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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

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.

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SafeBreak® Vascular is intended to separate when excessive tension 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 used with peripheral intravenous (IV) catheters and installed for in-line use with an IV administration set. It connects between the IV administration tubing and the patient's peripheral IV access device. When excessive force is applied to the IV administration set, SafeBreak® Vascular separates at a force lower than the force required to dislodge the peripheral IV catheter or disrupt the IV securement dressing (4 ± 1 1bf). 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 may be used for a maximum of seven days.

Here's a breakdown of the acceptance criteria and the studies that prove the SafeBreak® Vascular device meets those criteria, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

• Dislodgement: SafeBreak® Group: 2 (2.9% subjects, 2.5% catheters); Control Group: 4 (5.8% subjects, 4.3% catheters).
• Infiltration: SafeBreak® Group: 8 (11.4% subjects, 9.9% catheters); Control Group: 10 (14.5% subjects, 10.8% catheters).
• Occlusion: SafeBreak® Group: 2 (2.9% subjects, 2.5% catheters); Control Group: 1 (1.5% subjects, 1.1% catheters).
• Phlebitis (VIP Score ≥2): SafeBreak® Group: 1 (1.4% subjects, 1.2% catheters); Control Group: 10 (14.5% subjects, 10.8% catheters).
• Total MCs: SafeBreak® Group: 13 (18.6% subjects); Control Group: 25 (36.2% subjects). |
  | Separation Force Testing | The device separates at the specified force, 4 ± 1 lbf. (This specification was derived from a characterization study of peripheral IV securement devices to understand when the catheter would move/dislodge/securement device disrupt on swine skin). | Met. Non-clinical performance testing must demonstrate that the device performs as intended, including separation force testing. (The text states this was done and implied conformance without giving a specific value for the product itself, but rather stating the acceptance criteria was derived from this study. Therefore, the device is presumed to have met its own derived specification.) |
  | Validation of Anti-Reconnect Feature | After the separation of the two sub-assemblies, the device cannot be reconnected by hand. | Met. Non-clinical performance testing demonstrated this. |
  | Air Leak Testing | Air leakage on aged non-separated and separated device meets specified acceptance criteria: Non-separated (intact) (b) (4); Patient side (male) (b) (4); Administration set side (female) (b) (4). | Met. Non-clinical performance testing demonstrated this. |
  | Burst Pressure (check valve leakage) per ISO 8536-12 | No signs of air or water leakage when the IV tubing line is under pressure. | Met. Non-clinical performance testing demonstrated this. |
  | Counterflow (check valve leakage) per ISO 8536-12 A.1 | The check valve from the IV tubing line withstands a pressure of 200 kPa in the counter flow direction, while it is subjected to a water excess pressure at 40°C for fifteen (15) minutes. | Met. Non-clinical performance testing demonstrated this. |
  | Duckbill Valve Testing | The valve on the patient side withstands (b) (4) back pressure. | Met. Non-clinical performance testing demonstrated this. |
  | Luer Connection Testing (ISO 80369-7, ISO 80369-20) | Device passes tests for Falling Drop Positive Pressure Liquid Leakage, Sub-atmospheric pressure air leakage, Stress Cracking, Resistance to Separation from Axial load, Resistance to Separation from Unscrewing, Resistance to Overriding. | Met. Non-clinical performance testing demonstrated this. |
  | Pump Occlusion Alarm Testing | The check valve on the IV tubing side (separated) withstands (b) (4) of back pressure at various flow rates and triggers the occlusion alarm. | Met. Non-clinical performance testing demonstrated this. |
  | Flow Inhibition Testing | The device does not impact the flowrate accuracy of commonly used infusion pumps. | Met. Non-clinical performance testing demonstrated this. |
  | Crush Testing | The snap fit fingers are not broken or dislodged when the device is subjected to force of 200 lbf, which simulates a patient lying on the device. | Met. Non-clinical performance testing demonstrated this. |
  | Feature Verification: Transparency | The air-water interface is visually detectable, when the device is partially filled with distilled water, per ISO 8536-9, A.1. | Met. Non-clinical performance testing demonstrated this. |
  | Biocompatibility | Evaluated in accordance with FDA's Guidance Document titled Use of International Standard ISO 10993-1. Prolonged contact duration (>24hr to 30 days). Includes Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity, Subacute/Subchronic Toxicity, Particulates. | Met. Biocompatibility testing demonstrated that the device is biocompatible for its intended use across all specified endpoints. |
  | Shelf-Life/Sterility (1 year) | Shelf-life established at 1 year, based on testing non-aged devices after simulated shipping, 1-year accelerated aged devices, and 1-year real-time aged devices. Passed dye penetration and burst strength testing. Validated ethylene oxide sterilization to SAL of 10-6 per ISO 11135:2014. Sterilant residuals assessed per ISO 10993-7:2008. Bacterial endotoxin testing per ANSI/AAMI ST72:2011 ( (b)(4) | Met. Non-clinical performance testing demonstrated this. |

2. Sample Size and Data Provenance for the Clinical Test Set

• Sample Size (Test Set):
  • Intention to Treat (ITT) population: (b)(4) subjects (divided into roughly equal SafeBreak® and Control groups). Specific numbers: (b)(4) SafeBreak® and (b)(4) Control.
  • Per Protocol (PP) population: 139 subjects (70 SafeBreak®, 69 Control).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was performed in (b)(4), indicating a specific location rather than multiple. The fact it's a De Novo submission to the FDA implies the study was conducted to US regulatory standards, likely in the US or a country with comparable ethical and clinical trial standards.
  • Retrospective or Prospective: Prospective, randomized, controlled trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The clinical study did not use "experts" in the sense of adjudicators for imaging or similar interpretations. Instead, it was a randomized controlled trial where patient outcomes and events were directly measured and recorded by clinical staff.
• The "ground truth" for clinical endpoints like delays of therapy and mechanical complications was based on the direct observation and documentation of events in the study subjects during the clinical trial.
• The qualifications of the clinicians involved (e.g., nurses, physicians) are implied by their roles in a clinical trial setting but not explicitly detailed (e.g., "radiologist with 10 years of experience"). However, human factors testing did involve 15 registered nurses (RNs) as participants.

4. Adjudication Method for the Test Set

• For the clinical trial, there's no mention of an external adjudication committee or specific adjudication method (like 2+1 or 3+1).
• Events like mechanical complications and delays of therapy were recorded as part of the trial protocol. The data appears to have been collected directly by the study sites and analyzed as part of the trial results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where different readers interpret cases (e.g., radiologists interpreting images).
• The SafeBreak® Vascular is a mechanical device, and its effectiveness was measured by clinical outcomes (delays of therapy, mechanical complications) rather than interpretive performance.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was extensively done, but for bench testing, not clinical performance.
• The "Summary of Nonclinical/Bench Studies" section details numerous standalone tests performed on the device itself (e.g., Separation Force Testing, Anti-Reconnect Feature, Air Leak Testing, Luer Connection Testing, Flow Inhibition, Crush Testing, Biocompatibility, Shelf-Life/Sterility, Microbial Ingress, Transparency). These tests evaluate the device's inherent physical and functional characteristics without human interaction in a clinical setting.
• "Algorithm only" performance typically refers to AI/software, which is not applicable here as SafeBreak® Vascular is a mechanical device.

7. Type of Ground Truth Used

• For the clinical study (test set): The ground truth was clinical outcomes data obtained directly from the randomized controlled trial. This includes:
  • Direct measurements of "delay of therapy" (minutes per 24 hours per subject).
  • Observed and documented "peripheral IV mechanical complications" (dislodgement, infiltration, occlusion, phlebitis).
  • Observed and documented "SafeBreak® Vascular separations."
  • Reported "Adverse Events."
• For bench testing: The ground truth was established by engineering specifications, regulatory standards (e.g., ISO, ASTM, USP), and physiological models (e.g., swine skin for separation force characterization).

8. Sample Size for the Training Set

• Not applicable in the conventional sense for AI/machine learning. The SafeBreak® Vascular is a mechanical device, not typically trained using data sets.
• Instead of a "training set," the device underwent extensive design, development, and iterative testing to refine its performance characteristics (e.g., separation force). The "Separation Force characterization study" is an example of such a process, where a specification was defined based on understanding peripheral IV securement devices on swine skin. This could be considered analogous to a "training" or "development" phase for the device's physical design and specifications.

9. How the Ground Truth for the Training Set Was Established

• As mentioned above, for a mechanical device, the concept of a "training set ground truth" is not directly applicable.
• Ground truth for defining device specifications (which could be likened to "training"):
  • Bench Testing Standards: Established through validated engineering principles and national/international standards (e.g., ISO, ASTM).
  • Clinical Relevance Studies: The "Separation Force characterization study" used a clinically relevant model (swine skin) to understand critical forces on peripheral IVs. This empirical data informed the acceptable force range for the SafeBreak® Vascular's separation. This data acted as the "ground truth" to establish the device's target performance specification.

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