Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
Device Facts
| Record ID | K232205 |
|---|---|
| Device Name | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set |
| Applicant | Vesco Medical, LLC |
| Product Code | LZH · General Hospital |
| Decision Date | Oct 23, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for 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.
Device Story
Vesco Q™ Enteral Feeding Pump System is a rotary peristaltic pump for enteral nutrition delivery. System includes pump unit and disposable, single-patient-use feed sets (Bag, ENPlus, or Screw Cap styles). Pump features touchscreen interface for programming delivery rates; operates on internal rechargeable battery (up to 24 hours). Feed sets utilize anti-free flow silicone tubing and ISO 80369-3 compliant ENFit connectors to prevent misconnections. Used by healthcare professionals, patients, or caregivers in hospital or home settings. Pump delivers programmed fluid doses; healthcare providers monitor therapy via pump interface. Benefits include ergonomic, portable design and intuitive touchscreen to mitigate user-related hazards.
Clinical Evidence
No clinical data. Bench testing only. Performance validated via biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), human factors/usability testing, and mechanical/software verification and validation.
Technological Characteristics
Rotary peristaltic pump; touchscreen interface; internal rechargeable battery. Feed sets: PVC tubing, silicone tube, ABS plastic cassette. Connectivity: Standalone. Sterilization: Non-sterile. Software: Embedded microcontroller. Standards: ISO 80369-3 (ENFit), ISO 10993 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), EN ISO 20695:2020 (tubing).
Indications for Use
Indicated for intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) patients requiring feeding therapy in hospital and home care environments.
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
- EnteraLite Infinity™ Enteral Feeding Pump (K031199)
Related Devices
- K200051 — PUGGLE Enteral Feeding Pump and Feeding Set · Amsino International, Inc. · Sep 25, 2020
- K031199 — ENTERALITE INFINITY ENTERAL FEEDING PUMP · Zevex Intl., Inc. · Jul 9, 2003
- K220230 — AMSure Enteral Feeding Pump · Amsino International, Inc. · Nov 10, 2022
- K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS · Covidien · Dec 23, 2014
- K131154 — ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; · Zevex, Inc. · Feb 12, 2014
Submission Summary (Full Text)
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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)
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.
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'Keefe<br>Title: VP of Product Development and Innovation<br>Email: cokeefe@vescomedical.com |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|
| | Vesco Medical LLC<br>Address: 60 Collegeview Road, Suite 144<br>Westerville, OH 43081 |
| | Phone: 614-914-5991 |
| | Fax:<br>614-902-3275 |
| Date of Preparation | October 23, 2023 |
| II.<br>Device | |
| Trade Name: | Vesco Q™ Enteral Feeding Pump System |
| Common Name: | Infusion Pump, Enteral, External |
| Classification Name &<br>Number: | Enteral Infusion Pump<br>21 CFR 880.5725<br>Class 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 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.
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
| Proposed<br>Device<br>Model<br>Number | Device<br>Description | Predicate<br>Device<br>Model<br>Number | Differences |
|---------------------------------------|------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------|
| VED-050 | 500mL Feed<br>Set with ENFit<br>with Transition<br>Connector | INF0500-A | Both devices<br>use the same<br>material and<br>are supported<br>by<br>biocompatibility<br>testing |
| VED-051 | 1000mL Feed<br>Set with ENFit<br>with<br>Transition<br>Connector | INF1200-A | Both devices<br>use the same<br>material and<br>are supported<br>by<br>biocompatibility<br>testing |
| VED-052 | 40mm Screw<br>Cap Feed Set<br>with ENFit | INF0020-A | Both devices<br>use the same<br>material and<br>are supported<br>by<br>biocompatibility<br>testing |
| VED-053 | ENPlus Feed<br>Set with ENFit | INF0020-A | Both devices<br>use the same<br>material and<br>are supported<br>by<br>biocompatibility<br>testing |
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| Proposed Device<br>Number &<br>Device<br>Description | Proposed Device<br>Components | Predicate Device<br>Number & Device<br>Description | Predicate Device<br>Components | Difference in<br>Design | Difference in<br>Material |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| VED-050<br>500mL Feed Set<br>with ENFit with<br>Transition Connector | • 500mL Polymeric Film Bag<br>• PVC Tubing<br>• ABS Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Anti-free flow design | INF0500-A<br>500mL Pump<br>Administration Set<br>with Top Fill Bag | • 500mL Polymeric Film<br>Bag<br>• PVC Tubing<br>• Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Barbed Enteral<br>adaptor<br>• Anti-free flow design | None -<br>Devices are<br>identical in<br>function | None -<br>Devices are of<br>the same<br>materials |
| VED-051<br>1000mL Feed Set<br>with ENFit with<br>Transition<br>Connector | • 1000mL Polymeric Film<br>Bag<br>• PVC Tubing<br>• ABS Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Anti-free flow design | INF1200-A<br>1200mL Pump<br>Administration Set<br>with Top Fill Bag | • 1200mL Polymeric<br>Film Bag<br>• PVC Tubing<br>• Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Barbed Enteral<br>adaptor<br>• Anti-free flow design | None -<br>Devices are<br>identical in<br>function | None -<br>Devices are of<br>the same<br>materials |
| VED-052<br>40mm Screw Cap<br>Feed Set with ENFit | • Plastic 40mm Threaded<br>Opening<br>• PVC Tubing<br>• ABS Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Anti-free flow design | INF0020-A<br>Enteral Pump Delivery<br>Set with SpikeRight | • Plastic Spike<br>Connector<br>• PVC Tubing<br>• Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Barbed Enteral<br>adaptor<br>• Anti-free flow design | Moog doesn't<br>have a screw<br>cap enteral<br>feeding set.<br>However,<br>devices are<br>similar in<br>function | Moog doesn't<br>have a screw<br>cap enteral<br>feeding set.<br>However,<br>devices are of<br>the same<br>materials |
| VED-053<br>ENPlus Feed Set<br>with ENFit | • Plastic Spike Connector<br>• PVC Tubing<br>• ABS Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Anti-free flow design | INF0020-A<br>Enteral Pump Delivery<br>Set with SpikeRight | • Plastic Spike<br>Connector<br>• PVC Tubing<br>• Plastic Cassette with a<br>silicone tube<br>• Plastic Female ENFit<br>Connector<br>• Barbed Enteral<br>adaptor<br>• Anti-free flow design | None -<br>Devices are<br>identical in<br>function | None -<br>Devices are of<br>the same<br>materials |
# 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/<br>Function | EnteraLite Infinity™ Enteral<br>Feeding Pump K031199<br>(Predicate) | Vesco Q™ Enteral Feeding<br>Pump (Proposed) | Substantial<br>Equivalence |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device Description | Enteral infusion pump and<br>disposable enteral feeding set | Enteral infusion pump and<br>disposable enteral feeding set | Same |
| Indications for Use | EnteraLite Infinity™ Enteral<br>Feeding Pump is rotary<br>peristaltic pump designed to<br>deliver programmed doses of<br>enteral nutrition solutions at<br>selectable rates. | Vesco Q™ Enteral Feeding<br>Pump is a rotary peristaltic<br>pump engineered to deliver<br>programed doses of enteral<br>fluids 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,<br>child, and adolescent). | Different |
| Service life | Unknown | 3 years | Different |
| Design (Pump) | Rotary Peristaltic pump with a<br>motor that runs at a single<br>speed and is turned on and off<br>at programed intervals to<br>obtain the desire flow rate.<br>The motor circuit drive is<br>controlled by a microcontroller<br>with software embedded<br>within the microcontroller. | Rotary Peristaltic pump with a<br>motor that runs at a single<br>speed and is turned on and<br>off at programed intervals to<br>obtain the desire flow rate.<br>The motor circuit drive is<br>controlled by a<br>microcontroller with software<br>embedded within the<br>microcontroller. | Same |
| Rechargeable Battery | Operates up to 24 hours (at a<br>nominal flow rate of 125mL/hr)<br>from internal rechargeable<br>batteries.<br>Batteries are recharged by a<br>wall mounted charger. | Operates up to 24 hours (at a<br>nominal flow rate of<br>125mL/hr) from internal<br>rechargeable batteries.<br>Batteries are recharged by a<br>wall mounted charger. | Same |
| Graphic Display | Backlit LCD | Touchscreen | Different |
| Safety Features | Air-in-line sensor with visual<br>and audible alarms<br>Occlusion Sensors with visual<br>and audible alarms | Air-in-line sensor with visual<br>and audible alarms<br>Occlusion Sensors with visual<br>and audible alarms | Different design |
| Design (Feed Sets) | Bag Feed Set & Spike Feed Set:<br>Polymeric Film Bag (500mL<br>or 1200mL)DEHP free PVC connecting<br>tubingCassette with a silicone<br>tubePlastic Female ENFit<br>Connector | Bag Feed Sets<br>Polymeric Film Bag<br>(500mL or 1000mL)PVC Tubing from bag to<br>cassetteABS Plastic Cassette with<br>Anti-Free flow Silicone<br>Design | Different |
| | Enteral adaptor Anti-free flow design | PVC Tubing from cassette to patient enteral connector. Plastic Female ENFit Connector<br>ENPlus 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 Connector<br>Screw 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.
- 2. 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.
- 3. 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
- 4. Human Factors and Usability Validation Test in accordance with Vesco Medical's design requirement
- 5. Electromagnetic Compatibility Validation in accordance with IEC 60601-1-2
- 6. Hardware, Software, and Mechanical Safety Validation in accordance with IEC 60601-1
- 7. Software Verification and Validation test as recommended by the FDA guidance document Infusion Pump Total Product Life Cycle
- 8. Risk Hazard Analysis in accordance with ISO 14971:2007
- 9. 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.
