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The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

The Daig Ultra-Flex Hemostasis Introducer is an Introducer designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Ultra-Flex Hemostasis Introducer), focusing on its substantial equivalence to a predicate device and its intended use. It does not include details on performance testing, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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The Daig SpyglassTM angiographic catheters are designed for delivery of radiopaque contrast media during angiographic procedures.

The 5Fr Spyglass™ Angiographic Catheter is designed for delivery of radiopaque contrast media during angiographic procedures.

Daig SpyglassTM angiographic catheters are radiopaque polymer reinforced with braided stainless steel. This construction yields a small diameter catheter, which retains strength and high flow rate capabilities. A soft atraumatic tip provides good memory and protects against vessel damage. Preformed tip shapes matching or complementing specific anatomy allow access into a variety of vessels.

The provided text is a 510(k) summary for a medical device called the SpyglassTM 5Fr Angiographic Catheter. It outlines similarities to predicate devices to establish substantial equivalence for regulatory approval. However, it does not contain any information regarding acceptance criteria, study performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Manufacturers are required to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or that if there are differences, these differences do not raise new questions of safety or effectiveness.

Therefore, based on the provided document, I cannot complete the table or answer most of the questions as the specific details of a performance study are not present.

Here's what can be inferred from the document regarding the "study" for acceptance, which in this context is a comparison to a predicate device:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not applicable. This submission relies on a comparison of characteristics to a predicate device, not a new clinical performance study with a test set of patients/data.
• Data Provenance: Not applicable for a typical "test set." The basis of comparison is the existing predicate device's characteristics and historical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth here is derived from the established safety and effectiveness of the predicate device, not through expert consensus on a new test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable.

5. 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:

• No. This is a medical catheter, not an AI diagnostic device. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a physical medical device.

7. The type of ground truth used:

• Predicate Device Equivalence: The "ground truth" for this 510(k) submission is the pre-existing FDA clearance and established safety/effectiveness profile of the predicate Spyglass™ Angiographic Catheter family (K944284, K962805, and K965249). The new device is deemed safe and effective because it is substantially equivalent to these already approved devices.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable.

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The Fast-Cath™ Intra-Cardiac Introducer is intended for use when introducing various cardiovascular catheters or biopsy devices into the heart.

The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction/exchange. A sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc.

Based on the provided 510(k) summary, there is no detailed study described that establishes specific acceptance criteria and demonstrates the device's performance against those criteria in a quantitative manner. This 510(k) relies on substantial equivalence to a predicate device rather than presenting new performance data from an independent study.

Here's a breakdown of why many of the requested points cannot be answered from the provided text:

• No specific acceptance criteria are stated. The submission focuses on asserting that "All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the contraindications and instructions for use)." This implies the acceptance criteria are met by virtue of being identical to a device already deemed safe and effective.
• No detailed study is mentioned. The submission references "clinical literature" and the successful use of "similar commercially available catheter introducers" and the predicate device (Daig's Fast-Cath™ Transseptal Catheter Introducers) as evidence of safety and effectiveness, but it does not describe a specific study conducted for this particular 510(k) submission with a test set, ground truth, or expert review.

However, based on the information provided, we can infer some aspects and explicitly state what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. No dedicated test set described.
• Data Provenance: Not applicable. The "support" is based on existing clinical literature and historical use of predicate and similar devices, not a new dataset created for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth for a test set was established as part of this submission. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own historical use and regulatory pathway, which is not detailed here.

4. Adjudication method for the test set

• Not applicable. No test set was described.

5. 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

• No. This device is a medical introducer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This device is a medical introducer, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For this 510(k), the "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate device and the broader category of similar introducer devices as evidenced by "clinical literature" and successful market use. There is no new, explicitly defined ground truth established for this specific submission's performance claims.

8. The sample size for the training set

• Not applicable. No "training set" in the context of an algorithm or AI is described.

9. How the ground truth for the training set was established

• Not applicable. No "training set" or explicit ground truth for such a set is described.

In summary, this 510(k) submission primarily relies on the argument of substantial equivalence to an already legally marketed device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data. The support for substantial equivalence comes from:

• Identical technological characteristics to the predicate device.
• The general understanding and "clinical literature" demonstrating the safety and utility of similar introducer devices for cardiac procedures.
• The successful historical use of the predicate device (Fast-Cath™ Intra-Cardiac Catheter Introducer) and similar devices (Daig's Fast-Cath™ Transseptal Catheter Introducers).

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The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.

The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.

The provided text is a 510(k) summary for the Fast-Cath™ Intra-Cardiac Introducer. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies showcasing acceptance criteria. As such, the document does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for novel therapeutic or diagnostic devices.

The document states that the new indication for use is supported by demonstrating that "All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the new indications)." and by referencing "Clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy may reduce the complications associated with this procedure." and "Similar commercially available catheter introducers have been successfully used for introducing various cardiovascular catheters and biopsy devices into the heart."

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this 510(k) summary.

However, I can provide what is available based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria or report device performance data. The basis of the submission is substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new performance study with a test set is described in this 510(k) summary. The submission relies on the substantial equivalence to a predicate device and existing clinical literature concerning introducers in general.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

5. 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 (catheter introducer), not an AI/software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (catheter introducer), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no new performance study described in this 510(k) summary to generate ground truth. The basis for safety and effectiveness is substantial equivalence to an existing predicate device and general clinical literature.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not a machine learning model.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device