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.

Device Description

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".

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Compatibility ECG Trunk Cables." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/CADe device. Therefore, much of the requested information regarding AI/CADe specific study details is not applicable or available in this document.

However, I can extract the information that is relevant to the type of device described and interpret the closest equivalent of "acceptance criteria" and "device performance" in this context.

Device Type: Compatibility ECG Trunk Cables are medical devices used to transmit ECG signals from lead sets to patient monitors. They are cables and connectors, not an AI/CADe device.

Acceptance Criteria and Device Performance (Interpreted for a Cable Device):

For a cable, "acceptance criteria" are generally met through adherence to established electrical, mechanical, and biocompatibility standards, ensuring the cable functions as intended without introducing new risks. "Device performance" refers to the cable's ability to maintain signal integrity, withstand use, and be safe for patients.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a kabel, the "acceptance criteria" are primarily a demonstration of compliance with recognized standards. The "reported device performance" is the assertion that the device meets these standards and is substantially equivalent to the predicate.

Acceptance Criteria Category (Interpreted)	Specific Standard / Requirement	Reported Device Performance (Compliance)
Electrical Safety	EN 60601-1:1990 +A1:1993 +A2:1995 +A13:	"Assessed against" and "thoroughly tested through validation and verification of specifications."
Biocompatibility	ISO 10993-5:1995 (Cytotoxicity)	"Assessed against" and "thoroughly tested through validation and verification of specifications."
	ISO 10993-10:1996 (Irritation & Hypersensitivity)	"Assessed against" and "thoroughly tested through validation and verification of specifications."
EMC/Signal Integrity	ANSI/AAMI EC53-1995	"Assessed against" and "thoroughly tested through validation and verification of specifications."
	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	"Assessed against" and "thoroughly tested through validation and verification of specifications."
Labeling/Packaging	EN 980:2003	"Assessed against" and "thoroughly tested through validation and verification of specifications." (Implicitly, as package label is described)
	EN 1041:1998	"Assessed against" and "thoroughly tested through validation and verification of specifications."
Risk Management	ISO 14971:2000	"Assessed against" and "thoroughly tested through validation and verification of specifications."
General Safety/Effectiveness	Substantial Equivalence to Predicate K980582	"Substantially equivalent in safety and effectiveness" to the predicate.

2. Sample size used for the test set and the data provenance

Not applicable for this type of device and submission. The testing described is against engineering standards, not a clinical "test set" with patient data. The provenance of the "data" would be engineering test reports and compliance documentation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of an AI/CADe device, refers to a definitive diagnosis or finding. For a cable, "ground truth" is adherence to engineering specifications and performance within established standards, assessed by engineers and quality assurance personnel.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes. For a cable, compliance is determined by meeting objective engineering specifications.

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

Not applicable. This is not an AI/CADe device designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

The "ground truth" for this device is the successful performance against specified engineering and safety standards, as well as functional equivalence to the predicate device. This is confirmed through a combination of:

Engineering Test Results: Measurements and evaluations demonstrating the cable's electrical, mechanical, and material properties meet relevant standards.
Biocompatibility Testing: Lab tests (e.g., cytotoxicity, irritation) to ensure materials are safe for limited skin contact.
Predicate Device Comparison: Functional similarity and identical intended use as the legally marketed predicate device (Multilink ECG Cables K980582).

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning device.

Summary

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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(){)

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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)

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:

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5043572

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

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.

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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.

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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

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Indications for Use

510(k) Number (if known): __ Ko43572_

Device Name: Compatibility ECG Trunk Cables

Indications for Use:

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 ___

Regulation Number and Section

§ 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).