(403 days)
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.
The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.
This document is a 510(k) Premarket Notification for the Surflo Winged Infusion Set, seeking substantial equivalence to a legally marketed predicate device. As such, it describes performance testing conducted to demonstrate product safety and effectiveness, rather than a study proving a device meets acceptance criteria for an AI/ML product. Therefore, several points in your requested output, such as those related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth establishment, MRMC study, standalone performance) are not applicable to this type of medical device submission.
However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this traditional medical device:
Acceptance Criteria and Device Performance for Surflo Winged Infusion Set
The Surflo Winged Infusion Set underwent non-clinical performance testing to ensure it met predetermined specifications, conformed to applicable ISO and non-ISO standards, and demonstrated substantial equivalence to its predicate device.
1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance
For tests conducted against specific standards, the document implies that compliance with the standard is the acceptance criterion. For additional performance tests, the acceptance criterion was "Meets acceptance criteria," established based on the predicate device's performance.
| Test | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow rate | GB 18671-2009 Intravenous needles for single use | Complies with standard |
| Leak test | JIS T 3222:2011 Sterile winged intravenous devices | Complies with standard |
| Wing to tubing connection strength (static pull force) | ISO 8536-4:2019 Infusion equipment for medical use | Complies with standard |
| Tubing to connector connection strength (static pull force) | ISO 8536-4:2019 Infusion equipment for medical use | Complies with standard |
| Needle to wing connection strength (static pull force) | ISO 8536-4:2019 Infusion equipment for medical use | Complies with standard |
| Needle curvature | JIS T 3222:2011 Sterile winged intravenous devices | Complies with standard |
| Wing to tubing connection strength (dynamic pull force) | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Tubing to connector connection strength (dynamic pull force) | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Needle to wing connection strength (dynamic pull force) | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Wing-needle protector fit | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Needle penetration resistance | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Blockage test | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
| Priming volume | Meets acceptance criteria (based on predicate) | Meets acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each performance test. It only mentions that "Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications." The data provenance is implied to be from the manufacturer's internal testing facilities in Hangzhou, China, as it is manufactured by "Terumo Medical Products (Hangzhou) Co., Ltd." The testing is described as non-clinical, implying a prospective testing approach conducted specifically for this 510(k) submission.
3. Number of Experts Used and Qualifications
Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring expert readers for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring adjudication of expert readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-clinical performance test for a traditional medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a traditional medical device, not an AI/ML algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance tests were adherence to established industry standards (ISO, JIS, GB) and internal company specifications derived from the predicate device's performance.
8. Sample Size for the Training Set
Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.
Additional Test Information:
- Biocompatibility: Tests were conducted on non-aged and accelerated-aged devices according to ISO 10993-1, with results demonstrating biocompatibility throughout the product's shelf life.
- Sterilization: The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6, validated in accordance with ISO 11135:2014.
- Clinical Tests: The 510(k) submission states that it "does not include data from clinical tests."
§ 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.