(58 days)
Not Found
No
The description focuses on the physical transmission of electrical signals and does not mention any computational analysis or interpretation of data using AI/ML.
No
The device is described as an "electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes." It is used to collect data, not to deliver therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device transmits signals for "both diagnostic and monitoring purposes."
No
The device description explicitly states it is an "electrode cable system" and a "family of lead wires," which are physical hardware components used to transmit electrical signals.
Based on the provided information, the Kepler MedTec Single Patient Use ECG Lead Wire is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 living body ("in vitro").
- Device Function: The ECG Lead Wire's function is to transmit electrical signals from the patient's body (via electrodes on the skin) to an external device (ECG recorder/monitor). It does not analyze or test any bodily fluids or tissues.
- Intended Use: The intended use is for transmitting signals for diagnostic and monitoring purposes of the patient's electrical heart activity, not for analyzing samples taken from the patient.
The device is a component of a system used for in vivo (within the living body) diagnostic and monitoring purposes, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Single Patient Use ECG Lead Wire is an electrode cable systems used to transmit signals from patient 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. The Single Patient Use ECG Lead Wire set is intended to be used by trained operators in a medical professional's environment.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. 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 the chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators in a medical professional's environment. Such equipment is commonly located in 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)
Not Found
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
A) SUBMITTED BY : Kepler MedTec 223 Avenue D Willston, VT 05495 (facility registration # 3008160705)
CONTACT:
MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 508-231-8861 Fax
AUG 1 1 2010
| B) DEVICE NAME: | Single Patient Use ECG Lead Wire Set |
|---|---|
| COMMON NAME: | ECG Patient Cable |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | DSA, 870.2900 Cable, transducer and electrode, patient (including connector) |
C) PREDICATES:
K980582 Marquette Medical Systems: ECG Lead Wire and Cable System
Intended use: Multi-Link Cable and Lead Wire Systems are reusable electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders/monitors fro both diagnostic and monitoring purposes. Multi-Link Cable and Lead Wire Systems are limited to indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, and emergency vehicles, as well as in home use.
K082851 GE Medical Systems: Multi-Link Cable and Lead Wire System Intended use: Multi-Link Cable and Lead Wire Systems are electrocardiograph 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. Multi-Link Cable and Lead Wire Systems are intended to be used by trained operators in a medical professional environment.
Kepler MedTec
1
D) DEVICE DESCRIPTION:
The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
E) INTENDED USE:
The Single Patient Use ECG Lead Wire is an electrode cable systems used to transmit signals from patient 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. The Single Patient Use ECG Lead Wire set is intended to be used by trained operators in a medical professional's environment.
| Device Features | Single Patient Use ECG
Lead Wire Set | Predicate | Predicate |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | | K980582 Marquette
Medical Systems:
ECG Lead Wire and
Cable System | K082851 GE Medical
Systems: Multi-Link Cable
and Lead Wire System |
| Intended Use | Transmit signals from
patient electrodes to
various electrocardiograph
recorders / monitors for
both diagnostic and
monitoring purposes | Same | Same |
| Patient Usage | Reusable | Reusable | Reusable |
| Anatomical Sites | Attached to electrodes placed
at standard specified
locations on the chest wall | Same | Same |
| Sterilization | Provided non-sterile | Provided non-sterile | Provided non-sterile |
| Wire Material/
Connector
Design
Construction | Flexible, Shielded multi-
connector electrical cable
keyed to fit specific monitors
and snap for electrodes | Same but additionally
may use Grabber and
Banana electrode
termination
configuration | Same but additionally may use
Grabber, Banana, or Mactrode
electrode termination
configuration |
| Instrument
interface
connector | Compatible to MultiLink
yoke design | Compatible to
MultiLink yoke design | Compatible to MultiLink yoke
design |
| Connector
Retention Force | ANSI/AMMI EC 53A | Same | Same |
| Electrical
Performance | ANSI/AMMI EC 53A | Same | Same |
F) COMPARISON TO PREDICATE DEVICES(s):
The Single Patient Use ECG Lead Wire has a similar intended use, target population, clinical setting, and technology as its predicate devices.
Kepler MedTec
2
G) STANDARDS MET:
- . ANSI/AMMI EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except 4.3.1)
- ANSI/AAMI EC13:2002 Cardiac monitors, heart rate meters and alarms (only ● product markings, chapter 4.1.1.5)
- 21 CFR 898: Guidance Document on the Performance Standard for Electrode Lead . Wires and Patient Cables, May 11, 1998 IEC 601-1 (1998), "Medical Electrical Equipment - Part 1: General Requirements for Safety, " (R)1995 subclause 56.3(c)
- EN/ISO 10993-1:2003 Biological evaluation of Medical Devices, Part I: Guidance ● on selection of tests
H) CONCLUSION:
Kepler MedTec believes that the Single Patient Use ECG Lead Wire Set is as safe and effective and is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kepler MedTec c/o Mr. F. David Rothkopf MEDIcept, Inc. 200 Homer Ave. Ashland, MA 01721
AUG 1 1 2010
Re: K101660
Trade/Device Name: Single Patient Use ECG Lead Wire Set Regulatory Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II (Two) Product Code: DSA Dated: June 8, 2010 Received: June 14, 2010
Dear Mr. F. David Rothkopf:
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, Or ve 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 - Mr. F. David Rothkopf
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/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]
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known):
KIDIGGO
Device Name: Single Patient Use ECG Patient Lead Wire Set
AUG 1 1 2010
Indications for Use:
The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient 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. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.
Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use_21CFR 801.109
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
W. M.
510(k) Number
Kepler MedTec
June 8, 2010
Page 12