(52 days)
The Quantum" Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatic patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia.
The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.
The Quantum Blood and Fluid Warming System is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing laver. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery and Battery Chargers are reusable.
The provided document K192325 is a 510(k) premarket notification for the "Quantum Blood and Fluid Warming System". The submission concerns a change in the Indications for Use to include pediatric patients greater than 28 days old of normal birth weight. The device itself is "identical in design and technological features" to the predicate device (K181775). Therefore, the study described here primarily addresses the safety and effectiveness of using the existing device for this expanded patient population.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The core acceptance criterion for this submission is that the Quantum Blood and Fluid Warming System effectively warms blood and fluid for pediatric patients (greater than 28 days old of normal birth weight) to a target temperature without introducing new risks or exacerbating existing risks beyond acceptable levels. The performance of the device in meeting its primary function (warming) is assumed to be equivalent to the predicate device for adult use, and the performance for pediatric use is assessed by whether the device's capabilities accommodate pediatric physiological needs regarding flow rates and volumes.
| Acceptance Criteria (Pediatric Use) | Reported Device Performance / Assessment |
|---|---|
| Infusion Temperature: Maintain target temperature of $38 °C ± 2°C$ at delivery for pediatric patients. | The technological characteristics of the device, including the heating control (software) and target infusion temperature ($38 °C ± 2°C$), are unchanged from the predicate device (K181775). The document states that the system "can achieve its intended use at the resuscitation flow rates indicated for pediatric patients" and "Warming at the lower flow rates and volumes can be achieved with the Subject device." This implies that the device maintains the target temperature even at flow rates and volumes typical for pediatric patients. |
| Accommodation of Pediatric Flow Rates and Volumes: The device must be capable of handling resuscitation flow rates and volumes typical for pediatric patients without issue.** | The updated risk analysis explicitly compares "Resuscitation Flow Rate (mL/min)" and "Resuscitation Volume (mL)" across different pediatric age groups (Adolescents, Preadolescent, Children, Infants). The report concludes that "The table above lists the various fluid volume and flow requirements for pediatric patients which can all be achieved with the current Quantum System." This indicates the device's physical and functional capabilities are sufficient for pediatric resuscitation needs. |
| No New Risks: Inclusion of pediatric patients should not introduce new safety risks not present with adult use. | The risk analysis states, "No new risks were identified when using the Quantum with pediatric patients older than 28 days of age and of normal birth weight that were not identified with adults." |
| Mitigation of Exacerbated Risks: Any existing risks that could have more serious effects in pediatric patients must be adequately mitigated. | "Existing risks that relate to IV administration and blood warmer use that are inherent to the r severity unchanged when considering pediatric population since these risks were related to operator training and basic knowledge." However, "Some existing risks were identified that could have more serious effects with pediatric patients." These exacerbated risks (e.g., related to contamination, air embolisms, hypothermia) were mitigated through labeling, by incorporating "warnings and precautions specific to the pediatric population." The "Risk Benefit Analysis demonstrated that, even with increased risk severity for some risks, the risks were inherent to IV administration sets/sterile products and there is a benefit to providing treatment/warming versus risks associated with potential hypothermia." |
| No Device Modification Required: The expanded indication should not necessitate changes to the device's design or components. | The document explicitly states: "The only difference is the inclusion of pediatric patients... This difference does not result in any design change, new or increased risk." And "No modification to the device, different or additional equipment, set or training is required." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical study with a test set of patient data. This submission is a "Special 510(k)" which generally indicates a change to a currently cleared device that does not affect its fundamental scientific technology. The primary assessment made is a risk analysis and a comparison of the device's existing specifications against the physiological requirements of the new patient population.
Therefore, there is no sample size of patients in a traditional sense, nor data provenance (country, retrospective/prospective) for a clinical test set. The "test set" here refers to the parameters of pediatric physiology (flow rates, volumes, body weights) against which the device's known performance was evaluated.
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)
Not applicable in the context of a traditional clinical study. The "ground truth" used here is established medical knowledge regarding pediatric physiology, resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines mentioned in the risk table), and medical device safety standards. The document doesn't specify the number or qualifications of experts who conducted this particular risk analysis, but it would typically be performed by a team including engineers, regulatory affairs specialists, and possibly medical advisors with expertise in device design and pediatrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication of patient cases or outcomes. The assessment was based on existing technical specifications and medical knowledge.
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 a fluid warming system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device with software control, not an AI algorithm. Its performance is inherent to its design and how it delivers warmth, independent of human interaction once parameters are set, but it is always used "human-in-the-loop" as healthcare professionals administer fluids.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this submission primarily consists of:
- Established Medical Standards and Guidelines: Specifically, pediatric resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines are referenced in the risk analysis table).
- Physiological Data: Known ranges for pediatric body weights, fluid volumes, and flow rates.
- Device Specifications: The inherent technical capabilities and validated performance of the Quantum Blood and Fluid Warming System as previously cleared for adult use.
- Risk Analysis Principles: Standard methodologies for identifying, evaluating, and mitigating risks associated with medical devices.
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. No training set for an AI/ML model was used.
§ 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).