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510(k) Data Aggregation
(132 days)
SGARLATO LABORATORIES, INC.
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.
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(66 days)
SGARLATO LABORATORIES, INC.
The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.
The Pain Control Infusion Pump 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.
The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.
The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.
This document describes a 510(k) submission for the Pain Control Infusion Pump (K990101). Based on the provided text, the device is claiming substantial equivalence to a predicate device, the Burron Ambulatory Drug Delivery System (K896422).
The key aspect of this submission is that the Pain Control Infusion Pump is identical in design to the predicate device and will be manufactured by the same company (Burron, a division of B. Braun, Inc.). There are no changes in design, materials, manufacturing methods, or intended use; only minor name changes in the labeling.
Therefore, the acceptance criteria and proof of meeting those criteria for this specific submission are based on the demonstration of substantial equivalence to the predicate device, rather than a new performance study of the device itself.
Given this context, the request for a table of acceptance criteria and reported device performance through a study is not directly applicable in the way it might be for a novel device or an AI/ML powered device. This submission relies on the established performance and safety of the predicate device.
Here's how to address the questions based on the provided information:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for the Pain Control Infusion Pump (K990101)
This 510(k) submission for the Pain Control Infusion Pump (K990101) relies on the demonstration of substantial equivalence to a legally marketed predicate device, the Burron Ambulatory Drug Delivery System (K896422). The submission explicitly states that the proposed device is identical in design, materials, method of manufacture, and intended use to the predicate device. Therefore, the "acceptance criteria" revolve around proving this substantial equivalence, rather than conducting new performance studies on the Pain Control Infusion Pump itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance / Evidence |
|---|---|
| Intended Use: Device performs the same function as the predicate device. | "The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System." (Section 19) |
| Technological Characteristics: Device has the same design, materials, and manufacturing process as the predicate device. | "The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc." (Section 19) |
| "There is no change in design, materials, method of manufacture..." (Section 19) | |
| Labeling Equivalence: Only minor name changes from predicate device labeling, with no new safety or effectiveness concerns. | "...only minor name changes in the labeling from the Burron device." (Section 19) |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Implied by the identical nature to a legally marketed predicate and the absence of any design or material changes. (Section 19) |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) for this 510(k) submission.
Since the device is identical to a predicate, no new "test set" or performance data specific to the Pain Control Infusion Pump were required or submitted. The substantial equivalence relies on the established safety and effectiveness of the legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A).
No new clinical studies or "test set" requiring expert ground truth establishment were conducted for this substantial equivalence claim.
4. Adjudication method for the test set
Not Applicable (N/A).
No test set requiring adjudication was used.
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 (N/A).
This device is an infusion pump, not an AI/ML diagnostic or image analysis device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A).
This device is an infusion pump, not an algorithm, and does not operate in a standalone algorithmic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A), in the context of a new performance study.
The "ground truth" for this submission is the pre-existing regulatory approval and established safety and effectiveness of the identical predicate device, the Burron Ambulatory Drug Delivery System (K896422), which served as the basis for substantial equivalence.
8. The sample size for the training set
Not Applicable (N/A).
This device is an infusion pump and does not involve AI/ML or a "training set" in the context of device performance evaluation.
9. How the ground truth for the training set was established
Not Applicable (N/A).
As there is no training set, this question is not relevant.
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(62 days)
SGARLATO LABORATORIES, INC.
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.
I apologize, but the provided text from the 510(k) summary (K982931) for the "Threaded Fixation Pin" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
This 510(k) summary is a declaration of substantial equivalence to predicate devices, focusing on the device's intended use and design similarities, rather than detailed performance study results.
Therefore, I cannot populate the requested table or answer the specific questions about studies and data provenance based on this document. The document primarily acts as an FDA clearance letter and an "Indications for Use" statement.
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