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510(k) Data Aggregation
(169 days)
Bevel Up Holder
The Bevel Up Holder is used for the collection of blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. The device is to be used by trained healthcare professional only.
The Bevel Up Holder device is a single use and non-invasive device to be used in venipuncture procedures for the collection of blood specimens. It is to be used as a Tube Holder with blood collection tubes such as the Becton Dickinson Vacutainer® blood collection tube. The Bevel Up Holder device is also used with blood collection needles and blood collection sets such as the Becton Dickinson Eclipse Needle set, Becton Dickinson Vacutainer Multi Sample and Becton Dickinson Safety Lok Blood Collection Set for the collection of blood specimen into the blood collection tubes. The Bevel Up Holder is to be used by trained healthcare professional only and is intended for prescription use.
The Bevel Up Holder has a clear plastic holder body with an opening on one end for the insertion of blood collection tube and an interface device connecting feature on the other end for venous access device for connecting to blood collection needle and blood collection set.
The connecting end of the venous access device of the Bevel Up Holder (BUH) device allows the adjusting of the position of the venous access device with rotating it.
The provided document, a 510(k) premarket notification for the "Bevel Up Holder," details various tests and their outcomes. However, it does not delineate specific numerical acceptance criteria for each test nor present the reported performance values in a direct comparative table as requested. Instead, it generally states that the device "met the acceptance criteria" or "shows no permanent change."
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (not explicitly quantified in the document) | Reported Device Performance |
|---|---|---|
| Simulated Blood Collection | Proper fit, no leakage, and proper function when used for blood collection. | "All Bevel Up Holders met the acceptance criteria for fit, leakage and function when used for blood collection." |
| ASTM D4169-16 (Performance Testing of Shipping Containers and Systems) | Implied to withstand shipping conditions without degradation. | "The device meets the functional and performance requirements, underwent testing in accordance with..." |
| ISO 14971:2007 (Application of Risk Management to Medical Devices) | Implied to have acceptable risk levels. | "The device meets the functional and performance requirements, underwent testing in accordance with..." |
| ASTM F88/F883-15 (Seal Strength of Flexible Barrier Materials) | Implied to have adequate seal strength. | "The device meets the functional and performance requirements, underwent testing in accordance with..." |
| Deformation Test | No permanent change in outer diameter after applying 5 kg force for 5 minutes. | "Result of the test shows no permanent change in the outer diameter of the Bevel Up Holder (BUH)." |
| Insertion and Evacuation Force Test | Meeting defined acceptance criteria for the force required to insert/evacuate a blood collection tube. | "Result shows the device meeting the defined acceptance criteria in the insertion and evacuation of the blood collection tube into the Bevel Up Holder (BUH) for blood collection operation." |
| Connectivity Test | No leakage with good fit and function when connected to specified interface devices during simulated blood collection. | "Result shows no leakage with good fit and function for the connectivity of the Bevel Up Holder (BUH) to the interface devices." |
| Shelf Life (Accelerated Aging Test per ASTM F1980-2007) | Device still functioning well after simulating the defined years of shelf life (3 years). | "Result shows that the Bevel Up Holder (BUH) meeting the defined shelf life with device still functioning well." |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation Reactivity) | Meet biocompatibility requirements. | "The Bevel Up Holder (BUH) is deemed to have met the biocompatibility requirements for Cytotoxicity, Sensitization and Irritation Reactivity." |
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 the simulated blood collection test, 20 sets of the subject device (Bevel Up Holder) and interface device were used. For the deformation test, the sample size is not explicitly stated but implies testing of "the device." The same applies to the insertion and evacuation force test, connectivity test, and shelf life test. Biocompatibility was leveraged from another device.
- Data Provenance: The document does not specify the country of origin where the tests were conducted or if the data was retrospective or prospective. Given the applicant is from Singapore, it's plausible the testing occurred there, but this is not confirmed.
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)
This is not applicable as the device is a blood specimen collection tube holder, not an AI or diagnostic device that requires expert ground truth establishment in the traditional medical imaging sense. The testing focuses on physical and functional performance, not diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. No diagnostic interpretations or clinical assessments requiring adjudication were performed.
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
This is not applicable. The device is a physical medical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm. Performance tests evaluate the device's physical and functional properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically used for AI or diagnostic devices does not directly apply to this product. The "truth" for this device's performance is established by:
- Physical measurements (e.g., outer diameter in the deformation test, force in insertion/evacuation test).
- Visual inspection (e.g., fit, leakage, function in simulated blood collection and connectivity tests).
- Standardized test methods (e.g., ASTM, ISO standards).
- Leveraging prior biocompatibility data for a similar device.
8. The sample size for the training set
This is not applicable as the device is a physical product and does not involve AI or machine learning that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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