(89 days)
General surgical fluid irrigation and infiltration.
The principles of operation and technology incorporated in the 1000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids).
The provided text is a 510(k) summary for the "1000 Pressure Infusor" device. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to premarket approval.
This document describes a medical device called a "Pressure Infusor" for general surgical fluid irrigation and infiltration, not an AI/ML powered device.
Therefore, most of the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this type of device and submission.
The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel technology like AI/ML.
Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly not present due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This document does not present a table of specific quantitative acceptance criteria or reported performance data in the way an AI/ML device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices, meaning its performance characteristics are assumed to be similar and acceptable if proven equivalent in function and safety.
The "performance" demonstration for this type of device would typically involve showing that it achieves the intended function (pressurizing fluid bags for irrigation/infiltration) safely and effectively, similar to the predicate devices. This usually involves:
- Materials Compatibility: Ensuring materials in contact with fluids are safe.
- Pressure Control: Demonstrating the device can achieve and maintain appropriate pressure ranges without exceeding safe limits.
- Leakage/Integrity: Proving the system is robust and leak-proof.
- Biocompatibility: If applicable, ensuring materials are biocompatible.
- Sterilization Validation: If the device or components are sterile.
However, none of these specific performance criteria or results are quantified or tabulated in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. There is no "test set" in the context of an AI/ML algorithm evaluation mentioned in this document. The submission is for a physical medical device (Pressure Infusor).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. Ground truth, in the context of expert consensus, is irrelevant for a mechanical device like a pressure infusor.
4. Adjudication Method for the Test Set
Not Applicable. There is no "test set" or diagnostic decision to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of physical device. Such studies are used for evaluating diagnostic performance, often in imaging, involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
Not Applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) as applied to AI/ML diagnostics is not relevant here. The "truth" for this device lies in its mechanical function, safety, and effectiveness.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Device and 510(k) Submission:
- Device Name: 1000 Pressure Infusor
- Indication for Use: General surgical fluid irrigation and infiltration.
- Device Description: Uses compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion.
- Substantial Equivalence Claim: The device's principles of operation and technology are similar to other irrigation devices (listed as predicates) previously found substantially equivalent by the FDA.
- Predicate Devices:
- MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc (Medex, Inc. - K800560)
- Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (Davol, Inc. - K953574)
- Automatic Surgical Irrigation Pump/Autocuff (Alton Dean Medical, Inc./Spartamed, Inc. - K922286)
- Niagara Pump, 3.0 Liter High Volume (Cabot Medical Systems - K924530)
- Big Bag 3000 (Byron Medical - K973133)
- Lapro Flow 3000 (ASSC - K980089)
- FDA Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
In essence, the "study" proving this device meets acceptance criteria is the demonstration that its design and function are sufficiently similar to multiple existing, approved predicate devices, implying it shares their established safety and effectiveness profile. This is a common pathway for physical medical devices where there isn't a complex diagnostic algorithm or novel biological interaction.
§ 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).