(15 days)
Not Found
No
The device description focuses on the physical components and function of ECG leadwires, which are passive signal transfer devices. There is no mention of data processing, algorithms, or any technology that would typically involve AI/ML. The performance studies listed are related to electrical safety, biocompatibility, and basic ECG signal transmission standards, not algorithmic performance.
No
The device is described as leadwire sets used for monitoring cardiac signals for diagnostic purposes, transferring signals from electrodes to a patient monitoring device. It explicitly states its use is limited to diagnostic and monitoring purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the leadwire sets are "indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes."
No
The device description explicitly states it consists of "insulated copper conductors with connectors on each cable end" and is used to "transfer signals originating from skin-mounted ECG electrodes". This describes physical hardware components, not software.
No, 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 measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description clearly states it's used to "transfer signals originating from skin-mounted ECG electrodes (distal end) to a patient monitoring device (proximal end)." This describes a device that interacts with the patient's body to acquire a signal, not a device that analyzes a sample in a lab setting.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing information about a patient's health status based on the analysis of a sample
The device is a component used in the process of acquiring physiological data (ECG signals) from a patient. This falls under the category of medical devices used for monitoring and diagnosis based on direct interaction with the patient, not in vitro analysis of samples.
N/A
Intended Use / Indications for Use
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets 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
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are intended for use with ECG monitors manufactured by Philips Medical Systems. Both the Philips and the Tyco Electronics groups of leadwire sets are designed specifically for compatibility with Philips ECG monitors and consist of insulated copper conductors with connectors on each cable end.
The term leadwire set includes ECG leadwires as well as the attached proximal and distal connectors. Leadwire sets are used to transfer signals originating from skin-mounted ECG electrodes (distal end) to a patient monitoring device (proximal end).
Tvco Electronics ECG Leadwire Sets are single-use devices within the meaning of that term as used by FDA - that is, they cannot be reprocessed and re-used. As described by FDA', a single-use device, also referred to as a disposable device, is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient.
All leadwire sets addressed within this 510(k) submission are produced in a configuration that is shielded against electromagnetic interference; they are single-use devices, not sterilizable and not reusable, intended for short-term use only (recommended use duration 7 days or less).
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 operators in a medical environment.
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)
The Company has chosen to perform testing including but not necessarily limited to the external and/or 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 EC13:2002((R)2007, Cardiac monitors, heart rate meters, and alarms.
- AAMI / ANSI EC53:1995/(R) 2008, ECG cables and leadwires, including Amendment 1,
- 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 verfilcation testing. except in cases such as color and intrinsic design, where compliance will be achieved through product inspection. Testing against these standards is not complete at time of 510(k) filing. 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 Tyco Electronics also will 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
4. 510(k) Summary
4.1 General Information
| Submitter's Name: | Tyco Electronics Corporation |
|---|---|
| Address: | 10025 S.W. Freeman Court |
| Wilsonville, OR 97070 | |
| Establishment Registration: | 3026961 |
| Telephone Number: | (503) 673-5027 |
| Fax Number: | (503) 685-9305 |
| Contact Person: | Dennis M. Gilkey |
| Submission Preparation Date: | July 21, 2010 |
SEP 1 0 2010
4.2 Device
Trade/Proprietary Name: Common Name: Classification Name: Product Code: DSA CFR Reference: Class: -
Tyco Electronics Electrocardiograph (ECG) Leadwire Set ECG Leadwire Set Patient transducer and electrode cable (including connector) 21 CFR 870.2900
4.3 Predicate Device
| Common Name: | ECG Cables |
|---|---|
| Proprietary Name: | ECG Cables |
| Product Code: | DSA |
| 510(k) Owner: | Philips Medical Systems (Andover, MA) |
| 510(k) Number: | #K020531 (cleared March 20, 2002) |
4.4 Device Description
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are intended for use with ECG monitors manufactured by Philips Medical Systems. Both the Philips and the Tyco Electronics groups of leadwire sets are designed specifically for compatibility with Philips ECG monitors and consist of insulated copper conductors with connectors on each cable end.
The term leadwire set includes ECG leadwires as well as the attached proximal and distal connectors. Leadwire sets are used to transfer signals originating from skin-mounted ECG electrodes (distal end) to a patient monitoring device (proximal end).
Tvco Electronics ECG Leadwire Sets are single-use devices within the meaning of that term as used by FDA - that is, they cannot be reprocessed and re-used. As described by FDA', a single-use device, also referred to as a disposable device, is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient.
All leadwire sets addressed within this 510(k) submission are produced in a configuration that is shielded against electromagnetic interference; they are single-use devices, not sterilizable and not reusable, intended for short-term use only (recommended use duration 7 days or less).
Tyco Electronics Electrocardiograph (ECG) Leadwire Set
1 Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; August 14, 2000 Page 7 of 18 Premarket Notification:
Tyco Electronics Corporation
1
4.5 Intended Use
The Tyco Electronics ECG Leadwire Set is used to transmit signals from patient-connected electrodes or transducers to Philips electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are single-use devices; they are supplied non-sterile and are not sterilizable or reusable. Tyco Electrocardiograph (ECG) Leadwire Sets are intended for short-term use only (recommended use duration 7 days or less), by trained operators in a medical environment.
4.6 Product Comparison
The table below provides a comparison between Tyco Electronics ECG Leadwire Set cables and the predicate ECG cables manufactured by Philips Medical Systems. The primary difference between the two products is that Tyco Electronics ECG Leadwire Sets are single-use devices whereas Philips leadwire sets are reusable.
| Parameter | Tyco Electronics | Philips Medical Systems |
|---|---|---|
| New Device | Predicate Device | |
| Intended Use | Transmit signals from patient-connected | |
| surface electrodes to Philips | ||
| electrocardiograph recorders/monitors | ||
| for both diagnostic and monitoring | ||
| purposes. | Same | |
| Sterility | Supplied non-sterile; cannot be sterilized | |
| or otherwise reprocessed | Supplied non-sterile; can be sterilized | |
| (no autoclave) | ||
| Reusability | Not reusable | Reusable |
| Anatomical Sites | Attached to electrodes placed at | |
| standard specified locations on chest | ||
| wall and extremities | Same | |
| Design/Appearance | Cables with "snap" configuration of ECG | |
| electrode connector (distal connector) | ||
| and common "header" connection | ||
| (proximal connector) | Same | |
| Type of Construction | Flexible, shielded multi conductor | |
| electrical cable | Same | |
| Distal Connector | ||
| Design | 1. Incorporates proprietary design to | |
| facilitate connection with Philips ECG | ||
| monitors/recorders; |
- "Snap" electrode connectors are color
coded - e.g., red, white, green, black.
brown - Connector designations (LL, RL etc.)
molded into plastic | 1. Same - Same
- Connector designations (LL, RL etc.)
indicated by adhesive labels |
| Cable Length | 1.0 m | 1.0 m; 1.6 m |
| Wire Colors | White | Wires are color coded - e.g., red, white,
green, black, brown |
| Wire Material | Shielded copper lead wire with polymer
iacket | Same |
Premarket Notification: Tyco Electronics Electrocardiograph (ECG) Leadwire Set Tyco Electronics Corporation
Page 8 of 18
2
| Parameter | Tyco Electronics
New Device | Philips Medical Systems
Predicate Device |
|------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Proximal Connector
Design | All-in-one common connector, fits only
Philips ECG monitor/recorders; color-
coded for use with ECG systems | Same |
4.7 Performance Data
The Company has chosen to perform testing including but not necessarily limited to the external and/or 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 EC13:2002((R)2007, Cardiac monitors, heart rate meters, and alarms.
- · AAMI / ANSI EC53:1995/(R) 2008, ECG cables and leadwires, including Amendment 1,
- · 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 verfilcation testing. except in cases such as color and intrinsic design, where compliance will be achieved through product inspection. Testing against these standards is not complete at time of 510(k) filing. 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 Tyco Electronics also will be performed.
4.8 Conclusions
Tyco Electronics ECG Leadwire Sets (the new device) serve as a conductor of electrical energy. The new device is substantially equivalent to electrocardiograph cable sets manufactured by Philips Medical Systems (Andover, MA), cleared as components of the Philips M1275B Component Compact Monitor (#K020531, clearance date March 20, 2002).
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Electronics Corporation c/o Ms. Dawn Tibodeau Responsible Third Party Official TUV SUD America, Inc 1775 Old Hwy 8 NW, Ste 104 Wilsonville, OR 97070
SEP 1 0 2010
Re: K102430 Trade/Device Name: Tyco Electronics Electrocardiograph (ECG) Leadwire Set Regulatory Number: 21 CFR 870.2900 Regulation Name: Transducer and Electrode Patient Cable (including connector) Regulatory Class: II (two) Product Code: DSA Dated: August 21, 2010 Received: August 26, 2010
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.
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.
4
Page 2 – Ms. Dawn Tibodeau
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3. Indications for Use Statement
510(k) Number (if known):
Device Name: Tyco Electronics Electrocardiograph (ECG) Leadwire Set
SEP 1 0 2010
Indications for Use:
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets 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 (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K162430
Premarket Notification: Tyco Electronics Electrocardiograph (ECG) Leadwire Set Tyco Electronics Corporation
Page 6 of 18