(90 days)
No
The document describes a passive medical device (a pacing lead) and its mechanical and electrical properties, with no mention of computational processing, algorithms, or data analysis that would indicate AI/ML.
Yes
The device is a permanent pacemaker lead used to provide electrically conductive pathways between the pulse generator and the heart for pacing and sensing, which are therapeutic applications.
No.
The device is described as a "screw-in lead indicated for pacing and sensing applications." It is used to provide "channeled electrically conductive pathways between the pulse generator and the heart," which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details physical components like a helical tip electrode, conductors, insulation, and a connector, and the performance studies involve mechanical, electrical, and in-vivo testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "pacing and sensing applications in either the atrium or the ventricle" and is a "permanent pacemaker lead used to provide channeled electrically conductive pathways between the pulse generator and the heart." This describes a device that is implanted in vivo (within the body) to interact directly with the heart's electrical activity.
- Device Description: The description details a "transvenous screw-in pacing lead" with a "helical tip electrode" designed for "actively fixed in the endocardium." This further confirms its use within the body.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. The provided information does not mention any such testing or analysis of biological samples.
Therefore, the Medtronic model 5058 screw-in lead is an implantable medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.
Product codes
21 CFR Part 870 3680
Device Description
The Medtronic model 5058 transvenous screw-in pacing lead has a helical tip electrode made of platinum alloy that can be actively fixed in the endocardium. The helix can be extended or retracted by rotating the lead connector pin with a fixation tool. This lead also has a second. larger electrode proximal to the tip electrode and an IS-1 Bipolar connector with one terminal pin. It features MP35N nickel-alloy coil conductors and silicone rubber insulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrium or the ventricle
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
Not Found
Summary of Performance Studies
Mechanical, electrical and canine testing was performed to evaluate the model 5058 lead. Testing previously provided for the models 5024/5524 (P950089/S9) regarding the surface treatment of the silicone insulation and the biostability of the insulation, is considered relevant to the 5058. Additionally, testing previously provided on the lead models identified below, regarding biocompatibility, is also considered relevant to the model 5058 lead:
Lead Model Number 5023/5523, Document Control Number P850089/S6, Approval Date November 1988
Lead Model Number 5024/5524, Document Control Number P850089/S9, Approval Date December, 1989
Lead Model Number 5024M, Document Control Number P850089/S15, Approval Date December, 1990
Lead Model Number 5524M, Document Control Number P850089/S16, Approval Date December, 1991
Lead Model Number 4057/4557, Document Control Number K882452, Approval Date August, 1988
Lead Model Number 4058, Document Control Number K883743, Approval Date January, 1989
Lead Model Number 4558M, Document Control Number K940703, Approval Date November, 1994
Lead Model Number 5028, Document Control Number K933731, Approval Date March, 1994
Testing performed on the model 5058 included:
I. Environmental Conditioning
- EtO sterilization,
- Thermal shock,
II. Mechanical Testing - l. Helix electrode extension/retraction testing,
-
- Connector mating,
-
- Tip pressure testing,
-
- Leak testing,
-
- Joint and composite pull strength,
-
- Composite torsional strength,
-
- Anchoring sleeve suture test,
-
- Flex testing,
-
- Stylet insertion/withdrawal testing,
III. Electrical Testing
- Stylet insertion/withdrawal testing,
-
- Resistance,
-
- IS-1 offset block/AC impedance testing,
IV. Tip-to-ring Spacer Testing
V. In-vivo (canine) electrical performance testing
- IS-1 offset block/AC impedance testing,
All of the testing performed on the model 5058 lead, and previously submitted testing on the model 5024/5524, and the lead models identified above for biocompatibility testing, demonstrate that the model 5058 will perform to Medtronic specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
MEDIRONIC CONFIDENTIAL
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II.510(K) SUMMARY
A.General Information
Submitter's Name
Company Name and Address
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Todd A. Fonseca, RAC
Submission Date
૨/૪/૭૯
B. Device Name and Classification
| Device Generic Name | Transvenous screw-in pacing lead |
|---|---|
| Device Trade Name | Medtronic model 5058 Bipolar, Implantable, |
| Screw-In, Ventricular/Atrial, Transvenous | |
| Lead | |
| Classification Name and Number | Permanent Pacemaker Electrode |
| 21 CFR Part 870 3680 |
C.Predicate Devices
| Device | 510(k) Number / Approval Date |
|---|---|
| Medtronic model 4558M Bipolar, | |
| Implantable, Screw-In, Atrial, | |
| Transvenous Lead | K940703 / November 1994 |
| Medtronic model 4058M Bipolar, | |
| Implantable, Screw-In, | |
| Ventricular/Atrial, Transvenous Lead | K883743 / January 1989 |
1
D. Device Description
The Medtronic model 5058 transvenous screw-in pacing lead has a helical tip electrode made of platinum alloy that can be actively fixed in the endocardium. The helix can be extended or retracted by rotating the lead connector pin with a fixation tool. This lead also has a second. larger electrode proximal to the tip electrode and an IS-1 Bipolar connector with one terminal pin. It features MP35N nickel-alloy coil conductors and silicone rubber insulation.
E. Intended Use
The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.
F. Technology Comparison
The new model 5058 lead and the currently available model 4558M and 4058M leads all have extendible/retractable helix electrode lead tips. These tips act as the cathode electrodes for all three bipolar leads. The anodes for these leads consist of ring electrodes proximal to the helix. All electrodes for all leads are made of the same material, Platinum -Iridium (Pt-Ir).
The cathodes and anodes for all three leads are connected to conductor coils made of MP35N nickel-alloy. The MP35N conductor coils for the model 4558M and 4058M leads are platinum sputtered whereas the coils for the model 5058 lead are not sputtered.
The reason the model 5058 coils are not sputtered is because the inner and outer insulation material for the model 5058 lead is silicone rubber. The insulation material for the model 4558M and 4058M leads is polyurethane.
The conductor coils for all three leads terminate at the proximal end of the leads in the standard bipolar IS-1 (International Connector Standard ISO 5841-3:1992/E]) configuration. Furthermore, all three leads utilize 9 French introducers for access into the venous system.
G.Summary of Studies
Mechanical, electrical and canine testing was performed to evaluate the model 5058 lead. Testing previously provided for the models 5024/5524 (P950089/S9) regarding the surface treatment of the silicone insulation and the biostability of the insulation, is considered relevant to the 5058. Additionally, testing previously provided on the lead models identified below, regarding biocompatibility, is also considered relevant to the model 5058 lead:
2
| Lead Model
Number | Document Control
Number | Approval Date |
|----------------------|----------------------------|----------------|
| 5023/5523 | P850089/S6 | November 1988 |
| 5024/5524 | P850089/S9 | December, 1989 |
| 5024M | P850089/S15 | December, 1990 |
| 5524M | P850089/S16 | December, 1991 |
| 4057/4557 | K882452 | August, 1988 |
| 4058 | K883743 | January, 1989 |
| 4558M | K940703 | November, 1994 |
| 5028 | K933731 | March, 1994 |
Testing performed on the model 5058 included:
I. Environmental Conditioning
-
- EtO sterilization,
-
- Thermal shock,
II. Mechanical Testing
- l. Helix electrode extension/retraction testing,
-
- Connector mating,
-
- Tip pressure testing,
-
- Leak testing,
-
- Joint and composite pull strength,
-
- Composite torsional strength,
-
- Anchoring sleeve suture test,
-
- Flex testing,
-
- Stylet insertion/withdrawal testing,
III. Electrical Testing
-
- Resistance,
ે
- Resistance,
-
- IS-1 offset block/AC impedance testing,
-
IV. Tip-to-ring Spacer Testing
- V. In-vivo (canine) electrical performance testing
3
All of the testing performed on the model 5058 lead, and previously submitted testing on the model 5024/5524, and the lead models identified above for biocompatibility testing, demonstrate that the model 5058 will perform to Medtronic specifications.
H.Conclusion
The bench testing presented herein, along with the testing provided previously on the lead models identified above, provide reasonable assurance that the Medtronic model 5058 lead will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and in vivo electrical performance, the model 5058 is considered substantially equivalent to the model 4558M and model 4058M leads.