(64 days)
Not Found
No
The device is a simple cable and leadwire system for transmitting ECG signals, with no mention of any processing or analysis capabilities that would involve AI/ML.
No
This device transmits signals from electrodes to diagnostic/monitoring equipment; it does not provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to transmit signals from patient electrodes... for both diagnostic and monitoring purposes."
No
The device description explicitly states it is a "reusable electrode cable designed to transmit signals," indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The EWC: ECG II Cable and Leadwire System transmits electrical signals from electrodes placed on the patient's body to an ECG recorder or monitor. It is used for diagnostic and monitoring purposes of the patient directly, not by analyzing a sample taken from the patient.
- Intended Use: The intended use clearly states it transmits signals from patient electrodes to recorders/monitors for diagnostic and monitoring purposes. This is a direct physiological measurement, not an in vitro test.
The device is a component used in a system for in vivo (within the living body) diagnostic and monitoring procedures.
N/A
Intended Use / Indications for Use
The EWC: ECG II Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The EWC: ECG II Cable and Leadwire System is a reusable electrode cable designed to transmit signals from the patient connect electrodes (not supplied by EWC) to various electrocardiograph recorders/monitors (not supplied by EWC) for both diagnostic and monitoring purposes. This device is common to both the industry and to most medical establishments. The EWC: ECG II Cable and Leadwire System is offered in a 3, 5, 7, and 10 lead design. All cables have detachable leadwires that have AAMI compatible plug (patient side) and are supplied with user defined patient electrode connectors (snap, banana, pin or gripper style).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, doctor's offices, emergency vehicles, as well as in home use.
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 EWC: ECG II Cable and Leadwire System was tested to the requirements of the mandatory performance standard defined in 21 CFR 898, as identified in 2 above, and shown to comply. The system was also designed and tested to the requirements of the ANSI/AAMI performance standard covering ECG Cables and Leadwires (EC53-1995). Laboratory testing indicates compliance to the standard. Test results were retained in the design history file. Color coding for the labels and leadwires comply with the ANSI/AAMI standard EC13-92 (Cardiac monitors, heart rate meters and alarms, part 3.1.1.5). Visual inspection confirms appropriate color coding.
Simulated use testing, using an ECG Simulator, a ECG Monitor and a Tektronix TDS 380 recording Oscilloscope , was also completed on a five lead version of the predicate device and the five lead version of the EWC: ECG II Cable and Leadwire System. Test results were reviewed and indicate favorable and similar performance of both cables. Results are retained as part of the design history file.
Based on the results of the engineering/design level test, along with the simulated use tests, it is felt that the EWC: ECG II Cable and Leadwire System performs as expected and compares well, in terms of overall performance to the selected Tronomed device (predicate device).
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters. The characters are 'K', '9', '8', '4', '2', '6', and '3'. The characters are written in black ink on a white background. The handwriting appears to be somewhat messy.
Image /page/0/Picture/1 description: The image shows the logo for EWC. The logo consists of the letters "ewc" in a bold, sans-serif font. To the right of the letters are five horizontal lines of equal length, stacked vertically. The letters and lines are all black, and the background is white.
Image /page/0/Picture/2 description: The image shows a BSI Registered Firm logo. The logo is circular with the letters "BSI" at the top and the words "REGISTERED FIRM" around the perimeter. Below the logo are the text strings "FM 34863" and "ISO 9001".
FEB 2 1999
Summary and Certification 510(k) Summary Date: November 25, 1998
1. Establishment Information:
| Submittor: | EWC (Electri-Wire Corporation) |
|---|---|
| N26 W23315 Paul Road | |
| Pewaukee, WI 53072-4061 | |
| Registration #: | 9921058 (Owner/Operator) |
| Contact Person: | Timothy M. Davis |
| Contact Phone #: | (414) 548-3700 or 800-786-3707 |
| Manufacturing: | EWC (Electri-Wire Corporation) |
| 208 West Street | |
| Waupun, WI 53963 | |
| Registration #: | 2183764 |
2. General Device Information:
| Common Name: | ECG Cable and Leadwire System |
|---|---|
| Trade Name: | EWC: ECG II Cable and Leadwire System |
| Classification Name: | Patient transducer and electrode cable (including connector) |
| Device Classification: | Class II (21 CFR: part 870.2900) |
| Performance Std's.: | - 21 CFR Part 898: Performance Standard for Electrode |
| Leadwire and Patient Cables. This standard is effective on | |
| May 11, 1998 and was published in the Friday, May 9, | |
| 1997 Federal Register. | |
| - Voluntary Standard: ANSI/AAMI, EC53-1995, ECG | |
| cables and leadwires. | |
| - Voluntary Standard: ANSI/AAMI, EC13-92, Standard, | |
| Cardiac monitors, heart rate meters and alarms; part 3.1.1.5 | |
| only. Color coding for labels and leadwire requirements | |
| will be met |
- Substantial Equivalence: The EWC: ECG II Cable and Leadwire System is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884.
020
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
1
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Device Description: The EWC: ECG II Cable and Leadwire System is a reusable electrode cable designed to transmit signals from the patient connect electrodes (not supplied by EWC) to various electrocardiograph recorders/monitors (not supplied by EWC) for both diagnostic and monitoring purposes. This device is common to both the industry and to most medical establishments. The EWC: ECG II Cable and Leadwire System is offered in a 3, 5, 7, and 10 lead design. All cables have detachable leadwires that have AAMI compatible plug (patient side) and are supplied with user defined patient electrode connectors (snap, banana, pin or gripper style).
-
Intended Use: The EWC: ECG II Cable and Leadwire Systems are reusable electrode cables used to transmit signals from the patient connected electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
-
Technology comparison to legally marketed predicate device: The EWC: ECG II Cable and Leadwire System technological characteristics are similar, in comparison, to the Tronomed Patient Cable and Lead Wire Systems as identified in 3 above.
-
Test Summary and Conclusion: The EWC: ECG II Cable and Leadwire System was tested to the requirements of the mandatory performance standard defined in 21 CFR 898, as identified in 2 above, and shown to comply. The system was also designed and tested to the requirements of the ANSI/AAMI performance standard covering ECG Cables and Leadwires (EC53-1995). Laboratory testing indicates compliance to the standard. Test results were retained in the design history file. Color coding for the labels and leadwires comply with the ANSI/AAMI standard EC13-92 (Cardiac monitors, heart rate meters and alarms, part 3.1.1.5). Visual inspection confirms appropriate color coding.
Simulated use testing, using an ECG Simulator, a ECG Monitor and a Tektronix TDS 380 recording Oscilloscope , was also completed on a five lead version of the predicate device and the five lead version of the EWC: ECG II Cable and Leadwire System. Test results were reviewed and indicate favorable and similar performance of both cables. Results are retained as part of the design history file.
Based on the results of the engineering/design level test, along with the simulated use tests, it is felt that the EWC: ECG II Cable and Leadwire System performs as expected and compares well, in terms of overall performance to the selected Tronomed device (predicate device).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling an eagle. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1999 FEB
Mr. Timothy M. Davis Corporate Director RA/QA EWC N26W23315 Paul Road Pewaukee, WI 53072
Re: K984263 ECG II Cable and Leadwire System Regulatory Class: II (two) Product Code: DSA November 25, 1998 Dated: Received: November 30, 1998
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this
3
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
"Indication for Use Statement"
INDICATION FOR USE PAGE
510(k) Number (if known): Unknown
Device Name: EWC: ECG II Cable and Leadwire System
Indication for use: The EWC: ECG II Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
(Please do not write below this line - Continue on another page if required)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109)
or
Over-The-Counter Use
DaK Tiller
Vision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K984263
510k104