AMSure Enteral Feeding Pump

K220230 · Amsino International, Inc. · LZH · Nov 10, 2022 · General Hospital

Device Facts

• Record ID: K220230
• Device Name: AMSure Enteral Feeding Pump
• Applicant: Amsino International, Inc.
• Product Code: LZH · General Hospital
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSure® Enteral Feeding Pump and Feeding Set are intended 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 feeding pump and feeding sets are 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 Story

Rotary peristaltic pump; delivers nutritional formula to gastrointestinal system via enteral feeding sets. Inputs: user-defined feed rates/volumes via 4.3" color LCD touch screen. Operation: stepper motor drives tubing in tension against rotor. Sensors: infrared (upstream occlusion, empty bag, free flow), ultrasonic (air-in-line), pressure (downstream occlusion). Output: controlled liquid nutrition delivery. Used in healthcare facilities by licensed professionals. Benefits: maintains patient nutrition; includes KTO (keep-to-open) feature to maintain tube patency. Features: auto-prime, intermittent/continuous modes, RFID capability, lithium-ion battery. Alarms: occlusion, air-in-line, free flow, battery/motor errors, power failure.

Clinical Evidence

No clinical data. Bench testing only: software verification/validation (Major Level of Concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance testing (flow rate accuracy, alarm detection, reliability), human factors/usability engineering, and biocompatibility (ISO 10993).

Technological Characteristics

Flame-retardant plastic enclosure; stepper motor; rotary peristaltic mechanism. Sensors: infrared, ultrasonic, pressure. Power: 100-240VAC or Li-ion battery. Connectivity: RFID. Software: menu-controlled, dual MCU architecture. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366. IPX4 liquid ingress protection.

Indications for Use

Indicated for adult patients physically unable to eat/swallow or requiring supplemental nutrition. Not for pediatric use. For use in healthcare facilities by licensed professionals only.

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

• SENTINEL Enteral Feeding pump (K011587)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K220230

Device Name AMSure® Enteral Feeding Pump

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(K) SUMMARY

| Preparation Date: | 11/8/2022 |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer's Name: | Amsino International Inc. |
| Correspondions official : | 708 Corporate Center Drive, Pomona, CA91768<br>Jane Gao<br>VP of R&D and RA of Amsino<br>Mobile: [phone] |
| Email Address: | [e-mail] |
| Trade Name:<br>Common or Usual Name:<br>Regulation Name:<br>Regulation Number:<br>Product Code:<br>Device Class: | AMSure® Enteral Feeding Pump and Feeding Set<br>Enteral Feeding Pump and Set<br>Infusion Pump<br>21 CFR880.5725<br>LZH<br>Class II |
| Predicate Device(s): | SENTINEL Enteral Feeding pump (K011587) |

#### 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

#### Indication for Use:

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.

#### 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 | Subject<br>Device: AMSure<br>Enteral feeding pump<br>K220230 | Predicate: SENTINEL Enteral<br>feeding pump K011587 | Discussion between subject<br>device and predicate |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indications for use | The AMSure® Enteral Feeding<br>Pump and Feeding Set are<br>intended to deliver nutritional<br>formula to the gastrointestinal<br>system of adult patients who<br>are physically unable to eat and<br>swallow or who are unable to<br>get sufficient nutrition through<br>eating and swallowing.<br>Only intended for adult patients,<br>not for pediatric use.<br>The feeding pump and feeding<br>sets are intended to be used in<br>healthcare facilities by licensed<br>healthcare professional users<br>only.<br>The AMSure® Enteral feeding<br>pump is for use only with<br>Amsino AMSure® feeding sets. | The enteral feeding pump<br>accurately controls the flow of<br>liquid feeding solution to<br>patients who are unable or<br>unwilling to consume adequate<br>nutrients. Liquid feedings may<br>consist of commercially<br>prepared formulas or<br>blenderized foods and are most<br>often delivered by means of<br>nasogastric, nasoduodenal of<br>nasojenjunal feeding tubes. In<br>some cases, a surgically placed<br>esophagostomy, gastrostomy or<br>enterostomy tube may be used.<br>The pump is not intended for<br>use with blood or blood<br>products. The pump is not for<br>intravenous delivery. | No differences |

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| Prescription only or over the<br>counter | Prescription only | Prescription only | No differences |
|------------------------------------------|-----------------------|-----------------------|-------------------------------------------------------------------------|
| Intended population | Adult | Adult, pediatric | Different<br>Subject 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:<br>AMSure Enteral feeding pump<br>and feeding set | Predicate:<br>SENTINEL Enteral feeding<br>pump<br>K011587 | Discussion between subject<br>device and predicate |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design (pump) | The pump incorporates a menu-<br>controlled operating system which<br>contains on board custom<br>software designed to allow the<br>user to set feed rates and<br>volumes as well as other feeding<br>options. | The pump incorporates a menu-<br>controlled operating system which<br>contains on board custom<br>software designed to allow the<br>user to set feed rates and<br>volumes as well as other feeding<br>options. | Different.<br>The hardware and software are<br>different. The subject device<br>contains 2 separate MCUs, and<br>each MCU embeds a specific<br>software in order to secure the<br>pump's running. These<br>differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| Mode of Action | Tubing in tension against rotor | Tubing in tension against rotor | |
| Motor type | Stepper motor | Stepper motor | |
| Sensors and flow monitoring<br>alarms | The device incorporates 3<br>sensors.<br>Infrared for<br>• Upstream occlusion/empty bag<br>• Free flow<br>Ultrasonic for<br>• Air in line<br>Pressure sensors for<br>• Downstream occlusion | The device incorporates 1 sensor.<br>Infrared sensors for<br>• Upstream occlusion/empty bag<br>• Free flow | The subject device has added an<br>ultrasonic sensor to detect air in<br>line alarm based on bubble<br>accumulation calculation; also<br>added a pressure sensor to detect<br>downstream occlusion and<br>distinguish upstream or<br>downstream occlusion.<br>The predicate device has one<br>infrared sensor to monitor all the<br>flow related events including<br>occlusion/empty bag/free flow.<br>The alarms of subject device have<br>been verified and the results<br>passed the criteria.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Pump control alarms | • Upstream Tube Alarm<br>• Downstream Occlusion<br>• Free Flow<br>• Air in Line<br>• Feeding Complete<br>• Out of Battery<br>• Battery Error<br>• Motor Error<br>• Communication Fault<br>• Total power failure alarm<br>• Single Dose Complete<br>• Low Battery<br>• Battery Degradation<br>• No Operation | • Feeding complete<br>• Single dose complete<br>• Low battery<br>• Out of battery<br>• Battery error<br>• Motor error<br>• Communication fault<br>• No operation | Different<br>The subject device has more<br>control alarms than the predicate. |
| Display | Color 4.3" LCD touch screen | 4-digit LED | Different<br>The subject device has a larger |
| Characteristic | Subject Device:<br>AMSure Enteral feeding pump<br>and feeding set | Predicate:<br>SENTINEL Enteral feeding<br>pump<br>K011587 | Discussion between subject<br>device and predicate |
| | | | differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| Self-test | Automated self-tests at system<br>start-up | No | Different.<br>The self-test at system start-up to<br>check the functioning of major<br>components, motor, sensors etc.<br>In case of component failure, the<br>pump pop-up warning information<br>and the pump cannot be used.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Maximum occlusion pressure | 11 psi | 15 psi | Different.<br>The occlusion pressure of subject<br>device is lower than the predicate.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Electrical Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 62304<br>IEC 62366 | UL544 | Different<br>The subject device is designed to<br>follow the currently recognized<br>standards. These differences do<br>not raise different questions of<br>safety and effectiveness than the<br>predicate device. |
| EMC/ EMI and ESD standards | IEC 60601-1-2 | IEC601-1-1-2 | Different |
| Degree of Protection against<br>Electrical Shock | Class 2 Type BF per IEC<br>Standards<br>Pass | Class 2 Type BF<br>Pass | Different |
| Degree of Protection for liquid<br>ingress | IPX4<br>Pass | IPX1<br>Pass | Different<br>The subject device has higher<br>level of liquid ingress protection<br>than the predicate. These<br>differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| 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 | Different<br>The subject device is using<br>Lithium-Ion battery. This<br>difference does not raise safety<br>and effectiveness than the<br>predicate device. |
| Battery life | 7 hours at 120 mL/h | 12 hours at 125 mL/h | Different<br>The subject device has shorter<br>battery life than predicates.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Characteristic | Subject Device:<br>AMSure Enteral feeding pump<br>and feeding set | Predicate:<br>SENTINEL Enteral feeding<br>pump<br>K011587 | Discussion between subject<br>device and predicate |
| Battery recharge time | 5hr | 10hr | Different<br>The recharge time of subject<br>device is much shorter than the<br>predicate's |
| Battery operation indicator | Yes | Yes | Different |
| Feeding mode | Both continuous mode and<br>intermittent mode. | No | Different<br>The subject device has<br>intermittent feed mode, but the<br>predicate doesn't have. These<br>differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| Flow range | 1-400 mL/hr in 1 mL increments | 5-295 mL/hr in 1mL increments | Different.<br>The subject device has a wider<br>flow rate range to meet the update<br>market needs.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Volume range | 1-9999 mL 1 mL increments | Adjustable 1-2000 mL 1 mL<br>increments, and 2000-9999ml in<br>5ml increments | Different.<br>The subject device has a smaller<br>increment. These differences do<br>not raise different questions of<br>safety and effectiveness than the<br>predicate device. |
| Flow rate accuracy | $\pm$ 10% of selected rate under<br>normal or worst-case condition | $\pm$ 10% of selected rate under<br>normal or worst-case condition | Different |
| Auto prime | Yes - flow rate 1200 mL/h | No | Different<br>The subject device has auto prime<br>function, but the predicate doesn't<br>have this function . These<br>differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| Pump weight | 2.38pounds | 5.2pounds | Different<br>The pump weight of subject<br>device is less than the predicate's.<br>These differences do not raise<br>different questions of safety and<br>effectiveness than the predicate<br>device. |
| Pump size | 5.2"x4.3"x6.7" | 7.5"x9"x5.2" | Different<br>The pump size of subject device is<br>less than the predicate's. These<br>differences do not raise different<br>questions of safety and<br>effectiveness than the predicate<br>device. |
| Pole clamp mountable | Yes | Yes | Different |
| RFID | Yes | No | Different<br>As an optional feature, the subject<br>device incorporates RFID<br>technology. These differences do<br>not raise different questions of<br>safety and effectiveness than the<br>predicate device. |
| KTO | Yes | No | Different<br>As an optional feature, KTO<br>feature may help maintain tube<br>patency during the pump stop<br>interval. The KTO feature has |
| Characteristic | Subject Device:<br>AMSure Enteral feeding pump<br>and feeding set | Predicate:<br>SENTINEL Enteral feeding<br>pump<br>K011587 | Discussion between subject<br>device 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) | Different<br>The 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 |

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## 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 premarket<br>submissions for software contained in medical devices" for a Major Level of Concern<br>and FDA guidance document "Infusion pump total product life cycle" |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety | The electrical safety evaluation of the medical electrical equipment was performed<br>per standards IEC60601-1 medical electrical equipment part1: General requirements<br>for basic safety and essential performance, IEC60601-1 Canadian and US national<br>differences test. |
| EMC | The AMSure® pump was evaluated to IEC 60601-1-2: Medical electrical equipment-<br>Part 2: General requirement for basic safety and essential performance - Collateral<br>standard: electromagnetic compatibility - Requirements and tests. |
| Device performance | The essential performance requirements of the device (including feeding sets) were<br>verified through performance testing in accordance with the intended use of the<br>device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life<br>Cycle" including:<br>• Performance testing of essential performance attributes<br>• Reliability testing<br>• Flow rate accuracy testing across all operating conditions<br>• Alarm detection |
| Human factors | Follow FDA Guidance Applying Human Factors and Usability Engineering to Medical<br>Devices (February 3, 2016), the human factors studies were conducted with the<br>intended user population, use environment, and use scenarios to simulate clinical<br>conditions. Results of the human factors testing demonstrate validation of the device<br>per the intended use. |
| Biocompatibility | The biocompatibility test reports provided were conducted per ISO10993 series<br>standard following Good Laboratory Practices and the representative product tested<br>passed all acceptance criteria. |

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# 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.