(239 days)
Medtronic PhysioControl LifePak 500, Cardiac Science Powerheart G3, Zoll AED Pro, Philips Heartstream FR2+
Not Found
No
The document describes an "ECG analysis algorithm" but does not mention AI, ML, or any related terms. The description focuses on standard defibrillator functionality and ECG analysis, which is typically based on pre-defined rules and thresholds, not learned patterns.
Yes.
The device is intended for the emergency treatment of cardiac arrest and delivers a defibrillation shock, which is a form of therapy.
No
The device is primarily a therapeutic device (defibrillator) designed to treat cardiac arrest. While it has an "ECG analysis algorithm" to determine shockable rhythms and an "ECG monitoring mode cable feature to provide a non-diagnostic ECG rhythm display," its main function is not to diagnose. The "non-diagnostic" explicitly states it's not for diagnosis, and the analysis algorithm is for treatment determination rather than general diagnostic purposes.
No
The device description explicitly lists hardware components such as a battery, graphic display, buttons, and disposable pads, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a defibrillator designed for emergency treatment of cardiac arrest by delivering an electrical shock to the patient. It analyzes the patient's cardiac rhythm (ECG) in vivo (within the living body) to determine if a shock is needed.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the patient's body. Its function is directly applied to the patient.
Therefore, the Concord Medical Products MobileAED and its variations are therapeutic devices used on the patient, not diagnostic devices that analyze samples from the patient.
N/A
Intended Use / Indications for Use
The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device.
When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight.
The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 Ibs (25Kg).
The MobileALS and MobileAED+ products are the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users.
The rescuer may use the ECG monitoring mode cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECG analysis either in background or by pressing the analyze button.
Contraindications for Use - Defibrillation
Do not use the MobileAED for defibrillation when the patient;
Is conscious; or Is breathing; or Has a detectable pulse or other signs of circulation
Product codes
MKJ, LDD, DRT
Device Description
The MobileAED is a Biphasic AED which is a portable battery operated semiautomatic low power DC defibrillator. The device's ECG analysis algorithm analyzes the patient's cardiac rhythm to determine if a shockable versus nonshockable ECG rhythm is present. The operator follows the device instructions and presses the shock button to deliver a defibrillation shock.
The MobileAED and AdvantageAED product features include a Status Indicator, Graphic Display, Voice Messages, Buttons for Power and Shock, ECG algorithm analysis, Biphasic truncated exponential waveform, Lithium Manganese Dioxide Battery, and disposable Pads for defibrillation.
The MobileALS manual control features include Energy selection button, Charge button, Analysis button, and Sync button
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg).
The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 Ibs (25Kg).
Intended User / Care Setting
trained personnel, advanced cardiac life support (ALS) users.
emergency treatment of cardiac arrest
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 performance and safety test data demonstrate that the device meets all of its functional and performance specifications and complies with FDA guidelines and industry standards including the applicable sections of AAMI DF80, IEC 60601-1, IEC 60601-2-4 standards.
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.
Medtronic PhysioControl LifePak 500, Cardiac Science Powerheart G3, Zoll AED Pro, Philips Heartstream FR2+
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
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
109234
Concord Medical Products
APR - 1 2010
510(k) Summary
Submitter's Name and Address
Concord Medical Products 87 Cambridge St Burlington Ma 01803
Contact Person:
Randall Fincke 781-257-5172 Fax 781-998-0524
Date Prepared:
July 20, 2009
Device Name
Common or Usual Name: Automated External Defibrillator (AED) Device Name: MobileAED, MobileALS, MobileAED+, and AdvantageAED
Classification
Defibrillator Low energy DC Class II LDD (21 CFR 870.5300) Automatic External Defibrillators; Class III MKJ (AED) (21 CFR 870.5310) Cardiac Monitor (Cardiotachometer and Rate Alarm) Class II DRT (21 CFR 870.2300)
Device Description
The MobileAED is a Biphasic AED which is a portable battery operated semiautomatic low power DC defibrillator. The device's ECG analysis algorithm analyzes the patient's cardiac rhythm to determine if a shockable versus nonshockable ECG rhythm is present. The operator follows the device instructions and presses the shock button to deliver a defibrillation shock.
The MobileAED and AdvantageAED product features include a Status Indicator, Graphic Display, Voice Messages, Buttons for Power and Shock, ECG algorithm analysis, Biphasic truncated exponential waveform, Lithium Manganese Dioxide Battery, and disposable Pads for defibrillation.
The MobileALS manual control features include Energy selection button, Charge button, Analysis button, and Sync button
1
Substantial Equivalence
The MobileAED and AdvantageAED products included in this submission are substantially equivalent with regard to the performance, safety and effectiveness, to other legally marketed semi-automatic low power DC defibrillators. These predicate devices include Medtronic PhysioControl LifePak 500, Cardiac Science Powerheart G3, Zoll AED Pro, and Philips Heartstream FR2+. The MobileAED and AdvantageAED products have the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. Differences between these products and the predicate devices do not raise new questions of safety or efficacy.
Indication for Use
The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device.
When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight.
The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 lbs (25Kg).
The MobileALS and MobileAED+ products are the same as the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users.
The rescuer may use the ECG monitoring mode cable feature to provide a nondiagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECG analysis either in background or by pressing the analyze button.
Contraindications for Use - Defibrillation
Do not use the MobileAED for defibrillation when the patient;
- ls conscious: or
Is breathing; or
Has a detectable pulse or other signs of circulation
2
Comparison of Technological Characteristics
The MobileAED and AdvantageAED products have features and functional characteristics similar to those of the indicated predicate devices. These products analyze the patient ECG and advise the operator with visual and audible prompts to assess the patient status, perform CPR or deliver a shock. The optional ECG monitor cable and manual controls are substantially equivalent to the Zoll AED Pro and Philips Heartstart FR2+ defibrillators.
Performance Data
The performance and safety test data demonstrate that the device meets all of its functional and performance specifications and complies with FDA guidelines and industry standards including the applicable sections of AAMI DF80, IEC 60601-1, IEC 60601-2-4 standards.
Conclusion
Test data demonstrate that the safety and effectiveness of the features and functions in the MobileAED and AdvantageAED products with the Biphasic waveform is substantially equivalent to the listed predicate devices with regard to performance, safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, using black lines on a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 1 2010
Concord Medical Products c/o Mr. Randall Fincke President 87 Cambridge Street Burlington, MA 01803
Re: K092391
Trade/Device Name: MobileAED, MobileALS, MobileAED+, and AdvantageAED Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRT Dated: February 10, 2010 Received: March 2, 2010
Dear Mr. Fincke:
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.
4
Page 2 - Mr. Randall Fincke
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
W.W.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K092391
Device Name: MobileAED, MobileALS, MobileAED+, and AdvantageAED
Indications for Use:
The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device.
When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight.
The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 Ibs (25Kg).
The MobileALS and MobileAED+ products are the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users.
The rescuer may use the ECG monitoring mode cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECG analysis either in background or by pressing the analyze button.
Contraindications for Use - Defibrillation
Do not use the MobileAED for defibrillation when the patient;
Is conscious; or Is breathing; or Has a detectable pulse or other signs of circulation
| Prescription Use X |
|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
W.M. West
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_