(230 days)
TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.
The TERUMO® SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter). The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (
Here's an analysis of the acceptance criteria and supporting studies for the TERUMO® SURFLO® I.V. Catheter, based on the provided 510(k) summary:
This device is not an AI device, therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable. The provided document details a traditional medical device submission for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TERUMO® SURFLO® I.V. Catheter are based on conformity to recognized consensus ISO standards and specific internal performance tests. The reported performance indicates that the device Meets Standard or Meets acceptance criteria for all tests.
| Test Category | Specific Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO Standards | Force at break | ISO 10555-1 | Meets standard |
| Corrosion resistance | ISO 10555-1 | Meets standard | |
| Liquid leakage under pressure | ISO 10555-1 | Meets standard | |
| Air leakage into hub assembly during aspiration | ISO 10555-1 | Meets standard | |
| Vent fitting | ISO 10555-5 | Meets standard | |
| Flow rate | ISO 10555-5 | Meets standard | |
| Strength of union between needle hub and needle tube | ISO 10555-5 | Meets standard | |
| Gauging | ISO 594-1 | Meets standard | |
| Liquid leakage | ISO 594-1 | Meets standard | |
| Air leakage | ISO 594-1 | Meets standard | |
| Separation force | ISO 594-1 | Meets standard | |
| Stress cracking | ISO 594-1 | Meets standard | |
| Internal Tests | Cannula and needle hub fitting force | Acceptance criteria | Meets acceptance criteria |
| Catheter tube and catheter hub fitting force | Acceptance criteria | Meets acceptance criteria | |
| Catheter tube and catheter hub leakage | Acceptance criteria | Meets acceptance criteria | |
| Catheter tube and needle fitting force | Acceptance criteria | Meets acceptance criteria | |
| Flashback | Acceptance criteria | Meets acceptance criteria | |
| Needle and needle hub leakage | Acceptance criteria | Meets acceptance criteria | |
| Needle heel and catheter tip distance | Acceptance criteria | Meets acceptance criteria | |
| Needle penetration | Acceptance criteria | Meets acceptance criteria |
Biocompatibility Tests:
| Test | Reported Performance |
|---|---|
| Cytotoxicity | Biocompatible |
| Sensitization | Biocompatible |
| Intracutaneous reactivity | Biocompatible |
| Systemic toxicity (Acute) | Biocompatible |
| Pyrogenicity | Biocompatible |
| Subchronic toxicity (subacute toxicity) | Biocompatible |
| Hemocompatibility | Biocompatible |
| Genotoxicity | Biocompatible |
| Implantation | Biocompatible |
| Physicochemical Characterization | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units tested) for the performance tests. It states that "Performance testing was conducted to ensure the safety and effectiveness... and demonstrate substantial equivalence to the predicate device."
The data provenance is from the manufacturer, Terumo (Philippines) Corporation, and the tests were performed on the new device, comparing it to the legally marketed predicate device (K891087) manufactured by Terumo Medical Corporation, Elkton, Maryland. These are considered prospective tests performed on the device being submitted for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is a physical medical instrument (intravascular catheter), not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.
4. Adjudication Method for the Test Set
This information is not applicable because the performance tests involve objective measurements and comparisons against established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and AI assistance can impact their performance. This is not relevant for an intravascular catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance test in the context of an algorithm's performance was not done. The "standalone" performance here refers to the device's physical and biological characteristics as it would be used, independent of human interaction other than proper insertion and operation.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Established consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 10555 series, ISO 594 series, ISO 11137 for sterilization, ISO 10993-1 for biocompatibility).
- Predefined acceptance criteria: Internal specifications for physical properties and functionality (e.g., fitting forces, leakage, flashback, needle penetration).
- Demonstrated performance of a legally marketed predicate device: The new device's performance is compared to that of the predicate device (K891087) to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this type of device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).