EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

K060537 · Enginivity, LLC · LGZ · Jun 8, 2006 · General Hospital

Device Facts

• Record ID: K060537
• Device Name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
• Applicant: Enginivity, LLC
• Product Code: LGZ · General Hospital
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The eFlow IV Fluid Warmer is an in-line warming device for blood, blood products, and IV solutions. It consists of a warming unit and a single-use sterile disposable cartridge. The cartridge features a plastic housing and a biocompatible coated aluminum extrusion forming an enclosed fluid path. Heat is generated via electrical resistance and transferred through the extrusion to the fluid. The device operates on AC power or 12-30V DC sources. It is used by healthcare professionals in hospital, clinical, or field settings to prevent hypothermia. The device warms infusate to a maximum of 40°C at flow rates between 1 ml/min and 200 ml/min. Standard Luer fittings connect the device to hospital IV lines. By maintaining appropriate fluid temperatures, the device helps prevent patient hypothermia during infusion therapy.

Clinical Evidence

No clinical data. Bench testing only. Studies included biocompatibility testing of sterilized disposable cartridges and laboratory performance evaluations assessing temperature accuracy and hemolytic effects at flow rates ranging from 10 to 200 ml/min and during stopped flow conditions.

Technological Characteristics

In-line fluid warmer; sterile disposable cartridge with plastic housing and biocompatible coated aluminum extrusion. Heat generated via electrical resistance. Powered by AC adapter or 12-30V DC source. Flow rates: 1-200 ml/min; max temperature 40°C. Standard Luer fittings. Complies with ASTM F 2172-02.

Indications for Use

Indicated for warming blood, blood products, and IV solutions in hospital, clinical, and field environments to prevent hypothermia. Contraindicated for use with platelets or drugs.

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

• Thermal Angel, Model 200 (K012031)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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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.

- 1. Name of Submitter, Contact Person and Date Summary Prepared:

| Name: | Enginivity LLC. |
|----------------------|----------------------------------------------------|
| Address: | 9 Grapevine Avenue, Suite 2<br>Lexington, MA 02421 |
| Phone:<br>Fax: | 781-862-7008<br>781-674-9663 |
| Official Contact: | David Cassidy<br>Executive Vice President |
| Date of Preparation: | February 27, 2006 |

- 2. 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 |

- 3. Product Code: LGZ
Device Class: unclassified

- 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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K060537
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- 6. 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.

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.

- 7. 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.

- Comparison of technological characteristics with Predicate Devices: 8.
The Enginivity eFlow™ Fluid Warmer is substantially equivalent to Estill Medical Technologies' Thermal Angel, Model 200.

- 9. 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.

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.

- 10. 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

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