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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Enteral Nutrition Warmer:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria derived from clinical performance trials for the proposed device's efficacy in warming enteral fluid. The "acceptance criteria" can be inferred from the comparative table where the proposed device's characteristics are presented against those of the predicate. The "reported device performance" is then what the proposed device demonstrated in the non-clinical tests.

Inferred Acceptance Criteria Table:

Acceptance Criteria (from Predicate Device Specifications)	Reported Device Performance (Proposed Device)
Intended Use: Electronically powered dry warmer, supplies external heat to plastic tubing for intermittent use and low flow rate applications (0-7mL/min).	Same
Principle of Operation: Electrically powered, controlled heat to outer wall of extension set delivering enteral fluid.	Same
Flow rate: 0 to 7mL/min	0 to 7mL/min
Output temperature range: 32 C to 41 C	32 C to 41 C
Maximum heating plate temperature: 46 C (Predicate)	48.8 C (Proposed) - Note: Stated not to pose a burn hazard despite being higher.
Temperature sensor type: Thermocouple	Thermocouple
Safety feature: Temperature fuse shuts off power if sensor inoperable.	Temperature fuse shuts off power if sensor becomes inoperable.
Electrical source: Standard 120V electrical outlet.	Standard 120V electrical outlet.
Operating condition: 0 C to 40 C	0 C to 40 C
Materials: Fire rated for intended use.	All materials are fire rated for the proposed device's intended use.
Maximum temperature outside housing (top)	Tested (specific value not provided in summary)
Maximum temperature outside housing (bottom)	Tested (specific value not provided in summary)
Maximum temperature heat sink (tubing track)	Tested (specific value not provided in summary)
Maximum temperature of enteral fluid (portion under heater)	Tested (specific value not provided in summary)
Maximum temperature of enteral fluid (at extension set feeding tube portion)	Tested (specific value not provided in summary)
Time to reach nominal temperature	Tested (specific value not provided in summary)

Study Proving Acceptance Criteria:

The document describes non-clinical tests that were performed to demonstrate that the device is capable of meeting the predicate device's specifications, particularly for the addition of enteral fluids to the intended use.

Sample Size for Test Set and Data Provenance:
- The document does not specify a sample size for any "test set" in terms of cases or patients. The performance data section refers to "non-clinical tests" and a "human factors study."
- The document implies laboratory-based, engineering performance testing rather than clinical trials with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the traditional sense.
Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided. The study mentioned in the document is a human factors study and non-clinical performance tests, not a diagnostic study requiring expert ground truth for interpretation of cases.
Adjudication Method for the Test Set:
- Not applicable, as the tests described are non-clinical engineering and human factors assessments, not diagnostic performance studies requiring adjudication of results against a ground truth from experts.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done or reported. The submission is a 510(k) for a medical device (warmer) where the primary comparison is technical specifications and safety with a predicate device, not diagnostic efficacy with or without AI assistance for human readers.
Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is an enteral nutrition warmer, not an AI algorithm.
Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" would be the engineered specifications and measurements (e.g., target temperature ranges, maximum surface temperatures, flow rates, time to reach temperature). These are determined by physics and engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.
- For the human factors study, the "ground truth" would relate to identifying and mitigating risks related to usability and safety, likely against established human factors engineering principles and standards.
Sample Size for the Training Set:
- Not applicable. This device is a physical warmer, not a machine learning model, so there is no "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there's no training set, there's no ground truth to establish for it in this context.

Summary

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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 StreetBrea, CA 92821
APPLICANT PHONE	(714) 257-0470
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 NutritionWarmer is anelectronically powereddry warmer, whichsupplies external heatto the plastic tubingincorporatedadministration sets forintermittent use and low	The Enteral NutritionWarmer LIFORT LT-1 isan electronicallypowered, dry warmerwhich supplies externalheat to the plastic tubingincorporatedadministration sets forintermittent use and low	Same
Principle ofOperation	flow rate applications at0 to 7mL/min.	flow rate applications at0 to 7ml/min. The LT-1is available in two sizes:4mm and 5mm channelsfor administration sets.	Same
	Electrically powereddevice that incorporatescontrolled heat to theouter wall of anextension set that isdelivering enteral fluidto the patient.	Electrically powereddevice that incorporatescontrolled heat to theouter wall of anextension set that isdelivering enteral fluid tothe patient.
Materials	All materials are firerated for the proposeddevice's intended use	Unknown	All materials are firerated for theproposed device'sintended use
Flow rate	0 to 7mL/min	0 to 7mL/min	Same
Tubing OD size	2.4mm	4.1mm to 5.0mm	Acacia utilizes amore commonly usedtubing outer diameterfor enteral feeding ofpremature infants
Number ofheaters	One	Unknown	Only one sensor isrequired for theproposed device toperform as intended
Maximumheating platetemperature	48.8 C	46 C	The proposeddevice's maximumheating platetemperature does notpose a burn hazard
Outputtemperature	32 C to 41 C	32 C to 41 C	Same
Temperaturesensor	Thermocouple	Thermocouple	Same
Safety feature	Temperature fuse shutsoff power in casesensor becomesinoperable	Temperature fuse shutsoff power in case sensorbecomes inoperable	Same
Electricalsource	Standard 120Velectrical outlet	Standard 120V electricaloutlet	Same
Operatingcondition	0 C to 40 C	0 C to 40 C	Same
Warmer weight	22.8 ounces	19.75 ounces	The proposed deviceweighs 3.05 ouncesmore than thepredicate device;however, the unit thatwarms the tubing
			near bedside onlyweighs 3 ounces.The predicate deviceincludes thetemperaturecontroller and thewarming unit all inone unit, whichmakes the devicemore difficult to placeat the bedside.
Warmerdimensions	4.67in(length) x 3.42in(width) x0.74in(height)	6.9in(length) x2.6in(width) x1.5in(height)	The warming unitfootprint of both theproposed andpredicate devices issimilar. Thedifferences are notsignificant.

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 reusable and provided non-sterile.

Indications for Use:

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

Page 3 of 4

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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.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FDA

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

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ാടion of Anesthesiology, General Hospital ection Control, Dental Devices

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510(k) Number: K122449

Regulation Number and Section

§ 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).