(195 days)
No
The description focuses on mechanical automation of chest compressions and data retrieval, with no mention of AI or ML for decision-making, analysis, or adaptation.
Yes
The device is used for performing external cardiac compressions on adult patients with acute circulatory arrest, acting as an adjunct to manual cardiopulmonary resuscitation (CPR). Its purpose is to provide therapy by sustaining circulation in patients experiencing cardiac arrest.
No
The RMU-2000 is a therapeutic device that performs external cardiac compressions. Its purpose is to deliver treatment (CPR), not to diagnose a condition.
No
The device description clearly outlines multiple hardware components (Backboard, Frame, Compression Module, Battery Pack, piston drive, user interface, Bluetooth® technology, USB port) that are integral to the device's function of providing chest compressions. While it includes software for data retrieval and event reporting, it is not solely software.
Based on the provided information, the RMU-2000 Automated Chest Compression System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RMU-2000 Function: The RMU-2000 is a mechanical device that performs external chest compressions directly on the patient's body. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide mechanical support for circulation during cardiac arrest, not to diagnose or analyze a patient's condition through laboratory testing.
Therefore, the RMU-2000 falls under the category of a therapeutic or life-support device, not an IVD.
N/A
Intended Use / Indications for Use
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).
Product codes
DRM
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.
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
Intended User / Care Setting
in-hospital and out of hospital settings
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LUCAS3.1 Chest Compression System, #K173553
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows 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.
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
1
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
2
Indications for Use
510(k) Number (if known) K211289
Device Name
RMU-2000 Automated Chest Compression System
Indications for Use (Describe)
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).
| 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 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.
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.
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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 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).
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