(83 days)
For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system
Two joined silicone tubing sections; flat drain section is partially perforated for fluid collection, is ribbed to prevent collapse as suction is applied, and has blue radiopaque stripe; round tubing is connected to suction reservoir inlet; offered with an introduction Trocar attached as an option; silver ion surface treated to ease insertion and removal.
This 510(k) summary describes a medical device, not an AI/ML algorithm. Therefore, many of the requested categories in your prompt are not applicable. I will address the relevant sections based on the provided text and indicate "N/A" for those that do not apply to a device submission of this nature.
Here's the analysis of the provided information:
Acceptance Criteria and Device Performance
The 510(k) summary does not explicitly list "acceptance criteria" in the format typically used for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, for device submissions, the acceptance criteria are generally met by demonstrating substantial equivalence to a predicate device through shared technological characteristics, intended use, and performance claims.
The device performance is primarily established by referencing the performance of the predicate devices. The summary states:
"Sil-Med Corporation's Flat Suction Drain/Kit with Spi-Argent™ II, (with and without Trocar) is the same drain as the Sil-Slip Flat Suction Drain/Kit (with and without Trocar), K926408. The surface treatment is the same as the surface treatment on Sil-Med Corporation's Mediastinal Silicone Drain, K942709. No further claims will be made for the Flat Suction Drain/Kit with Spi-Argent™ II than made on K942709."
This indicates that the new device is considered to perform equivalently to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: Same as K926408 (Flat Suction Drain/Kit) | The new device is the same drain as K926408. |
| Surface Treatment: Same as K942709 (Mediastinal Silicone Drain) | The new device has the same surface treatment as K942709. |
| Intended Use: For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system | The new device shares the same intended use as the predicate devices. |
| Safety and Effectiveness: No further claims beyond K942709 | The device is expected to be as safe and effective as K942709. |
Study-Specific Information (Not applicable for this type of submission)
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel study results for AI/ML performance. Therefore, the following sections are not applicable and the information is not present in the provided text.
- Sample size used for the test set and the data provenance: N/A (No test set for AI/ML performance is described).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No expert ground truth for AI/ML performance is described).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set for AI/ML performance is described).
- 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: N/A (This is a physical medical device, not an AI/ML system).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a physical medical device, not an AI/ML system).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No ground truth, in the context of AI/ML, is mentioned).
- The sample size for the training set: N/A (This is a physical medical device, not an AI/ML system).
- How the ground truth for the training set was established: N/A (This is a physical medical device, not an AI/ML system).
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.