(134 days)
The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters.
The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undijuted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.
The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm.
A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.
This looks like a 510(k) premarket notification for a medical device called the BIOPORT™ Closed Blood Sampling System. As such, the information provided is a summary of the device's characteristics and its equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.
Therefore, many of the requested points (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable or cannot be determined from the provided text, as this type of submission focuses on demonstrating substantial equivalence to existing devices and adherence to recognized standards, rather than proving a specific performance level of a novel algorithm or diagnostic output.
However, I can extract the information that is present and explain why other points are not.
BIOPORT™ Closed Blood Sampling System Premarket Notification (K983372)
This submission describes a Class II medical device, the BIOPORT™ Closed Blood Sampling System, which is intended for closed, needle-free access of arterial blood from pressure monitoring catheters. The primary goal of the submission is to demonstrate substantial equivalence to predicate devices and compliance with applicable standards, rather than to present a performance study with specific acceptance criteria as you might see for a diagnostic AI.
1. A table of acceptance criteria and the reported device performance
| Performance Aspect | Acceptance Criteria (Stated Requirements/Standards) | Reported Device Performance (as per submission) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 and FDA's G95-1 Memorandum. | All components meet ISO 10993 and FDA's G95-1 Memorandum biocompatibility requirements. |
| Tensile Strength & Leakage Resistance | Meet or exceed requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use (now an FDA Consensus Standard). | Performance data demonstrate that the tensile strength and resistance to leakage under pressure of the BIOPORT System components meet or exceed the requirements listed in ISO 8536-4. |
| Frequency Response (Bandwidth) | Acceptable (>200 Hz) as evaluated in accordance with BP 22, American National Standard for Blood Pressure Transducers. | The bandwidth of the BIOTRANS Reusable Sensor Base with the BIOPORT sampling site was found to be acceptable (>200 Hz). |
| Reservoir Syringe Adequacy (Expulsion) | Adequate stop at the rear of the syringe barrel to minimize the potential for inadvertent expulsion of the plunger during anticipated hydrostatic pressures. | Tests of the Reservoir Syringes at hydrostatic pressures anticipated in the use of the device demonstrate the adequacy of the stop at the rear of the syringe barrel to minimize the potential for inadvertent expulsion of the plunger. |
| Needle-Free Access (Effectiveness) | (Implied: Functions as intended for needle-free blood sampling via the BIOPORT using a sampling syringe fitted with the Blunt Cannula Adapter (BPN), similar to predicate devices). | The identical BIOPORT access site and Blunt Cannula Adapter are used in the predicate Utah Medical Products' ABC and have been cleared for identical purposes. |
| Substantial Equivalence | Demonstrated equivalence to predicate devices (Utah Medical Products Inc.'s ABC Pressure Monitoring Kits; Baxter Healthcare Corporation's VAMP Venous/Arterial Blood Management Protection; Migada Blunt Cannula) or meets requirements of applicable, published, well-accepted standards. | Data gathered by Biosensors indicate that the performance of Biosensors BIOPORT System is equivalent to that of the predicate devices or meets the requirements of applicable, published, well-accepted standards. (FDA agrees and clears the device). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document references "Performance data" and "Tests," but does not provide details on the number of units tested, the number of measurements taken, or specific sample sizes.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies appear to be internal testing conducted by Biosensors International.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. This device submission does not involve expert-established ground truth in the context of diagnostic interpretation. The "ground truth" here is adherence to engineering standards and functional performance metrics.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies with subjective interpretations, which is not relevant for this device's performance assessment.
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 accessory (blood sampling system), not an AI-driven or diagnostic imaging system that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm. Its performance is assessed through physical and functional testing against established engineering and biocompatibility standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is based on objective engineering and biological standards and requirements. These include:
- International Standard ISO 10993 (Biocompatibility)
- FDA G95-1 Memorandum (Biocompatibility)
- International Standard ISO 8536-4 (Tensile strength, leakage resistance)
- BP 22, American National Standard for Blood Pressure Transducers (Frequency response/bandwidth)
- Functional testing to ensure syringe plunger retention under pressure.
- Demonstration of substantial equivalence to already cleared predicate devices.
8. The sample size for the training set
- Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML algorithm, there is no corresponding ground truth to be established for it.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).