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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.

• 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.

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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:

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.

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The ID Power Infuser® Model M100B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with Clinical Shock, hypovolemic shock, and septic shock. 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 (K992044), the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid fluids. The ID Power Infuser® Model M100B-3A is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is intended to deliver resuscitative fluids, whole blood and packed red blood cells. The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) clearance letter for a medical device (Infusion Dynamics (ID) Power Infuser® Model M100B-3A). While it states that the device is "substantially equivalent" to predicate devices, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document primarily focuses on the regulatory clearance based on substantial equivalence, rather than a detailed technical performance evaluation or study results.

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The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.

The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.

The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

Not Found

This document is a 510(k) premarket notification approval letter for the Infusion Dynamics Power Infuser Model M100B. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms substantial equivalence to a predicate device and allows the manufacturer to market the device for specific indications of use, focusing on fluid resuscitation therapy. Therefore, I cannot answer your request based on the provided text.

Ask a specific question about this device

The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.

The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.

The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

Not Found

The provided text describes a 510(k) premarket notification for a device named "ID Power Infuser™." However, the document is a regulatory approval letter and an 'Indications For Use Statement'. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the ID Power Infuser™.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Ask a specific question about this device