(27 days)
Not Found
No
The description focuses on the device's function as a signal transmission cable and mentions no AI/ML capabilities or related terms.
No.
The device is used to transmit signals for diagnostic and monitoring purposes, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the device is used for "both diagnostic and monitoring purposes." It transmits signals to "various electrocardiograph recorders/monitors" which are used for diagnosis.
No
The device description explicitly states it is a "reusable electrode cable systems" and mentions "electrical and mechanical testing," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes." This describes a device that connects to the patient's body to pick up electrical signals, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces this by stating it's a "reusable electrode cable systems used to transmit signals from patient electrodes."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the collection of electrical signals from the body surface.
N/A
Intended Use / Indications for Use
Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.
Product codes
74 DSA
Device Description
Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.
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, and 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)
A comparison of the predicate device's production and both electrical and mechanical testing to AAMI ECGC-5/83 was made to the equivalent production, electrical and mechanical testing of the Multi-Link Cable and Lead Wire Systems. Testing also demonstrated that the Multi-Link Cable and Lead Wire Systems meet 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables. Marquette Medical Systems has demonstrated that the use of the Multi-Link Cable and Lead Wire Systems is as safe and as effective, and performs substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 2 Summary and Certification 510(k) Summary Date: February 13, 1998
| 1. Establishment Information | Manufacturer/Submitter: Marquette Medical Systems
100 Marquette Drive
Jupiter, FL 33468 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Registration Number: 1051778 |
| | Contact Name/Phone #: Michael Laughran/ (561) 575-5000 |
| 2. | General Device Information |
| | Common/Usual Name: ECG Lead Wire and Cable System |
| | Trade/Proprietary Name: Multi-Link Cable and Lead Wire Systems |
| | Classification Name: Patient transducer and electrode cable (including connector) |
| | Device Classification: Class II. |
| | Performance Standards: 21CFR Part 898: Performance Standard for Electrode Lead Wire an
Patient Cables. This Standard is effective on May 11, 1998 and was |
-
Substantial Equivalence: Multi-Link Cable and Lead Wire Systems is substantially equivalent to ConMed 3. Corp. ECG Patient Cables and Leadwires which are currently legally marketed under 510(k) 933649.
published in the Friday, May 9, 1997 Federal Register. -
Device Description: Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used 4. to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.
-
Intended Use: Multi-Link Cable and Lead Wire Systems are reusable electrode cable systems used to transmit ട. signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Multi-Link Cable and Lead Wire Systems are limited by the indications for use of the connected monitoring or diagnostic equipment is commonly located in hospitals, doctor's offices, and emergency vehicles, as well as in home use.
-
Technological comparison to legally marketed predicate device: the Multi-Link Cable and Lead Wire 6. Systems technological characteristics are similar in comparison to the ConMed Corp. ECG Patient Cables and Leadwires
-
- Test Summary and Conclusion: A comparison of the predicate device's production and both electrical and mechanical testing to AAMI ECGC-5/83 was made to the equivalent production, electrical and mechanical testing of the Multi-Link Cable and Lead Wire Systems. Testing also demonstrated that the Multi-Link Cable and Lead Wire Systems meet 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables. Marquette Medical Systems has demonstrated that the use of the Multi-Link Cable and Lead Wire Systems is as safe and as effective, and performs substantially equivalent to its predicate device.
MAR 1 6 1998
1
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the department's name around the perimeter. In the center of the seal is an image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
MAR 16 1998
Mr. Michael Laughran Marquette Medical Systems 100 Marquette Drive Jupiter, FL 33458
Re: K980582 Multi-Link Cable and Lead Wire Systems Requlatory Class: II (two) Product Code: 74 DSA February 13, 1998 Dated: Received: February 17, 1998
Dear Mr. Laughran:
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 to 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this 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 regulations.
2
Page 2 - Mr. Michael Laughran
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) 594-4649. 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, "Misbranding by reference to premarket notification" (21 CFR 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 13 Indication for Use Statement
INDICATIONS FOR USE PAGE
510(K) Number (if known): Unknown - 510(k) filed February 13, 1998
Device Name: Multi-Link Cable and Lead Wire Systems
Indications for use:
Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over- The- Counter Use
(Division Sign-Off)