(115 days)
The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.
This 510(k) summary describes a submission for an infusion pump, which is a Class II medical device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or specific acceptance criteria with quantifiable performance metrics typically seen in AI/ML device submissions.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be definitively answered from the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in table format. The evaluation focused on non-clinical tests to verify that design modifications met "documented performance and safety requirements."
- Acceptance Criteria (Implicit): The device (ambIT® PreSet Ambulatory Infusion Pump) must perform safely and effectively for volumetric delivery of medicines/fluids at preset rates and volumes, similar to its predicate devices, particularly the Palm Pump (K002434), and meet all design requirements following software and PCB modifications.
- Reported Device Performance: "All tests will be conducted according to written test protocol, with defined test expectations and documented conclusions." The document claims that "documented verification and validation testing were defined and conducted... to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device." However, no specific performance values (e.g., accuracy of flow rate, battery life, alarm effectiveness) are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to "verification and validation testing" but does not indicate a sample size for any specific clinical or non-clinical test sets.
- Data Provenance: Not specified. The testing was conducted by Sorenson Medical, Inc.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. This device is an infusion pump, and its assessment focuses on engineering performance and safety rather than interpretative tasks requiring expert-established ground truth (like in medical imaging or diagnostic algorithms).
4. Adjudication Method for the Test Set:
Not applicable for a device of this nature. The "testing" referred to is performance and safety verification of the pump's mechanical and software functions, not interpretative data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret medical data, and the AI's impact on their performance is evaluated. This is an infusion pump, which does not involve human interpretation of complex medical data during its primary function.
6. If a Standalone Performance Study Was Done:
The document mentions "documented verification and validation testing were defined and conducted" to verify the design modifications met performance and safety requirements. This implies standalone testing related to the device's functional performance (e.g., accuracy of drug delivery, reliability of software). However, the specific methodology or quantitative results of such standalone functional testing are not detailed in this summary. The focus is on demonstrating substantial equivalence via design modifications and non-clinical testing.
7. Type of Ground Truth Used:
For an infusion pump, "ground truth" would relate to its engineering specifications and the accurate delivery of fluids.
- Ground Truth (Implicit): The ground truth for this device would be established by:
- Engineering Specifications: Pre-defined standards for flow rate accuracy, pressure limits, alarm thresholds, battery performance, etc.
- Bench Testing/Metrology: Using calibrated equipment to measure pump output, confirm programmed rates, and verify safety features against these specifications.
- Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (e.g., Palm Pump K002434) serve as a de-facto "ground truth" or benchmark for substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The device is a traditional electro-mechanical infusion pump with software.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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).