COMPATIBILITY ECG TRUNK CABLES

{0}------------------------------------------------ K043572 FEB 2 2 2005 Page 1 of 3 # Premarket Notification 510(k) Summary As required by section 807.92 Compatibility ECG Trunk Cables #### GENERAL COMPANY INFORMATION as required by 807.92(a)(1) #### COMPANY NAME/ADDRESS/PHONE/FAX: Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344 #### NAME OF CONTACT: Mr. Jocl Kent DATE: December 23, 2004 #### DEVICE NAME as required by 807.92(a)(2) #### TRADE NAME: Compatibility ECG Trunk Cables M1020453, 3-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/ 10 ft M1020454, 3-lead, from Multi-Link connector to 300 Series Leadset, AHA, 3.0 m/ 10 fi M1020541, 5-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/ 10 fi M1020546, 5-lead, from Multi-Link connector to 300 Series Leadset, AHA, 3.0 m/ 10 ft M1020547, 3/5-lead Trunk Cable from Round Nicolay Connector to Multi-Link Leadsets (3 or 5), IEC, 3.0 m/ 10 ft M1020563, 3/5-lead Trunk Cable from Round Nicolay Connector to Multi-Link Leadsets (3 or 5), AHA, 3.0 m/ 10 fi #### COMMON NAME: ECG Trunk Cables #### CLASSIFICATION NAME: The following Class II classifications appear applicable: Cable, transducer and electrode, Patient including connector DSA 870.29(){) {1}------------------------------------------------ # NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3) The Compatibility ECG Trunk Cables (REF M1020453, M1020454, M1020541, M1020546, M1020547 and M1020563) are substantially equivalent in safety and effectiveness to the predicate Multilink ECG Cables (K980582). #### DEVICE DESCRIPTION as required by 807.92(a)(4) Compatibility ECG Trunk Cables are used during ECG measurement. These ECG trunk cables consist of connectors on each cable end and a shiclded main electrical cable. Some products also have defibrillation protection resistors inside the yoke-connector. ECG trunk cables are used to transfer the ECG signal from lead sets to a patient monitor. These ECG trunk cables have limited skin contact with a patient while ECG leadwires attached on patient chest have more continuous skin contact. Some products are used with legacy GE Medical System monitors like Dash 3000/4000, Solar, TRAM and also with the new S/5 modules like M-PRESTN. Before the patient monitor can display ECG signals on the screen, leadwire sets and electrodes are needed in addition to these trunk cables. With these trunk cables, 300-series Datex-Ohmeda ECG lead sets are needed. Other products are used with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5, Light, or M-ESTPR having a blue and round 10-pin ECG connector. With these trunk cables, Multi-I ink leadwire sets are used. Products are packed individually into a plastic bag in non-sterife condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution *Federal (USA) law restricts this device to sale by or on the order of a physician". #### INTENDED USE as required by 807.92(a)(5) #### Intended use: The intended use for these trunk cables is to transmit an ECG signal from different GE Healthcare ECG leadwire sets to GE Healthcare patient monitors. #### Indication for use: Compatibility ECG Trunk Cables with green monitor side plug are used to connect Datex-Ohmeda 300-series leadwire sets to GE Healthcare patient monitors having green and rectangle GEEC-type 11-pin ECG connector. Compatibility ECG Trunk Cables with blue monitor side plug are used to connect GE Multi-Link leadwire sets to legacy Datex-Ohmeda patient monitors having a blue and round Nicolay-type ECG connector. {2}------------------------------------------------ 5043572 # SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The Compatibility ECG Trunk Cables (REF M1020453, M1020454, M1020541, M1020546, M1020547 and M1020563) are substantially equivalent in safety and effectiveness to the predicate Multilink ECG Cables (K980582). The Compatibility ECG Trunk Cable has the following similarities to the predicate device: - Non sterile, reusable ECG Trunk cable - Same monitor side connector on four products and same yoke connector on two products - Same type cable materials The proposed Compatibility ECG Trunk Cable has the following differences compared to the Multi-Link predicate device: - Cable length - Instruction for use - Availability of 12-leadwire trunk cable In summary, Compatibility ECG Trunk Cables, described in this submission are substantially equivalent to the predicate Multilink cables (K980582). ### SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3) Compatibility ECG Trunk Cables have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications. - EN 60601-1:1990 +A1:1993 +A2:1995 +A13: - 21 CFR Part 898 . - . EN 980:2003 - t EN 1041:1998 - . ISO 10993-5:1995, ISO 10993-10:1996 - t ANSI/AAMI EC53-1995 - ANSI/AAMI EC13-2002 Paragraphs:- 4.2.2.2.1, 4.2.2.2.3 .4.2.6.1 ,4.2.9.3 ,4.2.9.4 ,4.2.9.14 t - . ISO 14971:2000 #### CONCLUSION: The summary above shows that there are no new questions of safety and effectiveness for the Compatibility FCG Trunk Cables as compared to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms. FEB 2 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Datex-Ohmeda c/o Mr. Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492 Re: K043572 Trade Name: Compatability ECG Trunk Cables ne: Compatibility LCG Truint Cable, 3-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/10 ft Series Leadset, ILC, 5.0 m. 10 it M1020454, Compatibility Trunk Cable, 3-lead, from Multi-Link connector to 300 Series Leadset, AHA, 3.0 m/10 ft Selles Leadset, Artrix, 5.0 m 10 x M1020541, Compatibility Trunk Cable, 5-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/10 ft SCHCS Leadset, IDC, 5.0 mir of -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- --Scries Leadset, AHA, 3.0 m/10ft SCHCS Leadset, AHFT, 5:0 In 19x M1020547, Compatibility Multi-Link 3/5 lead Trunk Cable, from Round Nicolay connector to Multi-Leadsets (3 or 5). IEC, 3.0 m/10 ft Connector to Mani Beatistic (S 12 ink 3/5 lead Trunk Cable, from Round Nicolay connector to Multi-Leadsets (3 or 5), AHA, 3.0 m/10 ft. Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (including connector) Regulatory Class: II (two) Product Code: DSA Dated: December 23, 2004 Received: December 27, 2004 Dear Mr. Kent: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared or seems is substantially equivalent (for the indications relered above une nave acterings as a logally marketed predicate devices marketed in interstate for use sured in the encreative) it the enactment date of the Medical Device Amendments, or to conninered province that have been recordance with the provisions of the Federal Food, Drug, de rices mat navo been require approval of a premarket approval application (PMA). and Cosmetre Ace (110) that the device, subject to the general controls provisions of the Act. The I ou may, merelove, thanks of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. {4}------------------------------------------------ # Page 2 - Mr. Joel Kent If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 woor of als. Existing major regulations affecting your device can thay oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease oc advised that I Drivistian that your device complies with other requirements of the Act that I Drinas made a assoc regulations administered by other Federal agencies. You must or any I oderal statutes and streegirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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. product laciation some of to begin marketing your device as described in your Section 510(k) rms lotter will and wy Journe FDA finding of substantial equivalence of your device to a legally premative noticated 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), please n you assn. I specific at Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the O incr general international and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. B.L.mmumor for 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 510(k) Number (if known): __ Ko43572_ Device Name: Compatibility ECG Trunk Cables Indications for Use: Compatibility ECG Trunk Cables with green monitor side plug are used to connect Datex-Ohmeda 300-series leadwire sets to GE Healthcare patient monitors having green and rectangle GEEC-type 11-pin ECG connector. Compatibility ECG Trunk Cables with blue monitor side plug are used to connect GE Multi-Link leadwire sets to legacy Datex-Ohmeda patient monitors having a blue and round Nicolay-type ECG connector Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B. Camurano ardiovascular Devices Page __ of ___