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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 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 infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of 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.

The document provided is a 510(k) summary for the Orchid Safety Release Valve™ (K241415), which is being submitted for substantial equivalence to a previously cleared device (K232094). The primary difference between the two devices lies in a change to the contraindications, allowing for use with blood, which required additional hemocompatibility testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in numerical terms for the hemocompatibility testing. Instead, it states that "additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness." This implies that the device met internal acceptance criteria for these tests.

However, the "Table 1: General Technological Characteristics Comparison" provides a comparison of features, and for "Contraindications," it implicitly describes the change and how it was supported:

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 the sample size for the hemocompatibility tests or the provenance of the data (e.g., in vitro, animal, human). It only states that these tests were conducted.

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. The hemocompatibility tests are typically laboratory-based and follow established international standards (ISO 10993-4: 2017), which define parameters for assessing blood interactions, rather than relying on expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench or laboratory testing.

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 study was not done. This device is a mechanical medical device, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable and not provided. The device is a mechanical safety release valve, not an algorithm, so there is no "standalone" algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hemocompatibility testing, the ground truth is established by the accepted scientific principles and thresholds defined within the ISO 10993-4: 2017 standard for biological evaluation of medical devices. The test results are compared against these established criteria to determine safety.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical product, 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 and not provided, as there is no training set for this type of device.

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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 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 infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of 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.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting raw performance data or detailed study methodologies.

Here's a breakdown of why I cannot fulfill your request based on this document:

• Acceptance Criteria and Reported Device Performance: While the document implies certain performance characteristics (e.g., separating when excessive tension applies, closing flow path), it does not provide a table of explicit acceptance criteria or quantitative performance metrics from a study for the subject device. It states, "There is no change in performance data since there are no changes to the device or its manufacturing processes," referring back to the predicate device.
• Sample Size and Data Provenance (Test Set): No information on a test set sample size, country of origin, or whether data was retrospective or prospective is present.
• Number of Experts and Qualifications (Ground Truth for Test Set): The document does not describe the establishment of ground truth for any test set, nor does it mention experts or their qualifications.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance, as the device is a mechanical one, not an AI-powered diagnostic tool.
• Standalone Performance Study: No standalone performance study details are provided.
• Type of Ground Truth Used: Not applicable for a mechanical device in this context, as there's no diagnostic component.
• Sample Size for Training Set: Not applicable as this is a mechanical device, not a machine learning model.
• Ground Truth for Training Set: Not applicable.

What the document does state regarding performance:

The document relies on the equivalence to its predicate device (K230266) and an "extrapolation and benefit/risk assessment" to support the expanded indications for use. It explicitly says:

• "There is no change in performance data since there are no changes to the device or its manufacturing processes." (Page 9)
• "Extrapolation results supported safety and effectiveness of the Orchid SRV in all IVs." (Page 9)
• "The conducted extrapolation and benefit/risk assessment demonstrate that the differences in the indications for use do not raise any new or different questions of safety and efficacy." (Page 9)

In essence, this FDA summary asserts that because the device is fundamentally identical to its previously cleared predicate, its performance (and the studies supporting that performance) also remain unchanged. The new submission is primarily to expand the "Indications for Use" from "peripheral IV catheters" to "all IV catheters" based on an extrapolation assessment rather than new, large-scale clinical performance studies directly included in this specific 510(k) summary.

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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:

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.

Ask a specific question about this device

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

• 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.

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