Quantum Blood and IV Fluid Infusion Warmer
Device Facts
| Record ID | K181775 |
|---|---|
| Device Name | Quantum Blood and IV Fluid Infusion Warmer |
| Applicant | Life Warmer, Inc. |
| Product Code | LGZ · General Hospital |
| Decision Date | Jan 28, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital, clinical, field and transport environments to help prevent hypothermia.
Device Story
Portable, battery-powered, in-line fluid warming system; consists of controller, battery, charger, and sterile disposable thermal tubing (TIS/TTS-B). System uses resistive heating; warming element integrated into tubing layers without direct fluid contact. Microprocessor-based controller monitors thermistors at proximal, medial, and distal tubing segments; regulates energy to maintain fluid at 38°C ± 2°C. Used by healthcare professionals in hospital, clinical, field, and transport environments. Provides visual (LED) and audible feedback for temperature status, battery, flow, and system errors. Benefits patients by preventing hypothermia during fluid/blood administration in emergencies or surgeries.
Clinical Evidence
Bench testing only. Performance validated against ASTM F2172-02, ISO 1135-4/5, ISO 8536-4/8, and USP 788. Biocompatibility testing (ISO 10993) included cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility. Electrical safety/EMC testing per AAMI ES 60601-1, IEC 60601-1-2, and RTCA DO-160G.
Technological Characteristics
Resistive heating system; battery-powered. Components: Controller, Battery, Charger, sterile disposable thermal tubing (TIS/TTS-B). Tubing features double-extrusion process. Sensing via thermistors at proximal, medial, distal segments. Software-controlled temperature regulation. Sterilization via ethylene oxide (ISO 11135). Standards: ASTM F2172-02, ISO 1135-4/5, ISO 8536-4/8, USP 788, AAMI ES 60601-1, IEC 60601-1-2, RTCA DO-160G.
Indications for Use
Indicated for warming blood, blood products, and IV solutions in adult patients to prevent hypothermia. Intended for use by healthcare professionals (physicians, nurses, mid-level practitioners, EMT/paramedics, military medics) in hospital, clinical, field, and transport settings.
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
- enFlow IV Fluid Warmer by VITAL SIGNS, a GE Healthcare Company (K112902)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2019
Life Warmer, Inc. John Pettini Chief Medical Officer, Founder 840 F. Avenue Suite 104 Plano, Texas 75074
Re: K181775
Trade/Device Name: Quantum Blood and IV Fluid Infusion Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: December 27, 2018 Received: December 28, 2018
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn C. Dorgan -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation 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) K181775
Device Name
Quantum Blood and IV Fluid Infusion Warmer
#### Indications for Use (Describe)
The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital. clinical. field and transport environments to help prevent hypothenmia.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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Image /page/3/Picture/0 description: The image shows the logo for LifeWarmer. The logo consists of a stylized "W" made up of three red triangles, followed by the word "LIFEWARMER" in red, with the "LIFE" portion in a lighter shade than the "WARMER" portion. The logo is simple and modern, and the use of red gives it a sense of energy and warmth.
# 510(k) Summary K181775
| Submitted by/<br>Sponsor: | Life Warmer, Inc.<br>840 F. Avenue #104<br>Plano, TX 75074 USA<br>972-908-9808 | | Contact Person: | John Pettini, DO, FACEP<br>860-204-1711 | | |
|------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------|-----------------|-----------------------------------------|------------------|--|
| Date Prepared: | January 28, 2019 | | | | | |
| Trade Name: | Quantum Blood and IV Fluid Infusion Warmer | | | | | |
| 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 | | | | |
| | Class II | | | | | |
| Predicate Device | K112902: enFlow IV Fluid Warmer by VITAL SIGNS, a GE Healthcare | | | | | |
| | Company | | | | | |
#### Device Description:
The Quantum Blood and IV Fluid Infusion Warmer 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 IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital, field and transport environments to help prevent hypothermia.
Technological Characteristics: The Quantum Blood and IV Fluid Infusion Warmer is a light weight, portable, battery powered, in-line fluid warming system in which specially designed themal 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 proximal, medial and distal 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 doubleextrusion process results in tubing configuration with an inner tubing layer and an outer tubing layer. 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 and the 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 Chargers are reusable.
#### Comparison to Predicate
The Quantum has the same intended use as the predicate device and similar technological features. The primary difference between the Quantum and the predicate device is the warming path and the integrated thermal tubing. 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 is red and features a stylized "W" on the left side. The word "LIFEWARMER" is written in capital letters to the right of the "W".
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Image /page/5/Picture/0 description: The image shows the logo for LIFEWARMER. The logo consists of a stylized "W" made up of three red chevrons, followed by the word "LIFEWARMER" in red sans-serif font. The "LIFE" part of the word is a lighter shade of red than the "WARMER" part. The logo is simple and modern, and the red color gives it a sense of warmth and energy.
| Substantial Equivalence Comparison Table | | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device | Primary Predicate | |
| | Quantum Blood and IV Fluid<br>Infusion Warmer | enFlow IV/Blood Warming System<br>[510(k) K112902] | Comparison |
| Common Name | Sterile Fluid Path in-line Blood and<br>Fluid 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<br>Infusion Warmer is indicated for<br>warming blood, blood products and<br>intravenous solutions prior to<br>administration in adult patients. It is<br>intended for use by healthcare<br>professionals in hospital, clinical,<br>field and transport environments to<br>help prevent hypothermia. | The enFlow IV Fluid/Blood Warming<br>System is indicated for warming<br>blood, blood products and<br>intravenous solutions prior to<br>administration. It is intended for use<br>by healthcare professionals in<br>hospital, clinical and field<br>environments to help prevent<br>hypothermia. | Difference: Quantum<br>specifies "adult patients"<br>and transport<br>environment. |
| Intended Use | Medical Emergencies or surgeries<br>where warm fluid administration is<br>required to treat the patient.<br>Whenever parenteral introduction<br>of normothermic fluid are desired or<br>indicated. | Medical Emergencies or surgeries<br>where warm fluid administration is<br>required to treat the patient.<br>Whenever parenteral introduction of<br>normothermic fluid are desired or<br>indicated. | Same |
| User Population | Healthcare professionals (e.g.,<br>physicians, registered nurses, mid-<br>level practitioners, EMT/Paramedic,<br>military medics) | Healthcare professionals (e.g.,<br>paramedic, nurse, doctor, etc.) | Difference: Quantum<br>identifies additional<br>specialties (mid-level<br>practitioners,<br>EMT/Paramedic, military<br>medics) |
| Use Environment | Hospital, Clinic, Field and<br>Transport | Hospital, Clinic and Field | Difference: Quantum<br>adds Transport<br>environment |
| User Interface | Visual (LED) and audible | Visual (LED) and audible | Same |
| User Feedback<br>Provided | Over temperature, under<br>temperature, battery low, no-<br>flow/poor connection, system error | Over temperature, under<br>temperature, battery low condition | Difference: Quantum<br>includes system error |
| System<br>Components | Sterile disposable thermal tubing<br>(TIS/TTS-B), Controller (with<br>LEDs), Battery (w/ LEDs and<br>audible alert) | Fluid warmer with display, sterile<br>disposable heat exchanger | Difference: Quantum<br>contains thermal IV<br>administration tubing and<br>a controller which<br>regulates warming.<br>Predicate contains a heat<br>exchanger cartridge. |
| Infusion<br>Temperature | $38 °C ± 2°C$ | $Up to 40 °C (± 2 °C)$ | Difference: 36 to 40°C is<br>typical normothermic<br>range. To conserve<br>battery life, the Quantum<br>has a 38°C set point. |
| Fluid Path | Sterile; direct path with disposable<br>IV administration tubing | Sterile; intercept path with aluminum<br>extrusion cartridge | Quantum has direct fluid<br>path; no intercept and<br>redirect. |
| Flow Rate | Gravity<br>2 to 200 mL/min<br>(depending on starting<br>temperatures) | Gravity<br>1 to 200 ml/min | Difference: Quantum has<br>the ability to detect a<br>static line and initiates<br>warming at 2mL/min. |
| Heating Method | Resistive heating | Resistive Heating | Same |
| Heating Control | Software | Software | Same |
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Image /page/6/Picture/0 description: The image shows the logo for LifeWarmer. The logo consists of a stylized "W" made up of three red triangles, followed by the word "LIFEWARMER" in a light blue sans-serif font. The logo is simple and modern, and the colors are eye-catching.
| Substantial Equivalence Comparison Table (continued) | | | | | | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------|--|--|--|--|
| Power Source | Rechargeable battery | Rechargeable battery<br>110-120 or 220-240 VAC | Same | | | | |
| Biocompatibility | Biocompatibility testing<br>demonstrates tubing/fluid path to<br>be biocompatible and non-<br>bioreactive. | Fluid path contacts biocompatible<br>coated aluminum extrusion | Same<br>(Fluid path is<br>biocompatible) | | | | |
| Sterilization | Disposable TIS, TTS-B tubing:<br>(ethylene oxide) | Disposable unit: Sterile<br>(ethylene oxide) | Same<br>(sterilization method) | | | | |
| Product Specific<br>Standards | ASTM 2172: 2002<br>Standard specification for<br>blood/intravenous fluid irrigation<br>warmer | ASTM 2172:2002<br>Standard Specification for<br>blood/intravenous Fluid Irrigation<br>Fluid Warmers | Same | | | | |
Substantial Equivalence: The Quantum Blood and IV Fluid Infusion Warmer is substantially equivalent to the enFlow IV Fluid Warmer. Both the subject and predicate devices are under the same product code (LGZ and BSB), conform to the same device-specific standard AASTM 2172, and have the same intended use. As can be seen from the Substantial Equivalence Comparison Table above, many of the technological characteristics of both devices are the same. The main technological differences between the Quantum and the predicate device is the warming path, the method of sensing and controlling temperature, and the materials. These differences, however, are not considered to raise different questions of safety and effectiveness. Further, the technological differences are supported by performance and other substantiating testing.
## 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; ANS//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
The Quantum Blood and IV Fluid Infusion Warmer design requirements have been defined and successfully tested to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device as presented below:
#### Device-Specific Testing:
Quantum conforms to the following device specific standards:
- · ASTM F2172-02 (2011), Standard Specification for blood/intravenous fluid irrigation warmers;
- · ISO 1135-5 (2015), Transfusion equipment for medical use- Part 5: Transfusion sets for single use with pressure infusion apparatus;
- · ISO 1135-4 (2015) Transfusion equip. for medical use-Part 4: Transfusion sets for single use, gravity feed:
- · ISO 8536-4: (2010): Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed;
- ISO 8536-8: (2015): Transfusion equipment for medical use- Part 8: Infusion sets for single use with pressure infusion apparatus.
- · USP 788: Particulate Matter in Injections (Light Obscuration Testing)
Biocompatibility: The Quantum was successfully subjected to the following biocompatibility testing:
- Cytotoxicity: 1) MEM Elution Test; 2) Neutral Red Uptake (ISO 10993-5: 2009)
- · Sensitization: Kligman Maximization Test (ISO 10993-10: 2010)
- · Irritation/Intracutaneous Reactivity: Intracutaneous Injection Test (ISO 10993-10: 2010)
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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 word "LIFEWARMER" in a slightly lighter shade of red. The font used for the word "LIFEWARMER" is sans-serif and appears to be bolded.
- · Systemic Toxicity: 1) Systemic Injection Test, 2) Material Mediated Rabbit Pyrogen Test, 14-Day Repeat Dose Intravenous Toxicity Study; 3) Subchronic Systemic Toxicity: 14-Day Repeat Dose Intraperitoneal Toxicity Study in Rats (ISO 10993-11: 2017)
- · Interactions with Blood: 1) Rabbit Blood Hemolysis Test; 2) In Vitro Hemocompatibility Test (Direct); 3) C3A and SC58-B-9 Complement Activation Test (Direct); 4) Platelet Aggregation Test (direct); (ISO 10993-4: 2017
Electrical Safety and Electromagnetic Compatibility: The Quantum system has been subjected to testing and conforms with the following electrical safety and EMC standards:
- · AAMI ES 60601-1:2005 (R) 2012+ A1: 2012/CSAC22.2 No. 60601-1:14 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance'
- IEC 60601-6:2010 + A1:2013/CSAC22.2 No. 60601-1-6:11 + A1:15 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability;
- · IEC 60601-1-12: 2014 Medical electrical equipment-Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment;
- EMC: Type Ref. 63-5900 per IEC 60601-1-2: 2014; EMC: Type Ref: 63-5000 Quantum Battery/Quantum Charger (accessory);
- Emission Test: EN 55032: 2012/AC: 2013; CISPR 32: 2012;
- · Immunity Test: EN 55024: 2010: CISPR24: 2010:
- · EMC: Type Ref: 63-5900, tested to the requirements of RTCA DO-160G (Section 21).
#### Conclusion
Based on comparison of the Quantum Blood and IV Fluid Infusion Warmer to the predicate device with regard to intended use and technological characteristics, and the results of Quantum device testing submitted, the devices are substantially equivalent.
