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510(k) Data Aggregation
(264 days)
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set is intended to be used with vacuum blood collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube. The patient-end needle is punctured into vein, and non-patient end needle will penetrate into vacuum blood collection tube, blood will flow into blood collection tube under the action of differential pressure. The proposed devices are divided into several types and available in different specifications.
The provided document is a 510(k) Pre-market Notification from the FDA for blood collection needles and sets. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, but it does not contain information about studies involving human or expert evaluation of AI/algorithm performance, which is what your request is focused on. Therefore, I cannot provide details on the requested criteria related to AI/algorithm acceptance criteria, ground truth, expert involvement, or MRMC studies.
However, I can extract the acceptance criteria and performance related to the non-clinical tests performed on the physical device.
Here's the relevant information based on the non-clinical tests described in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Clause) | Device Performance |
|---|---|
| Physical, Mechanical, Chemical Testing (ISO 7864:2016) | |
| Cleanliness (Clause 4.3) | Met design specifications |
| Limits for acidity or alkalinity (Clause 4.4) | Met design specifications |
| Limits for extractable metals (Clause 4.5) | Met design specifications |
| Size designation (Clause 4.6) | Met design specifications |
| Colour coding (Clause 4.7) | Met design specifications |
| Needle hub (Clause 4.8) | Met design specifications |
| Needle Cap (Clause 4.9) | Met design specifications |
| Needle tube (Clause 4.10) | Met design specifications |
| Needle point (Clause 4.11) | Met design specifications |
| Bond between hub and needle tube (Clause 4.12) | Met design specifications |
| Patency of lumen (Clause 4.13) | Met design specifications |
| Physical, Mechanical, Chemical Testing (ISO 9626:2016) | |
| Surface finish (Clause 5.2) | Met design specifications |
| Cleanliness (Clause 5.3) | Met design specifications |
| Limits for acidity and alkalinity (Clause 5.4) | Met design specifications |
| Size designation (Clause 5.5) | Met design specifications |
| Dimensions (Clause 5.6) | Met design specifications |
| Stiffness (Clause 5.8) | Met design specifications |
| Resistance to breakage (Clause 5.9) | Met design specifications |
| Resistance to corrosion (Clause 5.10) | Met design specifications |
| Sterile Barrier Packaging Testing | |
| Seal strength (ASTM F88/F88-15) | Met design specifications |
| Dye penetration (ASTM F1929-15) | Met design specifications |
| Sterilization and Shelf Life Testing | |
| EO residue (ISO 10993-7:2008) | Met design specifications |
| ECH residue (ISO 10993-7:2008) | Met design specifications |
| Bacteria Endotoxin Limit (USP 38-NF 33 <85>) | Met design specifications |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples) | Verified claimed shelf life |
| Biocompatibility Testing | |
| In vitro cytotoxicity (ISO 10993-5) | Met design specifications |
| Skin sensitization (ISO 10993-10) | Met design specifications |
| Irritation sensitivity (ISO 10993-10) | Met design specifications |
| Acute Toxicity Test (ISO 10993-11) | Met design specifications |
| Pyrogen test (ISO 10993-11) | Met design specifications |
| Hemolysis Test (ASTM F756-17) | Met design specifications |
| Simulated Clinical Study (FDA Guidance, 2005) | |
| Safety mechanism evaluation | Met pre-established criteria |
| Safety Feature Test | |
| Comparison to predicate devices | Did not show a significant difference from 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)
The document does not specify the sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests. It only states that tests were "performed on the proposed device" and "on aging samples."
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 document describes non-clinical testing of a physical medical device (blood collection needles/sets), not an AI/algorithm. No experts were mentioned for establishing ground truth for a test set in the context of AI evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document is not about AI/algorithm evaluation.
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 document is not about AI/algorithm performance or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" refers to the established standards and specifications outlined in the referenced ISO, ASTM, and USP documents, as well as the company's own design specifications. For the simulated clinical study, "pre-established criteria" defined the success of the safety mechanism.
8. The sample size for the training set
Not applicable. This document is not about an AI/algorithm and therefore has no "training set."
9. How the ground truth for the training set was established
Not applicable. This document is not about an AI/algorithm and therefore has no "training set."
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