K-number	K243545
Device name	Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
Applicant	Philips Medizin Systeme Böblingen GmbH
Product code	DSA
Device class	Class II
Decision date	Jan 17, 2025
Decision	Substantially Equivalent
Regulation	870.2900

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Philips Reusable ECG Lead Sets and Trunk Cables are non-sterile, reusable medical devices designed to transfer ECG signals from patient electrodes to Philips monitors in healthcare facilities (ICU, OR, emergency settings). They support monitoring of cardiac signals for diagnostic and monitoring purposes in adult, pediatric, and neonatal patients, with a service life of 18 months.

Technological characteristics

The subject device includes reusable lead sets (vs. disposable in predicate), 3, 4, 5, and 6-lead configurations, Grabber/Snap/Mini-clip electrode connectors (vs. Pinch/Snap), 12-pin ECG trunk connectors for Philips monitors, and unshielded options for neonatal flexibility. Both use medical-grade materials and connect patient electrodes to monitoring equipment via flexible cable designs.

Test standards cited

IEC 60601-1:2005+A1:2012+A2:2020, ANSI AAMI EC53:2013/(R)2020, IEC 60601-2-25:2011/(R)2016, IEC 60601-2-27:2011(R)2016, IEC 60601-1-12:2020-07, IEC 62366-1:2015+AMD1:2020, ISO 17664-2:2021, AAMI TIR12, ANSI AAMI ST98:2022, and ISO 10993-1 for biocompatibility.

Substantial equivalence argument

The subject device performs the identical core function as the predicate (Medline Patient Cables and Lead Wires, K181726): connecting patient electrodes to monitoring equipment for ECG signal transmission in healthcare settings by healthcare professionals. Although the subject device is reusable rather than disposable, features additional lead configurations (4 and 6-lead sets), uses different connector types, and lacks an 8-pin connector option, these differences do not raise new safety/effectiveness questions because the signal transmission function is unchanged, materials meet durability/hygiene standards per ISO 17664-2:2021 and FDA guidance, performance testing validates the design, and the monitor's measurement accuracy is defined at the system level.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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