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).

AI/ML Overview

The provided document is a 510(k) premarket notification for the AutoPulse NXT Resuscitation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as an MRMC study or detailed analysis of ground truth establishment for AI models). The document primarily presents non-clinical evidence related to software verification and validation, safety testing against recognized standards, and usability testing.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially for AI/ML based devices), and ground truth establishment methods for large datasets is largely not applicable or not detailed in this document, as the device is a mechanical chest compressor and not an AI/ML diagnostic tool.

However, I can extract the information that is present and indicate where the requested details are not provided by this document:

Acceptance Criteria and Device Performance for AutoPulse NXT Resuscitation System

The provided document describes the AutoPulse NXT Resuscitation System, a mechanical chest compressor. The "acceptance criteria" in this context refer to the device's adherence to its design specifications, safety standards, and functional requirements, rather than performance metrics typically associated with AI/ML diagnostic tools (like sensitivity, specificity, or AUC). The study proving the device meets these criteria primarily involves non-clinical testing (software verification, safety standard compliance, and usability testing) rather than clinical trials with patient outcomes or large-scale data analysis for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document details a comparison of technological characteristics between the proposed device (AutoPulse NXT System) and its predicate (AutoPulse Resuscitation System Model 100). The "performance" here refers to operational parameters rather than diagnostic accuracy.

Feature/Functionality	Predicate Device (AutoPulse® Resuscitation System Model 100)	Proposed Device (AutoPulse® NXT System)	Acceptance Criteria Met?
Indications for Use	Intended as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.	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. 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).	Yes
Target Patient Population	Clinically dead adults as defined by a lack of spontaneous breathing and pulse.	Same	Yes
Min. Patient Chest Width	9.8"	Same	Yes
Patient Chest Circumference	Minimum: 30", Maximum: 51.2"	Minimum: Same (30"), Maximum: 56"	Yes (Improved)
Maximum Patient Weight	300 lbs.	400 lbs.	Yes (Improved)
Operating Temperature	0 – 40° C, 5 – 95% non-condensing relative humidity	0 – 45° C, 15 – 95% non-condensing relative humidity	Yes (Improved range)
Compression Frequency	80 ± 5 compressions per minute	Same	Yes
Compression Depth	Chest displacement equal to 20% reduction in anterior-posterior chest depth, +0.25/-0.5 inches.	Chest displacement equal to 20%, up to 2.1 +0.25/-0.5 inches reduction in anterior-posterior chest depth for each patient.	Yes (Clarified/Slightly adjusted limit)
Compression Modes	30:2; 15:2; Continuous	30:2; Continuous	Yes (Modified to 2 modes)
Physiologic Duty Cycle	50 ± 5%	Same	Yes
Patient Basline/Depth Control	Determined and controlled via load cell.	Determined and controlled via motor current.	Yes (Different mechanism)
User Control Panel	One (1) LCD screen with buttons on the side.	Two (2) identical simple non-LCD user interfaces on both sides for glanceability, intuitiveness, and minimizing physical, cognitive, and visual workload.	Yes (Improved design)
Band change (patient position)	Patient must be off the platform.	Patient can be either on or off the platform.	Yes (Improved flexibility)

Note: The "Acceptance Criteria Met?" column is inferred based on the FDA's clearance of the device, indicating that the differences were deemed acceptable and did not raise new questions of safety or effectiveness.

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

This document describes a medical device (mechanical chest compressor), not an AI/ML algorithm. Therefore, the concept of a "test set" in the sense of a data pipeline for AI validation does not directly apply. The "testing" involved here is primarily:

Software Verification and Validation: Conducted internally by the manufacturer. No specific sample sizes (e.g., number of cases/patients) are mentioned as it relates to software functionality testing, not diagnostic performance on a dataset.
Safety Testing: Compliance with international standards (e.g., ISO, IEC). This involves device testing under various conditions, not patient data sets.
Usability Testing: Formalized human factors analyses. While a "Summative Usability Test" was conducted, the document does not specify the number of participants (sample size) or their provenance. The testing was simulated use conditions.

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

Not applicable. This device is a mechanical therapeutic device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" as defined for AI/ML diagnostic purposes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic imaging AI. This document does not mention such a study, and it's not typically required for a mechanical chest compressor in a 510(k) submission, especially one relying on substantial equivalence to a predicate device. The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm but a mechanical device. Its performance is inherent to its mechanical and software operation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance would be its ability to mechanically deliver compressions according to its specifications and safely interact with users/patients, as verified by engineering tests, compliance with standards, and usability studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes a training phase with a dataset.

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

Not applicable. No training set is involved for this type of device.

In summary, the provided document is a regulatory submission for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, many of the questions asked, which are highly relevant to AI/ML device validation, are not applicable or detailed in this context. The "acceptance criteria" are met through adherence to design specifications, safety standards, and documented performance comparison to a predicate device, as demonstrated through engineering tests, software verification, and usability studies rather than clinical data from human subjects or AI model performance metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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,
KathleenM.Grunder -S	Digitally signedby Kathleen M.Grunder -SDate: 2023.03.0916:47:19 -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

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Indications for Use

510(k) Number (if known)

K221700

Device Name AutoPulse NXT Resuscitation System

Indications for Use (Describe)

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

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Image /page/4/Picture/0 description: The image contains 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 text "an Asahi Kasei company" in a smaller font.

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 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/Functionalities	Predicate DeviceAutoPulse® Resuscitation SystemModel 100	Proposed DeviceAutoPulse® NXT System
510(k) Number	K112998	K221700
Device Class	II	Same
Classification Regulation	21 CFR 870.5200 – External CardiacCompressor	Same
Product Code	DRM	Same
Indications for Use	The AutoPulse® Resuscitation SystemModel 100 is intended to be used as anadjunct to manual CPR, on adultpatients only, in cases of clinical deathas defined by lack of spontaneousbreathing and pulse.	The AutoPulse® NXT System isintended to be used as an adjunct tomanual CPR, on adult patients only,in cases of clinical death as definedby a lack of spontaneous breathingand pulse. The system must be usedonly in cases where chestcompressions are likely to help thepatient.The AutoPulse® NXT System isintended for use as an adjunct tomanual CPR when effective manualCPR is not possible (e.g., duringpatient transport or extended CPRwhen fatigue may prohibit thedelivery of effective or consistentcompressions to the victim, or wheninsufficient EMS personnel areavailable to provide effective CPR).
Target Patient Population	Clinically dead adults as defined by alack of spontaneous breathing andpulse.	Same
Min. Patient Chest Width	9.8"	Same
Patient Chest Circumference	Minimum: 30"Maximum: 51.2"	Minimum: SameMaximum: 56"
Maximum Patient Weight	300 lbs.	400 lbs.
Intended Environment	Point of Rescue, Ambulance, Hospital,Nursing home, Health Care Facility	Same
Operating Temperature	Temperature: 0 – 40° CRelative Humidity: 5 – 95% non-condensing relative humidity	Temperature: 0 – 45° CRelative Humidity: 15 – 95% non-condensing relative humidity
System Components	Platform, Band, Battery, BatteryCharger	Same
Single-Use/Reusable	Platform: Reusable•Band: Single-Use•	Same
Table 5-1: Comparison of Technological Characteristics
Features/Functionalities	Predicate DeviceAutoPulse® Resuscitation System Model 100	Proposed DeviceAutoPulse® NXT System
	Battery: Reusable Battery Charger: Reusable
Sterility	Non-sterile	Same
Prescription Use Only	Yes	Same
Energy Source	Platform: Battery-powered Band: N/A - non-active Battery: A/C Mains Battery Charger: A/C Mains	Same
Patient Contact	Platform: Direct (limited) Band: Direct (limited) Battery: None Battery Charger: None	Same
Patient Contact Materials	Platform: Thermoplastics Band: Tyvek, thermoplastic	Platform: 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 TechnologicalCharacteristics	Compression Frequency: 80 $\pm$ 5 compressions per minute	Same
	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; Continuous	Compression Modes: 30:2; Continuous
	Physiologic Duty Cycle: 50 $\pm$ 5%	Same
Platform	The 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 sternum	Same
Table 5-1: Comparison of Technological Characteristics
Features/Functionalities	Predicate Device	Proposed Device
	AutoPulse® Resuscitation SystemModel 100	AutoPulse® NXT System
	Patient baseline and compression depthis determined and controlled via loadcell.	Patient baseline and compressiondepth is determined and controlledvia motor current.
	User Control Panel:Panel type: LCD screen withseveral buttons and promptsavailable to user to operate thesystem.Quantity: One (1) controlpanel placed on the side of thedevice.	User Control Panel:Panel type: Simple non-LCD user interface designedto be glanceable andintuitive, minimizing thephysical, cognitive, andvisual workload on users.Quantity: Two (2) identicaluser control panels added toboth sides of the platform toprovide users access fromeither side of the patient.
Band	Single-use, non-sterile band thatprovides the mechanism of applyingcompressions to the chest and consistsof 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 theplatform.
Battery	Rechargeable Lithium-Ion battery	Same
Battery Charger	Capable of charging both the originalcleared nickel metal hydride (NiMH)battery and the Li-Ion Battery.	Capable of charging only theproposed 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 Designation	FDA Recognized Consensus Number
General Medical Device
ISO 13485:2012 Edition	Not Recognized (N/R)
ANSI AAMI ISO 14971:2007/(R)2016	5-40
IEC 60812 Edition 2.0	N/R
EN 1789:2020	N/R
Transport, Environmental, and Storage
IEC 60068-2-1 Edition 6.0	N/R
IEC 60068-2-2 Edition 5.0	N/R
IEC 60068-2-6 Edition 7.0	N/R
IEC 60068-2-13:1983	N/R
IEC 60068-2-27 Edition 4.0	N/R
IEC 60068-2-30 Edition 3.0	N/R
IEC 60068-2-31 Edition 2.0	N/R
IEC 60068-2-47 Edition 3.0	N/R
IEC 60068-2-78 Edition 2.0	N/R
IEC 60068-2-64 Edition 2.1	N/R
IEC 60529 Edition 2.2	N/R
UN3480:2014	N/R
Electrical and Battery
EN 61959:2004	N/R
IEC 62133-2 Edition 2.0 (2012-12)	19-13
UN38.3 Edition 7.0	N/R
EN 55011 CISPR-11:2009	N/R
CISPR-14-1:2005	N/R
CISPR-16-1-1 Edition 5.0	N/R
CISPR-16-1-2 (2003+2004+2006 Edition 2.1)	N/R
IEC 60073 Edition 6.0	N/R
ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	19-4
IEC-60601-1-2:2014 Edition 4.0	19-8
EN 301 489-1 V2.2.3	N/R
EN 301 489-17 V3.2.4	N/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 Designation	FDA Recognized Consensus Number
IEC 60601-1-6 Edition 3.1 (2013-10)	5-89
IEC 60601-1-9 Edition 1.1	N/R
IEC 60601-2-2 Edition 5.0	N/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 2.0	N/R
IEC 61000-3-2 Edition 3.2	N/R
IEC 61000-4-11 Edition 2.0	N/R
IEC 61000-4-2 Edition 2.0	N/R
IEC 61000-4-3 Edition 3.2	N/R
IEC 61000-4-4 Edition 3.0	N/R
IEC 61000-4-5 Edition 3.0	N/R
IEC 61000-4-6 Edition 4.0	N/R
IEC 61000-4-8 Edition 2.0	N/R
IEC 61960:2011	N/R
IEC 62281 Edition 2.0	N/R
IEC 62353 Edition 2.0	N/R
Materials
ANSI AAMI ISO-10993-1:2018	2-258
IEC 60085:2007	N/R
Human Factors/Usability
ANSI AAMI IEC 62366:2015	5-114
ISO/TR 7250-1:2008	N/R
ISO/TR 7250-2:2010	N/R
Software
ANSI AAMI IEC 62304:2006/A1:2016	13-79
Labeling
ISO 20417 First edition (2021-04)	15-135
ANSI AAMI ISO 15223-1:2016	5-117
IEC/TR 60878 Ed. 3.0 b:2015	5-104
Table 5-2: AutoPulse® NXT System Standards
Standard Designation	FDA Recognized Consensus Number
IEC 60417:2002 DB	5-102

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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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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.

Regulation Number and Section

§ 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.