STEALTHSHIELD

K970755 · Vital Connections, Inc. · DRX · Apr 15, 1997 · Cardiovascular

Device Facts

• Record ID: K970755
• Device Name: STEALTHSHIELD
• Applicant: Vital Connections, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Apr 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Device Story

Protected design leadwires for use with medical monitoring equipment; designed to prevent accidental contact with hazardous voltages; ensures patient and clinician safety during ECG or similar signal acquisition; tested for compliance with ANSI/AAMI EC53-1995 and additional internal specifications.

Clinical Evidence

Bench testing only. Samples passed all applicable sections of ANSI/AAMI EC53-1995 and additional internal performance testing.

Technological Characteristics

Protected design leadwires; compliant with ANSI/AAMI EC53-1995; mechanical design features to prevent hazardous voltage contact.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Submission Summary (Full Text)

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K970755
APR 15 1997

# PREMARKET 510(k) NOTIFICATION SUMMARY/CONCLUSION

## Conclusion

The submitted device meets the requirements of the Proposed Rule from 21 CFR Parts 895 and 897 regarding Protected Design Leadwires. Further, samples of the submitted device passed all applicable sections of the voluntary standard ANSI/AAMI EC53-1995. Also, samples of the submitted device passed additional testing, not a part of any standard. Based on the test results outlined in the Specifications Section of this Premarket 510(k) Notification, it is concluded that the submitted device raises no new concerns of safety or effectiveness, and should be considered Substantially Equivalent to the predicate devices listed in this submission.

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