PHILIPS ECG LEADWIRE SET

K110287 · Philips Medical Systems · DSA · Feb 15, 2011 · Cardiovascular

Device Facts

• Record ID: K110287
• Device Name: PHILIPS ECG LEADWIRE SET
• Applicant: Philips Medical Systems
• Product Code: DSA · Cardiovascular
• Decision Date: Feb 15, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2900
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

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.

Device Story

The Philips ECG Leadwire Set is a single-patient-use disposable cable system; it transfers electrical cardiac signals from patient-applied electrodes to compatible ECG monitors or recorders. The system consists of flexible shielded multi-conductor cables with a proximal 'header' connector and distal 'grabber' connectors that attach to electrodes on the patient's chest wall or extremities. It is used in clinical settings by trained healthcare professionals. The device acts as a passive conductor of electrical energy; it does not process signals itself. By providing a reliable electrical path, it enables the connected monitor to display and analyze ECG data, facilitating clinical decision-making regarding cardiac health. The device is non-sterile and intended for short-term use (average 5 days) before disposal.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of electrical safety (IEC 60601-1, AAMI/ANSI EC 13, AAMI/ANSI EC53) and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Flexible shielded multi-conductor electrical cable; ribbonized leads with individual coax shields. Distal 'grabber' connectors (color-coded); proximal all-in-one common connector. Non-sterile; single-patient-use. Complies with IEC 60601-1, AAMI/ANSI EC 13, AAMI/ANSI EC53, and ISO 10993 standards.

Indications for Use

Indicated for patients requiring cardiac signal monitoring for diagnostic or monitoring purposes. Intended for short-term use (average 5 days) by trained healthcare professionals. Use is restricted 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

• Tyco Electronics Electrocardiograph (ECG) Leadwire Set (K102430)

Submission Summary (Full Text)

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K110287

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 100

### Philips ECG Leadwire Set

FEB 1 5 2011

#### Submitter's Name and Address

| Submitter's Name: | Philips Medical Systems |
|-----------------------|-------------------------------|
| Division: | Medical Consumers and Sensors |
| Address: | 3000 Minuteman Road |
| City, State, and Zip: | Andover, MA 01810 |

#### Contact Person / Submission Correspondent

| Name: | Peter Schipelliti |
|------------|-------------------------------|
| Title: | Regulatory Program Manager |
| Telephone: | ( 978 ) 659-4744 |
| Facsimile: | ( 978 ) 659-7712 |
| E-mail: | [e-mail] |

#### Manufacturers' Information; Establishment Registration Number.

| Establishment name: | Philips Medical Systems | |
|--------------------------------|-------------------------|--|
| Address: | 3000 Minuteman Road | |
| | Andover, MA 01810 | |
| Establishment Registration No. | 1218950 | |

#### New Device Details

| Proprietary or Trade Name: | Philips ECG Leadwire Set |
|----------------------------|------------------------------------------------------------------|
| Common Name: | ECG Leadwire Set |
| Device Class: | Class II |
| Device Procode: | DSA |
| Device CFR: | 21 CFR 870.2900 |
| Classification Panel: | Cardiovascular |
| Classification Name: | Patient transducer and electrode cable (including<br>connector). |

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ر

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K110287

#### Predicate Device Details

| 510(k) Number | K102430 (cleared on September 10, 2010) |
|----------------------------|-----------------------------------------------------------------|
| Proprietary or Trade Name: | Tyco Electronics Electrocardiograph (ECG)<br>Leadwire Set |
| Common Name: | ECG Leadwire Set |
| Device Class: | Class II |
| Device Procode: | DSA |
| Device CFR: | 21 CFR 870.2900 |
| Classification Panel: | Cardiovascular |
| Classification Name: | Patient transducer and electrode cable (including<br>connector) |

#### Device Description

The Philips ECG Leadwire Set is a single patient electrode cable system used to transfer signals from patient electrodes to various electrocardiograph recorders and monitors. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

#### Intended Use

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 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).

#### Product Comparison

The new device has equivalent technological characteristics related to safety and effectiveness as the predicate device.

The primary difference between the new device and the predicate is that Philips ECG Leadwire Set utilizes a grabber connector and the predicate utilizes a snap connector to fasten to the electrode.

The indications for use for the new device is identical to the predicate. Though the leadsets are used to transfer signals from patient electrodes, actual use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The new device and the predicate cannot be sterilized or otherwise reprocessed for reuse; they are intended to be used only with one patient then discarded.

The following table provides a comparison between the Philips ECG Leadwire Set cables and the predicate Tyco Electronics ECG Leadwire Set cables.

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# 1410287

| Specification | Philips<br>ECG Leadwire Set<br>(New Device) | Tyco Electronics<br>ECG Leadwire Set<br>(Predicate)<br>K102430 | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Indications for Use | Philips ECG leadsets are<br>indicated for use in the<br>monitoring of cardiac<br>signals for both<br>diagnostic and<br>monitoring purposes.<br>Use is limited by the<br>indications for use of the<br>connected monitoring or<br>diagnostic equipment. | |
| Sterility | Supplied non-sterile;<br>cannot be sterilized or<br>otherwise reprocessed | Supplied non-sterile:<br>cannot be sterilized or<br>otherwise reprocessed | Same |
| Reusability | Not reusable | Not reusable | Same |
| Anatomical Sites | Attached to electrodes<br>placed at standard<br>specified locations on<br>chest wall and<br>extremities | Attached to electrodes<br>placed at standard<br>specified locations on<br>chest wall and<br>extremities | Same |
| Design / Appearance | Cables with "grabber"<br>configuration of ECG<br>electrode connector<br>(distal connector) and<br>common "header"<br>connection (proximal<br>connector) | Cables with "snap"<br>configuration of ECG<br>electrode connector<br>(distal connector) and<br>common "header"<br>connection (proximal<br>connector) | Substantially Equivalent |
| Type of Construction | Flexible shielded multi<br>conductor electrical<br>cable | Flexible shielded multi<br>conductor electrical<br>cable | Same |
| Distal Connector Design | "Grabber" electrode<br>connectors are color<br>coded (red, white, green,<br>black, brown) | "Snap" electrode<br>connectors are color<br>coded (red, white, green,<br>black, brown) | Substantially Equivalent |
| | Connector designations<br>(LL,RL etc.) molded<br>into plastic | Connector designations<br>(LL,RL etc.) molded<br>into plastic | Same |
| Cable Length | 1.0 m and 0.85 m | 1.0 m | Substantially Equivalent |
| Wire Colors | White | White | Same |
| Leadwire Construction | Ribbonized leads with<br>individual coax shields | Shielded copper lead<br>wire with polymer<br>jacket | Substantially Equivalent |
| Proximal Connector<br>Design | All-in-one common<br>connector, fits only<br>Philips ECG<br>monitor/recorders; color<br>coded for use with ECG | All-in-one common<br>connector, fits only<br>Philips ECG<br>monitor/recorders; color<br>coded for use with ECG | Same |

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#### Performance Data

Testing includes but is not necessarily limited to the recognized standards identified below:

- . Medical electrical equipment IEC 60601-1:1998, including Amendments 1 (1991) and 2 (1995) and the national deviations described within UL 60601-1:2003 and ANSI/AAMI ES 60601-1:2005.
- AAMI / ANSI EC 13:2002/(R)2007, Cardiac monitors, heart rate meters and . alarms
- . AAMI/ANSI EC53:1995/(R) 2008, ECG cables and leadwires, including Amendment l
- AAMI / ANSI / ISO 10993-5:2009, Biological evaluation of medical devices -. Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2002, Biological evaluation of medical devices - Part 10 and Amendment 1: Tests for irritation and delayed-type hypersensitivity (including sensitization)

Compliance with the requirements of these standards will be achieved through verification testing, except in cases such as color and intrinsic design, where compliance will be achieved through product inspection. Testing will be conducted and will meet specified acceptance criteria prior to market release of the associated medical device.

Additional preference testing of product characteristics not related to safety and effectiveness and as specified by Philips Medical Systems will also be performed.

#### Conclusions

The Philips ECG Leadwire Sets (the new device) serve as a conductor of electrical energy. The new devices are substantially equivalent to predicate.

Product design and testing will be in conformance with FDA-recognized standards. Conformance with recognized standards ensures product design and function will raise no new issues related to safety and effectiveness.

Based on similarity in technology, characteristics and indications for use as the predicate, the Philips ECG Leadwire Sets are substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three flowing lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Philips Medical Systems C/O Dawn Tibodeau TUV SUD America 1775 Old Highway 8 New Brighton. MN 55112-1891

FEB 1 5 2011

Re: K110287

Trade/Device Name: Philips ECG Leadwire Set Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: January 28, 2011 Received: January 31, 2011

Dear Ms. Tibodeau:

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 rr your as heet to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 I Teast of advised that I Drivedance or our device complies with other requirements of the Act that I Dr Has intess and regulations administered by other Federal agencies. You must or any I oded butters and requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Dawn Timbodeau

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

S 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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#### 4.0 Indications for Use Statement

**PHILIPS**

11023 510(k) Number:

Device Name: Philips ECG Leadwire Set

Indications for Use:

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.

| Prescription Use | X |
|------------------------|--------|
| (21 CFR 801 Subpart D) | AND/OR |

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.P

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K110028

Philips Medical Systems Philips ECG Leadwire Set 510(k) CONFIDENTIAL

December 14, 2010 And Products of the States