(62 days)
The Power Infuser® Model M100B-3A is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points.
The device is intended for use by medical, paramedical and EMT personnel in the field and in pre-hospital and hospital environments.
When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood.
The device is not intended to support the delivery of any pharmaceutical or other medications.
The Power Infuser model M100B-3A, reviewed and cleared under (K030739) is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field, in pre-hospital transport, or in the hospital. When used with the Crystalloid/Colloid Cartridge, the device infuses crystalloid and colloid IV fluids, the most common initial therapy used to restore a patient's blood pressure and intravascular volume in both pre-hospital and hospital settings. When the device is used with the Blood Cartridge, it is intended to deliver crystalloid and colloid resuscitative fluids as well as whole blood and packed red blood cells. The device is not intended to support the delivery of any pharmaceutical or other medications.
This 510(k) submission (K090736) is for a change in the intended use statement of the ZOLL Power Infuser M100B-3A.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new acceptance criteria are presented in this submission. This submission does not introduce new performance requirements as the device's design and functionality remain unchanged. | Performance of the Power Infuser M100B-3A has not changed and remains substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No new performance testing was conducted for this submission. The submission explicitly states: "Since the design and functionality of the Power Infuser M100B-3A has not changed, performance testing was not conducted."
- Data Provenance: Not applicable, as no new testing was performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No new testing was performed requiring an expert-established ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. No new testing was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is an infusion pump, which does not involve an algorithm with standalone performance testing in the same way an AI/ML device would. No such testing was performed.
7. The Type of Ground Truth Used:
- Not applicable. No new performance testing was conducted. The basis for this submission is the substantial equivalence of the unchanged device with an expanded intended use, rather than new performance data requiring a ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This device is not an AI/ML device, and no training set was used.
Summary of the Submission:
This 510(k) submission (K090736) is purely focused on expanding the intended use statement of the existing ZOLL Power Infuser Model M100B-3A. The manufacturer explicitly states that the design, functionality, software, and hardware of the device have not changed since its original clearance (K030739). Therefore, no new performance testing, clinical studies, or AI/ML-related evaluations were conducted or required for this submission. The basis for substantial equivalence is the unchanged device itself, and its performance is considered equivalent to its predicate devices from previous clearances.
§ 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).