The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.

Device Description

The Vesco Q™ Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable enteral feed sets. The Vesco Q™ Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. The Vesco Q™ Feed Sets are non-sterile, single patient use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading of the feed set without a pump door. The feed sets incorporate a female ENFit connector which is compatible with devices that have male ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.

Vesco Q™ Feed Sets are available in three different feed set styles: Bag Feed Sets, ENPlus Feed Sets and Screw Cap Feed Sets. All of the feed sets are made of flexible PVC tubing, a silicone tube, a feed set to pump interface, and a plastic ENFit female connecting port. Bag Feed Sets are available in two different volumes, 500mL and 1000mL. The difference between each feed set is how the liquid nutrition is introduced to the set. The Bag Feed Set has a translucent film bag, the Safety Screw Spike Feed Set has a plastic spike connector, and the Screw Cap Feed Set has a plastic 40mm threaded opening to connect to feed containers.

The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device – specifically, the Vesco Q™ Enteral Feeding Pump System. It aims to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed predicate device.

Crucially, this document focuses on establishing substantial equivalence for a physical medical device (an enteral feeding pump and its associated sets), not an AI/ML-driven diagnostic or assistive device that would require performance in terms of accuracy metrics like sensitivity, specificity, AUC, etc., or human-in-the-loop studies (MRMC).

Therefore, the specific acceptance criteria and study designs typically used for AI/ML devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. The "performance testing" section outlines tests for the physical device's mechanical, electrical, and biocompatibility properties, not AI/ML model performance.

Based on the provided text, I cannot provide information on the following as they are not relevant to this type of device submission:

A table of acceptance criteria and reported device performance related to AI/ML metrics: The acceptance criteria are for physical and functional parameters (e.g., pumping accuracy, battery life, biocompatibility), not diagnostic or classification performance.
Sample sizes used for the test set and data provenance: The "test set" in this context refers to physical units of the device, not a dataset for AI/ML evaluation.
Number of experts used to establish the ground truth for the test set and qualifications: Ground truth for this device is based on engineering specifications and physical test results, not expert interpretation of data.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on engineering standards and physical measurements.
The sample size for the training set: Not applicable as there is no AI/ML model being trained.
How the ground truth for the training set was established: Not applicable.

However, I can extract and describe the general "acceptance criteria" and "study" (performance testing) that proves the device meets them, as presented in the document for this physical medical device:

The acceptance criteria for the Vesco Q™ Enteral Feeding Pump System are based on establishing "substantial equivalence" to a predicate device (EnteraLite Infinity™ Enteral Feeding Pump) through a series of non-clinical performance and safety tests, and addressing any minor differences.

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

The document defines acceptance implicitly through demonstration of adherence to design requirements, relevant ISO standards, and comparison to the predicate device. The performance is "proven" by stating that "It was found that the pump and feed sets are in compliance with all design and performance requirements based on the completed testing."

Below is a summary of the broad categories of acceptance criteria and the statement of performance:

Category of Acceptance Criteria	Reported Device Performance (Proof of Meeting Criteria)
Biocompatibility	Compliance with ISO 10993-5, 10993-10, 10993-11, 10993-12, and USP 42-NF37 <151> (Pyrogen Test). Specific tests include Neutral Red Uptake (Cytotoxicity), Rabbit Pyrogen, Intracutaneous Injection, Systemic Injection, Kligman Maximization.
Safety Assurance	A safety assurance case developed as recommended by FDA Guidance for Infusion Pumps, supported by performance tests.
Performance (Functional)	Compliance with "Vesco Medical's design requirement" for: - Pumping accuracy - Gear box life cycle - Freefall - Air-in-Line - Button life cycle - Power adapter life cycle - Battery run time - Noise level - Pole clamp weight - Occlusion - Battery charge time - Bolus accuracy (under various conditions) - Cleanability and performance
Feed Set Integrity	Compliance with EN ISO 20695:2020 for unaged and aged product for: - Tensile test - Pressure leak test - Kink test (EN 13868:2002) - Anti-free flow test (Vesco Medical's design requirement) - Free flow rate test (Vesco Medical's design requirement)
User Interface/Human Factors	Compliance with "Vesco Medical's design requirement" for Human Factors and Usability Validation. (Noted the touchscreen UI was "designed to be easy to read and intuitive to help mitigate user related hazards.")
Electromagnetic Compatibility	Compliance with IEC 60601-1-2.
Hardware, Software, Mechanical Safety	Compliance with IEC 60601-1.
Software Verification & Validation	Compliance with FDA guidance document "Infusion Pump Total Product Life Cycle" recommendations.
Risk Management	Compliance with ISO 14971:2007 (Risk Hazard Analysis) and Vesco Medical's design requirements (DFMEA).
Material Compatibility	"Wipe and soak test for pump housing material selection" in accordance with Vesco Medical's design requirement.

2. Sample Size and Data Provenance for the Test Set:

Sample Size: The document does not specify the exact number of physical units (pumps and feed sets) tested for each performance criterion. It generally states that "Verification and validation testing were performed with the Vesco Q™ Enteral Feeding Pump and the Vesco Q™ Feed Sets." Typically, for such devices, a statistically appropriate number of units would be tested to ensure reliability, but the specific quantity is not disclosed in this summary.
Data Provenance: Not applicable in the context of data for an AI/ML model. The "data" here are the test results from physical devices, which would have been generated in a laboratory or testing facility, likely in the US as the manufacturer (Vesco Medical LLC) is based in Ohio. The testing is non-clinical.

3. Number of Experts/Qualifications for Ground Truth:

This concept is not relevant here as the "ground truth" for a physical pump's performance (e.g., flow rate accuracy, battery life) is determined by direct physical measurement against engineering specifications and industry standards, not by expert consensus on interpretations of data (like medical images).

4. Adjudication Method for the Test Set:

Not applicable, as there is no human interpretation or ground truth adjudication process akin to those used for AI/ML diagnostic data.

5. MRMC Comparative Effectiveness Study:

No MRMC study was done. This type of study (Multi-Reader Multi-Case) is specifically designed to assess how human reader performance changes when assisted by an AI system, typically in diagnostic imaging. The Vesco Q™ Enteral Feeding Pump is a physical medical device, not an AI diagnostic tool, so an MRMC study is not relevant or required.

6. Standalone Performance:

Not applicable. The device is a functional pump, not a standalone algorithm. Its performance is inherent in its operation (e.g., "Pumping accuracy test" refers to the pump itself, not an algorithm's output).

7. Type of Ground Truth Used:

The ground truth for this device's performance is based on engineering specifications, direct physical measurements, and compliance with industry standards (e.g., ISO, IEC, USP). This differs significantly from "expert consensus," "pathology," or "outcomes data" that would be used for AI/ML ground truth.

8. Sample Size for the Training Set:

Not applicable, as there is no AI/ML model being trained. The "training" for this physical device refers to its design, manufacturing processes, and quality control.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no AI/ML model being trained. The "ground truth" here is the established design requirements and performance targets set by the manufacturer and relevant regulatory standards, which the device aims to meet through its engineering and manufacturing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2023

Vesco Medical, LLC Chris O'Keefe VP of Product Development and Innovation 60 Collegeview Road. Suite 144 Westerville, Ohio 43081

Re: K232205

Trade/Device Name: Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco QTM 40mm Screw Cap Feed Set; Vesco QTM ENPlus Feed Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LZH Dated: July 20, 2023 Received: July 25, 2023

Dear Chris O'Keefe:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Digitally signed by Jake K. Jake K. Lindstrom -S Lindstrom -S Date: 2023.10.23 16:07:35
-04:00'

Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Vesco QTM Enteral Feeding Pump System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter l.

Official Contact	Name: Chris O'KeefeTitle: VP of Product Development and InnovationEmail: cokeefe@vescomedical.com
	Vesco Medical LLCAddress: 60 Collegeview Road, Suite 144Westerville, OH 43081
	Phone: 614-914-5991
	Fax:614-902-3275
Date of Preparation	October 23, 2023
II.Device
Trade Name:	Vesco Q™ Enteral Feeding Pump System
Common Name:	Infusion Pump, Enteral, External
Classification Name &Number:	Enteral Infusion Pump21 CFR 880.5725Class II

Legally Marketed Predicate Devices III.

EnteraLite Infinity™ Enteral Feeding Pump were cleared under notification K031199 (510k ● application by ZEVEX, Inc.)
- Product name: EnteraLite Infinity™ Enteral Feeding Pump o
- 510(k) Number: K031199 O
- Manufacturer: Zevex, Inc. O
- Product Code: LZH O
- Device Class: Class II O

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IV. Device Description

The Vesco Q™ Enteral Feeding Pump System is substantially equivalent to the predicate device.

V. Intended Use

The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professional, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.

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VI. Substantial Equivalence Discussion

The Vesco Q™ Enteral Feeding Pump System is substantially equivalent for its intended use, use conditions and use environment compared to the currently marketed predicate Enteralite® Infinity∞®Enteral Feeding Pump. Tables 6.1 and 6.2 are comparison summaries of the proposed feed sets with the predicate pump sets. Table 6.3 lists the comparison of the proposed pump to the predicate pump regarding substantial equivalence.

Table 6.1 Comparison Summary between the Vesco Q™ Feed Sets and the Predicate Device Pump Sets

ProposedDeviceModelNumber	DeviceDescription	PredicateDeviceModelNumber	Differences
VED-050	500mL FeedSet with ENFitwith TransitionConnector	INF0500-A	Both devicesuse the samematerial andare supportedbybiocompatibilitytesting
VED-051	1000mL FeedSet with ENFitwithTransitionConnector	INF1200-A	Both devicesuse the samematerial andare supportedbybiocompatibilitytesting
VED-052	40mm ScrewCap Feed Setwith ENFit	INF0020-A	Both devicesuse the samematerial andare supportedbybiocompatibilitytesting
VED-053	ENPlus FeedSet with ENFit	INF0020-A	Both devicesuse the samematerial andare supportedbybiocompatibilitytesting

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Proposed DeviceNumber &DeviceDescription	Proposed DeviceComponents	Predicate DeviceNumber & DeviceDescription	Predicate DeviceComponents	Difference inDesign	Difference inMaterial
VED-050500mL Feed Setwith ENFit withTransition Connector	• 500mL Polymeric Film Bag• PVC Tubing• ABS Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Anti-free flow design	INF0500-A500mL PumpAdministration Setwith Top Fill Bag	• 500mL Polymeric FilmBag• PVC Tubing• Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Barbed Enteraladaptor• Anti-free flow design	None -Devices areidentical infunction	None -Devices are ofthe samematerials
VED-0511000mL Feed Setwith ENFit withTransitionConnector	• 1000mL Polymeric FilmBag• PVC Tubing• ABS Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Anti-free flow design	INF1200-A1200mL PumpAdministration Setwith Top Fill Bag	• 1200mL PolymericFilm Bag• PVC Tubing• Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Barbed Enteraladaptor• Anti-free flow design	None -Devices areidentical infunction	None -Devices are ofthe samematerials
VED-05240mm Screw CapFeed Set with ENFit	• Plastic 40mm ThreadedOpening• PVC Tubing• ABS Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Anti-free flow design	INF0020-AEnteral Pump DeliverySet with SpikeRight	• Plastic SpikeConnector• PVC Tubing• Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Barbed Enteraladaptor• Anti-free flow design	Moog doesn'thave a screwcap enteralfeeding set.However,devices aresimilar infunction	Moog doesn'thave a screwcap enteralfeeding set.However,devices are ofthe samematerials
VED-053ENPlus Feed Setwith ENFit	• Plastic Spike Connector• PVC Tubing• ABS Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Anti-free flow design	INF0020-AEnteral Pump DeliverySet with SpikeRight	• Plastic SpikeConnector• PVC Tubing• Plastic Cassette with asilicone tube• Plastic Female ENFitConnector• Barbed Enteraladaptor• Anti-free flow design	None -Devices areidentical infunction	None -Devices are ofthe samematerials

Table 6.2 Technical Characteristic Comparison between the Vesco Q™ Feed Sets and the Predicate Device Pump Sets

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Table 6.3 Comparison of EnteraLite Infinity™ Enteral Feeding Pump to the Predicate Device Regarding Substantial Equivalence (SE)

Design Features/Function	EnteraLite Infinity™ EnteralFeeding Pump K031199(Predicate)	Vesco Q™ Enteral FeedingPump (Proposed)	SubstantialEquivalence
Device Description	Enteral infusion pump anddisposable enteral feeding set	Enteral infusion pump anddisposable enteral feeding set	Same
Indications for Use	EnteraLite Infinity™ EnteralFeeding Pump is rotaryperistaltic pump designed todeliver programmed doses ofenteral nutrition solutions atselectable rates.	Vesco Q™ Enteral FeedingPump is a rotary peristalticpump engineered to deliverprogramed doses of enteralfluids at selectable rates.	Same
Environment of Use	Hospital or home	Hospital or home	Same
Patient Population	Patients 1 year and up	Adult and Pediatric (infant,child, and adolescent).	Different
Service life	Unknown	3 years	Different
Design (Pump)	Rotary Peristaltic pump with amotor that runs at a singlespeed and is turned on and offat programed intervals toobtain the desire flow rate.The motor circuit drive iscontrolled by a microcontrollerwith software embeddedwithin the microcontroller.	Rotary Peristaltic pump with amotor that runs at a singlespeed and is turned on andoff at programed intervals toobtain the desire flow rate.The motor circuit drive iscontrolled by amicrocontroller with softwareembedded within themicrocontroller.	Same
Rechargeable Battery	Operates up to 24 hours (at anominal flow rate of 125mL/hr)from internal rechargeablebatteries.Batteries are recharged by awall mounted charger.	Operates up to 24 hours (at anominal flow rate of125mL/hr) from internalrechargeable batteries.Batteries are recharged by awall mounted charger.	Same
Graphic Display	Backlit LCD	Touchscreen	Different
Safety Features	Air-in-line sensor with visualand audible alarmsOcclusion Sensors with visualand audible alarms	Air-in-line sensor with visualand audible alarmsOcclusion Sensors with visualand audible alarms	Different design
Design (Feed Sets)	Bag Feed Set & Spike Feed Set:Polymeric Film Bag (500mLor 1200mL)DEHP free PVC connectingtubingCassette with a siliconetubePlastic Female ENFitConnector	Bag Feed SetsPolymeric Film Bag(500mL or 1000mL)PVC Tubing from bag tocassetteABS Plastic Cassette withAnti-Free flow SiliconeDesign	Different
	Enteral adaptor Anti-free flow design	PVC Tubing from cassette to patient enteral connector. Plastic Female ENFit ConnectorENPlus Feed Sets Plastic Spike Connector PVC Tubing from cassette ABS Plastic Cassette with Anti-Free flow Silicone Design PVC Tubing from cassette to patient enteral connector. Plastic Female ENFit ConnectorScrew Cap Feed Sets Plastic 40mm threaded opening PVC Tubing from cassette ABS Plastic Cassette with Anti-Free flow Silicone Design PVC Tubing from cassette to patient enteral connector. Plastic Female ENFit Connector
Single Patient Use	Yes	Yes	Same
Sterility Condition	Non-Sterile Feed Sets	Non-Sterile Feed Sets	Same
Type of Placement	Used with enteral feeding devices with ENFit compliant connector	Used with enteral feeding devices with ENFit compliant connector	Same
ENFit Connector	Yes	Yes; compliant with ISO 80369-3	Same
Anti-free flow	Yes	Yes	Same

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Discussion of Differences VII.

There are no differences between the indications for use, use conditions, and use environment of the predicate device and the Vesco Q™ Enteral Feeding Pump System. The primary difference between the predicate and proposed device is the newly designed purpose-specific touchscreen interface and an additional option for feed sets. The touchscreen user interface was designed to be easy to read and intuitive to help mitigate user related hazards. The differences were supported by performance testing.

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VIII. Performance Testing

Non-Clinical Tests

Verification and validation testing were performed with the Vesco Q™ Enteral Feeding Pump and the Vesco Q™ Feed Sets. It was found that the pump and feed sets are in compliance with all design and performance requirements based on the completed testing below.

1. Biocompatibility:
- a. Neutral Red Uptake (Cytotoxicity) per ISO 10993-5:2009 & ISO 10993-12:2012
- Rabbit Pyrogen per ISO 10993-11:2017, ISO 10993-12:2012 & USP 42-NF37:2019 <151> ﻗ Pyrogen Test
- Intracutaneous Injection per ISO 10993-10:2010 & ISO 10993-12:2012 C.
- d. Systemic Injection per ISO 10993-11:2017 & ISO 10993-12:2012
- Kligman Maximization per ISO 10993-10:2010 & ISO 10993-12:2012 e.
1. Safety Assurance Case:
- a. As recommended by the FDA Guidance Document, Infusion Pump Total Product Life Cycle, a safety assurance case was created for the Vesco Q™ Enteral Feeding Pump. The stated top-level claim of the assurance case is supported by the following performance tests.
1. Performance:
- a. Wipe and soak test for pump housing material selection in accordance with Vesco Medical's design requirement
- b. Pumping accuracy test in accordance with Vesco Medical's design requirement
- C. Gear box life cycle test in accordance with Vesco Medical's design requirement
- d. Freefall test in accordance with Vesco Medical's design requirement
- Air-in-Line test in accordance with Vesco Medical's design requirement e.
- f. Button life cycle test in accordance with Vesco Medical's design requirement
- Power adapter life cycle test in accordance with Vesco Medical's design requirement g.
- h. Battery run time test in accordance with Vesco Medical's design requirement
- Noise level test in accordance with Vesco Medical's design requirement i.
- Pole clamp weight test in accordance with Vesco Medical's design requirement j.

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k. Occlusion test in accordance with Vesco Medical's design requirement
l. Battery charge time test in accordance with Vesco Medical's design requirement
m. Tensile test on unaged and aged product in accordance with EN ISO 20695:2020
Pressure leak test on unaged and aged product in accordance with EN ISO 20695:2020 n.
Kink test in accordance with EN 13868:2002 o.
p. Anti-free flow test on unaged and aged product in accordance with Vesco Medical's design requirement
Free flow rate test on unaged and aged product in accordance with Vesco Medical's q. design requirement
Bolus accuracy in accordance with Vesco Medical's design requirement r.
Bolus accuracy under various conditions in accordance with Vesco Medical's design ડ. requirement
t. Cleanability and performance in accordance with Vesco Medical's design requirement
1. Human Factors and Usability Validation Test in accordance with Vesco Medical's design requirement
1. Electromagnetic Compatibility Validation in accordance with IEC 60601-1-2
1. Hardware, Software, and Mechanical Safety Validation in accordance with IEC 60601-1
1. Software Verification and Validation test as recommended by the FDA guidance document Infusion Pump Total Product Life Cycle
1. Risk Hazard Analysis in accordance with ISO 14971:2007
1. DFMEA in accordance with Vesco Medical's design requirements

Clinical Tests

Clinical tests were not required to demonstrate performance of the Vesco Q™ Enteral Feeding Pump System. Product functionality has been adequately assessed by non-clinical tests.

Animal Tests

Animal tests were not required to demonstrate the performance of the Vesco Q™ Enteral Feeding Pump System. Product functionality has been adequately assessed by non-animal tests.

IX. Conclusion

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The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Vesco Q™ Enteral Feeding Pump System is substantially equivalent to the EnteraLite Infinity™ Enteral Feeding Pump cleared under K031199 with respect to the indications for use, target populations, treatment method, and technological characteristics.

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).