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The SIMS Regional Anesthesia Tray is intended to be used to administer patient regional or local anesthesia.

The EpiFuse™ Catheter Connector is an alternate catheter connector for inclusion in the SIMS Regional Anesthesia Tray. The EpiFuse™ Catheter Connector consists of two halves joined by a living hinge. The main body contains an elastomeric tube. The catheter is inserted into the input hole at the base of the connector and is retained by the elastomeric tube when the two halves of the connector are folded together. The elastomeric tube also creates a seal to prevent leakage. The design of the modified EpiFuse™ Catheter Connector allows the user to close the device with one hand while holding the catheter with the other. To release the catheter, a Luer slip device is inserted into the release aperture and the two halves of the connector will separate allowing removal of the catheter. The key features and benefits of the EpiFuse™ Catheter connector include a yellow connector body for easy identification as Epidural during clinical use. The EpiFuseTM Catheter Connector is designed for use with 19G, 20G, and 21G epidural catheters. It offers one hand activation for a simplified ease of use and includes a secure locking mechanism to reduce the risk catheter disconnection.

This is a 510(k) premarket notification for a medical device modification, specifically for the EpiFuse™ Catheter Connector within the SIMS Regional Anesthesia Trays. The provided document is a summary and an FDA clearance letter, not a detailed study report. Therefore, much of the requested information regarding a comprehensive clinical study or specific acceptance criteria with detailed performance metrics is not present. This type of submission often relies on a comparison to predicate devices and verification/validation testing rather than extensive clinical trials with human subjects.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, numeric acceptance criteria. Instead, it broadly states that "Verification/validation testing confirm that the EpiFuse™ Catheter Connector is suitable for use with 19G, 20G, and 21G epidural catheters and is safe and effective for its intended use as a component of the SIMS Regional Anesthesia Tray."

This suggests that the acceptance criteria would have been defined internally by the manufacturer and likely cover aspects such as:

• Catheter Compatibility: Successful connection, retention, and release of 19G, 20G, and 21G epidural catheters.
• Leakage Prevention: Effective sealing to prevent leakage.
• Ease of Use: One-hand activation.
• Secure Locking Mechanism: Reduction of disconnection risk.
• Biocompatibility: Likely assessed based on material specifications, not explicitly detailed here.
• Sterility: Assessed as part of the overall tray.
• Dimensional Accuracy: Fit within the tray and with catheters.
• Material Strength/Durability: E.g., ability to withstand repeated use/sterilization if applicable (though this is a disposable connector).

Reported Device Performance:

• Compatibility: "suitable for use with 19G, 20G, and 21G epidural catheters."
• Safety and Effectiveness: "safe and effective for its intended use."
• Key Features and Benefits (implying performance):
  • Yellow connector body for easy identification as Epidural.
  • One-hand activation.
  • Secure locking mechanism to reduce risk of catheter disconnection.

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

• Sample Size: Not specified in the provided text. The phrase "Verification/validation testing" is broad and does not detail specific sample sizes for tests such as pull strength, leak tests, or functional evaluations.
• Data Provenance: Not specified. It's internal manufacturer testing, so it would be laboratory-based and likely conducted at the manufacturer's facility in Keene, NH, USA. It is not a clinical study with patient data, so "retrospective or prospective" is not applicable in the human-subject sense.

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

• This information is not provided. Given that this is a 510(k) for a device component, the "ground truth" would likely be established through engineering specifications, material standards, and performance testing against industry standards, not by clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies in expert interpretations (e.g., in reading medical images or clinical outcomes). This document describes engineering verification and validation, not a multi-expert review process for clinical data.

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

• No, an MRMC comparative effectiveness study was not done or reported in this document. Such studies are typically for diagnostic imaging devices or software where human readers interpret data with and without AI assistance. This device is a mechanical connector.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This is a physical medical device component, not an algorithm. Its performance inherently involves human interaction for placement and connection.

7. Type of Ground Truth Used

• The "ground truth" for this device would be established through engineering specifications, functional requirements, material standards, and performance against predefined testing protocols (e.g., for catheter retention force, leak integrity, ease of activation). It is not pathology, outcomes data, or expert consensus in the clinical sense. The document states "Verification/validation testing confirm..." which implies objective, measurable criteria were used.

8. Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set is involved for this type of device.

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The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.

The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.

The catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete.

The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).

The provided document, K994275, describes a 510(k) premarket notification for the SIMS Portex Anesthesia Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for a novel device, such as detailed performance metrics from a specific test set, expert adjudication, or MRMC studies, is not present in this document.

Instead, the document emphasizes equivalence through non-clinical data demonstrating that the new catheter performs equivalently to predicate devices for specific characteristics.

Here’s an analysis based on the provided text, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Inner Diameter (ID)
• Outer Diameter (OD)
• Length | Demonstrated equivalency to predicate devices. |
  | Functional Characteristics | - Flow Rate
• Leakage
• Eye Patency
• Tensile Strength
• Percentage Elongation
• Luer Taper
• Security of Connection of the catheter to the catheter connector
• Hub/Catheter Detachment | Demonstrated equivalency to predicate devices. |
  | Material Safety | - ETO residuals (Ethylene Oxide sterilization residuals)
• Biological Safety per ISO 10993 | Data submitted covers ETO residuals and biological safety per ISO 10993. |

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the way one would for a clinical study with patients or a specific set of images for an AI algorithm. The performance evaluation was based on non-clinical data comparing the new device's characteristics against predicate devices. The exact sample sizes for each physical or material test (e.g., number of catheters tested for flow rate, tensile strength, etc.) are not provided in this summary.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, bench-top type tests. The tests would likely have been conducted in a lab setting by the manufacturer (SIMS Portex Inc., likely in Keene, NH, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the evaluation was based on objective, quantifiable physical and material tests against manufacturer specifications and predicate device characteristics, not subjective interpretations by experts to establish a "ground truth" in a clinical diagnostic sense.

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

This is not applicable for the non-clinical, bench-top tests conducted.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an anesthesia catheter, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is an anesthesia catheter, not an algorithm.

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

The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate devices and recognized industry standards (e.g., ISO 10993 for biological safety). The new device's performance in dimensional, functional, and material safety tests was compared directly to these objective benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. The device is an anesthesia catheter and does not involve a training set as would be used for machine learning.

9. How the ground truth for the training set was established

This question is not applicable for the reasons stated above.

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The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.

The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks. The catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).

The provided 510(k) summary for the SIMS Portex Epidural Catheter indicates that no clinical data was submitted to demonstrate the device meets acceptance criteria. Instead, the submission relies on non-clinical data to establish substantial equivalence to a predicate device.

Therefore, many of the requested sections regarding clinical study design, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set. Non-clinical data was used.
• Data Provenance: Not applicable. Non-clinical data.

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

• Not applicable. No clinical test set requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication.

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

• Was an MRMC study done? No.
• Effect Size of Human Readers with/without AI assistance: Not applicable, as this is neither an AI device nor was an MRMC study performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Not applicable. This is not an AI algorithm. The device is a physical epidural catheter.

7. Type of Ground Truth Used

• For Non-Clinical Data: Engineering specifications, material science standards (e.g., ISO 10993 for biological safety), and comparative measurements against the predicate device.

8. Sample Size for the Training Set

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. This is not an AI algorithm requiring a training set or ground truth establishment for training.

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