(111 days)
5455, 5455L, 5455S, 5455SL
Not Found
No
The summary describes patient cables with a modified connector and focuses on mechanical, electrical, and environmental testing, with no mention of AI or ML.
No
The device described is a patient cable, which is an accessory used with other medical devices. It does not directly provide therapy. The "surgical cables" mentioned as predicates further suggest a connection to surgical equipment rather than therapeutic intervention itself.
No
Explanation: The device is described as "patient cables" specifically "surgical cables" with a modified connector for heart wires and leads. The summary of performance studies focuses on mechanical, electrical, environmental, and biocompatibility tests of the cables, not on diagnostic capabilities. The text does not mention any function related to identifying a disease or condition.
No
The device description explicitly states it is a "patient cable" and describes physical modifications and performance studies related to mechanical, electrical, and environmental properties, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on patient cables used in a surgical setting, connecting to heart wires and leads. There is no indication of the device being used to examine specimens (like blood, urine, or tissue) outside of the body.
- Focus on electrical and mechanical performance: The performance studies described are related to the physical and electrical properties of the cables, not the analysis of biological samples.
- Intended use in a surgical setting: The device is described as "surgical cables," which are used directly on or with a patient during a procedure, not for laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This description does not align with that purpose.
N/A
Intended Use / Indications for Use
The intended use of the patient cables is identical to previous patient cables.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Identical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
5455, 5455L, 5455S, and 5455SL
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
| Submission | |
| Preparation Date: | January 31, 1996 |
| Device Information | |
| Trade Name: | Models 5471 and 5471L Sterile Disposable Patient Cable |
| Assemblies | |
| Common Name: | Patient Cable |
| Classification Name: | Patient transducer and electrode cable (including |
| connector), 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.
1
- 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.