(316 days)
The Power Infuser® 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 and EMT personnel in the field and in pre-hospital and hospital environments.
When used with the Crystalloid 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 ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump designed for rapid intravenous fluid delivery in the field, in pre-hospital transport, or in the hospital. The device supports two types of Power Infuser Cartridges, both of which are sterile and intended for single use:
- · 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 cells.
The device, along with the cartridges, is not intended to support the delivery of any pharmaceutical or other medications.
Power infuser works on the principle of the shuttle pump mechanism wherein the tubing in the cartridges is squeezed (but not fully occluded) to allow the free flow of the fluid in the forward direction.
As a part of the current application we are proposing a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain).
The proposed material change is restricted to the Crystalloid/Colloid Cartridge and Blood Cartridge only. No changes has been made to the Power Infuser Pump as a result of the proposed change. The indications for use of the device, as described in the current application, has not changed as a result of the proposed modification.
No new accessories have been added, as part of the current submission, due to the proposed change. All the accessories offered with the ZOLL Power Infuser have been reviewed and cleared with the K090736.
This document is a 510(k) premarket notification for a material change to the ZOLL Power Infuser, not a study evaluating acceptance criteria of a novel AI-based medical device. Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.
The document describes a material change in the tubing of an existing infusion pump and provides non-clinical evidence (functional and biocompatibility testing) to demonstrate that the modified device remains substantially equivalent to its predicate.
However, based on the information provided in the document, here's what can be extracted regarding the device's testing and compliance, rephrased to align with the prompt's structure where possible, even if it doesn't directly answer all AI-focused questions:
1. A table of acceptance criteria and the reported device performance:
Since this is not a study presenting specific quantitative acceptance criteria and performance metrics for a novel device, the table below reflects what was tested and confirmed for the material change. Specific numerical acceptance criteria are not detailed in this summary.
| Acceptance Criteria Category | Reported Device Performance/Testing Result |
|---|---|
| Functional Tests | Device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-24. Further tested for accurate functioning of air alarms, occlusion alarms, and flow rate settings with the new tubing. (Results implicitly indicate compliance and accurate functioning as stated in the conclusion of substantial equivalence). |
| Biocompatibility Tests (new Tygon tubing) | Performed in accordance with FDA Guidance, Use of International Standard ISO 10993-1. Specific tests performed: |
- ISO 10993-5 Test for In Vitro Cytotoxicity
- ISO 10993-10 Test for Irritation and Skin Sensitization
- ASTM F 756-13 In Vitro Hemolytic Properties of Materials
- ISO 10993-11 Test for Acute Systemic Toxicity and Pyrogenicity Test
- ISO 10993-4 Selection of tests for interactions with blood (Complement Activation test, In-vitro Hemocompatibility test, and Partial Thromboplastin test).
The results of the Tygon Tubing Qualification and supplemental testing provide evidence that the cartridges with the new Tygon tubing meet the integrity and performance testing requirements. |
| Substantial Equivalence | Proven by demonstrating that the proposed Power Infuser, with the new tubing, maintains the same intended use, operating mechanism, and function as the predicate device (K090736), and meets safety and performance standards equivalent to or better than the predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document mentions "validation testing" and "further tested," implying a defined test set, but the number of units or test runs is not disclosed.
- Data Provenance: Not specified. The testing was conducted to support a U.S. FDA 510(k) submission, so it would likely follow U.S. regulatory guidelines. The nature of the tests (functional, biocompatibility) suggests laboratory-based testing rather than clinical data from a specific country or retrospective/prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This is not applicable as the submission pertains to a material change in an infusion pump, which does not involve "ground truth" derived from expert interpretation in the same way an AI diagnostic device would. Functional and biocompatibility testing results are objective measurements against established standards, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes for subjective assessments, which is not the nature of the validation testing described here.
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. This device is an infusion pump, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not have an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI device. For this submission, the "ground truth" for material properties and device function would be established by scientific and engineering standards (e.g., material safety standards, flow rate accuracy standards, alarm activation thresholds) as measured through laboratory testing.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a training set.
§ 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).