(179 days)
For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.
The proposed device is a patient controlled epidural analgesia (PCEA) syringe set. It is a single use disposable device intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device. It is a non-pyrogenic, sterile device that can be directly attached to a syringe. The PCEA syringe set consists of non-DEHP PVC tubing/bushing, female NRFit cap, female NRFit lock, anti-siphon valve, on-off clamp, male NRFit lock, and male NRFit cap. It is used to administer anesthetics and/or analgesics from a syringe to the patient's epidural space through an epidural access device.
Here's a breakdown of the acceptance criteria and study information for the Baxter Healthcare Corporation PCEA Syringe Set (K211649), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 80369-6 Tests on Male NRFit (Neuraxial Fit) Lock Connector | ISO 80369-6: 2016, Clause 5 (as applicable), and Clauses 6.1 through 6.6 | All tests met the acceptance criteria. |
| ISO 80369-6 Tests on Female NRFit (Neuraxial Fit) Lock Connector | ISO 80369-6: 2016, Clause 5 (as applicable), and Clauses 6.1 through 6.6 | All tests met the acceptance criteria. |
| Tensile Strength Test | ISO 8536-9:2015, Clause 5.3 | All tests met the acceptance criteria. |
| Leak Test | ISO 8536-9:2015, Clause A.4 | All tests met the acceptance criteria. |
| Counter Flow Test | ISO 8536-12:2007+A1:2013, Clause A.4 | All tests met the acceptance criteria. |
| Blocking Performance Test | ISO 8536-12:2007+A1:2013, Clause A.6 | All tests met the acceptance criteria. |
| Opening Pressure Test | ISO 8536-12:2007+A1:2013, Clause A.7.1 and per Baxter Test Method | All tests met the acceptance criteria. |
| Particulate Matter Test | USP Chapter | All tests met the acceptance criteria. |
| Clamp Activation Force Test | Per Baxter Test Method | All tests met the acceptance criteria. |
| Clamp Shut-Off Test | ISO 8536-14:2018, Clause A.1 | All tests met the acceptance criteria. |
| Non-DEHP Claim Verification | Per Baxter Test Method (as tested in K161808) | All tests met the acceptance criteria. |
| Biocompatibility | ISO-10993-1 categorization (for prolonged contact, external communicating device, tissue/bone/dentin) and FDA-2013-D-0350 Guidance. Specific assays: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous (Irritation) Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogen (ISO 10993-11), Genotoxicity (ISO 10993-3), Subacute Systemic Toxicity (ISO 10993-11). | The device met the designated ISO 10993-1 categorization and is biocompatible and appropriate for the intended use. |
| Sterility | Sterility Assurance Level (SAL) of ≤ 10-6 using ANSI/AAMI/ISO 11137-2. Endotoxin limit of 2.15 EU/device per USP . | MSD (Minimum Sterilizing Dose) required to provide a 10-6 SAL was established and validated. Routine periodic pre-sterilization bioburden testing is performed. (Implied to have met criteria, as the conclusion states substantial equivalence). |
| Shelf Life | Not explicitly stated as a numerical acceptance criterion in the table, but "supports a shelf-life claim of 3 (three) years." | Aging testing performed to support a 3-year shelf-life claim. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes "bench tests" and does not specify a separate "test set" in the context of clinical data, human readers, or image analysis. The tests appear to be conducted on the device itself. The provenance of the data is from Baxter Healthcare Corporation's internal testing. There is no information regarding country of origin or retrospective/prospective nature as this refers to device performance testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The "ground truth" for these tests relates to engineering and manufacturing standards (e.g., ISO standards, USP chapters) rather than human expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set:
Not applicable. The tests are based on objective measurements against established engineering and regulatory standards, not human opinion requiring adjudication.
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 administration set, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is established by:
- International and national standards bodies (e.g., ISO 80369-6, ISO 8536-9, ISO 8536-12, ISO 8536-14, ISO 10993, ANSI/AAMI/ISO 11137-2)
- Pharmacopeial standards (e.g., USP Chapter , USP )
- Baxter Test Methods, which are company-specific internal procedures developed to ensure quality and compliance.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is used.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.