To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Device Description

The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques.

1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
1. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit.
1. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
1. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.

AI/ML Overview

The provided text describes the ROSC-U Mini Chest Compressor (RMCC), a mechanical cardiopulmonary resuscitator, and makes claims of substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a device's performance, nor does it describe a study that explicitly proves the device meets specific performance acceptance criteria in the manner requested.

The document summarizes the device's technological characteristics and lists non-clinical performance tests. These tests are about fundamental safety and electromagnetic compatibility standards, not specific performance metrics like compression depth accuracy, rate stability, or physiological outcomes, which would typically be included in acceptance criteria for a device like this.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document only mentions the following non-clinical performance tests:

Functional verification	PASS
IEC 60601-1 (2012)	PASS
IEC 60601-1-2 (2007)	PASS

It concludes that "After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor." This suggests that the studies primarily aimed to show equivalence based on safety and general functional standards rather than defined performance acceptance criteria related to its CPR efficacy.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2016

Resuscitation International, LLC Havden Fleming Chairman and CEO 17797 N Perimeter Drive, Suite #105 Scottsdale, AZ 85255

Re: K153628

Trade/Device Name: ROSC-U Mini Chest Compressor (RMCC) Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: DRM Dated: December 18, 2015 Received: December 22, 2015

Dear Mr. Fleming:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR: Part 801): medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Willemsen
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement below.

510(k) Number ( if known )
-----------------------------------	--

K153628

Device Name

ROSC-U Mini Chest Compressor (RMCC)

Indications for Use (Describe)

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EB

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510(k) Summary

510(k) Owner	Resuscitation International, LLC17797 N Perimeter Drive, Suite #105Scottsdale, AZ 85255Phone: (949) 580.1266Fax: (949) 580.1270
Contact person	Hayden FlemingResuscitation International, LLC17797 N Perimeter Drive, Suite #105Scottsdale, AZ 85255Phone: (949) 580.1266Fax: (949) 580.1270Email: hayden@resusintl.com
Submission date	December 18, 2015
Product Code:Common NameTrade NameClassification NameRegulationClassPanelProduct Code	Mechanical Cardiopulmonary ResuscitatorROSC-U Mini Chest Compressor (RMCC)compressor, cardiac, external870.5200Class IIIGeneral & Plastic SurgeryDRM
Primary Predicate(MCC)	K102068 - Miniaturize Chest Compressor
Secondary Predicate	K090422 - LUCAS 2
Description	The RMCC is an automated, portable chest compressor, which providescontinuous chest compressions as an adjunct to performing manual CPR. It ispowered by a battery powered Control Unit. The RMCC provides consistentCPR support for cardiac arrest patients under conditions which might otherwisehinder the effectiveness of manual techniques.

1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
1. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit.
1. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.

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Description (con't)

1. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.

Intended Use

The ROSC-U Mini Chest Compressor (RMCC) is intended for use as a Mechanical Cardiopulmonary Resuscitator for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques.

Indications for Use

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Technological Characteristics

The predicate and the RMCC were compared in the following areas and found to have similar technological characteristics and to be equivalent:

	RMCC	MCC	LUCAS 2
User Population	Same	Same	Same
Compression Depth	Same	Same	Same
Compression Frequency	Same	Same	Same
Compression Duty Cycle	Same	Same	Same
Compression Modes	Same	Same	Same
Battery Voltage	Same	Same	Same
Follows AHA Guidelines	Same	Same	Same
Intended Use	Same	Same	Same
Contraindications	Same	Same	Same
Torso Restraint	Same	Same	Same
Stabilizer	Same	Same	Same
Electromechanical Design	Same	Same	Same

The predicate and the RMCC were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the RMCC.

	RMCC	MCC	LUCAS 2
Initial Battery Runtime	3.0 hours		45 minutes
Backplate	NoBackplate		Backplate
Suction Cup	No SuctionCup		SuctionCup
Compressed Air Piston Design	BatteryPowered	CompressedAir
Electromechanical Design	Electrical	Pneumatic

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The following non-clinical performance tests were conducted:

Functional verification	PASS
IEC 60601-1 (2012): Medical Electrical Equipment –Part 1: General Requirements for Safety	PASS
IEC 60601-1-2 (2007): Medical Electrical Equipment– Part 1-2: General Requirements for Basic Safetyand Essential Performance - Collateral Standard:Electromagnetic Compatibility – Requirements andTests.	PASS

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor.

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.