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510(k) Data Aggregation
(211 days)
QTI
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration.
The provided text describes the acceptance criteria and the results of various tests conducted for the BD PosiFlush™ SafeScrub device (K213955). This device is a pre-filled saline syringe with an integrated disinfection unit.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance/Design Verification Tests | ||
| Container Closure Integrity | No dye within the syringe | Pass |
| Leakage Test | No leakage from the syringe | Pass |
| Torque Removal Test | Tip Cap can be twisted off as per BD validated force | Pass |
| Sterile Fluid Path | SAL: 10-6 | Pass |
| Axial Pull Force | DU cannot be pulled off per BD validated force | Pass |
| Torque | DU cannot be twisted off as per BD validated force | Pass |
| Particulate Ingress | USP | Pass |
| Antimicrobial Efficacy | ≥ 4-log reduction | Pass |
| 70% IPA Concentration | 70±7% | Pass |
| Foam Rotation | Foam should not rotate >90 degrees within the DU housing during use | Pass |
| Foam Retention (before and during use) | Foam must be retained within the DU | Pass |
| Foam Retention (after use) | Foam must be retained within DU after scrubbing | Pass |
| Foam Durability | No ripped or ragged material and debris or particulate | Pass |
| Foam Compressibility and Wetness | Foam must be wet and compressible | Pass |
| 70% IPA Ingress | Maximum dose of 2 mg IPA/kg body mass/day per US EPA | Pass |
| Package integrity of DU | ||
| Bubble Leak | as per ASTM F2096 | Pass |
| Seal Width | ≥ 0.58 mm | Pass |
| Delamination | No delamination | Pass |
| Peel Force | USL: ≤ 12.9 N, LSL: ≥ 3.69 N | Pass |
| Microbial properties | as per ISO 11607-1:2019 | Pass |
| Biocompatibility | ||
| Cytotoxicity | Grade ≤ 2 (ISO 10993-5:2009) | Pass |
| Sensitization | Non-Sensitizer (ISO 10993-10:2010) | Pass |
| Irritation or Intracutaneous Activity | Final Test Sample Score ≤ 1 (ISO 10993-10:2010) | Pass |
| Acute Systemic Toxicity | No significantly greater biological reaction than the control (ISO 10993-11:2017) | Pass |
| Material Mediated Pyrogenicity | No temperature rise ≥ 0.5° C (ISO 10993-11:2017) | Pass |
| Hemocompatibility | ≤ 5% hemolysis (ISO 10993-4:2017, ASTM F756-17) | Pass |
| LAL Endotoxin | Below the Endotoxin Limit 20 EU/device (USP 43-NF38 ) | Pass |
| Extractable and Leachable Analysis | N/A (Result is a Toxicological Risk Assessment) | Toxicological Risk Assessment |
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 explicitly state the sample sizes for each test in the provided table. It mentions "BD validated force" for several tests, implying internal validation studies by the manufacturer. The document details that "The subject device is also evaluated throughout its shelf life by bench performance testing to ensure that the device meets the predetermined acceptance criteria."
The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but it implies a prospective testing approach as part of the device's development and regulatory submission.
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 section is not applicable. The tests performed are primarily bench performance, engineering, chemical, and biological evaluations, not requiring human expert interpretation in the way, for example, a medical imaging AI product would. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ISO, ASTM, USP guidelines) rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, these are objective physical and chemical tests, not requiring human interpretation or adjudication panels. The "Pass" results are based on meeting predetermined quantitative or qualitative criteria from recognized standards.
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 device is a medical product (a pre-filled syringe with a disinfection unit), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As mentioned, this is not an AI algorithm. The performance of the device itself (standalone) is what was tested through the various bench performance tests, antimicrobial efficacy, and biocompatibility studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the various tests relies on:
- Established scientific and engineering principles: e.g., for container closure integrity, leakage, torque, pull force.
- Recognized industry standards and guidelines: ISO 10993 series for biocompatibility, ASTM F2096 for package integrity, USP for particulate ingress, USP 43-NF38 for LAL Endotoxin.
- Predetermined chemical concentrations: 70±7% for IPA concentration.
- Microbiological reduction targets: ≥ 4-log reduction for antimicrobial efficacy, based on established efficacy standards for disinfectants.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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