(204 days)
Not Found
No
The device description and performance studies focus on the physical cooling mechanism and standard medical device testing, with no mention of AI or ML.
Yes
Explanation: The device is intended to cool fluids during intravenous administration for the reduction of patient temperature, which directly impacts a physiological condition as a therapeutic action.
No
Explanation: The device is described as an inline chiller for IV solutions intended to cool fluids for reduction of patient temperature, which is a therapeutic function, not a diagnostic one. It does not gather information about a patient's health condition.
No
The device description clearly outlines a physical device with hardware components (Luer-lock connectors, internal battery, handle, disposable housing) that performs a physical function (cooling IV fluids). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cool fluids during intravenous administration to reduce patient temperature. This is a therapeutic action performed on the patient, not a test performed on a sample from the patient to diagnose a condition.
- Device Description: The device is described as an "inline chiller for IV solutions." It cools fluids that are then administered to the patient.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Hypocore device does not perform any of these functions.
N/A
Intended Use / Indications for 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.
Product codes
NCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Both devices are designed for use in emergency medical situations and are provided for use in ambulances or other emergency vehicles.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
10 Minute Standard Device Performance - Level of cooling, fast flow
- Purpose: determine cooling capabilities for fast flow of IV fluids. 1 Liter of room temperature IV fluid was flowed from a standard bag via an administration set through the device in 10 minutes in room temperature conditions at a rate of 100 ml/min at room temperature. The average output temperature was measured.
- Results: All samples met the average output temperature acceptance criteria (range = 6.9-7.8 °C). Test was used to demonstrate that the Hypocore device meets its stated acceptance criteria to cool 1 liter of fluid to an average temperature of , Pyrogen Test, as recommended in ISO 10993-11.
- Results: Acceptance Criteria: No single animal temperature rise of 0.5°C or more above its baseline temperature. Test Results: 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)
- Purpose: evaluate and confirm acceptable Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) levels post Ethylene Oxide sterilization.
- Results: Acceptance Criteria #1: EO residuals - 50% of the negative control per ASTM F2382. Fluid Path Results: 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)
- Purpose: evaluate the Fluid Path components of the Hypocore device for the potential to cause acute systemic toxicity in mice. This study was conducted based on ISO 10993-11.
- Results: Acceptance Criteria: reference ISO 10993-11 (Section 5.3). Fluid Path Results: 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)
- Purpose: evaluate the Fluid Path components of the Hypocore device for the potential to cause hemolysis. This study was conducted based on ASTM F756 and ISO 10993-4.
- Results: Acceptance Criteria: Reference ISO 10993-4. Fluid Path Results: 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
- Purpose: Testing to establish a 1x10-6 SAL using ethylene oxide per ISO 11135.
- Results: 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
- Purpose: Testing in accordance with IEC 60601-1 and IEC 60601-1-2.
- Results: 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
- Purpose: Verify that the device is safe for the intended use, users, and use environment including interaction with sterile IV bags and standard IV sets by the expected user population. Testing was conducted in accordance with standards IEC 62366: 2007 (First Edition) + A1: 2014, IEC 60601-1-6: 2007 (3rd Ed.) and the FDA Draft Guidance "Applying Human Factors and Usability Engineering to Medical Devices" from February 3rd, 2016. Users were asked to setup and use the device independently without access to directions for use in a simulated use environment.
- Results: All users safely completed all use tasks successfully. This testing was used to demonstrate substantial equivalence regarding device connectivity to standard sterile IV bags and IV administration sets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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 Intravenous | |
| Fluid Chiller is intended to cool sterile | ||
| solutions during intravenous administration | ||
| where clinically indicated for reduction of | ||
| patient temperature. | 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. | ||
| Principle of Operation | Heat Exchanger - Cooling achieved via an | |
| adsorption process to transfer/remove heat | ||
| resulting in cooling | Heat Exchanger - Cooling achieved via an | |
| endothermic reaction to transfer/remove | ||
| heat, resulting in cooling | ||
| Cooling Chamber | Length of tubing, material unknown | Length of tubing, material - 60" of stainless |
| steel, 31" of DEHP-Free PVC IV tubing. | ||
| Cooling Chamber | ||
| Fluid Contact | None, cooling chamber fully sealed, no | |
| contact with sterile fluid | Same | |
| Materials of | ||
| Construction | Materials similar to those used in | |
| manufacture 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 |
| Temperature | ||
| Controller | None | Same |
| Activation Method | Button on the module | Same, Activation switch on front of module |
| Sterile Fluid Path | Sterile fluid path incorporated into heat | |
| exchanger | Same | |
| Disposable, Single | ||
| Use | Yes | Same |
| Pre-sterilized | Yes | Same |
| Time to Cool | , Pyrogen | |
| Test, as recommended in ISO 10993-11. | Acceptance Criteria: No single animal | |
| temperature rise of 0.5°C or more above its | ||
| baseline temperature. | ||
| Test Results: 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) | Purpose: evaluate and confirm acceptable | |
| Ethylene Oxide (EO) and Ethylene | ||
| Chlorohydrin (ECH) levels post Ethylene | ||
| Oxide sterilization. | Acceptance Criteria #1: EO residuals - 50% of the negative control per | |
| ASTM F2382. | ||
| Fluid Path Results: 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) | Purpose: evaluate the Fluid Path | |
| components of the Hypocore device for the | ||
| potential to cause acute systemic toxicity | ||
| in mice. This study was conducted based | ||
| on ISO 10993-11. | Acceptance Criteria: reference ISO 10993- | |
| 11 (Section 5.3). | ||
| Fluid Path Results: 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) | Purpose: evaluate the Fluid Path | |
| components of the Hypocore device for the | ||
| potential to cause hemolysis. This study | ||
| was conducted based on ASTM F756 and | ||
| ISO 10993-4. | Acceptance Criteria: Reference ISO | |
| 10993-4. | ||
| Fluid Path Results: 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 | Testing to establish a 1x10-6 SAL using | |
| ethylene oxide per ISO 11135. | 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 | Testing in accordance with 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 | Purpose: Verify that the device is safe for | |
| the intended use, users, and use | ||
| environment including interaction with | ||
| sterile IV bags and standard IV sets by the | ||
| expected user population. | ||
| Testing was conducted in accordance with | ||
| standards IEC 62366: 2007 (First Edition) |
- A1: 2014, IEC 60601-1-6: 2007 (3rd
Ed.) and the FDA Draft Guidance
"Applying Human Factors and Usability
Engineering to Medical Devices" from
February 3rd, 2016.
Users were asked to setup and use the
device independently without access to
directions for use in a simulated
useenvironment | All users safely completed all use tasks
successfully.
This testing was used to demonstrate
substantial equivalence regarding device
connectivity to standard sterile IV bags and
IV administration sets. |
Table 2. Non-clinical Performance Test Summary
Novocor Medical Systems, Inc.
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10
11
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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.