(111 days)
The intended use of the patient cables is identical to previous patient cables.
The proposed patient cables are identical to the commercially-approved Models 5455, 5455L, 5455S, and 5455SL surgical cables, with the exception of a modified connector for heart wires and leads.
The provided text describes a 510(k) summary for patient cable assemblies and does not contain information related to software performance, AI/ML models, or a clinical study that would typically involve acceptance criteria, test sets, ground truth establishment, or expert evaluations as requested.
The document focuses on demonstrating substantial equivalence of a new medical device (patient cable assemblies) to a predicate device, primarily through nonclinical tests (mechanical, electrical, environmental/packaging, and biocompatibility).
Therefore, I cannot extract the requested information as it is not present in the provided text. The submission is for a physical device, not an AI/ML-driven diagnostic or assistive tool.
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MAY 2 2 1996
K960446
510(k) SUMMARY [As required by 21 CFR 807.92(a)]
A. Submitter Information
| Submitter's Name: | Medtronic, Inc. |
|---|---|
| Address: | 7000 Central Ave. N.E.Minneapolis, MN 55432-3576 |
| Telephone Number: | 612/574-4654 |
| Fax Number: | 612/574-6424 |
| Contact Person: | Valerie K. Stuhr |
| SubmissionPreparation Date: | January 31, 1996 |
| Device Information | |
| Trade Name: | Models 5471 and 5471L Sterile Disposable Patient CableAssemblies |
| Common Name: | Patient Cable |
| Classification Name: | Patient transducer and electrode cable (includingconnector), Class II (21 CFR 870.2900) |
- This 510(k) summary iclentifies the Models 5455, 5455L, Predicate Device: 5455S, and 5455SL surgical cables as substantially equivalent to the proposed patient cable assemblies.
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- Device Description: The proposed patient cables are identical to the commercially-approved Models 5455, 5455L, 5455S, and 5455SL surgical cables, with the exception of a modified connector for heart wires and leads.
- Intended Use: The intended use of the patient cables is identical to previous patient cables.
- C. Comparison of Required Technological Characteristics
The proposed patient cables are substantially equivalent to the commerciallyavailable Models 5455, 5455L, 5455S, and 5455SL surgical cables. The proposed cables are identical to the current cables except that the proposed cables include a modified connector.
| Characteristics | Current and Proposed |
|---|---|
| a. Product Labeling | Substantially equivalent |
| b. Intended Use | Identical |
| c. Physical Characteristics | Substantially equivalent |
| d. Anatomical Sites | Identical |
| e. Target Population | Identical |
| f. Performance Testing | Substantially equivalent |
| g. Safety Characteristics | Substantially equivalent |
- D. Summary of Nonclinical Tests
Mechanical, electrical, and environmental/packaging tests show that the proposed patient cable assemblies are qualified and raised no new questions with regard to safety and efficacy. Mechanical test results for cable retaining force, lead, and heartwire connection withdrawal forces, and button depression all met requirements. Electrical tests for current, resistance, and dielectric withstanding voltage also met requirements. Environmental/packaging tests demonstrated that the packaging can withstand various shock, vibration, temperature, and humidity conditions. Biocompatibility tests showed that the connector does not produce cytotoxicity or dermal irritation. All tests met their respective requirements.
§ 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).