(144 days)
The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi.
The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device.
The provided document is a 510(k) summary for the Biowy PICC Catheter, which is a medical device and not an AI/ML software device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, adjudication methods, or training set details are not applicable in this context. The acceptance criteria and performance are based on physical and biological testing of the catheter.
Here's the information pulled from the document regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test | Standards and Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Critical Dimensions | ISO 9626:2015 (Met requirements) | Passed and met requirement |
| Priming Volume | Internal (Met requirements) | Passed and met requirement |
| Tensile Force | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Elongation and Stiffness | Internal (Met requirements) | Passed and met requirement |
| Flexural Fatigue | Internal (Met requirements) | Passed and met requirement |
| Aspiration Flow/Catheter collapse | Internal (Met requirements) | Passed and met requirement |
| Air Leakage during Aspiration | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Gravity Flow | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Pump Flow | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection and Leak Testing | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection/Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection (10x)/Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Printing Marking | ISO 10555-3:2013 (Met requirements) | Passed and met requirement |
| 6% Luer Taper | ISO 594-1:1986 (Met requirements) | Passed and met requirement |
| Luer | ISO 594-1:1986, ISO 594-2:1998 (Met requirements) | Passed and met requirement |
| Luer Color Orientation | Internal (Met requirements) | Passed and met requirement |
| Radiopacity | ASTM F640-12 (Detectible) | Passed and met requirement |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizer |
| Irritation | ISO 10993-10 | Non-irritant |
| Acute Systemic Injection | ISO 10993-11 | Non-toxic |
| Material Mediated Pyrogen | USP | Non-pyrogenic |
| LAL (Bacterial Endotoxins) | USP , | Passed and met requirements |
| Hemolysis (extract) | ISO 10993-4 | Non-hemolytic |
| Hemolysis (direct) | ISO 10993-4 | Non-hemolytic |
| Complement Activation | ISO 10993-4 (Similar to predicate) | Similar when compared to predicate |
| Partial Thromboplastin Time (PTT) | ISO 10993-4 (Minimal activator, same as predicate) | Minimal activator (same as predicate) |
| Dog Thrombogenicity | ISO 10993-4 (Similar to control) | Similar to control |
| Implantation | ISO 10993-6 | Non-irritant |
| Subacute/sub Chronic Toxicity, Genotoxicity, Chronic Toxicity, and Carcinogenicity | ISO 10993-17, ISO 10993-18 | Passed and met requirement |
| EtO sterilization | ISO 11135: 2014 (Met 10-6 SAL requirement) | Met 10-6 SAL requirement |
| Clinical Evaluation | Internal | Passed |
| Accelerated Aging (1.5 year, 3.0 year) | ISO 11607-1:2006, ASTM F88/F88M-15, ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
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 specific test. The data provenance is not mentioned, and tests appear to be laboratory-based design verification rather than clinical data from human subjects. The study is a non-clinical performance test.
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, as this is a medical device clearance based on non-clinical performance testing and biocompatibility, not an AI/ML algorithm requiring expert ground truth for interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is for studies involving human interpretation or assessments, such as in clinical trials or AI/ML evaluations.
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 for AI/ML software devices, not a physical medical device like a PICC catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI/ML software devices, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established engineering and biological standards (e.g., ISO, ASTM, USP). The device's performance is compared against these predetermined specifications and, in some cases for biocompatibility, against a legally marketed predicate device (5Fr DL PowerPICC® Catheter, K051672).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”