(186 days)
Not Found
No
The description focuses on hardware, firmware for data collection, and software for data transfer to separate processing software. There is no mention of AI/ML for analysis within the device itself.
No
The device is an ECG recorder used for diagnostic purposes (recording ECG data for analysis by healthcare providers) and does not directly provide therapy.
Yes
The device, myPatch, is an ambulatory electrocardiograph (ECG) recorder. It continuously records ECG data from patients who may have various symptoms, such as palpitations, shortness of breath, dizziness, or chest pain. The recorded data can then be processed and analyzed by qualified healthcare providers to assess the patient's cardiac activity, which is a diagnostic purpose.
No
The device description clearly outlines hardware components including a plastic casing, battery, electronics (microprocessor, measuring circuit, memory, data storage, LED), and physical connections for the electrode and USB. It also describes a separate electrode accessory. While it mentions firmware and software for data transfer, the core device is a physical ECG recorder.
Based on the provided information, the myPatch device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- myPatch Function: The myPatch is an ambulatory electrocardiograph (ECG) recorder. It measures and records electrical activity of the heart directly from the patient's body via electrodes placed on the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes recording ECG data for analysis by qualified healthcare providers to help diagnose or monitor conditions related to heart rhythm. This is a direct physiological measurement, not an in vitro test.
Therefore, the myPatch falls under the category of a medical device that performs a direct physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.
Product codes (comma separated list FDA assigned to the subject device)
DSH
Device Description
The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.
The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.
During the recording the patient wears the myPatch connected to an electrode on the sternym. The myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable.
The electrode (accessory to myPatch, ) is the passive part. The electrode consists of one layer of one sided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode.
Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single-use device and is disposed of after one single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
Indicated Patient Age Range
Not Found
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 myPatch ECG Recorder has undergone extensive testing, including:
IEC 60601 1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1/A11:2011 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance same as IEC 60601-1:2012 ed 3.1 Consol. with am1
EN 60601-1-11: 2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential perfor-mance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-47: 2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
EN 60601-1-2:2007 Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 62366:2008 Application of usability engineering to medical devices
EN 1041:2009 Information supplied by the manufacturer of medical devices
EN 980:2008 Symbols for use in the labeling of medical devices
EN 980 Bil.1:2008 CD-ROM Graphical symbols for use in the labeling of medical devices – Fact Sheet 1: Graphical symbols in electronic format
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
All testing demonstrated acceptable results.
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
§ 870.2800 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/0 description: The image shows the text "DMS SERVICE" in a bold, sans-serif font. The letters are black, and there is a black line underlining the text. A black dot is between DMS and SERVICE. The text appears to be a logo or heading.
ーストート アイトライト アート アイト アイト アイト アイト アイト アイト
2800 Neilson Wy Sto 1 Santa Monica, CA 90405 ph: {775} 315-0660 fax: (B00] 441-3437
OCT 2 9 2013
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
tervice.com
K131190 pg 1 of 3
510(k) Summary
March 26, 2013
.
Contact Person: Lynda Cole, Manager, Icole@dms-service.com,
ph: (775) 315-0660 fax: (800) 441-3437
Submitter: dms-service IIc, 2800 Neilson Way, Ste. 1, Santa Monica, CA 90405 Trade
Name: myPatch
Model #: Amors1000
Common Name: Ambulatory ECG Recorder
Classification: 21 CFR 870.2800, Medical Magnetic Tape Recorder, Cardiovascular Panel
Device Class: II
Product Code: DSH
Substantially Equivalent Devices
| Manufacturer | Substantially
equivalent devices | 510(k) |
|----------------------------|-------------------------------------|---------|
| iRhythm | Zio Patch | K113862 |
| Cardiac Science Corp. | mySense Heart | K113176 |
| Scole Engineering Co. Inc. | Scole 300 | K923664 |
1
Device Description:
The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.
The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.
During the recording the patient wears the myPatch connected to an electrode on the sternym. The
myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable.
The electrode ( accessory to myPatch, ) is the passive part. The electrode consists of one layer of onesided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode.
Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single- use device and is disposed of after one single use.
Indications for Use:
The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety,
Technological Characteristics/Substantial Equivalence:
myPatch has the same technological characteristics as the ZioPatch, mySense Heart and Scole 300 ambulatory monitors. myPatch, mySense and ZioPatch are all patch based monitors. The Scole 300 and myPatch can both continuously record 2 channels of ECG data. All monitors are powered by a battery, the frequency response will not degrade the system performance and all monitors can record a minimum of 24 hours. myPatch will record up to 3 days and Zio Patch will record up to 14 days of continuous ECG.
2
K131190 pg 3 of 3
All of the above mentioned devices are intended for the same use, recording continuous ECG signals. Any differences in the hardware design of the monitors and myPatch does not affect the safety or the effectiveness of the myPatch monitor. myPatch has met the design verification testing standards as set forth in IEC 60601-2-47, which is equivalent to ANSI/AAMI EC38.
Testing:
The myPatch ECG Recorder has undergone extensive testing, including testing listed below. All testing demonstrated acceptable results:
IEC 60601 1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1/A11:2011 Medical electrical
equipment - Part 1: General requirements for basic safety and essential performance same as
IEC 60601-1:2012 ed 3.1 Consol. with am1
EN 60601-1-11: 2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential perfor-mance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-47: 2012 Medical electrical equipment - Part 2-47: Particular requirements for
the basic safety and essential performance of ambulatory electrocardiographic systems
EN 60601-1-2:2007 Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 62366:2008 Application of usability engineering to medical devices
EN 1041:2009 Information supplied by the manufacturer of medical devices
EN 980:2008 Symbols for use in the labeling of medical devices
EN 980 Bil.1:2008 CD-ROM Graphical symbols for use in the labeling of medical devices – Fact Sheet 1: Graphical symbols in electronic format
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
The myPatch ECG Recorder has the CE Marking (CE 1008). The CE Mark is a statement that the myPatch ECG Recorder fulfills the guidelines established by the EU for medical devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three wavy lines underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 29, 2013
DMS-Service LLC C/O Lynda Cole 2800 Neilson Way, Ste. 1 Santa Monica, CA 90405 US
Re: K131190
Trade/Device Name: MyPatch Amores 1000 Ambulatory ECG Regulation Number: 21 CFR 870.2800 Regulation Name: Ambulatory Electrocardiograph (ECG) Recorder Regulatory Class: Class II Product Code: DSH Dated: September 26, 2013 Received: September 27, 2013
Dear Ms. Cole:
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
4
Page 2 - Lynda Cole
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 vours.
Owen注册_aris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k)
Number:K131190
Device Name: myPatch
Indications For Use:
The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.
Prescription Use _ _ X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Figure/13 description: The image shows a digital signature. The signature includes the text "Digitally signed by Owen P. Faris -S Date: 2013.10.29 13:00:42-04'00'". The signature also includes a stylized design to the left of the text.