Search Results
Found 1 results
510(k) Data Aggregation
(132 days)
The Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.
The Sgarlato PainFree pump is mechanically the same device currently legally marketed by Sgarlato Labs for continuous infusion of liquid medication into an intraoperative site for postoperative pain management. This infusion pump is one of a multiplicity of similar general purpose devices marketed to provide continuous infusion of moderate amounts of liquid medication (100-200 ml) over an extended period of time without use of electrical power. These mechanically-driven, single-use or reusable infusion pumps are therefore suitable for ambulatory use and can provide medication infusion via catheters for extended periods ranging from a few hours to several days. The PainFree pump uses a syringe-like reservoir that compresses the plunger against a self-contained spring to apply pressure to the liquid volume in the syringe. The Sgarlato device is distributed as a single-use sterile device.
This looks like a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a clinical study with detailed acceptance criteria and performance data in the way a PMA or clinical trial summary would.
Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The document describes the acceptance criteria by comparing the new device (Sgarlato PainFree pump) to two predicate devices (Paragon Infusion Kit K984146 and Sgarlato Pain Control Infusion Pump K990101) to establish substantial equivalence. The "performance" is demonstrated through this comparison, showing that its specifications are similar to or within the expected range of already cleared devices for its expanded indications.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates "performance" by being substantially equivalent to the predicate devices. The acceptance criteria are essentially met if the characteristics of the Sgarlato PainFree Pump are comparable to the Paragon Infusion Kit and the Sgarlato PCIP (Sgarlato Pain Control Infusion Pump), especially regarding the new indications.
| Item | Acceptance Criteria (from Predicate Devices) | Sgarlato PainFree Pump Performance (from device description) |
|---|---|---|
| Intended Use | Variety of continuous infusion for pain management (Intraoperative for PCIP; General Infusion for Paragon) | Continuous infusion of medication into a target site for pain management |
| Routes of Administration | Percutaneous (PCIP); Percutaneous, subcutaneous, intramuscular, and epidural (Paragon) | Percutaneous, subcutaneous, and epidural |
| Contraindications | Not for IV, blood products, lipids (Paragon); Not for epidural, subcutaneous, vascular, blood products, TPN (PCIP) | Not for IV, blood products, lipids, or fat emulsions |
| Reuse | Reusable pump, single-use administration sets (Paragon); Single Use (PCIP) | Single Use |
| Fill Volumes | 100 ml (Paragon); 100 or 200 ml (PCIP) | 100 or 200 ml |
| Flow Rates | 0.5, 1, 2, 4, or 10 ml/hr (Paragon); 0.5, 1, or 2 ml/hr (PCIP) | 1, 2, or 4 ml/hr |
| Flow control | Micro-bore tubing with medication filter (both predicates) | Micro-bore tubing with 5 micron medication filter |
| Pump Mechanism | Spring-scissors plate compressing PVC bag (Paragon); Spring-powered syringe plunger (PCIP) | Spring-powered syringe plunger |
| Power | Compressed spring (both predicates) | Compressed spring |
| Components and Materials | Conform with ISO 10993 part 1 for fluid path (both predicates) | Conform with ISO 10993 part 1 for fluid path |
| Safety/Alarms | None except fluid level indicator/plunger movement monitors flow (both predicates) | None except plunger movement monitors flow |
| Packaging | Tyvek-sealed tray with pump, administration sets, accessories (both predicates) | Tyvek-sealed tray with pump, administration sets, accessories, and catheter sets |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided within this 510(k) summary. This document relies on comparison to predicate devices, not a separate "test set" with patient data. The "test" is the comparison of device specifications and intended use against existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This is not a study requiring expert ground truth in the traditional sense. The "ground truth" for substantial equivalence is the FDA's existing clearances for the predicate devices.
4. Adjudication method for the test set
Not applicable/Not provided. No "test set" or adjudication process described as part of this substantial equivalence determination.
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 an infusion pump, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an infusion pump, not an algorithm. Its operation is purely mechanical.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness. The Sgarlato PainFree pump is deemed substantially equivalent if it shares similar technological characteristics and has the same or similar intended use, without raising new questions of safety and effectiveness, as demonstrated by the comparison table and descriptive text.
8. The sample size for the training set
Not applicable/Not provided. This is a mechanical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, no training set is relevant for this type of device submission.
Ask a specific question about this device
Page 1 of 1