(263 days)
The APOTECA® Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA® Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding.
The APOTECA® I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA® I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.
The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is a system for preparation and administration of drugs intended for use with APOTECAchemo automatic compounding system.
APOTECA® Drug Compounding Dosing Device: a single use piston syringe that consists of a syringe (3ml, 5ml, 10ml, 20ml, 50ml) with a luer lock connector bonded to a needle. The syringe consists of a plastic barrel with a graduated scale, a synthetic rubber stopper and a plastic plunger rod. The needle is a Huber point non-coring needle with 16G thin wall cannula (0.5" plus 0.5" inside the vented hub). The device is not manufactured with natural rubber latex. The device is designed to be handled manually or by automatic pharmacy compounding system for the preparation and admixture of drugs in healthcare establishments.
APOTECA® I.V. Transfer Set: a non-vented infusion set used as a connecting part between an IV bag and an external infusion line. The device comprises of the following components: Non-vented spike, Connecting tube, Spike port adaptor with Twist-Off cap and safety membrane, Luer lock adaptor with protective cap.
The provided 510(k) summary for the APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set details performance data primarily related to biocompatibility and basic physical properties, rather than diagnostic accuracy or comparative effectiveness with human readers. This device is a medical fluid transfer system, not an AI/ML-based diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to the information provided.
However, I can extract the acceptance criteria and reported performance for the characteristics that were evaluated.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Hemolysis | ISO 10993-4:2002/A:2006 | Non-Toxic | Non-Toxic |
| Cytotoxicity | ISO 10993-5:1999 | Non-Toxic | Non-Toxic |
| EO Residual | ISO 10993-7:2008 | Pass |
2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes for each bench test conducted for the APOTECA® devices. The tests were "bench tests" performed based on risk analysis to verify the device's compatibility with the APOTECAchemo automatic pharmacy compounding system and general safety. Data provenance (country of origin, retrospective/prospective) is not applicable to these types of bench tests, as they are laboratory evaluations of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML-based diagnostic device requiring expert consensus for ground truth. The performance data relates to material biocompatibility and physical integrity, evaluated through standardized laboratory tests.
4. Adjudication method for the test set:
Not applicable. See point 3.
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 not an AI/ML-based diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical and material properties.
7. The type of ground truth used:
For biocompatibility tests (Hemolysis, Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, EO Residual, Bacterial Endotoxins), the "ground truth" is defined by the objective pass/fail criteria established by international standards (ISO, USP) for specific biological responses or chemical levels. For physical tests (Leak proof, Airtight), the "ground truth" is observable evidence of passage (leaks, smoke) or lack thereof.
8. The sample size for the training set:
Not applicable. This is not a machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).