Unimed Disposable ECG lead wires

K142489 · Unimed Medical Supplies, Inc. · DSA · Nov 4, 2014 · Cardiovascular

Device Facts

• Record ID: K142489
• Device Name: Unimed Disposable ECG lead wires
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Nov 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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).

Device Story

Unimed Disposable ECG Lead Wires are single-patient-use cables designed to transmit cardiac signals from surface electrodes to ECG recorders/monitors. The system links the patient to compatible trunk cable systems via grabber or snap-style distal connectors and a common proximal header. Used in clinical settings by trained healthcare professionals for short-term monitoring (average 5-day stay). The device facilitates continuous ECG signal acquisition, enabling healthcare providers to monitor cardiac activity and make diagnostic decisions. Benefits include reliable signal transmission for patient monitoring while maintaining compatibility with existing clinical infrastructure.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against ANSI/AAMI EC53, ANSI/AAMI EC13, and FDA guidance for electrode lead wires. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/hypersensitivity).

Technological Characteristics

Materials: PA66, PVC, ABS. Construction: Flexible shielded multi-conductor electrical cable with shielded copper leadwire and polymer jacket. Connectivity: Compatible with MultiLink yoke design. Sterilization: Supplied non-sterile; not intended for reprocessing. Standards: IEC 60601-1, ANSI/AAMI EC53, ISO 10993-5/10.

Indications for Use

Indicated for monitoring cardiac signals for diagnostic and monitoring purposes in patients requiring ECG measurement. Use is limited by the connected monitoring or diagnostic equipment.

Regulatory Classification

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.

Predicate Devices

• Philips ECG Leadwire Set (K110287)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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:

| HT3-90DS | DG5-90DS | SMB3-90DP | HPA5-90DP | 2385DS | MR5-90DS | AP5-90DS |
|-----------|-----------|-----------|----------------------|----------|---------------------|-----------|
| MQ3-90DS | NKB6-90DS | D3-90DS | AAB5-90DS DT5-90DS | | 2586DP | MQB6-90DS |
| AAB3-90DP | AP6-90DS | DG3-90DP | AT5-90DP | | MR5-90DP DT3-90DS | DG6-90DS |
| AT3-90DS | 2396DS | 2386DP | HT5-90DS | SM5-90DS | 2585DP | NKB3-90DS |
| D5-90DP | AP3-90DP | 2596DS | 2312DP | 2512DP | HP3-90DS I | MQ5-90DS |

#### (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

| Name | Unimed Medical Supplies Inc |
|-----------------------------------|------------------------------------------------------|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | [phone] |
| Fax | [phone] |
| Establishment<br>Registration No. | 3007307487 |

## 2. Contact Person

| Contact person | Tan xinmei |
|----------------|------------------------------------------------------|
| Title | QA&RA manager |
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |

## 3. Manufacturer Information

| Name | Unimed Medical Supplies Inc |
|------------------|------------------------------------------------------|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Establishment | 3007307487 |
| Registration No. | |

### 4. Proposed Device Information

| Trade Name | Unimed Disposable ECG lead wires |
|--------------------------|--------------------------------------------------------------|
| Common name | ECG lead wires |
| Classification name | Patient transducer and electrode cable (including connector) |
| Regulatory class | Class 2 |
| Production<br>regulation | 21 CFR § 870.2900 |
| Product code | DSA |
| Panel | Cardiovascular |

{4}------------------------------------------------

K142489

#### Part 2 of 5

| 510(K)No. | K110287 |
|-----------------------|--------------------------------------------------------------|
| Submitter's Name | Philips Medical Systems |
| Trade Name | Philips ECG Leadwire Set |
| Common name | ECG Leadwire Set |
| Classification name | Patient transducer and electrode cable (including connector) |
| Regulatory class | Class 2 |
| Production regulation | 21 CFR § 870.2900 |
| Product code | DSA |
| Panel | Cardiovascular |

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