(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.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).