Search Results

The Pajunk Plexolong sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connectors to assist the physician pinpoint the area of application.

The PAJUNK Plexolong sets contain single use sterile and non-pyrogenic needles with tubing. with or without a plastic cannula and catheters intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

This 510(k) summary describes a medical device, specifically an Anesthesia Conduction Kit. For this type of device, "acceptance criteria" are typically defined by adherence to recognized consensus standards and "device performance" is demonstrated through testing to ensure conformance to these standards, as opposed to clinical performance metrics for an AI-enabled device.

Let's break down the information requested based on the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The PAJUNK Plexolong Sets are designed to conform to recognized national and international consensus standards relevant to medical devices, particularly those for needles, cannulas, Luer fittings, sterilization, packaging, and risk analysis. The study demonstrating that the device meets these acceptance criteria involved performance testing to verify conformance to these applicable standards.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/Machine Learning Specific Questions:

The provided document describes a conventional medical device (anesthesia conduction kit) and does not refer to any AI or machine learning components. Therefore, the following AI/ML-specific questions are not applicable to this submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes a physical medical device, not an AI/ML algorithm or software that uses test data in the conventional sense. Performance testing was conducted on samples of the physical device according to industry standards.

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)

• Not applicable. Ground truth in the context of expert consensus is not relevant for this physical device. Performance is assessed against engineering and material specifications as defined by consensus standards.

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

• Not applicable. This relates to AI/ML model performance evaluation, not a physical medical device.

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 does not involve human "readers" or AI assistance.

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

• Not applicable. There is no algorithm or software component described.

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

• For this device, "ground truth" is established by the specifications outlined in the referenced consensus standards. Device components (e.g., Luer fittings, cannula dimensions, material properties, sterility assurance) are tested against these published, accepted industry standards.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an AI/ML model.

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

• Not applicable. This device does not involve a training set for an AI/ML model.

Ask a specific question about this device

The Paragon Infusion Kit is intended to provide continuous infusion a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion. The Paragon pump is re-usable. The disposable Paragon administration set is single patient use only. No testing has been conducted to determine the efficacy of the Paragon for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is not intended for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The Paragon Infusion Kit is identical to the I-Flow PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump. The kit is comprised of a Paragon pump and administration set (K923875) and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The Paragon administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The provided text describes the "Paragon Infusion Kit" and includes a summary of safety and effectiveness, as well as operational specifications and performance data. The device is an infusion pump kit intended for continuous infusion of local anesthetics for postoperative pain management.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Flow Rate Accuracy: ±10% at 95% confidence interval (as stated in Section 3.1)

Additional Acceptance Criteria / Operational Specifications (Section 3.1):

• Priming/Residual Volume:

Ask a specific question about this device

1. The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative (soft tissue / body cavity) site for postoperative pain management.
2. The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
3. The PainBuster is single use only.
4. The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
5. The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
6. The PainBuster is not intended for chemotherapy drugs.
7. No testing has been conducted to determine the efficacy of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.

The PainBuster Infusion System is a kit that is comprised of an elastomeric infusion pump, a catheter and a needle. The PainBuster pump is the Homepump C-Series with a new intended use. The pump design is identical to the original Homepump C-Series except as follows: The PainBuster pump utilizes the same soft PVC shell that the Homepump Eclipse uses. The two (2) outer natural latex bladders have been replaced by a single thicker natural latex bladder. The PainBuster pump is intended to be used with a catheter that is included with the kit.

The provided document describes the I-Flow PainBuster Infusion System. This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel acceptance criteria.

The acceptance criteria primarily relate to the device's operational specifications, particularly its flow rate accuracy. The study demonstrating that the device meets these criteria is an engineering performance test rather than a clinical study involving human patients or ground truth established by experts.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Flow Rate Performance Data (Test Set):
  • 65ml x 0.5ml/hr model: 27 units
  • 125ml x 2.0ml/hr model: 26 units
• Sample Size for Back Pressure Comparison (on Homepump Eclipse, a predicate device):
  • 65ml x 0.5ml/hr model: 15 units at 16" HH, 10 units at 42" HH, 10 units at 3.1 psi
  • 100ml x 2.0ml/hr model: 15 units at 16" HH, 15 units at 42" HH, 15 units at 3.1 psi
• Sample Size for Drug Delivery Comparison (on Homepump Eclipse, a predicate device):
  • Saline: 30 units
  • 5% Dextrose: 15 units
• Sample Size for Catheter/PICC Line Effects (on Homepump Eclipse, a predicate device):
  • PICC Line (Room Temp): Not specified per test, but maximum/minimum/std dev suggest multiple runs/samples
  • PICC Line (31°C): Not specified per test
  • Epidural Catheter (Room Temp): Not specified per test
  • Epidural Catheter (31°C): Not specified per test
• Data Provenance: The data appears to be from prospective in-vitro engineering performance tests conducted by I-Flow Corporation. There is no information about the country of origin of the data, but it can be inferred that it was likely conducted in the US, given the company's address and the FDA submission.

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

Not applicable. The "ground truth" here is the physical performance of the device (flow rate, residual volume, etc.) determined through engineering measurements, not expert assessment of a condition.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This concept pertains to expert review of clinical cases. The tests described are objective engineering measurements.

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 is not a diagnostic device involving human readers or AI.

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

This refers to a standalone performance of the device itself (the infusion pump), which is what the engineering tests described in "Flow Rate Performance Data" and "Operational Specifications" represent. The device's performance is measured and compared against its defined accuracy criteria. Therefore, the standalone performance data is available.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used is the objective physical measurement of the device's operational parameters (e.g., actual flow rate per hour, volume, pressure) against predetermined engineering specifications and industry standards.

8. The Sample Size for the Training Set

Not applicable. This is an elastomeric infusion pump, not an AI/ML algorithm that requires a training set. The device is designed based on engineering principles and tested for its inherent physical properties.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device