(269 days)
The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The Pak 2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.
Each of the iv fluid warmer devices (Soft Pack, FloorMount and Pak 2) employs a heating plate or heating blanket to warm or maintain the temperature of iv fluids such as normal saline and ringers lactate. These devices use a standard temperature control method and operate reliably in the range of 36-38 degrees C. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field.
The Thermal Sack Pressure Infuser is an accessory to the Smithworks iv fluid warmer components. This device is wrapped around the iv fluid bag and is used to apply even pressure to the iv fluid bag when it cannot be maintained in the standard hanging state, which applies normal gravity pressure. This device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.
This document is a 510(k) premarket notification for "The Smithworks Company IV Fluid Warmer" product line, dated November 29, 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in a robust clinical trial setting.
The document does not contain explicit acceptance criteria tables or detailed study results (like clinical trials or performance studies with statistical analysis) in the way a typical academic paper or a more recent 510(k) summary might for a novel AI device. Instead, it describes characteristics and operational parameters, and then asserts substantial equivalence based on those.
However, we can infer some "acceptance criteria" based on the described features and comparison to predicate devices. For parts of your request that cannot be directly answered from the provided text, I will state that the information is not available in the given document.
Here's an attempt to answer your questions based on the provided text:
Analysis of Acceptance Criteria and Device Performance (Inferred)
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance characteristics of the device and its substantial equivalence to predicate devices, particularly regarding temperature control and fluid compatibility. There are no explicit, quantifiable acceptance criteria presented as a table with associated performance metrics from a formal study.
However, based on the Device Descriptions and Comparison with Legally Marketed Devices sections, we can infer the following:
| Acceptance Criterion (Inferred from Device Description & Predicates) | Reported Device Performance (Smithworks IV Fluid Warmer) |
|---|---|
| Fluid Temperature Maintenance: | |
| Maintains IV fluid temperature within an established range. | "Operate reliably in the range of 36-38 degrees C" |
| "Maintains 3 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)" (Soft Sack) | |
| "Maintains 4 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)" (FloorMount, Pak 2) | |
| Fluid Compatibility: | |
| Intended for use with crystalloid fluids. | "Intended for use with crystalloid fluids only, such as normal saline and ringers lactate." |
| Power Source/Safety: | |
| Operates on safe, portable voltage; includes safety features. | "40 watt, 12 VDC operation" |
| "Optional 120 VAC with 12 VDC adaptor" | |
| "Over-therm fuse protects silicone heater" | |
| "Fused circuit board controller for accurate thermal regulation and safety" | |
| Durability/Portability: | |
| Rugged construction for field environments; optimized for mobile use. | "Rugged anodized aluminum case" |
| "Exterior bag is built of rugged Cordura fabric" | |
| "Packaging and components have been optimized for mobile use, such as rescue and emergency operations" | |
| Thermal Sack Pressure Infuser: | |
| Enhances fluid delivery and thermal maintenance in hostile environments. | "Enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing." |
| "Help maintain a steady flow rate of iv fluids during rescue operations in hostile rescue environments." |
Study Information:
The provided document does not describe a detailed study in the traditional sense of a clinical trial or a performance study with a test set, ground truth, experts, or statistical analysis (like sensitivity/specificity, AUC, or MRMC studies).
Rather, it is a 510(k) Premarket Notification which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is typically done through:
- Comparison of technological characteristics.
- Comparison of indications for use.
- Risk analysis.
- Verification and validation testing (which are mentioned as being part of the product development process, but no detailed results are included in this summary).
Therefore, many of your specific questions cannot be answered directly from the text because such a study design is not presented.
Here's an attempt to address your questions given this context:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available/Not applicable (N/A): The document does not describe a "test set" in the context of a clinical or performance study with a defined sample size (e.g., number of patients or cases). The submission focuses on device characteristics and substantial equivalence to predicate devices, implying engineering verification and validation rather than a clinical "test set" presented in the summary. Data provenance is therefore not specified for such a "test set."
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)
- N/A: There is no "test set" described that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: There is no "test set" described that would require an adjudication method.
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
- N/A: This document is for an IV fluid warmer, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This document is for an IV fluid warmer, not an AI or algorithm-based device. "Standalone performance" in this context would refer to the device's ability to warm fluids to a specific temperature, which is implicitly stated ("operates reliably in the range of 36-38 degrees C"). No formal "standalone study" results are detailed with specific methodologies or metrics, beyond the claim of reliable operation within the specified temperature range.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A (for clinical ground truth): For an IV fluid warmer, "ground truth" would typically refer to accurate temperature measurements by calibrated sensors during engineering testing. The document states, "The Smithworks products are individually tested to operate reliably in the range of 36-38 degrees C." This implies internal testing and validation against known temperature standards, rather than clinical "ground truth" from experts or pathology.
8. The sample size for the training set
- N/A: This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- N/A: This is not an AI/machine learning device that would have a "training set."
Summary regarding "the study":
The provided document is a 510(k) summary, which outlines the basis for substantial equivalence to predicate devices for an IV fluid warmer. It explicitly states, "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." However, it does not present the detailed methodology, results, or data from specific "studies" (clinical trials, performance studies with defined test sets, etc.) within this summary document itself, beyond stating the device's operational temperature range and other features. The focus is on demonstrating that the device is as safe and effective as existing, legally marketed devices.
§ 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).