(56 days)
The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) is an extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45 100cm) product family (K120120 and K083214) and is available in both a 12Fr and 14Fr sheath size.
The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths with the exception of having a shorter 80 cm length and the tip taper length of the 12Fr (80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm) dilator.
The 80 cm length is consistent with several TorqVue Delivery System products including the TorqVue™ Delivery system (ITV) cleared under submission K072313 and the TorqVue™ (TVLA) delivery sheaths cleared under submission K120120.
Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flush adapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies the following essential components:
Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip.
Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy.
Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.
The document provided is a 510(k) summary for a medical device (AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath). However, it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device. This document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for new medical devices in the US, rather than proving performance against specific acceptance criteria through a clinical or performance study with a test set, ground truth, and expert interpretations.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document as it pertains to a different type of regulatory submission.
Here's what can be gathered, largely in the context of a substantial equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or report specific performance metrics in the way an AI/ML device study would (e.g., sensitivity, specificity, accuracy). The "performance" demonstrated here is primarily through a comparison to a predicate device and functional/safety testing, asserting that the new device performs equivalently and safely.
| Acceptance Criteria (Implied based on Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use Equivalence: Device provides a pathway through which devices are introduced within the chambers of the heart, similar to predicates. | The AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart, identical to predicate devices. |
| Technological Characteristics Equivalence: Similar design, materials, and manufacturing processes to predicates. | "The AMPLATZER™ TorqVue™ 45°x45° 80cm subject device...shares the same design (with the exception of being 80cm length versus 100cm), materials, accessories, and manufacturing processes as the predicate." |
| Functional & Safety Equivalence: Performs safely and effectively, with previous design verification and validation testing supporting equivalence. | "The intended use, components, materials and fundamental design of the TV45x45 80 cm are identical to the cleared predicate TV45x45 (100cm) device...Design Verification and Design Validation testing have been previously performed and provided in cleared applications for the predicate device." |
| Minor Design Changes (Length, Dilator Tip): The changes in length and dilator tip taper are considered not to raise new questions of safety or effectiveness. | The device is 80 cm (vs. 100 cm) and the 12 Fr dilator has an extended tip taper length modeled on the 14 Fr predicate dilator. This change is explicitly mentioned and considered acceptable. |
2. Sample size used for the test set and the data provenance
Not applicable. This document does not describe a test set or data provenance in the context of evaluating an AI/ML algorithm. The equivalence is established through engineering and design comparisons, and prior testing of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is a traditional medical device submission, not an AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there isn't a test set requiring expert consensus.
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 not an AI/ML device, so no MRMC study or AI assistance evaluation was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document relies on regulatory standards, engineering principles, and prior verification/validation for predicate devices, rather than a "ground truth" in a clinical study sense for a novel diagnostic or AI device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).