(233 days)
No
The summary mentions a "Glasgow algorithm for automatic interpretation," which is a known, rule-based algorithm for ECG analysis, not typically considered AI/ML in the modern sense. There is no mention of AI, ML, deep learning, or training/test data sets which are common indicators of AI/ML use.
No.
The device is indicated for evaluating and diagnosing cardiac function by measuring heart activity, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to evaluate and diagnose patient cardiac function." The "Device Description" also mentions it is "intended to screen cardiac abnormalities" and provides "analytical statements" and a "Glasgow algorithm for automatic interpretation," all of which point to its use in diagnosis.
No
The device description explicitly states it is a "portable 12 lead resting ECG system" that "acquires, permits viewing and storing signals" and uses "ten electrodes placed on the patient body which measure miniscule electrical activity". This indicates the presence of hardware components (electrodes, acquisition unit) beyond just software. The testing summary also includes standards related to medical electrical equipment (IEC 60601 series), further confirming hardware is involved.
Based on the provided information, the MESI mTABLET ECG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves testing blood, urine, tissue, etc., outside of the body.
- MESI mTABLET ECG Function: The MESI mTABLET ECG directly measures electrical activity from the patient's body using electrodes placed on the skin. It is a non-invasive measurement of a physiological signal.
- Intended Use: The intended use clearly states it's for evaluating and diagnosing patient cardiac function by measuring heart activity on the patient's body.
- Device Description: The description reinforces that it measures heart activity by electrodes placed on the patient body.
The MESI mTABLET ECG is a medical device, specifically an electrocardiograph, used for measuring and analyzing the electrical activity of the heart in vivo (within the living body). This is distinct from the in vitro testing characteristic of IVDs.
N/A
Intended Use / Indications for Use
The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function.
MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations.
The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information.
Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.
Product codes
DPS
Device Description
The MESI mTABLET ECG portable 12 lead resting ECG system is intended to screen cardiac abnormalities. The MESI mTABLET ECG System acquires, permits viewing and storing signals from adult and pediatric patients. The MESI mTABLET ECG is one of several variations of the company's MESI mTABLET system portfolio.
MESI mTABLET ECG is intended to measure heart activity by ten electrodes placed on the patient body which measure miniscule electrical activity generated by heart muscle depolarizations. This activity is captured and displayed on the MESI mTABLET UNIT. The MESI mTABLET ECG supports acquisition of 10 seconds signal or manual mode with acquisition up to 5 minutes.
The MESI mTABLET ECG provides analytical statements when configured with the appropriate options. It also comes with Glasgow algorithm for automatic interpretation which offers dagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment.
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
adult or pediatric patients
Intended User / Care Setting
professional clinical environment by trained healthcare personnel.
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
No clinical data is required to determine substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
July 28, 2023
MESI, Development of Medical Devices, Ltd; MESI, D.O.O. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K223670
Trade/Device Name: MESI mTablet ECG Diagnostic System, MESI mTablet ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 23, 2023 Received: June 27, 2023
Dear Elaine Duncan:
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
1
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 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,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K223670
Device Name MESI mTABLET ECG
Indications for Use (Describe)
The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function.
MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations.
The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information.
Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.
| 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) |
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3
510(k) Summary
| Submitted on behalf of: | MESI D.O.O |
|---|---|
| Date Prepared: | July 28, 2023 |
| Address: | Lesloskova cesta |
| 11A, 1000 Ljubijana | |
| Slovenia, Europe | |
| Telephone: | +386 1 620 34 87 |
- 386 8 2015 32 95 |
| Submitted by: | Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBE
President, Paladin Medical, Inc. |
| Trade name | MESI mTABLET ECG |
| Common name | 12-lead resting wireless ECG system |
| Classification name | Cardiac Electrophysiology, Diagnostics, and Monitoring Devices |
| Device classification | Class II |
| Product classification | 870.2340 |
| Product code | DPS |
| Classification panel | Cardiovascular |
4
DEVICE DESCRIPTION
The MESI mTABLET ECG portable 12 lead resting ECG system is intended to screen cardiac abnormalities. The MESI mTABLET ECG System acquires, permits viewing and storing signals from adult and pediatric patients. The MESI mTABLET ECG is one of several variations of the company's MESI mTABLET system portfolio.
MESI mTABLET ECG is intended to measure heart activity by ten electrodes placed on the patient body which measure miniscule electrical activity generated by heart muscle depolarizations. This activity is captured and displayed on the MESI mTABLET UNIT. The MESI mTABLET ECG supports acquisition of 10 seconds signal or manual mode with acquisition up to 5 minutes.
The MESI mTABLET ECG provides analytical statements when configured with the appropriate options. It also comes with Glasgow algorithm for automatic interpretation which offers dagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment.
INDICATIONS FOR USE:
The MESI mTABLET ECG is indicated for use on adult or pediatic patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure mimiscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare persomel. The MESI mTABLET ECG provides information the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.
PREDICATE DEVICE and EQUIVALENCE:
The MESI mTABLET ECG has a similar indication for use and intended use as the CARDIOLINE HD+ predicate device (K150289), manufactured by Cardioline S.p.A. In addition, the MESI mTABLET ECG is equivalent to the reference device "touchECG" (K160746) that is intended to be used in conjunction with CARDIOLINE HD+ device (K150289) that acquires the ECG signal and transmits it. The
"touchECG is a software medical device provided on a CD support. The touch ECG employs the Glasgow Algorithm for interpretation. The MESI mTABLET ECG is intended for spot-checking use.
Additionally, the MESI mTABLET ABI (K201046), manufactured by MESI D.O.O serves as a reference device to the basic technology of the tablet communication and several similar components, such as charging unit. Indeed, the MESI mTABLET ECG uses the same tablet device and charging plate as MESI mTABLET ABI, cleared under 510(k) number K201046.
5
| Substantial Equivalence Determination Table | |||||
|---|---|---|---|---|---|
| Device | CARDIOLINE HD+ | touchECG | MESI mTABLET ABI | MESI mTABLET | |
| ECG | Equivalence of | ||||
| features & | |||||
| characteristics | |||||
| 510(k) | |||||
| Number | K150289 | K160746 | K201046 | K223670 | |
| Manufacturer | Cardioline S.p.A. | ||||
| Predicate | Cardioline S.p.A | ||||
| Reference | MESI D.O.O. | ||||
| Reference | MESI D.O.O. | ||||
| Subject Device | |||||
| Indications | |||||
| for Use / | |||||
| Intended use | HD+ is a physiological | ||||
| ECG acquisition module. | |||||
| HD+ transmits wireless, | |||||
| via Bluetooth to a PC or | |||||
| Tablet, the data acquired, | |||||
| without making any | |||||
| analysis or filtering on | |||||
| the data acquired. |
HD+ acquires 12-lead
ECG waveforms meeting
the standards for clinical
and diagnostic
applications (AAMI,
ANSI, AHA, ACC) and
offers full ECG
acquisition.
HD+ is designed to
acquire and transmit a
high quality ECG data
allowing the patient to be
free to moving (without
cable connected to the
processing unit).
The HD+ transmits the
acquired physiological
signals in real-time to a
computer/device where a
compatible application is
installed.
All data acquired are sent
via Bluetooth to a
receiver that it can be a
PC, tablet or device
capable of receiving BT | touchECG is designed to
check and diagnose
cardiac function.
However, a physician
must validate the results
of the analysis run by the
ECG. touchECG is
intended for use in
hospitals, clinics and
outpatient departments of
any size. It is suited for
use by health professional
in emergencies
(ambulances). touchECG
is intended to be used in
conjunction with
CARDIOLINE HD+
device.
The device analyzes,
displays and prints out
electrocardiograms. The
ECG's are acquired from
CARDIOLINE HD+
device.
The device interprets the
data for review by a
physician.
The device must be used
by a physician or by
health professionals on
behalf of an authorized
doctor in clinical
facilities. It is not
intended as the only
means for determining the
diagnosis.
The device's | The MESI MTABLET ABI
is
indicated for use on adult
subjects at risk of having
or developing peripheral
arterial disease (PAD).
MESI MTABLET ABI is
intended for the rapid
measurement of ankle-
brachial pressure index
(ABI) and pulse volume
plethysmography in adults.
It is suitable for use in
wound care assessment,
for assessing symptomatic
PAD, and as a screening
device for PAD. It may
also be used on patients
with venous or arterial
ulcers prior to application
of compression therapy.
MESI MTABLET ABI can
be used on patients with
unilateral lower limb
amputation.
The MESI MTABLET ABI
is
intended to be used to spot-
check patients.
The MESI MTABLET ABI
provides information | The MESI MTABLET
ECG is
indicated for use on
adult or pediatric
patients, to evaluate
and diagnose patient
cardiac function.
MESI MTABLET
ECG is
intended to measure
hearth activity by ten
(10) electrodes placed
on the patient's body
which measure
miniscule electrical
activity generated by
the heart muscle
depolarizations.
The MESI MTABLET
ECG is
solely used in
professional clinical
environment by trained
healthcare personnel
for spot- checking.
The MESI MTABLET
ECG
provides information
regarding the patient's | EQUIVALENT;
MESI MTABLET ECG
has
same indication for use
as the Cardioline and is
also tablet and
bluetooth based. Both
can use 12 lead ECG
electrodes Both are
indicated for adult and
pediatric patients.
MESI MTABLET
ECG uses the same
technological platform
as the MESI
mTABLET ABI. |
| | The ECG is transmitted
verbatim to the receiving
system, without LSB or
sampling adjustment. It is
up to the receiving
system/application to
perform the necessary
processing such as (but
not limited to) LSB
scaling, signal filtering,
Resting ECG analysis
etc.
The device HD+ is
intended to be used on
adult and on all pediatric
patients.
The device is intended
for use by qualified,
trained nurses and
physicians operating in
hospitals, clinics and
medical
practices. | analysis is only
significant if used
together with an
additional analysis by the
physician and by an
assessment of all the
patient's important data.
The device can be used on
adults patients.
The device must not be
used as a physiological
monitoring of vital signs.
touchECGis intended to
be used in conjunction
with CARDIOLINE
HD+ device (K150289
that acquires the ECG
signal and transmits it.
touchECG is a software
medical device provided
on a CD support | The physician has the
responsibility of making
proper judgments based on
this information.
Prescription Use: Federal
law restricts the use of this
device to sale by or on the
order of a physician. | physician has the
responsibility of
making proper
judgments based on
this information.
Prescription Use:
Federal law restricts
the use of this device
to sale by or on the
order of a physician. | |
| Dimensions /
weight | Dimensions: 115 x 65 x
15 mm
Weight:
Power Supply
2x AAA standard 1,5 V batteries
Intrinsic to add on system
MESI mTABLET UNIT | MESI mTABLET UNIT
AC/DC adaptor:
FW8030M/05(FRIWO)
Input: 100-240 V~; 50-60 Hz
Output: 5 Vdc; 5000 mA Battery type:
RechargeableLithium-
Polymer battery(LP6058110)
Capacity: 8800 mAh,
Battery operation: more than 8 hours
MESI ECG UNIT
Battery type:
Rechargeable
Lithium-Polymer
battery, Capacity:
1240 mAh
Examinations per
battery charge: > 2000
Charge time for
depleted battery:
approximately 2 hours
(minimum charge time
for 1 automatic mode
ECG: 10 minutes)
MESI LARGE
CHARGING PLATE
UNIT
AC/DC adaptor:
FW8030M/05 | IDENTICAL TO THE
MESI mTABLET ABI |
| Display | LCD color touch screen | various | AC/DC adaptor:
FW8030M/05(FRIWO) Input:
100-240 V~; 50-60 Hz
Output: 5 Vdc; 5000 mA
Battery type:
RechargeableLithium- Polymer
battery(LP6058110) Capacity:
8800 mAh, Battery operation:
more than 8 hours
MESI TUBELESS CUFF
UNIT
Battery type: Rechargeable
Lithium-Polymer battery,
Capacity: 1240 mAh
Examinations per battery
charge: > MESI mTABLET
UNIT
AC/DC adaptor:
FW8030M/05(FRIWO) Input:
100-240 V~; 50-60 Hz
Output: 5 Vdc; 5000 mA
Battery type:
RechargeableLithium-Polymer
battery(LP6058110)
Capacity: 8800 mAh, Battery
operation: more than 8 hours
MESI ECG UNIT
Battery type: Rechargeable
Lithium-Polymer battery,
Capacity: 1240 mAh
IDENTICAL TO THE MESI
mTABLET ABI | (FRIWO FOX30-XM)
Input: 100-240 V~; 50-
60 Hz
Output: 5 Vdc / 5000
mA | IDENTICAL TO THE
MESI mTABLET ABI |
| | | | 10,1" color IPS screen with
1280x800 resolution | 10,1" color IPS screen
with 1280x800
resolution | |
| Applied parts
in contact
with the
patient | Disposable electrodes,
clamps | NONE | 2x tubeless arm cuffs 2x
ankle cuffs | Disposable electrodes | The user supplies the
disposable electrodes |
| Materials in
contact with
the patient | Not specified | NONE | ARM CUFFS:
TPU coated PU leather –
outside layer
Nylex based PU leather -
inside layer
TPU bladder | Requires user to
supply disposable
electrodes: Adhesive:
Medical grade
pressure sensitive
adhesive Foam: | MESI mTABLET ECG
uses
disposable electrodes,
which meet ISO
10993-1. Not supplied
by MESI. |
| | | | | cell; Connector:
stainless steel | |
| Bench
Testing | Applied parts: CF
RF emissions: Group 2,
Class B
Compliant with
standards: EC 60601-1
IEC 60601-1-2
IEC 60601-2-25
ETSI EN 300 328
ETSI EN 301 489 -1
ETSI EN 301 489 -17
ETSI EN 300 440 -2
FCC CFR47 Part 15 (US) | Defibrillation Protection
Overload Tolerance
Requirements for
mplitude measurements
Interval Measurements
Requirements for interval
measurements on
biological ECGs
Indication of Inoperable
ECG Leads
Minimum Lead
Configuration Wilson
Leads
Input Impedance
Required Gains
Common Mode Rejection
Line Filter Response
Noise Level
Channel Crosstalk
High Frequency
Response Low
Frequency Response
Linearity and Dynamic
Range Sampling and
Amplitude Quantization
Record Identification
Patient Identification
Recording Speed
Time and Amplitude
Ruling Use with Cardiac
Pacemakers | Type of protection against
electric shock: Class II
Applied parts: BF
SoftWare classification:
Class B RF emissions:
Group 1, Class B
Compliant with standards:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
EN 60601-1-
6:2010/A1:2015 EN
80601-2-30:2010
EN ISO 15223-1:2016
EN 303 446-1:2017
EN 62366:2008
EN 62304:2006/A1:2015
EN ISO 10993-
1:2009/AC:2010 EN ISO
14971:2012 IEEE/ANSI
C63.27-2017 | Type of protection
against electric shock:
Class II Applied parts:
CF
SoftWare
classification: Class B
RF emissions: Group 1,
Class B
Compliant with
standards: EN 60601-
1:2006/A1:2013 EN
60601-1-
6:2010/A1:2015 EN
60601-2-25:2015
EN
62304:2006/A1:2015
EN 62366:2008
EN 60601-1-2:2015
EN ISO 15223-1:2016
EN
1064:2005/A1:2007
EN 303 446-1:2017
EN ISO 14971:2012
EN ISO 10993-
1:2009/AC:2010
IEEE/ANSI C63.27-
2017 | MESI mTABLET ECG
meets more ECG
standards and better
RF emisson
compliance than
Cardioline HD+.
EMC and safety test
reports are available in
the Section 17 - Bench
Testing. Test reports:
T223-0126-20 60601-1
T251-0146-20 60601-
1-2
T223-0127-20_60601-
1-6
T223-0122-20 60601-
2- 25
F2P27871A-03E |
| Temperature
and humidity
range | Working environment:
Temperature between
+10 and
+40 °C inclusive,
Relative humidity
between 25 and 95
% inclusive (without
condensation),
Atmospheric pressure
between 700 and 1060
mbar
Transport and storage
environment: | | Working environment:
10° to 40°C,
relative air humidity: 25 to
85%
Transport and storage
environment: | Working environment:
10° to 40°C,
relative air humidity:
25 to 85%
Transport and storage
environment:
-15° to 50°C (