(204 days)
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube. During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port. It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off. The entire device is disposable, single use and is provided pre-sterilized.
The provided text describes the acceptance criteria and a series of performance tests for the Novocor Medical Systems, Inc. Hypocore device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 10 Minute Standard Device Performance - Level of cooling, fast flow | To cool 1 liter of fluid to an average temperature of <11ºC | All samples met the average output temperature acceptance criteria (range = 6.9-7.8 °C) |
| 30 Minute Standard Device Performance - Level of cooling, slow flow | To cool 1 liter of fluid to an average temperature of <11ºC | All samples met the average output temperature acceptance criteria (range = 6.1-8.5 °C) |
| 30 Minute Standard Device Performance - Time to achieve required cooling level | Time required to achieve the stated temperature threshold is less than 2 minutes | All samples met the acceptance criteria (range = 46-60 seconds) |
| Elevated Environmental Temperature Test | To cool IV fluids to less than 11ºC when flowed at 48 ml/min in a 32°C environment | All samples met the acceptance criteria. The average temperature of the exiting fluid ranged from 8.8-10.5 ℃ inside a 32°C chamber. |
| Flow Rate Test - Comparative flow rate of standard IV set with and without the Hypocore device in line | Flow rate reduction be less than 25% of the standard flow rate | All samples met the acceptance criteria (flow rate reduction ranged from 10.35-15.87%) |
| Tilt Test | The temperature of the exit fluid be less than that of the initial fluid | All samples met the acceptance criteria. The average environmental temperature ranged from 22.5-22.8°C. The output temperatures during the test ranged from 8.6-9.2°C at +45 degrees and 9.1-10.1°C at -45 degrees. |
| Activation Handle Force Test | Activation handle must withstand 20.36 lbs | All samples withstood the applied force and no sample devices broke. |
| Strap Performance Test - Device attachment | Devices must stay attached to the limb | All samples met the acceptance criteria. |
| Strap Performance Test - Pressure on limb | Pressure of the strap must not exceed 200 mmHg | All samples met the acceptance criteria (pressures ranged from 50-80 mmHg). |
| Strap Performance Test - Force on outlet tubing upon drop | Force of the device be less than 52.9 N (force required to pull out a taped IV catheter) | All test iterations met the acceptance criteria (forces ranged from 14.0-27.0 N). |
| Biocompatibility (Cytotoxicity) - Fluid Path | Non-cytotoxic with scores of 0, 1, or 2 per ISO 10993-5 (grade less than 2) | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test, since the grade was less than a grade 2 (mild reactivity). |
| Biocompatibility (Cytotoxicity) - Skin Contact | Non-cytotoxic with scores of 0, 1, or 2 per ISO 10993-5 (grade less than 2) | The test article extract showed evidence of causing slight cell lysis or toxicity; however, the test article extract met the requirements of the test, since the grade was less than a grade 2. |
| Biocompatibility (Irritation) - Fluid Path | Non-irritant with scores of 0-1 comparison between control and test sample reaction (ISO 10993-10) | The test article met the requirements, since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 for sodium chloride (SC) and sesame oil (SO) extracts. |
| Biocompatibility (Irritation) - Skin Contact | Non-irritant with scores of 0-1 comparison between control and test sample reaction (ISO 10993-10) | The test article met the requirements, since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. |
| Biocompatibility (Sensitization) - Fluid Path | Non-sensitizer or mild sensitizer with a score of 0 (non-sensitizer) or 1 (mild sensitizer), based on comparison between control and test sample (ISO 10993-10) | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer. |
| Biocompatibility (Sensitization) - Skin Contact | Non-sensitizer or mild sensitizer with a score of 0 (non-sensitizer) or 1 (mild sensitizer), based on comparison between control and test sample (ISO 10993-10) | The test article extracts showed no evidence of causing delayed dermal contact sensitization. (Result truncated in document, but implies acceptance criteria met for non-sensitization). |
| Biocompatibility (Pyrogenicity) | No single animal temperature rise of 0.5°C or more above its baseline temperature. | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.0°C. The test article was judged as non-pyrogenic. |
| Biocompatibility (Ethylene Oxide and Ethylene Chlorohydrin Testing) - EO and ECH residuals | EO residuals <= 4mg and ECH residuals <= 9mg. | EO and ECH levels were acceptable on Day 1. |
| Biocompatibility (Ethylene Oxide and Ethylene Chlorohydrin Testing) - Tolerable Contact Limits (TCL) | TCL for EO and ECH shall not exceed 10 μg/cm2 and 5 mg/cm2, respectively, or the device shall have negligible irritation as specified in ISO 10993-10. | The Hypocore device exhibited no irritation as demonstrated within biocompatibility irritation testing. |
| Biocompatibility (Partial Thromboplastin Time) | Test result clotting time > 50% of the negative control per ASTM F2382. | The plasma exposed to the test article had an overall average clotting time of 235.9 seconds, which represented 79.9% of the negative control. The test article was considered a minimal activator, and therefore, met the requirements of the test. |
| Biocompatibility (Acute Systemic Toxicity) | Reference ISO 10993-11 (Section 5.3) - no mortality or evidence of systemic toxicity. | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |
| Biocompatibility (Hemocompatibility) | Reference ISO 10993-4 - criteria for non-hemolytic/slightly hemolytic. | The hemolytic index for the test article in direct contact with blood was 2.0%, and the hemolytic index for the test article extract was 0.8%. The test article in direct contact with blood was slightly hemolytic and the test article extract was non-hemolytic. |
| Sterilization | Suitable to pass the acceptance criteria of ISO 11135 for a 1x10-6 SAL. | Testing demonstrated that the Hypocore device is suitable to pass the acceptance criteria of ISO 11135 therefore demonstrating substantial equivalence for sterilization compared to the predicate device. |
| Medical Electrical Safety | Meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2. | Testing demonstrated that the Hypocore device meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2 therefore demonstrating substantial equivalence to the predicate device with regard to electrical safety. |
| Human Factors Design Validation | All users safely complete all use tasks successfully. | All users safely completed all use tasks successfully. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific number of samples used for each test beyond indicating "All samples" met criteria. For some tests like "Strap Performance Test", it implies multiple tests were performed (e.g., three tests performed, "all samples met"). For the Biocompatibility tests, it refers to "test article extract" and "test article" but doesn't quantify the number of devices or extracts tested.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. The tests appear to be laboratory-based performance and safety evaluations rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this study. The study focuses on the physical and chemical performance, safety, and usability of a medical device, which are evaluated against predefined engineering specifications, international standards (ISO, IEC, ASTM, USP), and human factors guidance. There is no mention of expert consensus or interpretation required to establish a "ground truth" in the way it would be for diagnostic imaging or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where agreement among observers is critical. This study involves objective measurements and adherence to engineering and safety standards.
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
This information is not applicable. The device (Hypocore) is a thermal regulating system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study or assessment of AI's effect on human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Hypocore is a physical device, not an algorithm. Its "standalone" performance is assessed throughout the various performance and safety tests, which evaluate the device's ability to meet its specifications independently of human intervention during the measurement process. However, Human Factors Design Validation did evaluate user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests (cooling level, time to cool, flow rate, environmental conditions, tilt, handle force, strap performance), the "ground truth" or reference was predefined engineering specifications and benchmark values, often based on "known published literature regarding IV fluid cooling" or "standard of care" (e.g., refrigerated IV fluid bag temperature, strength limits for a human wrist).
For the biocompatibility tests, the "ground truth" or reference was international standards such as ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756, ASTM F2382, and USP General Chapter <151>.
For sterilization, it was ANSI/AAMI/ISO 11135.
For electrical safety, it was IEC 60601-1 and IEC 60601-1-2.
For Human Factors, it was FDA Draft Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and standards IEC 62366: 2007 + A1: 2014, IEC 60601-1-6: 2007 (3rd Ed.).
8. The sample size for the training set
This information is not applicable. This is a medical device performance and safety study, not an AI model development study that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2016
Novocor Medical Systems, Inc. % Ms. Tammy Carrea Regulatory Consultant (RegMatters, LLC) 2 Davis Drive Durham, North Carolina 27709
Re: K153162
Trade/Device Name: Hypocore Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: May 20, 2016 Received: May 23, 2016
Dear Ms. Tammy Carrea:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S-D/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153162
Device Name Hypocore
Indications for Use (Describe)
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [In accordance with 21CFR 807.92]
Novocor Medical Systems, Inc. Hypocore
1. Submitter / 510(k) Holder
Novocor Medical Systems, Inc. 2 Davis Drive Durham, NC 27709
| Contact Person: | Tammy B. Carrea |
|---|---|
| RegMatters, LLC |
May 20, 2016 Date Prepared:
2. Device Identification
| Common Name: | Thermal Regulating System |
|---|---|
| Trade Name: | Hypocore |
| Regulation Number: | 21 CFR 870.5900 |
| Regulation Description: | Cardiovascular therapeutic devices,Thermal regulating system |
| Regulation Medical Specialty: | Cardiovascular |
| Review Panel: | Neurology |
| Product Code: | NCX - system, hypothermia, intravenous, cooling |
| Device Class: | II |
3. Predicate Device
| CLASS | MANUFACTURER | 510(k) NUMBER | DEVICE NAME/DESCRIPTION |
|---|---|---|---|
| II | Medivance | K080899 | Arctic Blast Intravenous Fluid Chiller |
Novocor Medical Systems, Inc.
Hypocore May 20, 2016
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4. Device Description
The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube.
During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port.
It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off.
The entire device is disposable, single use and is provided pre-sterilized.
5. Indications for Use/Intended Use
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
Comparison of Intended Use 6.
The intended use of the Hypocore is essentially the same as the Medivance Arctic Blast Intravenous Fluid Chiller in K080899. The main difference is that the types of fluids intended for use with the device are specified within the intended use statement for the Hypocore device.
Comparison of Technological Characteristics 7.
The principles of operation and operational characteristics are the same and include a means of heat exchange resulting in the transfer or removal of heat from IV fluids.
Both devices are designed to connect the device inlet to the outlet of a sterile IV administration set and the device outlet to an IV access port and as such have similar connector materials and luer designs. Both device designs utilize a sealed sterile tubing fluid path as a cooling chamber. In both devices the sterile IV fluid flows through the tubing which acts as a means to transfer/remove heat resulting in fluid cooling. Neither device designs utilize an external power supply and neither of the devices utilizes software or a temperature controller for operation.
Both devices are designed for use in emergency medical situations and are provided for use in ambulances or other emergency vehicles. Both devices are activated using an activation switch or button on the front module.
Both devices are used in a sterile state and provided pre-sterilized. Both devices are disposable, for single use.
Novocor Medical Systems, Inc.
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The Hypocore device and predicate device are different in that the Hypocore device specifies slightly different performance specifications. The performance specifications of the Hypocore device are based on known published literature regarding IV fluid cooling for situations such as cardiac arrest. These differences in specifications do not present new issues of safety and effectiveness because the Hypocore has demonstrated that it achieves its stated performance specifications and performs similarly to the predicate device. Performance testing has demonstrated that the Hypocore device meets all stated performance criteria.
Furthermore the Hypocore device provides for a standardized means of cooling IV fluids compared to the current standard of care, which consists of applying external cooling to solution bags, such as placing the IV bag in a cooler with ice or ice packs or storing the solutions in a refrigerator. In the case of the Hypocore device, fluid chilling is performed in real time so that the fluid from an entire bag of solution is chilled continuously, assuring constant and more consistent cooling.
See Table 1 below for a comparison of technological features and performance specifications.
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| Product Feature | Predicate Device | Proposed Device |
|---|---|---|
| Medivance Artic Blast IV Fluid Chiller,K080899 | Novocor Hypocore Device | |
| Regulation Number | 21 CFR 870.5900 | Same |
| Product Code | NCX | Same |
| Intended Use | The Medivance Arctic Blast IntravenousFluid Chiller is intended to cool sterilesolutions during intravenous administrationwhere clinically indicated for reduction ofpatient temperature. | Hypocore™ is a single-use device intendedto cool sterile saline, lactated ringers andother comparable low viscosity inert fluidsduring intravenous administration whereclinically indicated for reduction of patienttemperature. |
| Principle of Operation | Heat Exchanger - Cooling achieved via anadsorption process to transfer/remove heatresulting in cooling | Heat Exchanger - Cooling achieved via anendothermic reaction to transfer/removeheat, resulting in cooling |
| Cooling Chamber | Length of tubing, material unknown | Length of tubing, material - 60" of stainlesssteel, 31" of DEHP-Free PVC IV tubing. |
| Cooling ChamberFluid Contact | None, cooling chamber fully sealed, nocontact with sterile fluid | Same |
| Materials ofConstruction | Materials similar to those used inmanufacture of IV administration sets | Same |
| Cooling Fluid | Unknown | Solution of Ammonium nitrate and water |
| Inlet | Connected to sterile saline bag | Same |
| Outlet | Connected to standard IV set | Same |
| External Power Source | None | Same |
| Software Control | None | Same |
| TemperatureController | None | Same |
| Activation Method | Button on the module | Same, Activation switch on front of module |
| Sterile Fluid Path | Sterile fluid path incorporated into heatexchanger | Same |
| Disposable, SingleUse | Yes | Same |
| Pre-sterilized | Yes | Same |
| Time to Cool | < 60 Seconds | Less than two minutes |
| Level of CoolingAchieved | 2 liters of fluid to 4-6°C | 1 liter of fluid to an average of less than11°C |
| Storage Temperature | Room temperature | Same |
Table 1. Substantial Equivalence Comparison
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8. Performance Testing Summary
A series of performance tests were performed to demonstrate the ability of the Hypocore device to cool fluids under expected conditions of use using low and high infusion rates as well as challenging environmental conditions including elevated temperatures.
Usability tests were conducted for the Hypocore device in accordance with the FDA Draft Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" from June 22, 2011.
Biocompatibility studies were performed in accordance with ISO 10993-1.
Sterilization studies were also performed in accordance with ANSI/AAMI/ISO 11135 to demonstrate that the Hypocore device is able to be ethylene oxide (EO) sterilized to a sterility assurance level of 1x10-6.
Transit testing and expiration dating/shelf life tests were also performed to validate the durability and shelf life of the sterile barrier and outer shipper packaging.
The Hypocore device was tested for medical electrical safety compliance in accordance with international IEC standards IEC 60601-1 and IEC 60601-1-2.
Any technological differences between the Hypocore and the predicate device have been mitigated via functional, simulated use/usability, and standards based safety testing. A summary of verification and validation testing used to support substantial equivalence with the predicate device is provided below in Table 2.
Thus the Hypocore device does not introduce any new issues of safety or effectiveness compared to the predicate device.
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| Test | Test Method Summary | Results |
|---|---|---|
| 10 Minute StandardDevice Performance -Level of cooling, fastflow | Purpose: determine cooling capabilities forfast flow of IV fluids.1 Liter of room temperature IV fluid wasflowed from a standard bag via anadministration set through the device in 10minutes in room temperature conditions ata rate of 100 ml/min at room temperature.The average output temperature wasmeasured. | All samples met the average outputtemperature acceptance criteria (range =6.9-7.8 °C).Test was used to demonstrate that theHypocore device meets its statedacceptance criteria to cool 1 liter of fluid toan average temperature of <11ºC (basedon standard of care- refrigerated IV fluidbag) and is therefore substantiallyequivalent in cooling capacity using thefastest expected flow rate. |
| 30 Minute StandardDevice Performance -Level of cooling, slowflow | Purpose: determine cooling capabilities forslow flow of IV fluids.1 Liter of room temperature IV fluid wasflowed from a standard bag via anadministration set through the device in 30minutes in room temperature conditions ata flow rate of 33 ml/min at roomtemperature. The average outputtemperature was measured. | All samples met the average outputtemperature acceptance criteria (range =6.1-8.5 °C).Test was used to demonstrate that theHypocore device meets its statedacceptance criteria to cool 1 liter of fluid toan average temperature of <11ºC (based onstandard of care- refrigerated IV fluid bag)and is therefore substantially equivalent incooling capacity using the slowest expectedflow rate. |
| 30 Minute StandardDevice Performance -Time to achieve requiredcooling level | Purpose: determine time to coolingcapabilities.1 Liter of room temperature IV fluid wasflowed from a standard bag via anadministration set through the device in 30minutes in room temperature conditions.The time to achieve the requiredtemperature threshold was measured. | All samples met the acceptance criteria forthe time required to achieve the statedacceptance criteria of less than 2 minutes(range = 46-60 sec).Test was used to demonstrate that theHypocore device meets its statedacceptance criteria and is thereforesubstantially equivalentfor the time required to achieve cooling i.e.the time required to achieve the neededtemperature threshold. |
| Elevated EnvironmentalTemperature Test | Purpose: demonstrate that the deviceperforms as intended under elevatedtemperature conditions, simulatingsummer like conditions1 Liter of room temperature fluid wasflowed from a standard IV bag at a rate of48 ml/min inside a 32°C environmentalchamber. | All samples met the acceptance criteria tocool the IV fluids to less than 11℃ whenflowed at 48 ml/min in a 32°Cenvironment.The average temperature of the exitingfluid ranged from 8.8-10.5 ℃ inside a32°C chamber. |
| Flow Rate Test -Comparative flow rate ofstandard IV set with andwithout the Hypocoredevice in line | Purpose: demonstrate that the Hypocoredevice does not noticeably reduce the flowrate of IV fluid.1 Liter IV bag was gravity flowed throughan IV administration set into a 14 gauge IVcatheter and the standard flow ratemeasured. Next the Hypocore device wasinserted and the flow rate measured. | Acceptance criteria required that the flowrate reduction be less than 25% of thestandard flow rate. All samples met theacceptance criteria (flow rate reductionranged from 10.35-15.87%). |
| Tilt Test | Purpose: evaluate the ability of theportable device to perform as intendedwhen not parallel to a surface, at a tilt | All samples met the acceptance criteriawhich required that the temperature of theexit fluid be less than that of the initial |
| angle of +/- 45 degrees. Test conductedwith a flow rate of 100 ml/min at bothangles. Temperature of fluid exiting the IVoutlet evaluated during the infusion of 1liter at each angle. | fluid. The average environmentaltemperature ranged from 22.5-22.8°C. Theoutput temperatures during the test rangedfrom 8.6-9.2°C at +45 degrees and 9.1-10.1°C at -45 degrees. | |
| Activation Handle ForceTest | Purpose: Demonstrate that the activationhandle does not break if over rotated.A force of 21 lb-in was exerted on thehandle and it was determined whether thehandle withstood the torque withoutbreaking. | The acceptance criteria was that theactivation handle must withstand 20.36 lbwhich is 50% of the highest wrist strengthfor 21-30 year old males. All sampleswithstood the applied force and no sampledevices broke. |
| Strap Performance Test | Purpose: Demonstrate that the Velcro strapperforms as intended to secure the portabledevice during operation.Three tests were performed: (1) TheHypocore device was subjected to a forceequal to its own weight, (2) The pressureexerted by the strap on a limb wasmeasured, (3) The Hypocore device wasdropped from 41.5 inches and the force onthe outlet tubing was measured. | (1) All samples met the acceptance criteriawhich was that the devices must stayattached to the limb.(2) All samples met the acceptance criteriawhich was that the pressure of the strapmust not exceed 200 mmHg, theminimum pressure required to create abloodless field for upper extremitysurgery (pressures ranged from 50-80mmHg).(3) All test iterations met the acceptancecriteria that the force of the device beless than 52.9 N which is the forcerequired to pull out a taped IV catheter.(forces ranged from 14.0-27.0 N) |
| Biocompatibility(Cytotoxicity) | Purpose: evaluate the Fluid Path and Skincontacting components of the Hypocoredevice for potential cytotoxic effects,based on using an in vitro mammalian cellculture test. The study was conductedfollowing the guidelines of ISO 10993-5. | Acceptance Criteria: Test results are non-cytotoxic with scores of 0, 1, or 2 per ISO10993-5.Fluid Path Results: The test article extractshowed no evidence of causing cell lysis ortoxicity. The test article extract met therequirements of the test, since the gradewas less than a grade 2 (mild reactivity).Skin Contact Results: The test articleextract showed evidence of causing slightcell lysis or toxicity; however, the testarticle extract met the requirements of thetest, since the grade was less than a grade2. |
| Biocompatibility(Irritation) | Purpose: evaluate the Fluid Path and SkinContact components of the Hypocoredevice for the potential to cause irritation,based on intracutaneous injection inrabbits. This study was conducted basedon ISO 10993-10. | Acceptance Criteria: Test results are non-irritant with scores of 0-1 comparisonbetween control and test sample reaction(ISO 10993-10).Fluid Path Results: The test article met therequirements of the test, since thedifference between each test article extractoverall mean score and correspondingcontrol extract overall mean score was 0.0and 0.0 for the sodium chloride (SC) andsesame oil (SO) test article extracts,respectivelySkin Contact Results: The test article metthe requirements of the test, since the |
| difference between each test article extractoverall mean score and correspondingcontrol extract overall mean score was 0.0and 0.1 for the SC and SO test articleextracts, respectively. | ||
| Biocompatibility(Sensitization) | Purpose: evaluate the Fluid Path and SkinContact components of the Hypocoredevice for the potential to cause delayeddermal contact sensitization, based on aguinea pig maximization test. This studywas conducted based on the requirementsof ISO 10993-10. | Acceptance Criteria: Test results are non-sensitizer or mild sensitizer with a score of0, non-sensitizer, or 1, mild sensitizer,based on comparison between control andtest sample (ISO 10993-10)Fluid Path Results: The test article extractsshowed no evidence of causing delayeddermal contact sensitization in the guineapig. The test article was not considered asensitizer in the guinea pig maximizationtest.Skin Contact Results: The test articleextracts showed no evidence of causing |
| Biocompatibility(Pyrogenicity) | Purpose: evaluate the Fluid Pathcomponents of the Hypocore device formaterial mediated pyrogenicity in therabbit. The test was conducted based onUSP, General Chapter <151>, PyrogenTest, as recommended in ISO 10993-11. | Acceptance Criteria: No single animaltemperature rise of 0.5°C or more above itsbaseline temperature.Test Results: No single animal showed atemperature rise of 0.5°C or more above itsbaseline temperature. The total rise of therabbits' temperature during 3 hours was0.0°C. The test article was judged as non-pyrogenic. |
| Biocompatibility(Ethylene Oxide andEthylene ChlorohydrinTesting) | Purpose: evaluate and confirm acceptableEthylene Oxide (EO) and EthyleneChlorohydrin (ECH) levels post EthyleneOxide sterilization. | Acceptance Criteria #1: EO residuals - <=4mg and ECH residuals - <= 9mg.Test Results: EO and ECH levels wereacceptable on Day 1.Acceptance Criteria #2: The tolerablecontact limits (TCL) for EO and ECH shallnot exceed 10 μg/cm2 and 5 mg/cm2,respectively, or the device shall havenegligible irritation as specified in ISO10993-10.Test Results: The Hypocore deviceexhibited no irritation asdemonstrated within biocompatibilityirritation testing. |
| Biocompatibility (PartialThromboplastin Time) | Purpose: evaluate the Fluid Pathcomponents of the Hypocore device for thepotential to cause an effect on thecoagulation cascade via the intrinsiccoagulation pathway. The study wasconducted in accordance to ASTM F2382. | Acceptance Criteria: test result clottingtime > 50% of the negative control perASTM F2382.Fluid Path Results: The plasma exposed tothe test article had an overall averageclotting time of 235.9 seconds, whichrepresented 79.9% of the negative control.The test article was considered a minimalactivator, and therefore, met therequirements of the test. |
| Biocompatibility(Acute SystemicToxicity) | Purpose: evaluate the Fluid Pathcomponents of the Hypocore device for thepotential to cause acute systemic toxicityin mice. This study was conducted basedon ISO 10993-11. | Acceptance Criteria: reference ISO 10993-11 (Section 5.3).Fluid Path Results: There was no mortalityor evidence of systemic toxicity from theextracts injected into mice. Each test articleextract met the requirements of the study. |
| Biocompatibility(Hemocompatibility) | Purpose: evaluate the Fluid Pathcomponents of the Hypocore device for thepotential to cause hemolysis. This studywas conducted based on ASTM F756 andISO 10993-4. | Acceptance Criteria: Reference ISO10993-4.Fluid Path Results: The hemolytic indexfor the test article in direct contact withblood was 2.0%, and the hemolytic indexfor the test article extract was 0.8%. Thetest article in direct contact with blood wasslightly hemolytic and the test articleextract was non-hemolytic. |
| Sterilization | Testing to establish a 1x10-6 SAL usingethylene oxide per ISO 11135. | Testing demonstrated that the Hypocoredevice is suitable to pass the acceptancecriteria of ISO 11135 thereforedemonstrating substantial equivalence forsterilization compared to the predicatedevice. |
| Medical Electrical Safety | Testing in accordance with IEC 60601-1and IEC 60601-1-2. | Testing demonstrated that the Hypocoredevice meets the acceptance criteria of IEC60601-1 and IEC 60601-1-2 thereforedemonstrating substantial equivalence tothe predicate device with regard toelectrical safety. |
| Human Factors DesignValidation | Purpose: Verify that the device is safe forthe intended use, users, and useenvironment including interaction withsterile IV bags and standard IV sets by theexpected user population.Testing was conducted in accordance withstandards IEC 62366: 2007 (First Edition)+ A1: 2014, IEC 60601-1-6: 2007 (3rdEd.) and the FDA Draft Guidance"Applying Human Factors and UsabilityEngineering to Medical Devices" fromFebruary 3rd, 2016.Users were asked to setup and use thedevice independently without access todirections for use in a simulateduseenvironment | All users safely completed all use taskssuccessfully.This testing was used to demonstratesubstantial equivalence regarding deviceconnectivity to standard sterile IV bags andIV administration sets. |
Table 2. Non-clinical Performance Test Summary
Novocor Medical Systems, Inc.
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9. Preclinical and/or Clinical Tests
No preclinical or clinical testing was required to demonstrate that the Hypocore device met performance specifications and intended use.
10. Conclusion
The Hypocore device has been shown to be equivalent to the predicate in terms of intended use and operational and design features. Any differences in technology have been tested and verified and do not raise any new issues of safety and effectiveness.
- Both the Hypocore and Arctic Blast have the same intended use. Both devices . provide for real time, continuous cooling of IV solutions during intravenous administration.
- o Both devices utilize the same principle of operation which is to cool IV fluids via heat exchange.
- The operational functions and design features of the two devices are the same. Both . devices connect to IV administration sets and provide a sealed sterile tubing fluid path which acts as a heat exchanger to remove/transfer heat. The materials of construction for both devices are compatible with or similar to those used in IV administration sets.
- Both devices are provided pre-sterilized and are disposable, single use. .
- Both devices have been tested for biocompatibility and medical electrical safety. .
- The only difference between the two devices is the stated cooling specifications. . The performance specifications for the Hypocore device are based on research which measured and derived the temperature and flow rate of fluids used to achieve IV fluid cooling.
The conclusion drawn from the test data is that the Hypocore device has a safety and effectiveness profile that is similar to the predicate device, performs similarly to the predicate device, meets its stated performance criteria, and has a design that is substantially equivalent to the predicate device. Thus the Hypocore device is considered substantially equivalent to the Medivance Arctic Blast (K080899) predicate device.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).