(444 days)
The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.
Sdispensinglineisadevice for the transferofiquids, with the purpose of preparation of in drugs. The device is intended to be used with APOTECAsyringe automatic compoundingsystem. Thedeviceissingleuse, sterilizedbyEOandsingle-packagedinablister. The device is not manufactured with natural rubber latex. Medical grade plastics are used, according to ISO 10993 series standards. Sdispensingline is a non-vented infusion setused as a connecting part be rock syringe without hypodermic needle. The tip in contact with the syringe must perfectly by means of a pressure connector (not by screwind). in ordertoavoidloss ofmedication; the connectoris to be assembled atthe endof the line. The short line enables the transfer of drug from a bag to a luer lock syringe through the APOTECAsyringe automated system. The line is intended for the connection of the spike perforator; a check valve prevents the flow back towards thebag.
The provided text describes the regulatory clearance for the "S dispensing line" device, which is an intravascular administration set. The information focuses on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex algorithms.
Therefore, many of the requested categories for acceptance criteria and study details (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to clinical or AI algorithm performance, which was not the basis for this regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria/Standard | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Right connection/absence of ruptures between syringe tip and connector after 100 usages | Right connection/absence of ruptures between syringe tip and connector after 100 usages | Right connection, no ruptures |
| Absence of leakage during filling after 100 usages | Absence of leakage during filling after 100 usages | No leakage |
| Right disconnection/absence of ruptures between syringe tip and connector after 100 usages | Right disconnection/absence of ruptures between syringe tip and connector after 100 usages | Right disconnection, no ruptures |
| Absence of spilling after the disconnection | Absence of spilling after the disconnection | No spilling |
| Performance testing after real aging (ongoing) | No change in performances after 3 years | Results of ongoing real aging study not provided, but implies satisfactory performance based on 3-year shelf life claims and completed accelerated aging study. |
| Test for particulate contamination | ISO 8536-4:2010 | Implied compliance with ISO 8536-4:2010, as demonstrated by favorable outcome of testing for substantial equivalence. |
| Test for leakage | ISO 8536-4:2010 | Implied compliance with ISO 8536-4:2010, as demonstrated by favorable outcome of testing for substantial equivalence. |
| Test for tensile strength | ISO 8536-4:2010 | Implied compliance with ISO 8536-4:2010, as demonstrated by favorable outcome of testing for substantial equivalence. |
| Test for the closure-piercing device | ISO 8536-4:2010 | Implied compliance with ISO 8536-4:2010, as demonstrated by favorable outcome of testing for substantial equivalence. |
| Test for transparency | ISO 8536-4:2010 | Implied compliance with ISO 8536-4:2010, as demonstrated by favorable outcome of testing for substantial equivalence. |
| Biocompatibility Testing | ||
| Cytotoxicity MEM | ISO 10993-5:2009, ISO 10993-12:2012 | Implied compliance with ISO 10993-5:2009, ISO 10993-12:2012. |
| Elution test | No specific standard listed in the table, but falls under biocompatibility. Implied satisfactory results. | Implied satisfactory results for elution test. |
| Sensitization (Guinea Pig Sensitization Test) | ISO 10993-10:2010, ISO 10993-12:2012 | Implied compliance with ISO 10993-10:2010, ISO 10993-12:2012. |
| Irritation or Intracutaneous Reactivity (Rabbit Intracutaneous reactivity) | ISO 10993-10:2010, ISO 10993-12:2012 | Implied compliance with ISO 10993-10:2010, ISO 10993-12:2012. |
| Acute Systemic Toxicity | ISO 10993-11:2017, ISO 10993-12:2012 | Implied compliance with ISO 10993-11:2017, ISO 10993-12:2012. |
| Material-Mediated Pyrogenicity (Pyrogen Test (USP Rabbit Test)) | USP 41-NF36:2018 Pyrogen Test (USP Rabbit Test) | Implied compliance with USP 41-NF36:2018 . |
| Hemocompatibility (Haemolysis test indirect contact) | ISO 10993-4:2017, ISO 10993-12:2012 | Implied compliance with ISO 10993-4:2017, ISO 10993-12:2012. |
| Particulate matters testing | USP 788 | Implied compliance with USP 788. |
| Sterilization and Shelf Life | ||
| Sterilization Validation | ISO 11135:2014 | Implied compliance with ISO 11135:2014. |
| Packaging Validation | Effective microbiological barrier, product sterility and integrity preservation | Implied satisfactory results, indicating effective microbiological barrier and product integrity preservation. |
| Shelf life - 3 years | Sterility and product integrity maintained over the entire shelf life / Sterility and product integrity maintained over 3 year shelf life | Accelerated Ageing Study completed, 3 year Real Time Study (Ongoing). The completion of the accelerated study and the ongoing real-time study with the stated acceptance criteria indicate performance for 3-year shelf life. |
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: Not explicitly stated for performance or biocompatibility tests. The "100 usages" for connection/disconnection/leakage tests indicates a sample of 100 operations for these specific tests. Other tests likely followed the sample size requirements dictated by the respective ISO standards.
- Data Provenance: Not specified. These are non-clinical bench and lab tests.
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. Ground truth, in this context, refers to a clinical diagnosis or outcome, typically established by medical experts for AI/clinical studies. This submission is for a physical medical device and relies on engineering and laboratory testing protocols against established international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image interpretation/AI algorithm development where human reviewers may disagree. This is a non-clinical device clearance.
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 a non-clinical submission for a physical medical device (intravascular administration set), not an AI algorithm or a diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device; there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on objective measurements and assessments against established engineering and biocompatibility standards (e.g., ISO 8536-4:2010, ISO 10993 series, USP standards). For specific tests like "Right connection/absence of ruptures," the ground truth is a direct observation of the device's physical integrity and functional performance under defined conditions.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
§ 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).