(97 days)
The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic syringe infusion pump and pump accessories. The Perfusor Space Infusion Syringe Pump System utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.
The provided text describes a 510(k) premarket notification for the B. Braun Medical Inc. Perfusor® Space Infusion Syringe Pump System. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical trial for a diagnostic AI device would.
Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study, standalone performance) is not present in the provided text.
Specifically, the document addresses new functionalities added to an existing device: barcode, out-bound wireless data transmission, and PCA (Patient-Controlled Analgesia) functionality. The primary claim is "substantial equivalence" to predicate devices, meaning it performs similarly and presents similar safety and effectiveness.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document focuses on substantial equivalence based on comparable type, indications for use, and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe a "test set" or a study designed to measure performance metrics. It's a regulatory submission for device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no mention of a ground truth being established by experts for a test set in this regulatory submission.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC study is mentioned. The document primarily discusses the technical features and intended use of the infusion pump system and its new functionalities. This is a medical device, not a diagnostic AI system, so MRMC studies are not typically conducted for this type of product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is an infusion pump system, not an AI algorithm designed to interpret data or diagnose conditions. Its performance is inherent in its mechanical and software functions for drug delivery.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as used in evaluating AI or diagnostic systems does not apply to this medical device submission. The "truth" here relates to the reliable and accurate functioning of the pump in delivering fluids/medications as intended.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a traditional medical device, not an AI/machine learning device that would typically involve a training phase on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of the document's content relevant to evaluation:
The document establishes that the Perfusor® Space Infusion Syringe Pump System, with its added barcode, out-bound wireless data transmission, and PCA functionalities, is substantially equivalent to predicate devices:
- Predicate device for the original pump system: The Perfusor® Space Infusion Syringe Pump System (K062699).
- Predicate device for barcode and out-bound wireless data transmission: B. Braun Medical Inc. Outlook® Safety Infusion System (K011975).
- Predicate device for PCA functionality: MEDLEY™ PCA Module (K032233) by ALARIS Medical Systems Inc.
The argument for substantial equivalence is based on:
- Comparable type: All are computer-controlled electrical, external, syringe infusion pumps.
- Similar indications for use: For infusion of parenteral fluids/medications, blood, and blood products for adults, pediatrics, and neonates.
- Similar technological characteristics: Implementing advanced features (barcode, wireless, PCA) in a similar manner, using communication protocols (CAN bus) for data exchange with hospital information systems. All data transmitted uses B. Braun's proprietary information protocol to ensure data integrity.
- Similar accessories: Providing clinician flexibility, organizing the bedside, central power supply, tubing retainers, ease of transportation, and customization of menu/drug library parameters.
§ 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).