ENTERAL NUTRITION WARMER

K122449 · Acacia, Inc. · LGZ · Jun 13, 2013 · General Hospital

Device Facts

• Record ID: K122449
• Device Name: ENTERAL NUTRITION WARMER
• Applicant: Acacia, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Jun 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

Device Story

The Enteral Nutrition Warmer is an electronically powered dry warmer designed for use in clinical settings, such as the NICU, to warm enteral nutrition fluids. It operates by applying controlled external heat to the outer wall of an administration set tubing. The device features a single heating plate, a thermocouple for temperature sensing, and a temperature fuse as a safety mechanism to shut off power if the sensor fails. It is operated by hospital staff via an on/off switch and includes an LED indicator for operational status. By maintaining enteral fluids at a controlled temperature (32°C to 41°C) during delivery, the device aims to improve patient comfort and tolerance during feeding. It is a reusable, non-sterile device powered by a standard 120V electrical outlet.

Clinical Evidence

A human factors study was conducted to assess clinical risks related to the use of the device for warming enteral fluids in neonatal patients by NICU staff. All identified risks were mitigated. Non-clinical bench testing was performed to verify specifications, including maximum temperatures of the housing, heat sink, and enteral fluid, as well as time to reach nominal temperature.

Technological Characteristics

Electronically powered dry warmer; utilizes a thermocouple for temperature sensing and a temperature fuse for over-temperature protection. Heating plate maximum temperature is 48.8°C. Operates on standard 120V AC. Dimensions: 4.67in x 3.42in x 0.74in. Weight: 22.8 ounces. Materials are fire-rated. Provided non-sterile, reusable.

Indications for Use

Indicated for warming enteral fluids in plastic administration tubing for intermittent, low flow rate (0-7 mL/min) applications in neonatal patients.

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

• Elltec Enteral Nutrition Warmer (K024373)

Submission Summary (Full Text)

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# JUN 1 3 2013

### 510(k) Summary of safety and effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Acacia, Inc. |
|------------------------|-------------------------------------------|
| APPLICANT ADDRESS | 785 Challenger Street<br>Brea, CA 92821 |
| APPLICANT PHONE | [phone] |
| CONTACT PERSON | Fergie Ferguson |
| PREPARATION DATE | 05/15/13 |
| TRADE NAME: | Enteral Nutrition Warmer |
| COMMON NAME: | Warmer, Thermal, Infusion Fluid |
| CLASSIFICATION NAME: | Warmer, Thermal, Infusion Fluid |
| DEVICE CLASSIFICATION: | Unclassified |
| PRODUCT CODE | LGZ |
| PREDICATE DEVICES: | Elltec Enteral Nutrition Warmer (K024373) |

#### Purpose

The purpose of this submission is to introduce a new device for Enteral Nutrition Warming.

#### Substantially Equivalent To:

The Acacia, Inc. Enteral Nutrition Warmer is substantially equivalent in intended use, principle of operation and technological characteristics to the Elltec Enteral Nutrition Warmer (K024373) for the delivery of enteral fluids.

The Acacia, Inc. Enteral Nutrition Warmer and the Elltec Enteral Nutrition Warmer are both electronically powered dry warmers, which supplies external heat to the outside of the administration set tubing. The flow rates, output temperature, along with dimensions and weight are equivalent.

The table below describes the characteristics reviewed to determine substantial equivalence.

| Item Reviewed | Proposed Device | Predicate Device | Equivalence |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Enteral Nutrition<br>Warmer is an<br>electronically powered<br>dry warmer, which<br>supplies external heat<br>to the plastic tubing<br>incorporated<br>administration sets for<br>intermittent use and low | The Enteral Nutrition<br>Warmer LIFORT LT-1 is<br>an electronically<br>powered, dry warmer<br>which supplies external<br>heat to the plastic tubing<br>incorporated<br>administration sets for<br>intermittent use and low | Same |
| Principle of<br>Operation | flow rate applications at<br>0 to 7mL/min. | flow rate applications at<br>0 to 7ml/min. The LT-1<br>is available in two sizes:<br>4mm and 5mm channels<br>for administration sets. | Same |
| | Electrically powered<br>device that incorporates<br>controlled heat to the<br>outer wall of an<br>extension set that is<br>delivering enteral fluid<br>to the patient. | Electrically powered<br>device that incorporates<br>controlled heat to the<br>outer wall of an<br>extension set that is<br>delivering enteral fluid to<br>the patient. | |
| Materials | All materials are fire<br>rated for the proposed<br>device's intended use | Unknown | All materials are fire<br>rated for the<br>proposed device's<br>intended use |
| Flow rate | 0 to 7mL/min | 0 to 7mL/min | Same |
| Tubing OD size | 2.4mm | 4.1mm to 5.0mm | Acacia utilizes a<br>more commonly used<br>tubing outer diameter<br>for enteral feeding of<br>premature infants |
| Number of<br>heaters | One | Unknown | Only one sensor is<br>required for the<br>proposed device to<br>perform as intended |
| Maximum<br>heating plate<br>temperature | 48.8 C | 46 C | The proposed<br>device's maximum<br>heating plate<br>temperature does not<br>pose a burn hazard |
| Output<br>temperature | 32 C to 41 C | 32 C to 41 C | Same |
| Temperature<br>sensor | Thermocouple | Thermocouple | Same |
| Safety feature | Temperature fuse shuts<br>off power in case<br>sensor becomes<br>inoperable | Temperature fuse shuts<br>off power in case sensor<br>becomes inoperable | Same |
| Electrical<br>source | Standard 120V<br>electrical outlet | Standard 120V electrical<br>outlet | Same |
| Operating<br>condition | 0 C to 40 C | 0 C to 40 C | Same |
| Warmer weight | 22.8 ounces | 19.75 ounces | The proposed device<br>weighs 3.05 ounces<br>more than the<br>predicate device;<br>however, the unit that<br>warms the tubing |
| | | | near bedside only<br>weighs 3 ounces.<br>The predicate device<br>includes the<br>temperature<br>controller and the<br>warming unit all in<br>one unit, which<br>makes the device<br>more difficult to place<br>at the bedside. |
| Warmer<br>dimensions | 4.67in(length) x 3.42in<br>(width) x<br>0.74in(height) | 6.9in(length) x<br>2.6in(width) x<br>1.5in(height) | The warming unit<br>footprint of both the<br>proposed and<br>predicate devices is<br>similar. The<br>differences are not<br>significant. |

Acacia, Inc. Enteral Nutrition Warmer

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## 510(k) Summary of safety and effectiveness

Acacia, Inc. Enteral Nutrition Warmer

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#### 510(k) Summary of safety and effectiveness

#### Description of the Device Subiect to Premarket Notification:

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the outside of the administration set tubing. The warmer includes an LED light to indicate the warmer is operating and a switch that will turn the warmer on and off.

The Enteral Nutrition Warmer is reusable and provided non-sterile.

#### Indications for Use:

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

## Technical Characteristics:

The Enteral Nutrition Warmer is the same in indications for use, principle of operation and overall technological characteristic compared to the predicate device.

#### Performance Data:

A human factors study was conducted to assess the clinical risks related to the use of the Enteral Nutrition Warmer for warming enteral fluids during the feeding of neonatal patients by the hospital NICU staff. All identified risks have been identified and adequately mitigated to ensure the system is safe for use.

The following non-clinical tests were performed to ensure the device is capable of meeting the predicate device's specifications when tested for the addition of enteral fluids to the intended use:

- ◆ Maximum temperature outside housing (top)
- Maximum temperature outside housing (bottom) .
- Maximum temperature heat sink (tubing track) .

Acacia, Inc. Enteral Nutrition Warmer

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## 510(k) Summary of safety and effectiveness

- Maximum temperature of enteral fluid (portion under heater) �
- Maximum temperature of enteral fluid (at extension set feeding tube portion) .
- Time to reach nominal temperature .

.

## Basis for Determination of Substantial Equivalence:

Since the proposed and predicate devices have no significant technological differences, it is concluded that the proposed device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.

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## Acacia, Inc. Enteral Nutrition Warmer

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

· June 13, 2013

Ms. Fergie Ferguson Director of Operations 785 Challenger Street BREA California 92821

Re: K122449

Trade/Device Name: Enteral Nutrition Warner Regulation Number: Unclassified Regulation Name: Warmer, Thermal, Infusion Fluid Regulatory Class: Unclassified Product Code: LGZ Dated: May 15, 2013 Received: May 24, 2013

Dear Ms. Ferguson:

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. Ilisting 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

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Page 2 - Ms. Ferguson

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/5/Picture/8 description: The image contains the names "Susan Runner DDS, MA" and "Mary S. Runner -S". The text is in a variety of fonts and sizes. The image appears to be a business card or advertisement.

Kwame Ulmer M.S. Acting Division 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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## Indications for Use

510(k) Number (if known): K122449

Device Name: Enteral Nutrition Warmer

Indications for Use:

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

Prescription Use ਮ (Part-21-CFR 801-Subpart-D)- AND/OR Over-The-Counter Use (21-CFR 801 Subpart.C).

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

FDA

Richard C. Chapman 2013.06.12 13:47:56 -04'00'

- Ivision Sign-Off)

ാടion of Anesthesiology, General Hospital ection Control, Dental Devices

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510(k) Number: K122449