(110 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Identical intended use to predicate device | Met: "The Daig SpyglassTM angiographic catheters are designed for delivery of radiopaque contrast media during angiographic procedures." (Matches predicate's likely use) |
| Identical technological characteristics to predicate device | Met: "All technological characteristics of the Spyglass™ 5Fr Angiographic Catheter are identical to the predicate device (K962805) including product design, packaging, sterilization, and labeling." |
| No new questions of safety or effectiveness raised by differences | Met: The FDA's letter of clearance (K982299) indicates substantial equivalence, implying no new safety/effectiveness concerns were identified. |
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.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).