The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients 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 personnel are available to provide effective CPR).

Device Description

The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest.

The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

· Provide consistent depth and rate chest compressions.

• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.

Be applied to the patient with minimal interruption of CPR.
The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions.

The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module.

Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge.

A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Defibtech RMU-2000 Automated Chest Compression System, asserting its substantial equivalence to the predicate device, the LUCAS Chest Compression System. This document focuses on demonstrating that the RMU-2000 functions safely and effectively, similar to an already cleared device. As such, it does not contain details about a study evaluating AI performance, specifically the acceptance criteria or device performance in the context of AI. The device described is a mechanical system, not an AI or software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets these criteria because the document does not pertain to an AI device.

However, I can extract the information related to the performance testing and safety/effectiveness claims made for this non-AI mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria and a direct comparison table for the RMU-2000 against pre-defined performance thresholds (as would be typical for an AI study) are not detailed. Instead, the submission relies on demonstrating substantial equivalence to a predicate device. The performance claims are primarily comparative:

Performance Characteristic	Acceptance Criteria (Implicit - Substantial Equivalence to Predicate)	Reported Device Performance (RMU-2000)
Operational Capability (Continuous)	At least 45 minutes (Predicate: LUCAS 3.1)	At least 1 hour
Compression Rate	Within recommended AHA Guidelines (Predicate: 102 ± 1 cpm)	101 ± 1 compressions per minute
Compression Depth Setting	Within recommended AHA Guidelines (Predicate: 2.1 ± 0.1 inch for Anterior-Posterior diameter ≥ 7.3 inch; 1.5 ± 0.1 inch for Anterior-Posterior diameter < 7.3 inch)	1.5 - 2.4 ± 0.1 inch (determined by anterior-posterior diameter of patient chest measured from piston position)
Safety and Effectiveness	Equivalent to predicate device, no new issues	Testing and performance evaluations demonstrate substantial equivalence and no new issues of safety or effectiveness.

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

This information is not provided in the document. The text mentions "hardware verification, software validation, design validation and compression waveform comparison" and "Performance testing summaries, including waveform comparison testing," but does not explicitly detail sample sizes for any test sets or data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided as the submission is for a mechanical device, not an AI system requiring expert-adjudicated ground truth.

4. Adjudication Method:

This information is not provided as it's not relevant to the type of device and submission described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the document describes a mechanical chest compression system, not an AI diagnostic or assistive device that would involve human readers.

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

This is not applicable as the document describes a mechanical chest compression system, not an AI algorithm.

7. The type of ground truth used:

This is not explicitly stated in terms of a "ground truth" for a dataset, as would be relevant for an AI study. For this mechanical device, "ground truth" would be related to biomechanical measurements, physical parameters (rate, depth), and safety standards. The document mentions "resuscitation guideline recommendations" (e.g., American Heart Association Guidelines) as a reference point for desired performance. Compliance with these guidelines and functional equivalence to the cleared predicate device serve as the basis for evaluation.

8. The sample size for the training set:

This information is not provided as the device is mechanical and does not involve an AI training set.

9. How the ground truth for the training set was established:

This information is not provided as the device is mechanical and does not involve an AI training set.

Summary

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November 9, 2021

Defibtech, LLC Allison Bohren Senior Regulatory Affairs Specialist 741 Boston Post Road Guilford, Connecticut 06437

Re: K211289

Trade/Device Name: RMU-2000 Automated Chest Compression System Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II Product Code: DRM Dated: October 14, 2021 Received: October 15, 2021

Dear Allison Bohren:

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 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

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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.

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

Enclosure

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Indications for Use

510(k) Number (if known) K211289

Device Name

RMU-2000 Automated Chest Compression System

Indications for Use (Describe)

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

Type of Use (Select one or both, as applicable)
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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 logo for Defibtech. The logo consists of a red heart with a yellow lightning bolt through it, followed by the word "defibtech" in black and gray letters. The first part of the word, "defib", is in black, while the second part, "tech", is in gray.

1. Date Summary Prepared

April 26, 2021

2. 510(k) Owner Information

Defibtech, LLC 741 Boston Post Road Guilford, CT

3. Primary Contact Information

Ms. Allison Bohren Senior Regulatory Affairs Specialist Defibtech, LLC 741 Boston Post Road Guilford, CT 06437

Phone: 203-453-6651, extension 159 Fax: 203-453-6657 Email: abohren@defibtech.com

4. Trade (Proprietary) Name

RMU-2000 Automated Chest Compression System

5. Common Name

Mechanical chest compressor

Regulation/Classification Name and Code 6.

External Cardiac Compressor (product code DRM)

7. Regulation/Classification Code

21 CFR 870.5200

8. Predicate Device Information

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The predicate device is the LUCAS Chest Compression System, which has been previously cleared in various 510(k) submissions. The RMU-2000 ACC is substantially equivalent in performance and safety to the LUCAS and accessories cleared under the following:

Proprietary Name	Manufacturer	Submission Number
LUCAS3.1 Chest Compression System	Jolife AB	#K173553

The submission utilized a reference device, RMU - 1000, which has been previously cleared in K141809. 9. Device Description

The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable,

battery-powered device that provides chest compressions on adult patients who have cardiac arrest.

The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

· Provide consistent depth and rate chest compressions.

• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.

Be applied to the patient with minimal interruption of CPR.
The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions.

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Image /page/5/Picture/0 description: The image shows the logo for "defibtech". The logo consists of a red heart with a yellow lightning bolt through it on the left side. To the right of the heart is the word "defibtech" in black and gray letters. The first six letters are black, and the last four letters are gray.

10. Indications for Use/Intended Use

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

While the Indications for Use/Intended Use of the RMU-2000 contains minor clerical differences from the Indications for Use/Intended Use of the identified predicate device, the differences are not critical to the intended therapeutic use of the device, and the differences do not affect the safety and effectiveness of the device when used as labeled.

11. Comparison of Technology Characteristics

The intended use, operating principle, and basic design of the RMU-2000 ACC are the same as those in the LUCAS 3.1 predicate device. These similarities also include device features such as the compression mechanism, power sources, deployment operations and user interface controls. Both devices treat a similar adult patient population, with similar compressions rates, and have similar contraindication information. Both the Defibtech RMU-2000 and the LUCAS 3.1 utilize a suction cup which comes into direct contact with the patient's skin. The two devices are designed to meet the same resuscitation guideline recommendations, are marketed for the same clinical applications, and are intended to be used by similar populations of users in similar use environments.

In comparison, the technology differences between the RMU-2000 ACC and the predicate device includes an extended operational capability of 1 hour for the RMU-2000 compared to 45 minutes with the LUCAS 3.1. Additionally, there is a marginal difference in compression rates between the two devices (101±1 compressions per minute for the RMU-2000, and 102 ±1 compressions per minute for the LUCAS 3.1). Both device's compression rates are within the range for recommended American Heart Association (AHA) Guidelines compression rates. The available compression depth setting for the RMU-2000 (1.5 - 2.4 ±0.1 inch determined by anterior-posterior diameter of patient chest measured from piston position) is also different as compared to the LUCAS 3.1 (2.1 ± 0.1 inch for anterior posterior diameter ≥ 7.3 inch, 1.5 ± 0.1 inch for anterior posterior diameter < 7.3 inch for the LUCAS 3.1). As noted, the range of compression depth for the RMU-2000 is within the recommended range of AHA Guidelines compression depths.

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The differences between the devices are not significantly different and are related to design enhancements for users and implementation decisions.

12. Performance Testing

The RMU-2000 ACC uses the same underlying technologies to provide functionally equivalent performance characteristics as the predicate device. Additional testing, including hardware verification, software validation, design validation and compression waveform comparison, demonstrates that the RMU-2000 meets functional and performance specifications. Performance testing summaries, including waveform comparison testing, and applicable objective evidence are provided are as noted in Volume 018 of this submission. A summary of compliance testing and applicable objective evidence are provided in Volume 017 of this submission.

13. Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the RMU-2000 ACC is substantially equivalent to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. The introduction of the RMU-2000 ACC does not present new issues of safety or effectiveness.

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.