(64 days)
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.
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).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mandatory Performance Standard: 21 CFR Part 898: Performance Standard for Electrode Leadwire and Patient Cables (effective May 11, 1998) | "shown to comply" |
| Voluntary Standard: ANSI/AAMI, EC53-1995, ECG Cables and Leadwires | "Laboratory testing indicates compliance to the standard." |
| 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) | "Color coding for the labels and leadwires comply with the ANSI/AAMI standard EC13-92... Visual inspection confirms appropriate color coding." |
| Comparative Performance to Predicate Device: Tronomed Patient Cable and Lead Wire Systems | "favorable and similar performance of both cables" (EWC: ECG II Cable and Leadwire System vs. Tronomed) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document specifies "a five lead version of the predicate device and the five lead version of the EWC: ECG II Cable and Leadwire System" were used for simulated use testing. This indicates a sample size of one of each device type (total of two devices) for this specific test.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the context of FDA submission in the US, it's highly probable the testing was conducted in the United States. The testing appears to be prospective as it's described as "Simulated use testing" and "Laboratory testing" conducted to show compliance before market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The evaluation largely relies on compliance with established technical standards (21 CFR 898, ANSI/AAMI EC53-1995, ANSI/AAMI EC13-92) and comparative testing with a predicate device, rather than expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. It primarily relies on objective measurements against engineering standards and comparison with a predicate device. Visual inspection for color coding is mentioned, implying a single assessment or team assessment without a formal adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an ECG cable and leadwire system, a hardware accessory for medical monitoring equipment. It does not involve AI or human readers in the way typically seen in diagnostic AI systems.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical cable and leadwire system, not an algorithm, so a standalone algorithm-only performance assessment is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is primarily compliance with mandatory and voluntary engineering/performance standards (21 CFR Part 898, ANSI/AAMI EC53-1995, ANSI/AAMI EC13-92). Additionally, comparative technical performance against a legally marketed predicate device served as a form of reference for "expected performance." There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device.
8. The sample size for the training set
Not applicable. This device is a hardware component and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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 ElectrodeLeadwire and Patient Cables. This standard is effective onMay 11, 1998 and was published in the Friday, May 9,1997 Federal Register. |
| - Voluntary Standard: ANSI/AAMI, EC53-1995, ECGcables and leadwires. | |
| - Voluntary Standard: ANSI/AAMI, EC13-92, Standard,Cardiac monitors, heart rate meters and alarms; part 3.1.1.5only. Color coding for labels and leadwire requirementswill 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.
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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).
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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.
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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.
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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).
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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
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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
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"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.
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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
§ 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).