(90 days)
Not Found
No
The description focuses on the mechanical and software aspects of a peristaltic pump and its accessories, with no mention of AI or ML capabilities for data analysis, decision-making, or adaptive control.
Yes
The device is intended for "feeding therapy," which is a form of treatment, indicating a therapeutic purpose.
No
The device is an enteral feeding pump system designed for the delivery of enteral fluids, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of an "enteral infusion pump" and "disposable enteral feed sets," which are physical hardware components. The summary also details hardware-specific testing like "pumping accuracy," "gear box life cycle," and "battery run time."
Based on the provided information, the Vesco Q™ Enteral Feeding Pump System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "intermittent and continuous delivery of enteral fluids for adult and pediatric... feeding therapy." This describes a device used to administer substances directly into the body's digestive system, not to perform tests on samples taken from the body.
- Device Description: The description details a pump and feed sets designed to deliver fluids. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the pump and feed sets (pumping accuracy, battery life, safety, etc.), not on the accuracy or reliability of diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Vesco Q™ Enteral Feeding Pump System is a medical device used for administering nutrition, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
LZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (infant, child, and adolescent)
Intended User / Care Setting
healthcare professionals, patients and caregivers for feeding therapy in hospital and home care environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Biocompatibility:
- 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 Pyrogen Test
- Intracutaneous Injection per ISO 10993-10:2010 & ISO 10993-12:2012
- Systemic Injection per ISO 10993-11:2017 & ISO 10993-12:2012
- Kligman Maximization per ISO 10993-10:2010 & ISO 10993-12:2012
- Safety Assurance Case:
- 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.
- Performance:
- Wipe and soak test for pump housing material selection in accordance with Vesco Medical's design requirement
- Pumping accuracy test in accordance with Vesco Medical's design requirement
- Gear box life cycle test in accordance with Vesco Medical's design requirement
- Freefall test in accordance with Vesco Medical's design requirement
- Air-in-Line test in accordance with Vesco Medical's design requirement
- 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
- Battery run time test in accordance with Vesco Medical's design requirement
- Noise level test in accordance with Vesco Medical's design requirement
- Pole clamp weight test in accordance with Vesco Medical's design requirement
- Occlusion test in accordance with Vesco Medical's design requirement
- Battery charge time test in accordance with Vesco Medical's design requirement
- 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
- Kink test in accordance with EN 13868:2002
- 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 design requirement
- Bolus accuracy in accordance with Vesco Medical's design requirement
- Bolus accuracy under various conditions in accordance with Vesco Medical's design requirement
- Cleanability and performance in accordance with Vesco Medical's design requirement
- Human Factors and Usability Validation Test in accordance with Vesco Medical's design requirement
- Electromagnetic Compatibility Validation in accordance with IEC 60601-1-2
- Hardware, Software, and Mechanical Safety Validation in accordance with IEC 60601-1
- Software Verification and Validation test as recommended by the FDA guidance document Infusion Pump Total Product Life Cycle
- Risk Hazard Analysis in accordance with ISO 14971:2007
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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).
2
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
3
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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4
510(k) Summary
Submitter l.
| Official Contact | Name: Chris O'Keefe
Title: VP of Product Development and Innovation
Email: cokeefe@vescomedical.com |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|
| | Vesco Medical LLC
Address: 60 Collegeview Road, Suite 144
Westerville, 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 Pump
21 CFR 880.5725
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
5
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.
6
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
Device
Model
Number | Device
Description | Predicate
Device
Model
Number | Differences |
|---------------------------------------|------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------|
| VED-050 | 500mL Feed
Set with ENFit
with Transition
Connector | INF0500-A | Both devices
use the same
material and
are supported
by
biocompatibility
testing |
| VED-051 | 1000mL Feed
Set with ENFit
with
Transition
Connector | INF1200-A | Both devices
use the same
material and
are supported
by
biocompatibility
testing |
| VED-052 | 40mm Screw
Cap Feed Set
with ENFit | INF0020-A | Both devices
use the same
material and
are supported
by
biocompatibility
testing |
| VED-053 | ENPlus Feed
Set with ENFit | INF0020-A | Both devices
use the same
material and
are supported
by
biocompatibility
testing |
7
| Proposed Device
Number &
Device
Description | Proposed Device
Components | Predicate Device
Number & Device
Description | Predicate Device
Components | Difference in
Design | Difference in
Material |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| VED-050
500mL Feed Set
with ENFit with
Transition Connector | • 500mL Polymeric Film Bag
• PVC Tubing
• ABS Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Anti-free flow design | INF0500-A
500mL Pump
Administration Set
with Top Fill Bag | • 500mL Polymeric Film
Bag
• PVC Tubing
• Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Barbed Enteral
adaptor
• Anti-free flow design | None -
Devices are
identical in
function | None -
Devices are of
the same
materials |
| VED-051
1000mL Feed Set
with ENFit with
Transition
Connector | • 1000mL Polymeric Film
Bag
• PVC Tubing
• ABS Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Anti-free flow design | INF1200-A
1200mL Pump
Administration Set
with Top Fill Bag | • 1200mL Polymeric
Film Bag
• PVC Tubing
• Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Barbed Enteral
adaptor
• Anti-free flow design | None -
Devices are
identical in
function | None -
Devices are of
the same
materials |
| VED-052
40mm Screw Cap
Feed Set with ENFit | • Plastic 40mm Threaded
Opening
• PVC Tubing
• ABS Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Anti-free flow design | INF0020-A
Enteral Pump Delivery
Set with SpikeRight | • Plastic Spike
Connector
• PVC Tubing
• Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Barbed Enteral
adaptor
• Anti-free flow design | Moog doesn't
have a screw
cap enteral
feeding set.
However,
devices are
similar in
function | Moog doesn't
have a screw
cap enteral
feeding set.
However,
devices are of
the same
materials |
| VED-053
ENPlus Feed Set
with ENFit | • Plastic Spike Connector
• PVC Tubing
• ABS Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Anti-free flow design | INF0020-A
Enteral Pump Delivery
Set with SpikeRight | • Plastic Spike
Connector
• PVC Tubing
• Plastic Cassette with a
silicone tube
• Plastic Female ENFit
Connector
• Barbed Enteral
adaptor
• Anti-free flow design | None -
Devices are
identical in
function | None -
Devices are of
the same
materials |
Table 6.2 Technical Characteristic Comparison between the Vesco Q™ Feed Sets and the Predicate Device Pump Sets
8
Table 6.3 Comparison of EnteraLite Infinity™ Enteral Feeding Pump to the Predicate Device Regarding Substantial Equivalence (SE)
| Design Features/
Function | EnteraLite Infinity™ Enteral
Feeding Pump K031199
(Predicate) | Vesco Q™ Enteral Feeding
Pump (Proposed) | Substantial
Equivalence |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device Description | Enteral infusion pump and
disposable enteral feeding set | Enteral infusion pump and
disposable enteral feeding set | Same |
| Indications for Use | EnteraLite Infinity™ Enteral
Feeding Pump is rotary
peristaltic pump designed to
deliver programmed doses of
enteral nutrition solutions at
selectable rates. | Vesco Q™ Enteral Feeding
Pump is a rotary peristaltic
pump engineered to deliver
programed doses of enteral
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,
child, and adolescent). | Different |
| Service life | Unknown | 3 years | Different |
| Design (Pump) | Rotary Peristaltic pump with a
motor that runs at a single
speed and is turned on and off
at programed intervals to
obtain the desire flow rate.
The motor circuit drive is
controlled by a microcontroller
with software embedded
within the microcontroller. | Rotary Peristaltic pump with a
motor that runs at a single
speed and is turned on and
off at programed intervals to
obtain the desire flow rate.
The motor circuit drive is
controlled by a
microcontroller with software
embedded within the
microcontroller. | Same |
| Rechargeable Battery | Operates up to 24 hours (at a
nominal flow rate of 125mL/hr)
from internal rechargeable
batteries.
Batteries are recharged by a
wall mounted charger. | Operates up to 24 hours (at a
nominal flow rate of
125mL/hr) from internal
rechargeable batteries.
Batteries are recharged by a
wall mounted charger. | Same |
| Graphic Display | Backlit LCD | Touchscreen | Different |
| Safety Features | Air-in-line sensor with visual
and audible alarms
Occlusion Sensors with visual
and audible alarms | Air-in-line sensor with visual
and audible alarms
Occlusion Sensors with visual
and audible alarms | Different design |
| Design (Feed Sets) | Bag Feed Set & Spike Feed Set:
Polymeric Film Bag (500mL
or 1200mL)DEHP free PVC connecting
tubingCassette with a silicone
tubePlastic Female ENFit
Connector | Bag Feed Sets
Polymeric Film Bag
(500mL or 1000mL)PVC Tubing from bag to
cassetteABS Plastic Cassette with
Anti-Free flow Silicone
Design | Different |
| | Enteral adaptor Anti-free flow design | PVC Tubing from cassette to patient enteral connector. Plastic Female ENFit Connector
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
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 |
9
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.
10
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.
-
- 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 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.
-
- 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.
-
- 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.
11
- 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
-
- Human Factors and Usability Validation Test in accordance with Vesco Medical's design requirement
-
- Electromagnetic Compatibility Validation in accordance with IEC 60601-1-2
-
- Hardware, Software, and Mechanical Safety Validation in accordance with IEC 60601-1
-
- Software Verification and Validation test as recommended by the FDA guidance document Infusion Pump Total Product Life Cycle
-
- Risk Hazard Analysis in accordance with ISO 14971:2007
-
- 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
12
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.