(91 days)
The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
The VASOSHIELD Pressure Controlling Syringe is identical to the InPress Syringe in design, materials, principles of operation, and manufacturing process. The syringe is comprised of 10 biocompatible components including a syringe, a syringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, black acetal pusher, a white acetal knob and body. The syringe has three predetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg. The syringe is a single use device, supplied sterile.
The provided 510(k) summary for the VASOSHIELD Pressure Controlling Syringe (K082725) states that performance data was reviewed and demonstrated that the device "meets the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the document does not provide explicit details on the specific acceptance criteria or the study that generated the performance data.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what information can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document only broadly states "meets the established acceptance criteria." | "performs in a manner equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
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. This device is a medical instrument (syringe), not an AI/diagnostic software that requires expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical instrument, not an AI/diagnostic software.
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 instrument, not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument, not an AI/diagnostic software. The performance data would likely relate to the mechanical and functional properties of the syringe (e.g., pressure control accuracy, sterility, material biocompatibility, and durability).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. For a device like this, ground truth would typically refer to established engineering specifications, industry standards, or performance benchmarks related to pressure accuracy, material strength, sterility, etc. The document mentions "equivalent to the predicate devices," suggesting the predicate devices' established performance serves as a benchmark.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI algorithm.
§ 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.