(31 days)
SafeBreak® Vascular is intended to separate when is exerted across a peripheral IV administration set. When SafeBreak@ Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
SafeBreak® Vascular is placed in-line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.
SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.
The purpose of this special 510(k) is to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Characteristic) | Target / Specification (for K222791) | Reported Device Performance (for K222791) |
|---|---|---|
| Separation Force Tolerance | 1-5 lbf | 1-5 lbf |
| Indication for Use | Aid in reduction of peripheral IV mechanical complications requiring IV replacement. Used on peripheral IV catheters in adults and adolescent populations (18+) receiving intermittent or continuous infusions with an electronic pump. | Identical to target |
| Materials | Makrolon, Polycarbonate, Saint-Gobain, INEOS ABS Lustran, Silicone | Identical to target |
| Environment of Use | Hospital | Identical to target |
| Principle of Operation | Connects to needleless connector and IV administration set via luer. Separates upon tension, valves close to stop fluid/blood flow. | Identical to target |
| Vascular Access Type | Peripheral intravenous catheter | Identical to target |
| For Use with Electronic Pump | Yes | Identical to target |
| Single Use | Yes | Identical to target |
| Continuous and Intermittent Infusion | Yes | Identical to target |
Explanation of the Primary Difference:
The K222791 device is a special 510(k) to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf. The predicate device (DEN190043) had a separation force of "4 ± 1 lbf." The reference device (K212064, Orchid SRV™) supported the expanded pull force range.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample size used for the performance testing.
The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. The testing appears to be primarily mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is mechanical performance (Separation Force Testing), which typically does not involve human experts establishing ground truth in the same way clinical studies or image analysis tasks would.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the testing described is mechanical performance. Adjudication methods are typically associated with subjective assessments or diagnostic studies.
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
An MRMC comparative effectiveness study was not conducted. This device is a mechanical device, not an AI or diagnostic imaging device that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a mechanical IV catheter force-activated separation device, not an algorithm or software. The performance testing was for the mechanical function of the device itself.
7. The Type of Ground Truth Used
The ground truth for the performance testing (mechanical testing) was the pre-defined engineering specification for the separation force range (1-5 lbf). The "ground truth" here is the physical measurement against a specified engineering tolerance.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a mechanical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided as there is no training set for a mechanical device.
§ 880.5220 Intravenous catheter force-activated separation device.
(a)
Identification. An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.