(305 days)
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion.
The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
The Orchid SRV™ is for use with patients eighteen (18) years of age and older.
The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.
The provided text describes the Orchid Safety Release Valve™ (Orchid SRV™), a medical device intended to reduce peripheral IV mechanical complications. The information focuses on its substantial equivalence to a predicate device (SafeBreak® Vascular) and outlines various performance and safety tests.
Here's a breakdown of acceptance criteria and associated study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Subject Device (Orchid Safety Release Valve™) Performance | Predicate Device (SafeBreak® Vascular) Performance (for comparison) | Substantial Equivalence Determination / Comment |
|---|---|---|---|
| Intended Use | Tension-activated accessory for single patient use, placed between IV administration set and IV extension set connection. Designed to allow flow, separate and close flow path in both directions when excessive tension acts on the line. Intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. For use with patients 18 years and older. | Separates when excessive tension is exerted across a peripheral IV administration set. Stops fluid flow from infusion pump and blood flow from patient's IV catheter. Intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. For use on peripheral IV catheters in adults and adolescent populations 18 years and older receiving intermittent or continuous infusions with an electronic pump. | Same intended use; subject device has a lower separation force designed to prevent dislodgement with lower pull-force securement methods. |
| Separation Force | 1-4.2 lbf | 4 ± 1 lbf | The lower limit of the Orchid SRV's separation force (1-4.2 lbf) was specifically designed to provide separation prior to securement device failure, even for securement devices with lower pull forces used for fragile skin. Performance testing demonstrated device conforms to this specification. |
| Functional Testing | - Tensile Strength Testing (ISO 8536-4 A-3) |
- Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D)
- Force to Disconnect
- Air Leakage Device Activated (ISO 80369-20:2015 Annex D)
- Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C)
- Water Leakage Female (ISO 80369-20:2015 Annex C)
- Water Leakage Male (ISO 80369-20:2015 Annex C)
- Flow Rate
- Re-assembly Prevention
- Assembly Weight
- Particulate Testing (USP ) | Not explicitly stated in the comparison table, but implied similar functionalities. | These tests were performed to demonstrate that the proposed Orchid SRV™ met applicable design and performance requirements. |
| Usability Testing | Performed | Not specified | Performed. |
| Clinical Simulation Testing | Performed | Not specified | Performed. |
| Sterilization | Ethylene Oxide, SAL 10⁻⁶ | Ethylene Oxide, SAL 10⁻⁶ | Same. Sterilization validation followed AAMI TIR28:2016 and ISO 14937:2009 (half dose method, overkill approach). |
| Biocompatibility | Meets requirements outlined in ISO 10993-1:2018 for externally communicating, prolonged exposure device indirectly contacting the blood path. Required tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Haemocompatibility) were performed. | Not specified, but generally a requirement for such devices. | Biocompatibility testing performed on the final Orchid Safety Release Valve™ demonstrates compliance. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices or cases) for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for the performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The listed tests are primarily engineering and laboratory-based performance evaluations, rather than studies requiring expert interpretation of diagnostic inputs or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests described are objective performance evaluations based on established international standards (ISO, ASTM, USP) and device specifications, not subjective assessments requiring adjudication by multiple experts.
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
Not applicable. This device is a mechanical IV accessory, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers with AI assistance" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a mechanical component and does not involve an algorithm. The performance evaluation is inherently "standalone" in the sense that it assesses the device's functional characteristics directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests is derived from:
- Engineering specifications and design requirements: For parameters like separation force.
- International standards (ISO, ASTM, USP): These standards define acceptable methodologies and thresholds for various tests (e.g., tensile strength, air/water leakage, sterilization, biocompatibility).
- Functional objectives: The device must reliably separate and close flow paths under specific tension.
8. The sample size for the training set
Not applicable. This device is a mechanical component, not a machine learning model, so there is no concept of a "training set" in the context of its development or validation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.