(17 days)
FOR 7th Collections AND Ax بي جي جي هم INDICATED OF White -17-11-17 Blours SPECIMIANS Priva 70 FURTHER TESTING
The One Stick™ Volumeters™ and Y-Set families are indicated for the collection and handling of blood specimens prior to further testing.
One Stick" Volumeters™ and Y-Set family of sets are supplied as sterile devices, and are intended for single patient use only. They are available in 3cc and 5cc sizes and are manufactured per cGMP Standards. The Y sets are comprised of standard components currently on the market. The Y sets are currently covered by 510(k) K051499. The barrel of the Volumeter™ is currently marketed by Becton Dickinson in their 3ml syringe. The Vent cap is molded with Class VI polypropylene, silicone O-ring and a Gore expanded PTFE supported membrane.
The One Stick™ Device is a blood collection assistance device for drawing samples from patients with suboptimal blood flow for standard procedures (Elderly and pediatric patients, those patients that may experience blood vessel collapse or excessive hemolysis when conventional Vacutainers are used directly). The device consists of a male luer fitting for attaching to a venipuncture, a section of tubing connecting the luer to a Y-Connector with a Roberts clamp for interrupting flow, two additional sections of tubing attached to needless access devices. This Y device is then attached to a vented volume collection tube.
The provided text is a 510(k) summary for the "One Stick™ Y Extension Set and Volumeter™". It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria, the specific study design to prove acceptance criteria were met, sample sizes, expert involvement, or AI-related aspects.
The document focuses on establishing substantial equivalence based on descriptive and technological characteristics, and mentions general "performance characteristics" and "laboratory testing and biocompatibility information" without providing specifics.
Therefore, I will extract the information that is present and clearly state when the requested information is not available in the provided text.
Acceptance Criteria and Device Performance Study
The provided 510(k) summary does not explicitly define specific acceptance criteria or present a table comparing them to reported device performance. Instead, it relies on the concept of substantial equivalence to a predicate device. The general statement about performance is: "The results of these test show that when the devices are built to specifications they all function as expected. Detailed results can be found in engineering reports dated July 13th and August 17th 2005."
This indicates that internal testing was conducted to ensure the device met its design specifications and functioned as intended. The "acceptance criteria" can be inferred to be related to functioning as expected according to these specifications, which would align with the performance of the predicate device (Medegen Medical Manufacturing Services 510(k) K051499).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "functions as expected" and predicate equivalence) | Reported Device Performance (as stated in the summary) |
|---|---|
| Device built to specifications functions as expected | "when the devices are built to specifications they all function as expected." |
| Biological compatibility (biocompatibility information mentioned) | Biocompatibility information presented. |
| Meets minimum requirements for intended use | The information presented provides assurance that the One Stick Blood collection assistance device will meet the minimum requirements that are considered acceptable for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The document refers to "engineering reports dated July 13th and August 17th 2005" for detailed results, which would likely contain this information.
- Data Provenance: Not explicitly stated. Given it's an in-house engineering report, it's likely internal (possibly laboratory or bench testing) data. It is not indicated whether it is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This information is typically relevant for studies involving subjective assessments (e.g., image interpretation). This document describes performance testing of a physical medical device.
4. Adjudication method for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies with multiple expert readers/assessors. This document describes performance testing of a physical medical device.
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 document describes a physical medical device (blood collection assistance device) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document describes a physical medical device and not an algorithm.
7. The type of ground truth used
- For this type of device, the "ground truth" would be established by engineering specifications and functional requirements (e.g., flow rates, sterility, material properties, structural integrity, absence of hemolysis or clotting under specific conditions) rather than expert consensus, pathology, or outcomes data in the typical sense. The testing would verify that the device meets these pre-defined specifications.
8. The sample size for the training set
- Not applicable/Not specified. This device is not an AI/machine learning model, so there is no "training set" in that context. If referring to manufacturing process validation or component testing, the sample sizes would be detailed in the referenced engineering reports, but are not provided here.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.