(149 days)
The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting
The MedSource IV Administration Set is a medical device designed to administer parenteral fluids. The submission focuses on demonstrating substantial equivalence to a predicate device, the Angletouch IV Administration Set (K012189), through various performance tests.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (MedSource IV Administration Set) | Predicate Device Performance (Angletouch IV Administration Set (K012189)) | Result of Comparison |
|---|---|---|---|---|
| Intended Use | Administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein. | Designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein. | To Administer parenteral fluids/medication into the patient's intravascular system | Substantially equivalent |
| Technological Characteristics | Conforms to ISO 8536-4 | Conforms to ISO 8536-4 | Conforms to ISO 8536-4 | Substantially equivalent |
| Materials of Construction | Materials compatible with intended use (PP, ABS, HDPE, PVC, PP, Latex for predicate) | Poly-Propylene, ABS, PVC, HDPE+Nylon, Silicon, HDPE (all material of not made of natural latex) | PP, ABS, HDPE, PVC, PP, Latex | Substantially equivalent |
| Performance (Drip Rate) | Drip rate for parenteral fluid administration | Used to administer parenteral fluids at either 10 drops/ml, 15 drops/ml or 60 drops/ml | Use to administer parenteral fluids at 20 drops per ml | Substantially equivalent |
| Description of Device | Single Use Sterile Infusion Set for Medical Use | Product is a single use sterile infusion set for medical use | The product is a Single Use Sterile Infusion Set for Medical Use | Substantially equivalent |
| Instructions for Use | Standard procedure for preparing and using an IV administration set. | Prepare IV container, Remove set from pouch and close roller clamp, Remove spike protector from spike, Insert spike into container, Hang container, fill drip chamber by squeezing until approximately half full, remove protector from adaptor, open roller clamp, prime set and purge air from tubing, close roller clamp until roller meet bottom of frame, attached adapter to venipuncture device, adjust fluid flow with roller clamp, check maintenance of proper flow rate at regular intervals. | Disinfect inlet of solution container, remove set from pouch and close the air vent and roller clamp respectively. Remove spike protector from spike, insert spike into solution container, hang container, squeeze drip chamber to fill approximately half full, remove protector from Luer lock adaptor, Open the air vent and roller clamp and solution to expel air from set, close roller clamp and attach set to access device, adjust flow wit roller clamp, check maintenance for proper flow rate a regular intervals. | Substantially equivalent |
| Chemical Tests | MedSource IV Administration Set | Angletouch IV Administration Set (K012189) | ||
| Clarity | Meets stated specification for material (Clear) | Meets stated specification for material | Clear | Pass |
| Color | Meets stated specification for each material | Meets stated speciation for each material | Meets stated speciation for each material | Pass |
| Odor | Odorless | Odorless | Odorless | Pass |
| pH | 4.5-7.5 | 4.5-7.5 | 4.5-7.5 | Pass |
| Acidity/Alkalinity | NMT 1 ml of 0.01M NaOH / HCl Solution | NMT 1 ml of 0.01M NaOH / HCl Solution | NMT 1 ml of 0.01M NaOH / HCl Solution | Pass |
| Heavy Metals | NMT 1 | NMT 1 | NMT 1 | Pass |
| Oxidizable Matter | NMT 2ml | NMT 2ml | HMT 2mL | Pass |
| No Volatile Matter | NMT 5 | NMT 5 | NMT 5 | Pass |
| Absorbance | NMT 0.1 in wavelength range 250-320nm | NMT 0.1 in wavelength range 250-320nm | NMT 0.1 in wavelength range 250-320nm | Pass |
| Biological Tests | ||||
| Sterility | Sterile ETO | Sterile ETO | Sterile ETO | Pass |
| Pyrogen | Non pyrogenic | Non pyrogenic | Non pyrogenic | Pass |
| Toxicity | Non toxic | Non toxic | Non toxic | Pass |
| Physical Tests | ||||
| Integrity | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | Pass |
| Flow-rate | Deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter. | The complete set should deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter. | Not less than 100ml/min | Pass |
| Tensile | 15N for 15 seconds | 15N for 15 seconds | 15N | Pass |
Study Proving Acceptance Criteria:
The study proving the MedSource IV Administration Set meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Angletouch IV Administration Set (K012189). This type of study is common for Class II medical devices seeking 510(k) clearance, where the primary goal is to demonstrate that the new device is as safe and effective as a previously cleared device.
Additional Information Required by the Prompt (not explicitly detailed in the provided text):
Since this is a submission for a physical medical device (IV administration set) and not an AI/software device, many of the requested points related to AI/software evaluation (e.g., ground truth, experts, MRMC studies) are not applicable. The information provided focuses on the physical and chemical properties and general performance of the device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific test (e.g., how many IV sets were tested for flow rate, tensile strength, etc.). It describes the criteria and results of the tests.
- Data Provenance: The data provenance is from bench testing conducted on the MedSource IV Administration Set itself and comparative analysis against the specifications and performance of the predicate device (Angletouch IV Administration Set, K012189). This is a prospective evaluation of the new device's performance based on established standards and predicate device data. The country of origin for the testing is not specified, but the submitter is Medsource International, LLC, located in Mound, MN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable: This request is typically relevant for studies involving subjective human interpretation (e.g., image analysis, diagnosis). For a physical medical device like an IV administration set, the "ground truth" for chemical, biological, and physical properties is established by adherence to recognized consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, etc.) and objective laboratory measurements, rather than expert consensus on subjective interpretations. There's no mention of experts establishing a "ground truth" in this context.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or annotators when establishing ground truth for subjective tasks. This is not relevant for the objective physical and chemical testing performed on an IV administration set. The tests performed yield objective, measurable results that either meet or do not meet the predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Done: An MRMC comparative effectiveness study is used to evaluate the performance of human readers with and without AI assistance for interpretative tasks. This is not applicable to the evaluation of a physical IV administration set.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not Applicable: This also refers to AI/software performance. The device is a physical IV administration set, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the performance evaluation of the MedSource IV Administration Set is based on:
- Defined Standards and Specifications: Adherence to recognized international consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, EN 980, ISO 11138, BS EM 556-1, ISO 11135).
- Predicate Device Performance: Comparison against the known performance characteristics and materials of the legally marketed predicate device (Angletouch IV Administration Set, K012189).
- Objective Laboratory Measurements: Chemical, biological, and physical tests yielding quantifiable results that are compared against predefined acceptance thresholds derived from these standards and predicate device data.
8. Sample Size for the Training Set:
- Not Applicable: This concept of a "training set" is relevant for machine learning algorithms. For a physical device, there isn't a "training set" in the common AI sense. The design and manufacturing process are refined through engineering, testing, and adherence to quality systems and standards, not through "training data."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no "training set" in the AI sense, this question is not relevant to the evaluation of this physical medical device.
§ 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.