing and analysis of any residual risk.

Based on the findings of the Summative Usability Test, the AutoPulse® NXT System (AP 200) was found to be safe and effective for the intended users, uses, and use environments with acceptable risk.

This determination is based on application of human factors and usability engineering processes throughout design and development of the system, including:

  • Items addressed from preliminary analyses and formative evaluations. .
  • Results of ZOLL's use-related risk-based comparison of the predicate device user interface (AP 100) to the proposed device (AP 200).
  • . Results of HF validation testing of the AutoPulse® NXT System, which collected performance, subjects' interview, and critical knowledge task data under simulated use conditions.
  • Results of ZOLL's cross-functional risk-based review of the use-related hazards of the AutoPulse® NXT System.

The residual risks will continue to be evaluated based on the available data generated both internally and externally through our established feedback systems. At this time, all identified risks have been reduced as far as possible (RAFAP), and the overall residual risk is acceptable.

Substantial Equivalence - Clinical Evidence

Clinical evidence was not necessary to show substantial equivalence.

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Image /page/11/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo consists of the word "ZOLL" in large, bold, blue letters. Below the word "ZOLL" is the phrase "an Asahi Kasei company" in a smaller font size.

K221700 ZOLL Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131 Phone: 408-419-2950 Fax: 408-541-1030 zoll.com

Conclusion

The information presented in this 510(k) demonstrates that the proposed AutoPulse® NXT System is substantially equivalent to its predicate AutoPulse® Resuscitation System Model 100. Objective evidence is provided to show the proposed device meets its design, performance, and safety specifications, such that it will consistently operate safely and effectively if used as intended in the patient care environment. Furthermore, performance data demonstrates that the features and functions of the proposed device are substantially equivalent, in safety and effectiveness, to those of the predicate device.