(43 days)
Not Found
No
The description focuses on mechanical and electrical components for automated chest compressions and does not mention any AI/ML capabilities or data processing for decision making.
Yes
The device is intended to perform cardiopulmonary resuscitation (CPR) on patients in cases of clinical death, which is a therapeutic intervention aimed at restoring vital functions.
No
The device description indicates that the RMCC is an automated chest compressor used to perform CPR. Its function is to provide continuous chest compressions, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components (Compressor Assembly, Control Unit, Torso Restraint, Stabilizer) that are integral to the device's function. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described, the RMCC, is an automated chest compressor used to perform cardiopulmonary resuscitation (CPR) on patients experiencing cardiac arrest. It physically interacts with the patient's chest to provide compressions.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and external.
Therefore, based on the provided information, the RMCC falls under the category of a therapeutic or life-support device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRM
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.
-
- Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
-
- 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.
-
- Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Adult patients and only adult patients
Intended User / Care Setting
Not Found
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)
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 Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests: PASS
After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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
2
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 ) | |
|---|---|
| ----------------------------------- | -- |
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.
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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
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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, LLC
17797 N Perimeter Drive, Suite #105
Scottsdale, AZ 85255
Phone: (949) 580.1266
Fax: (949) 580.1270 |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Hayden Fleming
Resuscitation International, LLC
17797 N Perimeter Drive, Suite #105
Scottsdale, AZ 85255
Phone: (949) 580.1266
Fax: (949) 580.1270
Email: hayden@resusintl.com |
| Submission date | December 18, 2015 |
| Product Code:
Common Name
Trade Name
Classification Name
Regulation
Class
Panel
Product Code | Mechanical Cardiopulmonary Resuscitator
ROSC-U Mini Chest Compressor (RMCC)
compressor, cardiac, external
870.5200
Class III
General & Plastic Surgery
DRM |
| Primary Predicate
(MCC) | K102068 - Miniaturize Chest Compressor |
| Secondary Predicate | K090422 - LUCAS 2 |
| 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. |
-
- Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
-
- 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.
-
- Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
4
Description (con't)
-
- 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 | No | ||
| Backplate | Backplate | ||
| Suction Cup | No Suction | ||
| Cup | Suction | ||
| Cup | |||
| Compressed Air Piston Design | Battery | ||
| Powered | Compressed | ||
| Air | |||
| Electromechanical Design | Electrical | Pneumatic |
5
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 Safety | |
| and Essential Performance - Collateral Standard: | |
| Electromagnetic Compatibility – Requirements and | |
| Tests. | 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.