The EnteraLite® Infinity™ Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

Device Description

The EnteraLite® Infinity™ Enteral Feeding Pump as referred to as Infinity™ with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bedridden or ambulatory patients. The device is also designed for use with pediatric patients.

The device is a software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 100 to 240 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 5 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.

The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller is extensively validated and verified as part of the design process.

The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.

The disposable tubing set consists of a bag, or spike for nutrient bag, DEHP free PVC connecting tubing, an integral cassette with a silicone pumping segment, and an enteral adapter. The set also contains a patented anti-free flow device within the cassette, a version of which is used in the stationary pumps manufactured by ZEVEX, which prevents free flow of fluids if the tubing set is inadvertently or purposely removed from the pump.

A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.

AI/ML Overview

The provided text is a 510(k) summary for the EnteraLite® Infinity™ Enteral Feeding Pump. This document is a regulatory submission to the FDA, primarily focusing on establishing substantial equivalence to a predicate device.

It does not contain information about acceptance criteria or a study proving device performance against those criteria in the context of many of the requested categories. This type of information is typically found in detailed design validation reports, risk analysis documents, and specific performance testing protocols, which are usually part of the full 510(k) submission but are not included in this publicly available summary.

Specifically, the document discusses the device's technical characteristics, intended use, and its similarities to a predicate device (K954735). It mentions software validation and verification as part of the design process and highlights safety features like air-in-line and pressure sensors. However, it does not provide quantitative data, sample sizes, expert qualifications, or details on ground truth establishment as would be present in a study report.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be addressed based on the provided text, alongside an explanation of why other points cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not list specific acceptance criteria for performance metrics (e.g., flow rate accuracy, alarm response time) nor does it present reported device performance against such criteria in a quantitative format. It generally states that the software is "extensively validated and verified" and describes safety features, but no numerical performance data is given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention any specific "test set" or sample sizes used for performance testing. It focuses on the device's design and features, not the methodology or results of extensive testing with a defined test set. Data provenance is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. This question pertains to studies involving expert review for establishing ground truth, typically in AI/ML performance evaluation (e.g., image interpretation). This document describes a medical device (an enteral feeding pump), which does not involve establishing ground truth through expert review in this manner. The "ground truth" for a pump would be established by physical measurements and engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Similar to point 3, adjudication methods are relevant for expert consensus in classification or diagnostic tasks, which is not applicable to the description of an enteral feeding pump in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. MRMC studies are specific to evaluating diagnostic technologies (like AI in radiology). This document describes a mechanical/electrical medical device (an infusion pump) and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described. The device itself is not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. This question is also typically relevant for AI algorithms. While the pump is "software controlled," the "standalone performance" refers to the entire device's operation, not an isolated algorithm in the context of AI evaluation. The document implies the pump's performance is tested as a complete system, but it doesn't detail standalone algorithm testing in the way this question implies for AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided as requested. For a device like an enteral feeding pump, "ground truth" would be established by:
- Engineering specifications and calibration standards: for flow rate accuracy, pressure limits, alarm thresholds, battery life.
- Simulated usage conditions: testing air-in-line detection, occlusion detection with known conditions.
- Pre-defined pass/fail criteria: based on regulatory standards and user needs.
  However, the document does not explicitly state the types of "ground truth" or how they were established. It only mentions the features.

8. The sample size for the training set

Cannot be provided. The concept of a "training set" is relevant for AI/ML models that learn from data. While the pump has software, it's not described as an AI/ML device that requires a training set in the typical sense. The software is validated through traditional software engineering verification and validation processes, not machine learning training.

9. How the ground truth for the training set was established

Cannot be provided. As explained in point 8, the concept of a "training set" for AI/ML does not apply to the device described in this document in the traditional sense. Therefore, ground truth establishment for a training set is not pertinent here.

Summary

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9 2003 JUL

K031199

510(k) Summary

Date prepared:	March 7, 2003
Submitter:	ZEVEX, Inc.
	4314 ZEVEX Park Lane
	Salt Lake City, UT 84123
Contact person:	Sean M. Curry
	16787 Bernardo Center Drive, Suite A-1
	San Diego, CA 92128
Phone number:	(858) 675-8200
Fax number:	(858) 675-8201
Proprietary name:	EnteraLite® Infinity™ Enteral Feeding Pump
Common name:	Infusion pump, Enteral, External
Classification:	Class II
Product Code:	80LZH, 880.5725

Substantial equivalence claimed to:

K954735 - EnteraLite Enteral Feeding Pump - ZEVEX, Inc.

Description:

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A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.

Intended use:

The EnteraLite® Infinity™ Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

Summary of technological characteristics:

The EnteraLite® Infinity™ Enteral Feeding Pump is the next generation of the predicate device EnteraLite Enteral Feeding Pump by ZEVEX, Inc. This is essentially the same -pump except that the EnteraLite® Infinity™ Enteral Feeding Pump uses optical sensors

for the pressure detection and air in line detection.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2003 JUL

Zevex International, Incorporated C/O Mr. Sean Curry Certified Software Solutions, Incorporated 16787 Bernardo Center Drive, Suite A-1 San Diego, California 92128

Re: K031199

Trade/Device Name: EnteraLite® Infinity™ Enteral Feeding Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZH Dated: April 9, 2003 Received: April 18, 2003

Dear Mr. Curry:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Curry

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Russo

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. 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):

Device Name: EnteraLite® Infinity™ Enteral Feeding Pump

Indications for Use:

The EnteraLite® Infinity™ Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

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

CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031199

Prescription Use __ OR Over-the-Count

(Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

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).