Quantum Blood and Fluid Warming System
Device Facts
| Record ID | K192325 |
|---|---|
| Device Name | Quantum Blood and Fluid Warming System |
| Applicant | Life Warmer, Inc. |
| Product Code | LGZ · General Hospital |
| Decision Date | Oct 18, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
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.
Device Story
Portable, battery-powered, in-line fluid warming system; consists of controller, battery, charger, and sterile disposable thermal IV tubing (TIS/TTS-B). Warming element integrated into tubing; does not contact fluid directly. Microprocessor-controlled resistive heating; thermistors on tubing provide feedback to maintain 38°C ± 2°C. Used by healthcare professionals (physicians, nurses, EMTs, military medics) in hospitals, clinics, field, and transport environments. Output is warmed fluid delivered to patient; visual/audible alerts for temperature, battery, and flow status. Benefits include hypothermia prevention during fluid/blood administration. Clinicians use device output to manage patient temperature during emergencies or surgeries.
Clinical Evidence
No clinical data; bench testing only. Substantial equivalence supported by risk analysis, design controls, and previously cleared performance data. Pediatric use supported by analysis of fluid volume/flow rate requirements and updated labeling.
Technological Characteristics
Resistive heating; microprocessor-controlled. Components: Controller, battery, charger, sterile disposable thermal tubing (double-extrusion). Connectivity: Standalone. Sterilization: Ethylene oxide (EO) for tubing. Standards: ASTM 2172:2002, ANSI/AAMI/ISO 11135:2014, ISO 10993, IEC 60601.
Indications for Use
Indicated for warming blood, blood products, and IV solutions in adult and pediatric patients >28 days old of normal birth weight. Contraindicated for neonates (birth to 28 days) and infants of low birth weight.
Regulatory Classification
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.
Predicate Devices
- Quantum Blood and IV Fluid Infusion Warmer (K181775)
Submission Summary (Full Text)
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October 18, 2019
Life Warmer, Inc. John Pettini Chief Medical Officer, Founder 4813 Keller Springs Rd Addison, Texas 75001
Re: K192325
Trade/Device Name: Quantum Blood and Fluid Warming System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG, BSB Dated: August 26, 2019 Received: August 27, 2019
Dear John Pettini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Nikhil Thakur Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
#### K192325
Device Name Quantum Blood and Fluid Warming System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitted by/<br>Sponsor: | Life Warmer, Inc.<br>4813 Keller Springs Rd<br>Addison, TX 75287 USA<br>972-908-9808 | Contact Person: | John Pettini, DO, FACEP<br>860-204-1711 |
|------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------|
| Date Prepared: | October 18, 2019 | | |
| Trade Name: | Quantum Blood and Fluid Warming System | | |
| Common Name: | Sterile Fluid Path in-line Blood and Fluid Warmer | | |
| Classification Code<br>Name & Reference: | LGZ | Warmer, Thermal, Infusion Fluid 21 CFR §880.5725 | |
| | BSB | Warmer, Blood, Non-electromagnetic radiation | |
| Predicate Device | K181775: Quantum Blood and IV Fluid Infusion Warmer by Life Warmer, Inc. | | |
# Device Description:
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.
Indications for Use: 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 to be used by healthcare professionals in hospital, 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.
Technological Characteristics: The technological characteristics of the Quantum Blood and Fluid Warming System are unchanged from the 510(k)-cleared device which is also the predicate. The 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 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.
### Comparison to Predicate
The design and technological features of the Quantum Blood and Fluid Warming System that is the subject of this Special 510(k) is identical to the Quantum Blood and IV Fluid Infusion Warmer previously cleared under K181775. The only difference is the inclusion of pediatric patients. This difference does not result in any design change, new or increased risk. The following table presents a comparison of the devices' technology and features.
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Image /page/4/Picture/0 description: The image shows the logo for LifeWarmer. The logo consists of a stylized letter "W" in red, followed by the word "LIFEWARMER" in a lighter shade of red. The logo is simple and modern, and the colors are eye-catching.
| Substantial Equivalence Comparison Table | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device | Primary Predicate | |
| Trade Name | Quantum Blood and Fluid Warming<br>System (K192325) | Quantum Blood and IV Fluid Infusion<br>Warmer (K181775) | |
| Common Name | Sterile Fluid Path in-line Blood and Fluid<br>Warmer | Sterile Fluid Path, In-Line Blood Fluid<br>Warmer | Same |
| Regulation | 21 CFR Part 880.5725 | 21 CFR Part 880.5725 | Same |
| Prod. Code | LGZ, BSB | LGZ, BSB | Same |
| Indication for<br>Use | The Quantum™ Blood and IV Fluid Infusion<br>Warmer is indicated for warming blood,<br>blood products and intravenous solutions<br>prior to administration in adult and pediatric<br>patients greater than 28 days old of normal<br>birth weight. It is intended for use by<br>healthcare professionals in hospital, clinical,<br>field and transport environments to help<br>prevent hypothermia.<br>The Quantum is not for use with neonates<br>(birth to 28 days old) or infants of low birth<br>weight. | The Quantum™ Blood and IV Fluid<br>Infusion Warmer is indicated for warming<br>blood, blood products and intravenous<br>solutions prior to administration in adult<br>patients. It is intended for use by<br>healthcare professionals in hospital,<br>clinical, field and transport environments to<br>help prevent hypothermia. | Different:<br>Pediatric<br>patients are<br>included in the<br>indication for<br>use.<br>Labeling was<br>modified to<br>mitigate new<br>and increased<br>risks to<br>pediatric<br>patients. |
| Intended Use | Medical emergencies or surgeries where<br>warm fluid administration is required to treat<br>the patient. Whenever parenteral<br>introduction of normothermic fluid is desired<br>or indicated. | Medical emergencies or surgeries where<br>warm fluid administration is required to<br>treat the patient. Whenever parenteral<br>introduction of normothermic fluid is<br>desired or indicated. | Same |
| User Population | Healthcare professionals (e.g., physicians,<br>registered nurses, mid-level practitioners,<br>EMT/Paramedic, military medics) | Healthcare professionals (e.g., physicians,<br>registered nurses, mid-level practitioners,<br>EMT/Paramedic, military medics) | Same |
| Use Environment | Hospital, Clinic, Field and Transport | Hospital, Clinic, Field and Transport | Same |
| User Interface | Visual (LED) and audible | Visual (LED) and audible | Same |
| User Feedback<br>Provided | Over temperature, under temperature,<br>battery low, no-flow/poor connection,<br>system error | Over temperature, under temperature,<br>battery low, no-flow/poor connection,<br>system error | Same |
| System<br>Components | Sterile disposable thermal tubing (TIS/TTS-<br>B), Controller (with LEDs), Battery (w/<br>LEDs and audible alert) | Sterile disposable thermal tubing<br>(TIS/TTS-B), Controller (with LEDs),<br>Battery (w/ LEDs and audible alert) | Same |
| Infusion<br>Temperature | $38 °C ± 2°C$ | $38 °C ± 2°C$ | Same |
| Fluid Path | Sterile; direct path with disposable IV<br>administration tubing | Sterile; direct path with disposable IV<br>administration tubing | Same |
| Flow Rate | Gravity<br>2 to 200 mL/min<br>(depending on starting temperatures) | Gravity<br>2 to 200 mL/min<br>(depending on starting temperatures) | Same |
| Heating Method | Resistive heating | Resistive Heating | Same |
| Heating Control | Software | Software | Same |
| Warmer Type | In-line | In-Line | Same |
| Power Source | Rechargeable battery | Rechargeable battery | Same |
| Biocompatibility | Biocompatibility testing demonstrates<br>tubing/fluid path to be biocompatible and<br>non-bioreactive. | Biocompatibility testing demonstrates<br>tubing/fluid path to be biocompatible and<br>non-bioreactive | Same |
| Sterilization | Disposable TIS, TTS-B tubing:<br>(ethylene oxide) | Disposable TIS, TTS-B tubing<br>(ethylene oxide) | Same |
| Product Specific<br>Standards | ASTM 2172: 2002<br>Standard specification for<br>blood/intravenous fluid irrigation warmer | ASTM 2172:2002<br>Standard Specification for<br>blood/intravenous Fluid Irrigation Fluid<br>Warmers | Same |
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Image /page/5/Picture/0 description: The image contains the logo for LIFEWARMER. The logo consists of a stylized letter "W" in red, followed by the word "LIFEWARMER" in a smaller, sans-serif font, also in red. The logo appears to be for a company or product named LIFEWARMER.
Substantial Equivalence: The Quantum Blood and Fluid Warminq System subject device is identical in design and technological features as the 510(k) cleared, commercially distributed Quantum predicate device (K181775). The only difference is the inclusion of pediatric patients greater than 28 days old of normal birth weight as stated in the indications for use statement. The additional risks from this device to pediatric patients have been mitigated through labeling, by incorporating warnings and precautions specific to pediatrics. No modification to the device, different or additional equipment, set or training is required. No new questions of safety and effectiveness are raised by this modification.
# Sterilization and Shelf-Life
The Quantum TIS and TTS-B tubing assemblies are disposable with a sterile fluid path. Sterilization was achieved by exposure to ethylene oxide (EO) and validated in accordance with ANSI/AAMI/ISO 11135:2014. ANSI/AAMI/ISO 11737-1: 2006/(R) 2011: ANSI/AAMI/ISO 11737-2: 2009/(R) 2014: ANSI/AAMI/ISO 11138-1: 2006/R) 2015: ANSI/AAMI/ISO 11138-2: 2006/(R) 2015: ANSI/AAMI/ISO10993-7: 2008/(R) 2012; ISO 11607-1:2006, ANSI/AAMI/ISO 10993/(R) 2013.
The TIS and TTS-B shelf-life was supported with testing performed in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ISTA-2A (2011) Partial Simulation Performance Tests. Bacterial Endotoxin testing was performed using the Kinetic-Chromogenic Method.
# Performance Testing Summary
No additional performance testing was required to support the addition of pediatric patients greater than 28 days old of normal birth weight to the patient user group for this device. The Quantum Blood and Fluid Warming System has been subjected to Design Controls and previously tested to appropriate devicespecific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device as presented below:
### Risk Analysis:
The risk profile has changed with the addition of the pediation. An updated risk analysis has been performed to support the addition of all pediatric populations, with the exception of neonates and low birth weight infants. The Table below shows of how each residual risk applies to this population.
| System/ Patient | Adult | Adolescents (12-<br>21 years)<br>39.5 kg to 70.3kg | Preadolescent<br>(11-13 years)<br>35.6 kg to 45.3 kg | Children (2-12<br>years) 12.5 kg<br>to 39.5 kg | Infants (29<br>days to 2<br>years) 4.4 kg-<br>12.5 kg |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Users | Healthcare<br>professionals (e.g.,<br>physicians,<br>registered<br>nurses, midlevel<br>practitioners,<br>EMT/Paramedic,<br>military medics | Healthcare<br>professionals (e.g.,<br>physicians,<br>registered nurses,<br>midlevel<br>practitioners,<br>EMT/Paramedic,<br>military medics | Healthcare<br>professionals (e.g.,<br>physicians,<br>registered<br>nurses, midlevel<br>practitioners,<br>EMT/Paramedic,<br>military medics | Healthcare<br>professionals (e.g.,<br>physicians,<br>registered<br>nurses, midlevel<br>practitioners,<br>EMT/Paramedic,<br>military medics | Healthcare<br>professionals (e.g.,<br>physicians,<br>registered nurses,<br>midlevel<br>practitioners,<br>EMT/Paramedic,<br>military medics |
| Tubing Set<br>Components | Y-spike (vented an<br>and non-vented), 3<br>roller clamps, drip<br>chamber, 2<br>injection ports, 2<br>slide clamps, luer<br>adapter | No additional<br>components<br>required | No additional<br>components<br>required | No additional<br>components<br>required | No additional<br>components<br>required |
| Fluids | IV Fluids, Blood,<br>Blood components | IV Fluids, Blood,<br>Blood components | IV Fluids, Blood,<br>Blood components | IV Fluids, Blood,<br>Blood components | IV Fluids, Blood,<br>Blood components |
| Resuscitation<br>Flow Rate<br>(mL/min) with 10<br>mL/kg bolus<br>over 5 minutes | 100 - 200 | 70 - 200 | 71.2 - 90.6 | 25 - 79 | 6.6 - 25 |
| Resuscitation<br>Flow Rate<br>(mL/min) with 20<br>mL/kg bolus<br>over 5 minutes | 100 - 200 | 79 - 200 | 142.2 - 181.2 | 50 - 158 | 17.6 -50 |
| Resuscitation<br>Volume (mL)<br>From AHA<br>Pediatric<br>Advanced Life<br>Support<br>Guidelines | 1000 - 2000 mL | 20 mL/kg bolus up<br>to X3 isotonic<br>crystalloids.<br>10 mL/kg PRBC's<br>for hemorrhagic<br>shock | 20 mL/kg bolus up<br>to X3 isotonic<br>crystalloids.<br>10 mL/kg PRBC's<br>for hemorrhagic<br>shock | 20 mL/kg bolus up<br>to X3 isotonic<br>crystalloids.<br>10 mL/kg PRBC's<br>for hemorrhagic<br>shock | 20 mL/kg bolus up<br>to X3 isotonic<br>crystalloids.<br>10 mL/kg PRBC's<br>for hemorrhagic<br>shock |
| Labelling | Currently available | Additional<br>warnings and<br>precautions<br>regarding<br>hypothermia,<br>contamination,<br>infection,<br>thermoregulation | Additional<br>warnings and<br>precautions<br>regarding<br>hypothermia,<br>contamination,<br>infection,<br>thermoregulation | Additional<br>warnings and<br>precautions<br>regarding<br>hypothermia,<br>contamination,<br>infection,<br>thermoregulation | Additional warning<br>to not use with low<br>birth weight infants<br>Additional<br>warnings and<br>precautions<br>regarding<br>hypothermia,<br>contamination,<br>infection,<br>thermoregulation |
| Biocompatibility | ISO 10993 | No additional<br>requirements | No additional<br>requirements | No additional<br>requirements | No additional<br>requirements |
| Electrical Safety | IEC 60601 | No additional<br>requirements | No additional<br>requirements | No additional<br>requirements | No additional<br>requirements |
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Image /page/6/Picture/0 description: The image shows the logo for LIFEWARMER. The logo consists of a stylized "W" symbol in red, followed by the word "LIFEWARMER" in a sans-serif font, also in red. The logo is simple and modern, with a focus on the company name.
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Image /page/7/Picture/0 description: The image shows the logo for LifeWarmer. The logo consists of a stylized letter "W" in red, followed by the text "LIFEWARMER" in a bold, red font. The left side of the text is slightly blurred, while the right side is more sharply focused.
### Risk Analysis Summary:
The predicate K181775 Quantum system is indicated for adult patients. Hypothermia prevention also applies to pediatric patient can achieve its intended use at the resuscitation flow rates indicated for pediatric patients. Additional requirements or safety measures were assessed, including biocompatibility, electrical safety, design, and changes in the users and use scenarios of the device. The system has no additional biocompatibility or electrical safety requirements when used with pediatrics. The design of the patient contacting component, the tubing set, was assessed to address whether any additional risk may arise when with pediatric population. The users are generally the same, however there are differences in use cases when being used with pediatrics. Clinician users of the Quantum who treat pediatric patients would have the same credentials as current Quantum users, and by training be knowledgeable in appropriate fluid volume requirements and flow rates for pediatric patients. Hence, this narrows the focus of the risk assessment down to use. The table above lists the various fluid volume and flow requirements for pediatic patients which can all be achieved with the current Quantum System. The Quantum Use Failure Modes and Effects Analysis (FMEA) and Thermal Tube Set (TTS) Design FMEA has been updated to assess if any additional risks arise when considering a pediatric patient population and labeling was updated to include warnings and precautions specific to the pediatric population in order to mitiqate for the change in risk severity has been increased for risks related to contamination, air embolisms, hypothermia and others, since pediatric patients are at a higher risk for certain failure modes as compared to adult patients.
Considering risks involved with device use with pediatric patients, existing risks were revaluated to confirm whether their severity scores remained the same or were increased due to possibly more serious effects with pediatric patients, and the analysis was reviewed in order to identify any new risks. 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. Some existing risks were identified that could have more serious effects with pediatric patients.
A 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 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. The pediatric nurses and physicians have similar training to adult nurses and physicians pertaining to transfusions. Warming at the lower flow rates and volumes can be achieved with the Subject device. Therefore, the Quantum would be beneficial to pediatric patients when fluid warming is desired. Clinician users of the Quantum who treat pediatric patients would have the same credentials as current Quantum users, and by training be knowledgeable in appropriate fluid volume requirements and flow rates for pediatric patients.
#### Conclusions
The Quantum Blood and Fluid Warming System is indicated for use in both adult and pediatric patients greater than 28 days old of normal birthweight and is substantially equivalent to the predicate device, based on the performed risk analysis.
