(87 days)
The Medtronic Model 9210 Delivery Catheter is intended for device passage and placement within the venous vessels and chambers of the heart.
The Medtronic Model 9210 delivery catheter is designed to provide a pathway through which Medtronic transvenous devices, such as leads or catheters, are introduced into the venous vessels and chambers of the heart.
The delivery catheter features two lumens. The large lumen is used for passing Medtronic leads or other Medtronic transvenous devices. The small lumen is designed to accept a stylet; the stylet facilitates passage and placement of the delivery catheter. The proximal opening of the small lumen features a stylet guide on the proximal end of the delivery catheter. This delivery catheter is intended for temporary use (contemplated implant duration of eight hours or less).
The catheter will be introduced into the patient via standard cut down or percutaneous technique, maneuvered through the vasculature using a stylet in the small lumen and appropriately positioned in the heart for the introduction of devices through the larger lumen.
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Device Name: Medtronic Model 9210 Delivery Catheter
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Device Description: The Medtronic Model 9210 delivery catheter is designed to provide a pathway for Medtronic transvenous devices (leads or catheters) into the venous vessels and chambers of the heart. It features two lumens: a large lumen for device passage and a small lumen for a stylet to facilitate passage and placement. It is intended for temporary use (eight hours or less).
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Predicate Device: Medtronic Vector Vector X Guide Catheter (K950179).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document details various tests performed to ensure the Model 9210 Delivery Catheter conforms to design specifications and reliability intent. However, it does not explicitly state quantitative acceptance criteria or specific numerical performance results for these tests. Instead, it states that the tests were performed "to assure" conformity. We can infer the areas of performance based on the tests conducted.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Integrity & Steerability: | |
| Ability to prevent stylet perforation | Tested ("dry stylet perforation") to assure conformity to design specification. |
| Ability to prevent stylet bottoming | Tested ("dry stylet bottoming") to assure conformity to design specification. |
| Compatibility with Medtronic leads/devices | Tested ("catheter compatibility") to assure conformity to design specification. Functionality with typical Medtronic leads was "demonstrated through bench testing." |
| Sufficient torsional strength | Tested ("composite torsional strength") to assure conformity to design specification. |
| Sufficient tensile strength | Tested ("composite tensile strength") to assure conformity to design specification. |
| Biocompatibility: | |
| Biocompatibility of tissue-contacting materials | Tested according to FDA Blue Book Memorandum #G95-1 and ISO Standard 10993-1. Materials for both the Model 9210 and predicate (GC III) were "fully tested for biocompatibility; therefore, any potential risks due to biocompatibility have been mitigated." |
| Functional Equivalence to Predicate: | |
| Overall functionality for indications for use | "The functionality of the Model 9210 catheter for use with typical Medtronic leads has been demonstrated thorough bench testing." The differences in design from the predicate "do not require comparative testing" and were determined substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the numerical sample sizes for the "bench testing" or "qualification testing" studies. It only lists the types of tests performed.
- Data Provenance: The studies were conducted by Medtronic, Inc. as part of their 510(k) submission. The data is retrospective in the sense that it pertains to laboratory testing conducted for regulatory clearance. There is no information regarding the country of origin of the data beyond Medtronic's Minneapolis, MN location. No clinical data or human subject data is mentioned for these specific tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The studies mentioned are primarily bench/laboratory tests of physical and material properties, not diagnostic or clinical performance requiring expert ground truth assessment in the typical medical imaging or diagnostic sense.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The tests are objective physical and material property tests. There is no indication of human interpretation or adjudication required for the results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not a study involving human readers or clinical cases. The comparison is made to a predicate device based on design differences and functional equivalence proved by bench testing, not a comparative effectiveness study with human readers.
6. If a Standalone (Algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical catheter, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance described relates to the physical and material properties of the catheter itself.
7. The Type of Ground Truth Used:
The ground truth for the performance evaluations appears to be based on:
- Design Specifications: The tests were performed to "assure the Model 9210 Delivery Catheter conforms to design specification and reliability intent."
- Regulatory Standards: Biocompatibility testing was conducted "according to FDA Blue Book Memorandum #G95-1, and ISO Standard 10993-1."
- Functional Equivalence: The device's functional equivalence to its predicate for its intended use was demonstrated through bench testing.
8. The Sample Size for the Training Set:
- Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The studies are for product qualification and regulatory submission.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/provided. As there is no training set for an AI algorithm, this question is not relevant to the information provided.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).