(93 days)
The Linear Health Science™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension. 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 SRVTM 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 infusion and continuous infusion.
The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
The Orchid SRVTM is for use with patients two (2) weeks 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, 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.
This document does not contain acceptance criteria or study results that demonstrate the device meets those criteria.
The information provided confirms that the Orchid Safety Release Valve™ (K230266) is substantially equivalent to its predicate device, also named Orchid Safety Release Valve™ (K212064). The only difference between the proposed device and the predicate is an update to the Indications for Use to include pediatric patients two (2) weeks of age and older, whereas the predicate was for patients eighteen (18) years of age and older.
The justification for this expanded indication is that "Pediatric extrapolation results supported safety and effectiveness of the Orchid SRV in pediatric patients." Additionally, the submission states that "The device performance of the subject and predicate device are identical and compatible with IV therapy in adult and pediatric patients. The results of pediatric extrapolation supported the similarities in risk profiles across all patient populations. Therefore, the change in indication does not questions of safety or effectiveness."
Here's what can be extracted based on your request, though limited by the document's content:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state specific acceptance criteria in a numerical or measurable format for performance, nor does it provide a table reporting on these. It generally asserts that the device is identical in performance to its predicate. The only performance-related characteristic mentioned is:
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Separation Force | The document states the predicate had a separation force of "1-4.2 lbf" and that the proposed device has "same". | "1-4.2 lbf" |
| Safety and Effectiveness | Demonstrated through pediatric extrapolation, implying comparability to adult use. | Supported by pediatric extrapolation results, with no new or different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size or data provenance for any test set. It mentions "Pediatric extrapolation results," but no details on how these results were obtained (e.g., sample size, type of study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The concept of "ground truth" and expert involvement in a test set as typically found in AI/imaging studies is not relevant to this device's submission, which relies on demonstrating substantial equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as there is no described test set or adjudication process in the context of this 510(k) submission.
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:
This is not applicable as the device (Orchid Safety Release Valve™) is a physical, tension-activated accessory, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" in the context of an algorithm's performance is not applicable here. The safety and effectiveness for the expanded pediatric indication were supported by "pediatric extrapolation results," implying an analysis of existing data or principles rather than a new data collection with a "ground truth" as typically defined for AI/diagnostic studies.
8. The sample size for the training set:
There is no mention of a training set in this document as the device is not an AI algorithm.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set mentioned.
§ 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.