The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.

Only intended for adult patients, not for pediatric use.

The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

Device Description

The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food

AI/ML Overview

The provided text does not contain information about an AI/ML-driven medical device, an acceptance criteria table with reported device performance for such a device, or a study that proves a device meets specific acceptance criteria using AI/ML technology.

The document is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically an AMSure® Enteral Feeding Pump and Feeding Set. It details the device's indications for use, technological characteristics, and compares it to a predicate device (SENTINEL Enteral Feeding pump K011587) to demonstrate substantial equivalence.

While the document mentions "custom software designed to allow the user to set feed rates and volumes as well as other feeding options" and "2 separate MCUs, and each MCU embeds a specific software in order to secure the pump's running," this refers to basic embedded software for controlling the pump's mechanical functions and not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance for an AI/ML device, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details, or ground truth establishment) because the document describes a traditional medical device without AI/ML components.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for 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 in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.

November 10, 2022

Amsino International Inc. Jane Gao VP of R&D and RA 708 Corporate Center Drive Pomona, California 91768

Re: K220230

Trade/Device Name: AMSure Enteral Feeding Pump and Feeding Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: October 12, 2022 Received: October 12, 2022

Dear Jane Gao:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pm.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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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).

Sincerely,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220230

Device Name AMSure® Enteral Feeding Pump

Indications for Use (Describe)

Only intended for adult patients, not for pediatric use.

The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

Preparation Date:	11/8/2022
Manufacturer's Name:	Amsino International Inc.
Correspondions official :	708 Corporate Center Drive, Pomona, CA91768Jane GaoVP of R&D and RA of AmsinoMobile: +86 139 1614 7664
Email Address:	Jane_gao@amsino.com
Trade Name:Common or Usual Name:Regulation Name:Regulation Number:Product Code:Device Class:	AMSure® Enteral Feeding Pump and Feeding SetEnteral Feeding Pump and SetInfusion Pump21 CFR880.5725LZHClass II
Predicate Device(s):	SENTINEL Enteral Feeding pump (K011587)

Device Description:

Indication for Use:

Only intended for adult patients, not for pediatric use.

The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

Substantial Equivalence Discussion

Intended use comparison

The table below includes a comparison of the intended use between the new device and the predicate device:

Characteristic	SubjectDevice: AMSureEnteral feeding pumpK220230	Predicate: SENTINEL Enteralfeeding pump K011587	Discussion between subjectdevice and predicate
Indications for use	The AMSure® Enteral FeedingPump and Feeding Set areintended to deliver nutritionalformula to the gastrointestinalsystem of adult patients whoare physically unable to eat andswallow or who are unable toget sufficient nutrition througheating and swallowing.Only intended for adult patients,not for pediatric use.The feeding pump and feedingsets are intended to be used inhealthcare facilities by licensedhealthcare professional usersonly.The AMSure® Enteral feedingpump is for use only withAmsino AMSure® feeding sets.	The enteral feeding pumpaccurately controls the flow ofliquid feeding solution topatients who are unable orunwilling to consume adequatenutrients. Liquid feedings mayconsist of commerciallyprepared formulas orblenderized foods and are mostoften delivered by means ofnasogastric, nasoduodenal ofnasojenjunal feeding tubes. Insome cases, a surgically placedesophagostomy, gastrostomy orenterostomy tube may be used.The pump is not intended foruse with blood or bloodproducts. The pump is not forintravenous delivery.	No differences

{4}------------------------------------------------

Prescription only or over thecounter	Prescription only	Prescription only	No differences
Intended population	Adult	Adult, pediatric	DifferentSubject device for adults uses only, not for pediatric use
Environment of use	Healthcare facilities	Healthcare facilities	No differences

Discussions of differences in indications for use statement:

The subject device has same indications for use with the predicate, but not for pediatric use. This difference does not raise different questions of safety and effectiveness than the predicate device.

Technological characteristics

The table below includes a comparison of the technological characteristics between the new device and the predicate device:

Characteristic	Subject Device:AMSure Enteral feeding pumpand feeding set	Predicate:SENTINEL Enteral feedingpumpK011587	Discussion between subjectdevice and predicate
Design (pump)	The pump incorporates a menu-controlled operating system whichcontains on board customsoftware designed to allow theuser to set feed rates andvolumes as well as other feedingoptions.	The pump incorporates a menu-controlled operating system whichcontains on board customsoftware designed to allow theuser to set feed rates andvolumes as well as other feedingoptions.	Different.The hardware and software aredifferent. The subject devicecontains 2 separate MCUs, andeach MCU embeds a specificsoftware in order to secure thepump's running. Thesedifferences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Mode of Action	Tubing in tension against rotor	Tubing in tension against rotor
Motor type	Stepper motor	Stepper motor
Sensors and flow monitoringalarms	The device incorporates 3sensors.Infrared for• Upstream occlusion/empty bag• Free flowUltrasonic for• Air in linePressure sensors for• Downstream occlusion	The device incorporates 1 sensor.Infrared sensors for• Upstream occlusion/empty bag• Free flow	The subject device has added anultrasonic sensor to detect air inline alarm based on bubbleaccumulation calculation; alsoadded a pressure sensor to detectdownstream occlusion anddistinguish upstream ordownstream occlusion.The predicate device has oneinfrared sensor to monitor all theflow related events includingocclusion/empty bag/free flow.The alarms of subject device havebeen verified and the resultspassed the criteria.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Pump control alarms	• Upstream Tube Alarm• Downstream Occlusion• Free Flow• Air in Line• Feeding Complete• Out of Battery• Battery Error• Motor Error• Communication Fault• Total power failure alarm• Single Dose Complete• Low Battery• Battery Degradation• No Operation	• Feeding complete• Single dose complete• Low battery• Out of battery• Battery error• Motor error• Communication fault• No operation	DifferentThe subject device has morecontrol alarms than the predicate.
Display	Color 4.3" LCD touch screen	4-digit LED	DifferentThe subject device has a larger
Characteristic	Subject Device:AMSure Enteral feeding pumpand feeding set	Predicate:SENTINEL Enteral feedingpumpK011587	Discussion between subjectdevice and predicate
			differences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Self-test	Automated self-tests at systemstart-up	No	Different.The self-test at system start-up tocheck the functioning of majorcomponents, motor, sensors etc.In case of component failure, thepump pop-up warning informationand the pump cannot be used.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Maximum occlusion pressure	11 psi	15 psi	Different.The occlusion pressure of subjectdevice is lower than the predicate.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Electrical SafetyStandards	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 62304IEC 62366	UL544	DifferentThe subject device is designed tofollow the currently recognizedstandards. These differences donot raise different questions ofsafety and effectiveness than thepredicate device.
EMC/ EMI and ESD standards	IEC 60601-1-2	IEC601-1-1-2	Different
Degree of Protection againstElectrical Shock	Class 2 Type BF per IECStandardsPass	Class 2 Type BFPass	Different
Degree of Protection for liquidingress	IPX4Pass	IPX1Pass	DifferentThe subject device has higherlevel of liquid ingress protectionthan the predicate. Thesedifferences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Enclosure	Flame retarded plastic	Flame retarded plastic	Different
Power adapter	Yes	Yes	Different
Power requirement	100-240VAC, 50-60Hz	120VAC,60Hz	Different
Rechargeable battery	Lithium-ion	Sealed lead acid	DifferentThe subject device is usingLithium-Ion battery. Thisdifference does not raise safetyand effectiveness than thepredicate device.
Battery life	7 hours at 120 mL/h	12 hours at 125 mL/h	DifferentThe subject device has shorterbattery life than predicates.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Characteristic	Subject Device:AMSure Enteral feeding pumpand feeding set	Predicate:SENTINEL Enteral feedingpumpK011587	Discussion between subjectdevice and predicate
Battery recharge time	5hr	10hr	DifferentThe recharge time of subjectdevice is much shorter than thepredicate's
Battery operation indicator	Yes	Yes	Different
Feeding mode	Both continuous mode andintermittent mode.	No	DifferentThe subject device hasintermittent feed mode, but thepredicate doesn't have. Thesedifferences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Flow range	1-400 mL/hr in 1 mL increments	5-295 mL/hr in 1mL increments	Different.The subject device has a widerflow rate range to meet the updatemarket needs.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Volume range	1-9999 mL 1 mL increments	Adjustable 1-2000 mL 1 mLincrements, and 2000-9999ml in5ml increments	Different.The subject device has a smallerincrement. These differences donot raise different questions ofsafety and effectiveness than thepredicate device.
Flow rate accuracy	$\pm$ 10% of selected rate undernormal or worst-case condition	$\pm$ 10% of selected rate undernormal or worst-case condition	Different
Auto prime	Yes - flow rate 1200 mL/h	No	DifferentThe subject device has auto primefunction, but the predicate doesn'thave this function . Thesedifferences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Pump weight	2.38pounds	5.2pounds	DifferentThe pump weight of subjectdevice is less than the predicate's.These differences do not raisedifferent questions of safety andeffectiveness than the predicatedevice.
Pump size	5.2"x4.3"x6.7"	7.5"x9"x5.2"	DifferentThe pump size of subject device isless than the predicate's. Thesedifferences do not raise differentquestions of safety andeffectiveness than the predicatedevice.
Pole clamp mountable	Yes	Yes	Different
RFID	Yes	No	DifferentAs an optional feature, the subjectdevice incorporates RFIDtechnology. These differences donot raise different questions ofsafety and effectiveness than thepredicate device.
KTO	Yes	No	DifferentAs an optional feature, KTOfeature may help maintain tubepatency during the pump stopinterval. The KTO feature has
Characteristic	Subject Device:AMSure Enteral feeding pumpand feeding set	Predicate:SENTINEL Enteral feedingpumpK011587	Discussion between subjectdevice and predicate
			been verified to meet the specifications, this difference does not raise different questions of safety and effectiveness than the predicate device.
Operating Temperature Range	16°-40°C (60.8°-104°F)	16°-40°C (60.8°-104°F)
Storage Temperature Range	-20°- 60°C (-4°-140°F)	-10°- 50°C (14°-122°F)	DifferentThe subject device has wider storage temperature range. These differences do not raise different questions of safety and effectiveness than the predicate device.
Anti-free flow	Yes	Yes	No differences

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

Performance Tests:

A safety assurance case as recommended by the FDA guidance document, "Infusion pumps total product life cycle" was provided for the AMSure® Enteral Feeding Pump and Feeding Set.

The stated top-level goal of the safety assurance case is the pump and set are adequately safe for its intended use.

The following specific evidence were included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices.

Software	Software verification and validation per FDA guidance for the "Content of premarketsubmissions for software contained in medical devices" for a Major Level of Concernand FDA guidance document "Infusion pump total product life cycle"
Electrical safety	The electrical safety evaluation of the medical electrical equipment was performedper standards IEC60601-1 medical electrical equipment part1: General requirementsfor basic safety and essential performance, IEC60601-1 Canadian and US nationaldifferences test.
EMC	The AMSure® pump was evaluated to IEC 60601-1-2: Medical electrical equipment-Part 2: General requirement for basic safety and essential performance - Collateralstandard: electromagnetic compatibility - Requirements and tests.
Device performance	The essential performance requirements of the device (including feeding sets) wereverified through performance testing in accordance with the intended use of thedevice and in accordance with the FDA Guidance "Infusion Pumps Total Product LifeCycle" including:• Performance testing of essential performance attributes• Reliability testing• Flow rate accuracy testing across all operating conditions• Alarm detection
Human factors	Follow FDA Guidance Applying Human Factors and Usability Engineering to MedicalDevices (February 3, 2016), the human factors studies were conducted with theintended user population, use environment, and use scenarios to simulate clinicalconditions. Results of the human factors testing demonstrate validation of the deviceper the intended use.
Biocompatibility	The biocompatibility test reports provided were conducted per ISO10993 seriesstandard following Good Laboratory Practices and the representative product testedpassed all acceptance criteria.

{8}------------------------------------------------

Clinical Tests

Not Applicable

Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The AMSure® Enteral Feeding Pump and Feeding Set is substantially equivalent to the SENTINEL Enteral Feeding pump (K011587) 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).