(130 days)
The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vascular Sheath and is designed to assist in the placement and removal of catheters.
The Intravascular Access Introducer Sheath is a sterile single use Sheath intended Decerption placement and removal of vascular catheters, it is manufactured from polyurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and (penouiners) and re man pouch.
The provided text describes a 510(k) summary for the "Applied Medical Intravascular Access Introducer Sheath". Based on the information, here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit via equivalence) | Reported Device Performance |
|---|---|---|
| Bench Top Testing | Comparison to predicate device to ensure safety and effectiveness. | "Bench top testing was conducted and comparisons were made to the predicated device." This implies the device performed comparably to the predicate for all tested parameters. Specific performance metrics are not detailed but the conclusion is that the new device did not introduce new safety and effectiveness issues. |
| Biocompatibility | Compliance with ISO 10993-1 requirements for materials used. | "The material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements." |
| Design Control/Risk Analysis/Design Verification | Adherence to 21 CFR § 820.30, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971. Risk factors identified and addressed. Validation and verification activities completed using established methods, tests, and acceptance criteria. | "Design control, risk analysis and design verification... have been conducted in accordance with all applicable internal Applied Medical Procedures." "The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30." "The risk analysis preformed identified the risks relative to the performance requirements..." "validation and verification activities addressed the profile." "Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied." |
| Technological Characteristics | The "Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues." | The device was found to be "substantially equivalent" to the predicate devices (Applied Medical Catheter Introducer Sheath K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set) for the stated indications for use, meaning its performance, safety, and effectiveness are considered to be on par with these existing devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the traditional sense for evaluating AI performance. Instead, it relies on bench testing and comparison to a predicate device. Therefore, no information on sample size for a test set or data provenance (country, retrospective/prospective) is applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device (introducer sheath), not an AI/software device requiring expert-established ground truth from images or other data. The "ground truth" for this submission is implicitly established by the performance and safety profiles of the predicate devices and the results of the described bench testing and design controls.
4. Adjudication Method for the Test Set
Not applicable, as a test set for a comparative study involving expert adjudication is not mentioned.
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 submission is for a physical medical device and does not involve AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is established through:
- Performance of predicate devices: The historical safety and effectiveness of the legally marketed predicate devices (Applied Medical Catheter Introducer Sheath K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set).
- Bench testing: The objective measurements and comparisons performed in a laboratory setting to ensure the device meets specified engineering and functional requirements.
- Biocompatibility testing: Standardized laboratory tests to ensure material safety.
- Compliance with regulatory standards: Adherence to established quality system regulations (e.g., 21 CFR § 820.30, ISO standards).
8. The sample size for the training set
Not applicable. This submission is for a physical medical device and does not involve a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI model or training set involved.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).