(82 days)
The intended use of the SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.
The SCOUT Accessories for Implanting in the Coronary Sinus are for introducing legally marketed leads into the vessels of the left heart via the coronary sinus. The following SCOUT Accessories for Implanting in the Coronary Sinus are the subject of this 510(k):
- 1 Hemostatic Valve .
- 2 Guiding Catheters Peel-Away (Long Sheaths) ●
- 1 Dilator (for Long Sheath) ●
- 1 Introducer Peel-Away 11F .
- . 1 - Guidewire
- 1 Cannula .
- . 1 - Syringe Body
- 1 Peel Tool ●
Here's an analysis of the provided text regarding theacceptance criteria and substantiating study for the BIOTRONIK SCOUT Accessories:
The provided documents (K020821) describe a 510(k) submission for the BIOTRONIK SCOUT Accessories for Implanting in the Coronary Sinus. This submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way one might expect for a novel or high-risk device.
Therefore, the information you've requested regarding acceptance criteria and a detailed study proving the device meets those criteria is largely absent from these documents because the regulatory pathway chosen (510(k)) relies on demonstrating equivalence rather than comprehensive standalone performance testing against pre-defined quantitative criteria.
However, I can extract the relevant information and fill in the blanks where the document explicitly states the approach.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The SCOUT Accessories must be functionally equivalent to legally marketed delivery systems for introducing leads into the left heart via the coronary sinus. This implies demonstrating similar performance characteristics (e.g., ability to introduce leads, material compatibility, safety profile) without necessarily quantifying specific metrics beyond those of the predicate. | The SCOUT Accessories for Implanting in the Coronary Sinus are stated to be "functionally equivalent to market-released delivery systems." Specifically, "the materials used and design are similar to Medtronic's LDS 6216 Left-Heart Delivery System (K012130, cleared 08-28-01)." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. In a 510(k) submission based on substantial equivalence, the "test set" is often implicit in the comparison to the predicate device's design and materials, rather than a dedicated clinical trial or large-scale performance study. If any testing was done beyond comparison, the specific "sample size" for such tests is not detailed here.
- Data Provenance: Not explicitly stated as "retrospective" or "prospective" clinical data. The primary "data" for substantial equivalence is the comparison to the predicate device's design, materials, and intended use, which are established and legally marketed. Compliance with manufacturing (Quality Systems Regulation) is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The regulatory approach here does not involve establishing "ground truth" for a test set in the sense of clinical annotations or diagnostic accuracy, but rather validating design and functional similarity to a predicate device. The experts involved would likely be internal engineers and regulatory affairs personnel from BIOTRONIK, and later, FDA reviewers.
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Adjudication method for the test set:
- Not Applicable. As no specific "test set" in the context of clinical evaluation or diagnostic performance is described, no adjudication method would be reported.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a medical device for lead delivery, not an AI/diagnostic imaging device. Therefore, MRMC studies and AI-assisted improvements are not relevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device for lead delivery, not an algorithm.
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The type of ground truth used:
- The "ground truth" in this context is the safety and effectiveness of the predicate device (Medtronic's LDS 6216 Left-Heart Delivery System, K012130) as having been legally marketed and cleared by the FDA. The SCOUT Accessories aim to demonstrate equivalence to this established "truth." The "evidence" typically involves bench testing, material comparisons, and adherence to relevant standards to show the new device performs as intended and is as safe and effective as the predicate.
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The sample size for the training set:
- Not Applicable. This is a hardware medical device; no "training set" in the machine learning sense is relevant.
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How the ground truth for the training set was established:
- Not Applicable. (See point 7).
Summary of the Regulatory Approach:
The provided documents clearly indicate a 510(k) pathway for the SCOUT Accessories. This means the primary "study" performed is an extensive comparison to a predicate device (Medtronic's LDS 6216 Left-Heart Delivery System). The "acceptance criteria" revolve around demonstrating that the new device shares similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness when compared to the predicate. This typically involves:
- Comparison of Intended Use: Identical or very similar uses.
- Comparison of Technological Characteristics: Similar materials, design, operating principles.
- Performance Data: Often bench testing, material testing, and biocompatibility, but not necessarily de novo clinical trials with large patient cohorts and complex statistical analyses, unless a significant difference from the predicate is identified.
The absence of detailed clinical study data with specific patient sample sizes, expert panels, and statistical endpoints is typical for a 510(k) submission where substantial equivalence is the goal. The FDA's clearance (JUN 03 2002) signifies that the agency accepted this comparison and deemed the device substantially equivalent to the predicate.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.