(15 days)
Not Found
No
The summary describes a passive cable system for transferring ECG signals and makes no mention of AI/ML, image processing, or data analysis beyond standard signal transmission.
No
The device is indicated for monitoring cardiac signals, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the leadsets are "indicated for use in the monitoring of cardiac signals 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," indicating it is a hardware component used to transfer signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring of cardiac signals for both diagnostic and monitoring purposes." This involves collecting electrical signals from the patient's body.
- Device Description: The device is described as a "single patient electrode cable system used to transfer signals from patient electrodes to various electrocardiograph recorders and monitors." This is a physical connection for signal transmission.
- Lack of In Vitro Activity: IVD devices are designed to be used in vitro, meaning outside of the living body, to examine specimens such as blood, urine, or tissue. This device is used in vivo, directly on the patient.
- Standards: The listed standards (IEC 60601-1, AAMI/ANSI EC 13, AAMI/ANSI EC53, ISO 10993-5, ISO 10993-10) are relevant to medical electrical equipment, ECG cables, and biological evaluation for devices that come into contact with the body, not specifically for in vitro testing.
Therefore, the Philips ECG leadsets described are medical devices used for in vivo monitoring and diagnosis, not IVDs.
N/A
Intended Use / Indications for 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).
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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 870.2900 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
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: | peter.schipelliti@philips.com |
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 |
| connector). |
Image /page/0/Picture/12 description: The image shows the word "Philips" in a simple, sans-serif font. A horizontal line is placed above the word. The text and line are black against a white background.
ر
1
Predicate Device Details
| 510(k) Number | K102430 (cleared on September 10, 2010) |
|---|---|
| Proprietary or Trade Name: | Tyco Electronics Electrocardiograph (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 |
| 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.
Image /page/1/Picture/13 description: The image shows a black blob on a white background. The blob is made up of two overlapping circles. The larger circle is on the bottom, and the smaller circle is on the top. The blob is slightly off-center.
2
1410287
| Specification | Philips
ECG Leadwire Set
(New Device) | Tyco Electronics
ECG Leadwire Set
(Predicate)
K102430 | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | 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. | |
| Sterility | Supplied non-sterile;
cannot be sterilized or
otherwise reprocessed | Supplied non-sterile:
cannot be sterilized or
otherwise reprocessed | Same |
| Reusability | Not reusable | Not reusable | 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"
configuration of ECG
electrode connector
(distal connector) and
common "header"
connection (proximal
connector) | Cables with "snap"
configuration of ECG
electrode connector
(distal connector) and
common "header"
connection (proximal
connector) | Substantially Equivalent |
| Type of Construction | Flexible shielded multi
conductor electrical
cable | Flexible shielded multi
conductor electrical
cable | Same |
| Distal Connector Design | "Grabber" electrode
connectors are color
coded (red, white, green,
black, brown) | "Snap" electrode
connectors are color
coded (red, white, green,
black, brown) | Substantially Equivalent |
| | Connector designations
(LL,RL etc.) molded
into plastic | Connector designations
(LL,RL etc.) molded
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
individual coax shields | Shielded copper lead
wire with polymer
jacket | Substantially Equivalent |
| Proximal Connector
Design | All-in-one common
connector, fits only
Philips ECG
monitor/recorders; color
coded for use with ECG | All-in-one common
connector, fits only
Philips ECG
monitor/recorders; color
coded for use with ECG | Same |
Image /page/2/Picture/2 description: The image shows a black blob on a white background. The blob is round and slightly irregular in shape. It appears to be a solid object, with no visible texture or detail. The blob is positioned in the upper left corner of the image.
3
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.
Image /page/3/Picture/14 description: The image shows a black blob on a white background. The blob is irregularly shaped and appears to be a solid color. The blob is positioned in the center of the image. The image is simple and lacks any additional details.
4
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
5
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 (800) 638-2041 or (301) 796-7100 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
6
Pg 1 of 1
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