(311 days)
Yes
The intended use explicitly mentions "software-assisted analysis of the potential causes of these symptoms is desirable," and the device description mentions "ECG signal characterization." While AI/ML is not explicitly named, "software-assisted analysis" and "signal characterization" in the context of ECG data strongly suggest the use of advanced algorithms, which often include AI/ML techniques for pattern recognition and anomaly detection in cardiac signals. The lack of explicit mention of AI/ML in the "Mentions AI, DNN, or ML" section is not definitive proof of its absence, as this section might not always be comprehensively filled out in 510(k) summaries. The focus on analyzing symptoms and characterizing ECG signals points towards algorithmic analysis beyond simple thresholding.
No.
The device is a monitor used for diagnosis and not for treatment of any medical condition.
Yes
The device is designed for monitoring ECG data in patients displaying specific symptoms, and the software-assisted analysis of this data is intended to help understand the potential causes of these symptoms, which is a diagnostic purpose.
No
The device description explicitly states it is a "patch-style, single-use cardiac monitor" with a physical housing and is worn on the patient's chest, indicating it is a hardware device that collects ECG data. While it includes a software application for data analysis, the core device is hardware.
No, the Stealth™ Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves analyzing blood, urine, tissue, or other bodily fluids outside of the body to provide information about a person's health.
- The Stealth™ Monitor is a device that is worn on the patient's chest to collect physiological data (ECG). It is collecting electrical signals directly from the body, not analyzing a specimen taken from the body.
The description clearly states it's a "continuous recording ECG monitor" worn "on the patient's chest." This aligns with the definition of a medical device used for physiological monitoring, not an in vitro diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.
Product codes
MLO, DXH, DPS, DSH
Device Description
The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams).
A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
Adult
Intended User / Care Setting
physician's office / Ambulatory outpatient use
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 device was evaluated for safety and performance to accepted standards in a laboratory environment and detailed documentation has been provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, one behind the other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2015
Cardiac Insight, Inc. % Deborah Sheffield Regulatory Consultant Deborah L. Sheffield Consulting 5672 Flagler Road Norland, Washington 98358
Re: K142468
Trade/Device Name: StealthTM Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO, DXH, DPS, DSH Dated: August 31, 2014 Received: September 3, 2014
Dear Deborah Sheffield,
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
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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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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
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 vours.
A. Mitchell Stein
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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510(k) PREMARKET NOTIFICATION INDICATION FOR USE
510(k) Number: _ K142468 ________
Device Name: Stealth™ Monitor
Indications For Use:
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Premarket Notification Summary
1. Submitter's Information
| Company Name: | Cardiac Insight, Inc. |
|---|---|
| Company Address: | 2815 Eastlake Avenue, Suite 300 |
| Seattle, WA 98102 | |
| Company Phone: | 206-596-2060 |
| Contact: | Brad Harlow / bharlow@cardiacinsightinc.com |
| Trade Name: | Stealth System |
| Common Name: | ECG Recorder |
| Classification Name: | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| 21 CFR 870.2800 |
2. Predicate Device Identification
| Device Name | Clearance Number | Product Code |
|---|---|---|
| SEER MC | K042782 | MLO |
| AliveCor Heart Monitor | K142743 | DXH, DPS |
| Stealth™ System (M100) | K130288 | DSH |
All predicates are Class II devices.
3. Indications for Use and Device Description
Indications for Use
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.
The Indications for Use are consistent with those of the predicate devices.
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Device Description
The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams).
Image /page/4/Picture/4 description: The image shows a white, three-compartment tray against a dark background. Each compartment is square-shaped with rounded corners and slightly raised edges. The compartments are connected to each other, forming a single unit. The tray appears to be made of a molded material, possibly plastic or foam.
A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.
4. Technological Characteristics of the Device as Compared to Predicate Devices
| Device
Characteristics | Stealth™ System S200
(K142468) | SEER MC (K042782) | AliveCor Heart Monitor
(K142743) | Stealth™ System S100
(K130288) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Stealth™ Monitor is a
prescription only single
use, continuous recording
ECG monitor
that can be worn up to
168 hours
(7 days) during activities
of daily living.
It is indicated for use on
adult patients who may be
asymptomatic or
who may suffer from
transient symptoms such
as palpitations, dizziness,
anxiety, fatigue, syncope,
pre-syncope, light-
headedness, shortness of
breath and where a
software-assisted analysis
of the potential causes of
these symptoms
is desirable. | The SEER MC Ambulatory
Digital Analysis Recorder
is intended to provide
ambulatory ECG signal
and automated analysis of
the recorded ECG data.
Results of the automated
analysis, when used in
conjunction with an
ECG review system, are
intended to assist the
physician in the
interpretation of the
recorded data. | The AliveCor Heart
Monitor is intended to
record, store and transfer
single-channel
electrocardiogram
(ECG) rhythms. The
AliveCor Heart Monitor
also displays ECG rhythms
and detects the presence of
atrial fibrillation and
normal sinus rhythm
(when prescribed or used
under the care of a
physician). The AliveCor
Heart Monitor is intended
for use by healthcare
professionals, patients
with known or suspected
heart conditions and
health conscious
individuals. | The Stealth™ Monitor is a
prescription only
single use, continuous
recording ECG monitor
that can be worn up to
24 hours. It is indicated
for use with patients
where it would be
desirable to record
ECG signals for this period
of time. |
| Product Code | MLO | MLO | DXH, DPS | DSH |
| Device
Classification | II / 870.2800 | II / 870.2800 | II / 870.2920 | II / 870.2800 |
| Where used | Ambulatory outpatient
use | Ambulatory outpatient
use | Ambulatory outpatient use | Ambulatory outpatient use |
| Prescription Req'd | Prescription only | Prescription only | Prescription only | Prescription only |
| Adult/Pediatric | Adult | Both | Adult | Adult |
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| Single Use/
Reusable | Single use | Reusable, single-use
electrodes | Reusable | Single use |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------|
| ECG Storage | At least 168 hours | 48 hours | "Practically unlimited" | At least 24 hours |
| Recording Type | Continuous | Continuous | Continuous | Continuous |
| Application/Wear | Adhesive, body worn | Holster for device,
adhesive electrodes | Patient applied, held in
place for duration of
recording | Adhesive, body worn |
| User Interface | On/Off, Event button | On/Off, Event Button | Smartphone app | On, Event Button |
| Data Transfer | USB 2.0 | Serial | Telephonic/Network | RS-232 to USB 2.0 |
| Arrhythmias
and/or statistics | Normal, fastest heart
rate, slowest heart rate,
average heart rate,
pauses, bradycardia
(run), tachycardia (run) | Normal, fastest heart rate,
slowest heart rate,
ventricular beats,
supraventricular beats,
pauses, ST segment
changes, prolonged QT,
T-wave alternans, Heart
rate turbulence, Heart Rate
Variability | Normal Rhythm, Atrial
fibrillation | None |
| Software Used | Yes | Yes | Yes | Yes |
| Full Disclosure | | | | |
| Power Supply | Battery | Battery | Battery | Battery |
| Electrodes | 3 integrated electrodes | 3 individual electrodes | 2 integrated electrodes | 3 integrated electrodes |
| Lead Wires | Integrated into device | External | Integrated into device. | Integrated into device |
| Lead Vector | Lead I | Multiple | Lead I | Lead I |
| Sterile | No | No | No | No |
| Patient Contact
Materials | Conventional electrodes
/ hydrogel | Conventional electrodes
/ hydrogel | Hard electrodes
(metallic) | Conventional electrodes
/ hydrogel |
None of the differences outlined in this table raise new issues of safety or effectiveness. The Indications for Use and technological characteristics of the device and its predicates are consistent with one another. Therefore, we believe the device to be Substantially Equivalent to the predicate devices.
Note: Response-Part 5 (Substantial Equivalence Discussion) contains a detailed analysis of this table.
5. Biocompatibility
No new issues of biocompatibility are raised with this device. All materials contained in the device are commonly employed in medical devices in the United States.
6. Summary of Performance Testing
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The device was evaluated for safety and performance to accepted standards in a laboratory environment and detailed documentation has been provided.
| Performance Documentation | Status |
|---|---|
| Level of Concern Determination (Moderate) | Provided |
| Development Plans | Provided |
| Device Description | Provided |
| System Requirement Specifications | Provided |
| Risk Management / Safety | Provided |
| Hazard Analysis Report | Provided |
| Component Requirement Specifications | Provided |
| Software/Hardware Design Descriptions | Provided |
| Traceability Matrix | Provided |
| Verification and Validation Protocols and Reports | Provided |
| Unresolved Anomalies (Bugs or Defects) | Provided |