K Number
K142489
Device Name
Unimed Disposable ECG lead wires
Date Cleared
2014-11-04

(61 days)

Product Code
Regulation Number
870.2900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Device Description
The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
More Information

Not Found

No
The device description and intended use clearly define it as a simple cable system for transmitting ECG signals, with no mention of any processing or analysis capabilities that would involve AI/ML. The performance studies focus on electrical safety and biocompatibility standards, not algorithmic performance.

No
The device is described as being used for "monitoring of cardiac signals for both diagnostic and monitoring purposes" and not for treating a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes." It also mentions that the "Device Description" states it is used to "transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes."

No

The device description explicitly states it is a "single patient electrode cable system" and a "family of lead wires," which are physical hardware components.

Based on the provided information, 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 Unimed Disposable ECG Lead Wires are described as a system used to transmit electrical signals from electrodes placed on the patient's skin to monitoring or diagnostic equipment. This is a direct connection to the patient's body to capture physiological signals, not a test performed on a sample taken from the body.
  • Intended Use: The intended use is for "monitoring of cardiac signals for both diagnostic and monitoring purposes," which aligns with capturing electrical activity from the heart through the skin.
  • Anatomical Site: The device is attached to electrodes placed on the "chest wall and extremities," which are external locations on the body.

Therefore, the function and intended use of this device clearly fall outside the scope of in vitro diagnostics.

N/A

Intended Use / Indications for Use

The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Product codes

DSA

Device Description

The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Attached to electrodes placed at standard specified locations on chest wall and extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained healthcare professionals

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

The subject device meets the following the recognized standards:

  • ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except4.3.1)
  • ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
  • FR 898: Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables, May 11, 1998
  • IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
  • ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
  • ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010

Key Metrics

Not Found

Predicate Device(s)

K110287

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).

0

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4, 2014

Unimed Medical Supplies, Inc. Ms. Tan Xinmei QA & RA Manager No.37, Yanshan Road, Shekou Shenzhen, 518067 China

K142489 Re:

Trade/Device Name: Unimed Disposable ECG Lead Wires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: August 10, 2014 Received: September 4, 2014

Dear Ms. Tan Xinmei.

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

1

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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 yours,

M.A. Hilleman

for

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

K142489

Page __ 1__ of___ 1_

510(k) Number (if known): __K142489

Device Name: Unimed Disposable ECG Lead Wires

Indications for Use

The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Model:

HT3-90DSDG5-90DSSMB3-90DPHPA5-90DP2385DSMR5-90DSAP5-90DS
MQ3-90DSNKB6-90DSD3-90DSAAB5-90DS DT5-90DS2586DPMQB6-90DS
AAB3-90DPAP6-90DSDG3-90DPAT5-90DPMR5-90DP DT3-90DSDG6-90DS
AT3-90DS2396DS2386DPHT5-90DSSM5-90DS2585DPNKB3-90DS
D5-90DPAP3-90DP2596DS2312DP2512DPHP3-90DS IMQ5-90DS

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use x (Per 21 CFR 801.109)

Over-The-Counter Use

OR

3

K142489

Page 1 of 5

510(K) Summary

Prepared Date: 2014-8-15

1. Submitter Information

NameUnimed Medical Supplies Inc
AddressNo. 37, Yanshan Road, Shekou, Shenzhen, China 518067
Tel+86-755 26695165
Fax+86-755 26697984
Establishment
Registration No.3007307487

2. Contact Person

Contact personTan xinmei
TitleQA&RA manager
AddressNo. 37, Yanshan Road, Shekou, Shenzhen, China 518067
Tel+86-755 26695165
Fax+86-755 26697984
E-mailtanxinmei@unimed.cn

3. Manufacturer Information

NameUnimed Medical Supplies Inc
AddressNo. 37, Yanshan Road, Shekou, Shenzhen, China 518067
Establishment3007307487
Registration No.

4. Proposed Device Information

Trade NameUnimed Disposable ECG lead wires
Common nameECG lead wires
Classification namePatient transducer and electrode cable (including connector)
Regulatory classClass 2
Production
regulation21 CFR § 870.2900
Product codeDSA
PanelCardiovascular

4

K142489

Part 2 of 5

510(K)No.K110287
Submitter's NamePhilips Medical Systems
Trade NamePhilips ECG Leadwire Set
Common nameECG Leadwire Set
Classification namePatient transducer and electrode cable (including connector)
Regulatory classClass 2
Production regulation21 CFR § 870.2900
Product codeDSA
PanelCardiovascular

5. Predicate Device Information

6. Device description

The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

7. Intended use

The subject device are intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These leadwires are intended for short-term use only (an average patient stay of 5 days).

| Comparison
item | Subject Device
Unimed | Predicate Device
K110287 | Note |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended use | The subject device are
intended for use only by
trained healthcare
professionals for
measurement of a patient's
ECG for both diagnostic and
monitoring purposes. Use is | Philips Single-Patient-Use
Disposable ECG Leadsets are
intended for use only by
trained
healthcare professionals for
measurement of a patient's
ECG for both diagnostic and | Same |
| | limited by the indications for
use of the connected
monitoring or diagnostic
equipment. These leadwires
are intended for short-term
use only (an average patient
stay of 5 days). | monitoring purposes. Use is
limited by the indications for
use of the connected
monitoring or diagnostic
equipment. These Philips
leadsets are intended for
short-term
use only (an average patient
stay of 5 days). | |
| Indications
for Use | The subject device are
indicated for use in the
monitoring of cardiac signals
for both
diagnostic and monitoring
purposes. Use is limited by
the indications for use of the
connected monitoring or
diagnostic equipment. | Philips ECG leadsets are
indicated for use in the
monitoring of cardiac signals
for both
diagnostic and monitoring
purposes. Use is limited by
the indications for use of the
connected monitoring or
diagnostic equipment. | Same |
| Anatomical
Sites | Attached to electrodes placed
at standard specified
locations on chest wall and
extremities | Attached to electrodes placed
at standard specified
locations on chest wall and
extremities | Same |
| Design
/Appearance | Cables with "grabber/snap"
configuration of ECG
electrode connector (distal
connector) and common
"header" connection
(proximal connector) | Cables with "grabber"
configuration of ECG
electrode connector (distal
connector) and common
"header" connection
(proximal connector) | Same |
| Sterility | Supplied non-sterile;cannot
be sterilized or otherwise
reprocessed | Supplied non-sterile;cannot be
sterilized or otherwise
reprocessed | Same |
| Usage | Single patient use | Single patient use | Same |
| Material | PA66,PVC,ABS | PA66,PVC,ABS | Same |
| Cable Length | 0.9m/3.4m | 1.0m/0.85m | Similar |
| Cable
Construction | Flexible shielded multi
conductor electrical cable | Flexible shielded multi
conductor electrical cable | Same |
| Wire Color | White | White | Same |
| Leadwire
Construction | Shielded copper leadwire
with polymer
jacket | Ribbonized leads with
individual coax shields | Same |
| Lead number | 3,5&6 | 3,5 | Similar |
| Proximal
connector
Design | Compatible to MultiLink
yoke design | Compatible to MultiLink
yoke design | Same |
| Distal
connector
Design | "Grabber"or"Snap"electrode
connectors are labeled
LL(red),RA(white),RL(green)
,LA(black)&,V(brown) | "Grabber" electrode
connectors are color coded
(red, white, green, coded
(red, white, green,
black, brown)
Connector designations
(LL,RL etc.) molded
into plastic | Similar |
| Conformance
standard | IEC60601-1(Safety)
EC53(Performance)
ISO10993-5,-10(Biocompati
bility ) | IEC60601-1(Safety)
EC53(Performance)
ISO10993-5,-10(Biocompati
bility) | Same |

8. Comparison to predicate device

5

6

From the comparison form above, both devices have the same intended use ,indications for use, Anatomical Sites, Design /Appearance, Sterility, Usage, Material,Cable Construction, Wire Color& Conformance standard,have the similar cable length, Lead number& Distal connector Design item.

But in cable length, Lead number& Distal connector Design item,both devices have some difference, please see the following analysis.

Note1 Cable Length

The subject devices is longter than philips unit,but unimed units meet the requirements of EC53 and IEC60601-1, so this difference does not bring any safety and effectiveness problem.

Note2 Lead number

The subject devices have 6 lead type which fit the clinical use. Meanwhile the subject units meet the requirements of EC53 and IEC60601-1, so this difference also does not bring any safety and effectiveness problem.

Note3 Distal connector Design

In this item,the suject device have grabber type and snap type ,which is more suitable for clinical use.Futhermore, the subject devices meet the requirements of EC53 and IEC60601-1, so this difference also does not bring any safety and effectiveness problem.

9. Performance data

The subject device meets the following the recognized standards:

  • ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except4.3.1)
  • ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
  • FR 898: Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables, May 11, 1998

7

K142489 Part 5 of 5

  • IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
  • ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
  • ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010

10. Substantial Equivalence Statement

Based on the comparison ,analysis, and the submitted performance data, unimed believes that the unimed disposable ECG Lead Wire is as safe and effective and is substantially equivalent to the predicate devices.