ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

K101660 · Kepler Medtec · DSA · Aug 11, 2010 · Cardiovascular

Device Facts

Record IDK101660
Device NameECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
ApplicantKepler Medtec
Product CodeDSA · Cardiovascular
Decision DateAug 11, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2900
Device ClassClass 2

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 Story

Single Patient Use ECG Lead Wire Set; electrode cable system; transmits electrical signals from patient surface electrodes to ECG recorders/monitors. Used in medical professional environments by trained operators. Device consists of flexible, shielded multi-connector electrical cables; keyed for specific monitor compatibility; snap-style electrode interface. Provides physical link between patient and trunk cable system. Facilitates diagnostic and monitoring functions by maintaining signal integrity from electrodes to equipment. Benefits patient by enabling continuous or diagnostic cardiac monitoring via standard ECG equipment.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AMMI EC53-1995 (R)2001/2008 for connector retention force and electrical performance. Biocompatibility evaluated per EN/ISO 10993-1:2003. No clinical data presented.

Technological Characteristics

Flexible, shielded multi-connector electrical cable; keyed for monitor compatibility; snap-style electrode interface. Complies with ANSI/AMMI EC53 for electrical performance and connector retention. Non-sterile. No active electronic components; passive signal transmission.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording. Intended for use by trained operators in medical professional environments. Use is restricted to the indications of the connected monitoring or diagnostic equipment.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary K101660 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<br>Lead Wire Set | Predicate | Predicate | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | | | K980582 Marquette<br>Medical Systems:<br>ECG Lead Wire and<br>Cable System | K082851 GE Medical<br>Systems: Multi-Link Cable<br>and Lead Wire System | | Intended Use | Transmit signals from<br>patient electrodes to<br>various electrocardiograph<br>recorders / monitors for<br>both diagnostic and<br>monitoring purposes | Same | Same | | Patient Usage | Reusable | Reusable | Reusable | | Anatomical Sites | Attached to electrodes placed<br>at standard specified<br>locations on the chest wall | Same | Same | | Sterilization | Provided non-sterile | Provided non-sterile | Provided non-sterile | | Wire Material/<br>Connector<br>Design<br>Construction | Flexible, Shielded multi-<br>connector electrical cable<br>keyed to fit specific monitors<br>and snap for electrodes | Same but additionally<br>may use Grabber and<br>Banana electrode<br>termination<br>configuration | Same but additionally may use<br>Grabber, Banana, or Mactrode<br>electrode termination<br>configuration | | Instrument<br>interface<br>connector | Compatible to MultiLink<br>yoke design | Compatible to<br>MultiLink yoke design | Compatible to MultiLink yoke<br>design | | Connector<br>Retention Force | ANSI/AMMI EC 53A | Same | Same | | Electrical<br>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) //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// Concurrence of CDRH, Office of Device Evaluation (ODE) W. M. 510(k) Number Kepler MedTec June 8, 2010 Page 12
Innolitics
510(k) Summary
Decision Summary
Classification Order
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