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510(k) Data Aggregation
(66 days)
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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(76 days)
The Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into the intraoperative (soft tissue / body cavity) site and synovial cavity.
The Nerve Block Infusion Kit is nearly identical to the I-Flow PainBuster Infusion Kit with the exception of a new intended use, the addition of three new pump models and the addition of three new kit components (insulated Tuohy needle, hemostasis valve assembly and hookup wire). The kit is comprised of an elastomeric infusion pump (K944692) and various components such as catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, hookup wire and accessories such as carry case, power ring and clothing attachment clip (E-Clip). The Nerve Block pump is a disposable device intended for single patient use. The Nerve Block pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Here's an analysis of the provided text regarding the Nerve Block Infusion Kit, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Flow Rate Accuracy | ±15% at 95% confidence interval | "All models produced an average flow rate within the ±15% accuracy claim." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "nominal fill volumes for each model" but does not provide specific numbers of pumps or tests conducted.
- Data Provenance: Not explicitly stated, but it is implied to be internal testing conducted by I-Flow Corporation ("Testing occurred at standard operating conditions. Testing occurred at nominal fill volumes for each model."). There is no mention of external validation or data from specific countries. It is prospective in nature, as the testing was performed to support the premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study is a performance test of a medical device (infusion pump flow rate) and does not involve human expert interpretation or a "ground truth" in the clinical sense. The ground truth here is the physical measurement of the flow rate against a specified engineering tolerance.
4. Adjudication Method for the Test Set
Not applicable. This was a technical performance test, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an elastomeric infusion pump, not an AI-powered diagnostic or assistive technology involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance test was done. The device (Nerve Block pump) was tested to measure its flow rate performance against pre-defined accuracy claims. This refers to the intrinsic performance of the pump itself, independent of human interaction during operation beyond initial setup.
7. The Type of Ground Truth Used
The ground truth used was engineering specification/measurement against a defined tolerance. The "ground truth" for flow rate accuracy is the desired flow rate, and the measured flow rate must fall within ±15% of that desired rate at a 95% confidence interval.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."
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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