(100 days)
Not Found
No
The description focuses on the physical components and basic heating mechanism, with no mention of AI or ML terms or functionalities.
No.
The device's primary function is to warm fluids to prevent hypothermia, not to directly treat a disease or medical condition.
No
The device is a fluid warmer, not a diagnostic tool. Its purpose is to warm fluids prior to administration to a patient, not to identify or monitor medical conditions.
No
The device description clearly outlines hardware components including a warming device, a disposable set with a plastic housing and aluminum extrusion, and power adapters (AC and DC). This indicates it is a physical medical device with software likely controlling its functions, but not a software-only device.
Based on the provided information, the eFlow IV Fluid Warmer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous solutions prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device description focuses on the mechanism of warming fluids for infusion. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. The eFlow IV Fluid Warmer's function is to prepare fluids for infusion into the body, not to analyze samples from the body.
N/A
Intended Use / Indications for Use
The eFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Product codes (comma separated list FDA assigned to the subject device)
LGZ
Device Description
The Enginivity cFlow™ IV Fluid Warmer consists of a warming device and a single use disposable set. The warmer can be powered by either an AC power adapter supplied by Enginivity LLC or a12-30 volt DC source meeting the requirements listed in the operators' manual. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
The sterile disposable cartridge consists of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path.
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
healthcare professionals in hospital, clinical and field environments
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)
Results of studies conducted on sterilized eFlow™ Disposable Carticiges demonstrate the materials to be biocompatible for its intended use. In addition, performance data demonstrate the temperature accuracy of the device at different flow rates.
Laboratory evaluations have been conducted to evaluate the hemolytic effect of the eFlow IV Fluid warmer during flows ranging from 10 to 200 ml/min and stopped flow.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
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 stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Enginivity LLC C/O Penelope H. Greco Vice President MedApprove, Incorporated 8 Gray Lodge Road Kittery, Maine 03904
JAN 1 0 2017
Re: K060537
Trade/Device Name: Enginivity™ eFlow IV Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: May 24, 2006 Received: May 24, 2006
Dear Ms. Greco:
This letter corrects our substantially equivalent letter of June 8, 2006.
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
1
Page 2 - Ms. Penelope H. Greco
CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 8091 ), 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" (21CFR 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.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K O 6 05 3 7
Device Name: Enginivity eFlow™ IV Fluid Warmer
Indications for Use:
The eFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Contraindications of use: The cFlow Disposable, Model 200 is not for use with platelets or drugs.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cain Bunk
on Contral. Ber
Number
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K060537
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JUN - 8 2006
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k)s.
-
- Name of Submitter, Contact Person and Date Summary Prepared:
| Name: | Enginivity LLC. |
|---|---|
| Address: | 9 Grapevine Avenue, Suite 2 |
| Lexington, MA 02421 | |
| Phone: | |
| Fax: | 781-862-7008 |
| 781-674-9663 | |
| Official Contact: | David Cassidy |
| Executive Vice President | |
| Date of Preparation: | February 27, 2006 |
-
- Device Trade Name and Common Name:
| Trade Name: | eFlow™ Model 100 IV Fluid Warmer |
|---|---|
| Common/Usual Name: | Sterile Fluid Path, in-line Blood Fluid Warmer |
| Classification Name: | Warmer, Thermal, Infusion Fluid |
-
- Product Code: LGZ
Device Class: unclassified
- Product Code: LGZ
-
Legally Marketed Equivalent Device Names: 4.
Substantial equivalence is claimed to Estill Medical Technologies' Thermal Angel, Model 200 cleared under 510(k) K012031 on July 26, 2001.
ર્ડ Performance Standards:
ASTM F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers.
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4
K060537
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-
- Description of the Device:
The Enginivity cFlow™ IV Fluid Warmer consists of a warming device and a single use disposable set. The warmer can be powered by either an AC power adapter supplied by Enginivity LLC or a12-30 volt DC source meeting the requirements listed in the operators' manual. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
- Description of the Device:
The sterile disposable cartridge consists of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path.
-
- Intended Use of the Device:
The Enginivity eFlow™ IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
- Intended Use of the Device:
-
Comparison of technological characteristics with Predicate Devices: 8.
The Enginivity eFlow™ Fluid Warmer is substantially equivalent to Estill Medical Technologies' Thermal Angel, Model 200. -
- Discussion of Non-clinical Studies;
Results of studies conducted on sterilized eFlow™ Disposable Carticiges demonstrate the materials to be biocompatible for its intended use. In addition, performance data demonstrate the temperature accuracy of the device at different flow rates.
- Discussion of Non-clinical Studies;
Laboratory evaluations have been conducted to evaluate the hemolytic effect of the eFlow IV Fluid warmer during flows ranging from 10 to 200 ml/min and stopped flow.
-
- Conclusion:
Results of studies performed have demonstrated the safety and efficacy of Enginivity's eFlow™ IV Fluid Warmer and substantial equivalence to its predicate devices
- Conclusion:
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