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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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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.

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General surgical fluid irrigation and infiltration.
The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the 3600 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 a medical device (3600 Pressure Infusor) and the FDA's response. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML medical devices.

Instead, this document describes a traditional medical device submission for substantial equivalence. The "study" here is essentially the comparison to predicate devices, and the "acceptance criteria" are implied by the FDA's finding of substantial equivalence.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) do not apply to this type of regulatory submission.

Here's how to interpret the document in the context of the prompt:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This is a comparison to predicate devices, not a performance study with a test set of data.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth, in the sense of expert consensus on diagnostic or prognostic outcomes, is not part of a substantial equivalence submission for this type of device.

4. Adjudication method for the test set

• Not applicable.

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 is not an AI/ML device, nor is it a study comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not applicable in the common sense for AI/ML. The "ground truth" for this submission is established through comparison to legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a traditional medical device (a pressure infusor). The "study" is the comparison to predicate devices, and the "acceptance criteria" are met by demonstrating substantial equivalence to those legally marketed devices based on shared principles of operation, technological characteristics, and intended use. The concepts of test/training sets, expert consensus for ground truth, and reader studies are not relevant to this type of regulatory submission.

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The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the Big Bag 3000 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 Byron Medical Big Bag 3000 Pressure Infusor, which is a device used for general surgical fluid irrigation and infiltration. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel or entirely new class of medical device.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for performance validation.
• Sample size for the training set or how ground truth for the training set was established.

Explanation of document content:

The core of this 510(k) submission is to establish that the Big Bag 3000 Pressure Infusor is "substantially equivalent" to legally marketed predicate devices. This means that its fundamental technology, principles of operation, and indications for use are similar enough to existing devices that it does not raise new questions of safety or effectiveness.

The document explicitly states:

• "The principles of operation and technology incorporated in the Big Bag 3000 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." (Page 1)
• "The principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below." (Page 1)

It then lists several predicate devices (e.g., Medex. Inc. Pressure Infusor, Davol, Inc. Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer) with their 510(k) numbers and substantial equivalence dates. This is the primary "proof" provided – a comparison to devices already cleared by the FDA.

In summary, this document is a regulatory submission for substantial equivalence based on technological similarity to existing devices, not a detailed clinical or performance study with specific quantitative acceptance criteria.

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