(87 days)
The Model 6992A coronary sinus lead and its predecessors.
No
The summary describes a passive pacing lead and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
Yes
The device is intended for "atrial pacing," which is a therapeutic intervention to regulate heart rhythm.
No
Explanation: The device is described as a "coronary sinus lead" designed for "atrial pacing and sensing." Pacing and sensing are functions of therapeutic or interventional devices, not diagnostic ones. Its purpose is to deliver electrical impulses (pacing) and detect electrical activity (sensing) for treatment in permanent atrial or dual-chamber pacing systems.
No
The device description clearly states it is a "bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "atrial pacing and sensing in the coronary sinus" and for "permanent atrial or dual-chamber pacing systems." This describes a device that is implanted within the body to interact directly with the heart's electrical system.
- Device Description: The description details a "bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode." This is a physical component designed for insertion into the body.
- Anatomical Site: The specified anatomical site is the "coronary sinus," which is a blood vessel in the heart.
- Performance Studies: The performance studies described are "In Vitro/Bench Testing," "In Vivo Canine Testing," "Package Qualification Testing," and "Biocompatibility Testing." These types of studies are typical for implantable medical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body to diagnose a condition. The device's function is to directly interact with the patient's physiology.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Model 2188 coronary sinus lead is a bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode which is canted toward the lead body. The distal portion of the lead is pre-shaped at a 45° angle. The conductor coils utilize a platinum sputtered MP35N nickel-alloy material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies were performed to ensure that the Model 2188 lead meets all of its design and performance requirements. In addition, the suitability of the new leads package was evaluated.
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In Vitro/Bench Testing: To evaluate the Model 2188 coronary sinus lead, the following in vitro testing was performed:
- A. Environmental Conditioning
- B. Mechanical Testing
- C. Electrical Testing
The Model 2188 pacing lead passed all of the in vitro bench test requirements.
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In Vivo Canine Testing: The data generated as a result of this testing demonstrated that the pacing and sensing thresholds produced by the Model 2188 coronary sinus lead is substantially equivalent to the Model 6992A coronary sinus lead.
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Package Qualification Testing: A new package was designed for this lead. Package qualification testing was performed as follows:
- A. Ethylene Oxide (EtO) Sterilization Conditioning/Testing (Environmental Conditioning)
- B. Visual Inspection Testing
- C. Packaging Conditioning/Testing
- D. Lead Mechanical Testing
- E. Lead Electrical Testing
- F. Shelf Life Testing
The testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.
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Biocompatibility Testing:
- a) Lead Biocompatibility: Biocompatibility information for the materials used in the Model 2188 coronary sinus lead is presented. The materials were approved for use with Medtronic CapSure SP Model 4524 (Document Control Number P830061/S12).
- b) Package Biocompatibility: The use of uncoated PETG was approved for use with Medtronic pulse generators in PMA Supplements P850051/S44, P850051/S49 and P890003/S30. Biocompatibility information for the silicone-coated PETG used with the new package was performed and proved to be biocompatible.
- C) Sterilization Validation: All Medtronic leads are sterilized using a 100% Ethylene Oxide (EtO) sterilization process. A process appropriate for sterilizing the Model 2188 coronary sinus lead was validated.
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Conclusion: The testing described above provides reasonable assurance that the Medtronic Model 2188 coronary sinus lead will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and canine in vivo electrical performance, Medtronic considers the Model 2188 coronary sinus lead to be substantially equivalent to the Model 6992A coronary sinus lead and other Medtronic pacing leads found to be substantially equivalent to preregulation leads. In addition, the new package met all qualification requirements. As such, the testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Model 6992A coronary sinus lead and its predecessors.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
P830061/S12, K896313, K780621, K772104
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the words "MEDTRONIC CONFIDENTIAL" in bold, black, sans-serif font. Below that is a handwritten number, "K961936", in black ink. The number is written in a cursive style, with the letters and numbers connected.
510(k) Summary 2)
a) Submitter
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Contact: Nora K. Hadding, Product Regulation Associate Telephone: (612) 574-4189 Fax: (612) 574-6424
Name of Device b)
Trade Name: Model 2188 Coronary Sinus Lead
Common Name: Pacing Lead
Classification Name: Cardiovascular permanent or temporary pacemaker electrode (21 CFR 870.3680)
Predicate Device C)
The Model 2188 lead is substantially equivalent to the Model 6992A coronary sinus lead and its predecessors. The Model 6992A coronary sinus lead has been in commercial distribution since at least 1974. Since the Model 6992A was in existence prior to medical device regulations, no FDA document control number can be referenced. In addition, the Model 2188 relies on technology used with Medtronic Models 4524, 4582, 6990, and 6991A (Document Control Numbers P830061/S12, K896313, K780621 and K772104, respectively).
Device Description d)
The Model 2188 coronary sinus lead is a bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode which is canted toward the lead body. The distal portion of the lead is pre-shaped at a 45° angle. The conductor coils utilize a platinum sputtered MP35N nickel-alloy material.
Intended Use e)
The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.
1
Technological Characteristics f)
1. Lead Characteristics
The Medtronic Model 2188 coronary sinus lead is a bipolar coaxial polyurethane pacing lead with a canted porous electrode tip (5.8 mm²) and an IS-1 connector. The distal portion of the lead is pre-shaped at a 45° angle. The Model 2188 coronary sinus lead is designed for atrial pacing and sensing applications in the coronary sinus. The lead has application where implantable atrial or coronary sinus single- or dual-chamber pacing systems are indicated.
The lead has a porous tip electrode made of platinum alloy that can be positioned in the coronary sinus. In addition, the tip is canted toward the lead body at the end to facilitate contact with the coronary sinus wall.
The lead also has a ring electrode proximal to the tip electrode and an IS-1 bipolar (BI) connector. It features platinum sputtered MP35N nickel-alloy conductor coils and polyurethane 55D insulation. The lead will be packaged in a new packaging configuration but with the same accessories as the Model 6992A pacing lead.
The following section describes in detail the physical characteristics of the Model 2188 in comparison with existing Medtronic leads.
Medtronic Model 4582 Target Tip Pacing Lead (Document Control Number a) K896313)
The Model 2188 utilizes a bipolar coaxial design with an IS-1 connector. The conductor coil is platinum sputtered MP35N nickel alloy. The Medtronic Model 4582 pacing lead features a similar coaxial design with an IS-1 connector and MP35N nickel alloy conductor coils.
b) Medtronic Model 4524 CapSure SP Pacing Lead (Document Control Number P890061/S12)
The Model 2188 pacing lead utilizes 55D polyurethane insulation. The canted electrode is platinum material and has a porous surface electroplated with platinum black. The Model 4524 CapSure SP lead utilizes the same 55D polyurethane insulation and tip electrode technology. However, the Model 2188 does not contain steroid in the tip electrode and it is canted toward the lead body. The Model 2188 and Model 4524 also share an identical IS-1 connector.
Medtronic Models 6990 and 6991A Pacing Leads (Document Control c) Numbers K780621 and K772104)
The Model 2188 coronary sinus lead utilizes an electrode tip which is canted toward the lead body to better facilitate contact with the coronary sinus vein. Models 6990 and 6991A also utilized a canted tip electrode
2
Package Characteristics 2.
The Model 2188 coronary sinus lead will be provided in a package which uses an uncoated and silicone-coated polyethylene terephthalate, glycol modified (PETG) material. This package was successfully qualified for use with the Model 2188 lead.
Summary of Studies g)
The following studies were performed to ensure that the Model 2188 lead meets all of its design and performance requirements. In addition, the suitability of the new leads package was evaluated.
In Vitro/Bench Testing 1.
To evaluate the Model 2188 coronary sinus lead, the following in vitro testing was performed:
- A. Environmental Conditioning
- Mechanical Testing B.
- C. Electrical Testing
The Model 2188 pacing lead passed all of the in vitro bench test requirements.
2. In Vivo Canine Testing
The data generated as a result of this testing demonstrated that the pacing and sensing thresholds produced by the Model 2188 coronary sinus lead is substantially equivalent to the Model 6992A coronary sinus lead.
3. Package Qualification Testing
A new package was designed for this lead. Package qualification testing was performed as follows:
- Ethylene Oxide (EtO) Sterilization Conditioning/Testing (Environmental A. Conditioning)
- Visual Inspection Testing B.
- ﺯ Packaging Conditioning/Testing
- Lead Mechanical Testing D.
- Lead Electrical Testing E.
- Shelf Life Testing F.
ー
The testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.
3
4. Biocompatibility Testing
Lead Biocompatibility a)
Biocompatibility information for the materials used in the Model 2188 coronary sinus lead is presented. The materials were approved for use with Medtronic CapSure SP Model 4524 (Document Control Number P830061/S12).
Package Biocompatibility b)
The use of uncoated PETG was approved for use with Medtronic pulse generators in PMA Supplements P850051/S44, P850051/S49 and P890003/S30. Biocompatibility information for the silicone-coated PETG used with the new package was performed and proved to be biocompatible.
Sterilization Validation C)
All Medtronic leads are sterilized using a 100% Ethylene Oxide (EtO) sterilization process. A process appropriate for sterilizing the Model 2188 coronary sinus lead was validated.
ડ. Conclusion
The testing described above provides reasonable assurance that the Medtronic Model 2188 coronary sinus lead will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and canine in vivo electrical performance, Medtronic considers the Model 2188 coronary sinus lead to be substantially equivalent to the Model 6992A coronary sinus lead and other Medtronic pacing leads found to be substantially equivalent to preregulation leads.
In addition, the new package met all qualification requirements. As such, the testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.