PUGGLE Enteral Feeding Pump and Feeding Set

K200051 · Amsino International, Inc. · LZH · Sep 25, 2020 · General Hospital

Device Facts

• Record ID: K200051
• Device Name: PUGGLE Enteral Feeding Pump and Feeding Set
• Applicant: Amsino International, Inc.
• Product Code: LZH · General Hospital
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

Device Story

Enteral feeding pump and disposable feeding set; delivers nutritional formula via rotary peristaltic pumping system. Used in clinical or home settings by laypersons or physicians. Pump features graphical interface for setting feed rates (1-400 mL/h) and volumes (1-9999 mL). Incorporates ultrasonic sensors for air and blockage detection. Includes anti-free flow valve. Powered by NiMH battery. Healthcare providers use the interface to program feeding protocols; output is controlled delivery of nutrition. Benefits patients unable to orally ingest food.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included software testing (Major Level of Concern), cybersecurity evaluation, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), battery safety (IEC 62133), human factors/usability studies, biocompatibility (ISO 10993), and performance testing for flow accuracy, occlusion detection, and alarm functionality.

Technological Characteristics

Rotary peristaltic pump. Materials: PVC (bags/caps/tubing), Silicone (peristaltic tubing), ABS (spike/tube holder/cassette). Connectivity: Standalone. Power: NiMH battery. Software: Major Level of Concern. Ingress protection: IP44. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62304, IEC 62366-1, ISO 80369-3 (ENFit).

Indications for Use

Indicated for delivery of nutritional formula to the gastrointestinal system of patients age infant and older who are physically unable to eat and swallow. Contraindicated for neonates.

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

• Kangaroo™ Connect Enteral Feeding Pump and Set (K143263)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

September 25, 2020

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

Re: K200051

Trade/Device Name: PUGGLE Enteral Feeding Pump and Feeding Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: August 25, 2020 Received: August 27, 2020

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/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.

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

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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-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 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-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Dorgan Acting 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) K200051

Device Name

PUGGLE® Enteral Feeding Pump and Feeding Set

Indications for Use (Describe)

The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.

The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

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

| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
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### 510(K) SUMMARY

| Preparation Date: | 9/25/2020 |
|-------------------------|----------------------------------------------|
| Manufacturer's Name: | Amsino International Inc. |
| | 708 Corporate Center Drive, Pomona, CA 91768 |
| Corresponding Official: | Jane Gao |
| | VP of R&D of Amsino International |
| Telephone Number: | Mobile: [phone] |
| Email Address: | [e-mail] |
| Trade Name: | PUGGLE® Enteral Feeding Pump and Feeding Set |
| Common or Usual Name: | Enteral Feeding Pump and set |
| Regulation Name: | Infusion Pump, |
| Regulation Number: | 21 CFR 880.5725 |
| Product Code: | LZH |
| Device Class: | Class II |

### Device Description:

The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and 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.

The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.

### Indication for Use:

The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates.

The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.

The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

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## Substantial Equivalence Discussion

### Intended Use Comparison

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

| Characteristic | Predicate Device<br>Kangaroo™ Connect Enteral Feeding<br>Pump and Set<br>K143263 | Subject Device<br>PUGGLE® Enteral Feeding<br>Pump and Feeding Set<br>K200051 | Discussion |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Kangaroo™ Connect Enteral<br>Feeding Pump with Kangaroo<br>Connect™ Feeding Sets is intended<br>to deliver nutritional formula at a<br>controlled rate to the gastrointestinal<br>system of a patient age infant and<br>older who is physically unable to eat<br>and swallow. Not for use with<br>neonates.<br>The feeding pump and feeding sets<br>are intended to be used in clinical or<br>home care settings by users ranging<br>from laypersons to clinicians. | The PUGGLE® Enteral<br>Feeding Pump and<br>Feeding Set are<br>intended to deliver<br>nutritional formula to<br>the gastrointestinal<br>system of a patient age<br>infant and older who is<br>physically unable to eat<br>and swallow. Not for<br>use with neonates.<br>The PUGGLE® Enteral<br>Feeding Pump and<br>Feeding Set are intended<br>to be used in clinical or<br>home care settings by<br>users ranging from<br>laypersons to physicians.<br>The PUGGLE® Enteral<br>Feeding Pump and Feeding<br>Set shall be used together<br>only. | No differences between the<br>devices |
| Prescription<br>Only or<br>Over the<br>Counter | Prescription Only | Prescription Only | No differences between the<br>devices |
| Intended<br>Population | Adult, pediatric | Adult, pediatric | No differences between the<br>devices |
| Environment of<br>Use | Hospital, home use, ambulatory<br>(ground) | Hospital, home use, ambulatory<br>(ground) | No differences between the<br>devices |
| Features | Predicate Device<br>KangarooTM Connect Enteral Feeding<br>Pump and Set<br>K143263 | Subject device<br>PUGGLE® Enteral Feeding<br>Pump and Feeding Set K200051 | Explanation of Difference |
| Technological<br>Characteristics<br>(Pump and Set) | The feeding sets are based on peristaltic<br>pumping using a rotating wheel which<br>presses against the tubing and moves the<br>fluid at a controlled rate | Same. | NA |
| Design (Pump) | The pump incorporates a menu-<br>controlled operating system which<br>contains on board custom software<br>designed to allow the user to set feed<br>rates and volumes as well as other<br>feeding options. The device incorporates<br>ultrasonic sensors to detect the air and<br>blockages in the<br>feeding set | Same. | NA |
| Flow range | 1-600 mL/hour in 1 mL increments | 1-400 mL/hour 1 mL increments | The subject device has a<br>narrower flow rate range,<br>but the range remains within<br>the predicate device range. |
| Volume range | 1-3000 mL in 1 mL increments | 1-9999 mL 1 mL increments | The subject device has a<br>wider volume range than the<br>predicate device. The<br>subject device maintains<br>performance over the full<br>volume range, as verified<br>through performance testing. |
| Motor speed | Discontinuous rotation | 2 speed modes:<br>Discontinuous 0 to 19 mL/h<br>Continuous rotation 20mL/h | The subject device maintains<br>adequate continuous motor<br>speed as verified through<br>performance testing. |
| Accuracy | +/- 5% or 0.5 mL/h according to IEC<br>Standard 60601-2-24 | +/- 5% | The subject device's flow<br>rate accuracy is consistent<br>at all flow rates as verified<br>through performance<br>testing, not just those<br>outlined in IEC 60601-2-<br>24. |
| Auto prime | Yes - flow rate 1200 mL/h | Yes - flow rate 600 mL/h | Both devices have auto-<br>prime functionality, with the<br>subject device having a<br>slower rate of prime than the<br>predicate. This does not<br>raise new questions of safety<br>and effectiveness. |
| Protocol function | Yes, 1 - 99 boluses | Yes, 1- 8 Bolus | The number of<br>programmable bolus<br>functions does not impact<br>the substantial equivalence<br>of the subject device. |
| Anti-free flow<br>/One-way valve | Yes (opening pressure 3.47 psi) | Yes (opening pressure 2.90 psi) | The opening pressure is<br>lower and was verified |
| | | | through performance testing |
| Maximum<br>occlusion pressure | 20 psi (138 kPa) | 16 psi (110 kPa) | The subject device in<br>general has a more sensitive<br>detection of occlusions and<br>raises an occlusion alarm in<br>a shorter period of time than<br>the predicate device. This<br>does not raise different<br>questions of safety or<br>effectiveness based on the<br>risk associated with an<br>occlusion for the intended<br>use of the subject device. |
| Power adapter | Yes | Same | NA |
| Display | Color TFT (320x240 pixels) | Color LCD (320x240 pixels) | NA |
| Battery life | 24 hours at 125 mL/h (using power safe<br>mode) | 20 hours at 120 mL/h using<br>normal mode9 | The subject device has a<br>shorter battery life than the<br>predicate device but both<br>have similar rechargeable<br>power sources and alarms<br>for battery life . |
| Rechargeable<br>battery | Lithium-ion | NiMH | Substantial equivalence of<br>different battery type<br>evaluated through<br>performance testing |
| Operating<br>Temperature Range | 5°-40°C (41°-104°F) at 93% R.H.<br>(non-condensing) | Same | NA |
| Storage<br>Temperature<br>Range | 0°- 50°C (32°-122°F) at 93% R.H.<br>(non-condensing) | Similar: 0°- 40°C (32°-104°F) at<br>93 % R.H. (non-condensing) | Similar |
| Medical and<br>Electrical Safety<br>Standards | IEC 60601-1<br>ANSI/AAMI ES 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-2-24<br>IEC 62304<br>IEC 62366 | IEC 60601-1<br>ANSI/AAMI ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-2-24 *not FDA<br>recognized<br>IEC 62304<br>IEC 62366-1 | NA |
| Degree of<br>Protection against<br>Electrical Shock | Class 2 Type BH per IEC Standards | Same | NA |
| Degree of<br>Protection for<br>liquid ingress | IP26 per IEC 60529 | IP44 per IEC 60529 | The ingress protection of<br>IP44 is adequate for the<br>intended use environment of<br>the subject device. |
| EMC/ EMI and<br>ESD standards | IEC 60601-1-2 Parts 1 and 2 | IEC 60601-2:2015 | NA |
| | The pump set incorporates 5 basic<br>segments:<br>• Fluid reservoir(s), which may be an<br>attached bag (500ml or 1000ml) or<br>a spike for connection to a formula<br>container | The pump set incorporates 5<br>basic segments:<br>• Fluid reservoir(s), which may<br>be an attached bag (500ml<br>or 1200ml) or a spike for<br>connection to a formula | Differences in design do not<br>raise different questions of<br>safety or effectiveness and<br>performance testing verified<br>that this design meets the<br>essential performance |
| Design (Feeding<br>set) | • Tubing from fluid reservoir to pump<br>(14inches) | container<br>• Tubing from fluid reservoir to | requirements. |
| | • Cassette containing pump interface<br>module (peristaltic tubing)<br>• Tubing from pump to patient<br>connector (66 inches) | pump (12inches)<br>• Cassette containing pump<br>interface module<br>(peristaltic tubing) | |
| | | • Tubing from pump to<br>patient connector<br>(59 inches) | |
| Feeding Set<br>Connector | Patient connector (ENFit connector<br>compliant to ISO 80369-3) | Patient connector (ENFit<br>connector compliant to ISO<br>80369-3) | NA |
| Pump feeding set<br>Materials/Chemical | Polyvinyl chloride (PVC): Feeding bags<br>and caps, Tubing | Polyvinyl chloride (PVC):<br>Feeding bags and caps, Tubing | Differences in materials<br>were evaluated for<br>substantial equivalence |
| composition | Silicone: Peristaltic tubing | Silicone: Peristaltic tubing | through performance and<br>biocompatibility testing. |
| | Polycarbonate: Cassette body<br>CoPolyester: Patient connector | ABS: Spike, Tube holder and<br>cap, Cassette body, Patient | |
| | ABS: Spike, Tube holder and cap<br>Strontium Ferrite/nylon: Set ID magnets | connector | |
| Drip chamber | No | No | NA |
| Anti-free flow | Yes | Yes | NA |

Discussions of differences in Indications for Use statement

The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

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## Technological Characteristics

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

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### Performance Testing:

A safety assurance case as recommended by the FDA guidance document, "Infusion Pumps Total Product Life Cycle" was provided for the PUGGLE® Enteral Feeding Pump and Feeding Set.

The stated top level goal of the safety assurance case is: The pump is acceptably safe for its intended use.

The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments.

The information in the safety assurance case was supplemented by additional test reports and hazard analysis documents to augment the arguments for acceptability of risk mitigations, reliability and device requirements verification and validation to meet the top level goal that the device is safe for its intended use.

The following specific evidence was 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 FDA<br>guidance document “Infusion Pump Total Product Life Cycle” |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance “Content of Premarket Submissions for<br>Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug<br>Administration Staff,” (October 2, 2014) and the risk associated cybersecurity related hazards is<br>determined to be low |

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| Electrical Safety | Electrical Safety testing in accordance with applicable IEC standards (IEC 60601-<br>1:2005 AAMI ES 60601- 1:2005, Medical electrical equipment-Part1: General<br>requirements for basic safety and essential performance) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EMC | Electromagnetic compatibility evaluation in accordance with applicable standards (IEC 60601-1-<br>2:2014, Medical electrical equipment-Part 1-2: General requirements for basic safety and<br>essential performance-Collateral standard: Electromagnetic compatibility Requirements and<br>tests) |
| Administration Set<br>Compatibility | Verification of the pump essential performance was completed with the indicated administration<br>sets |
| Device performance | The essential performance requirements of the device (including feeding sets) were verified<br>through performance testing in accordance with the intended use of the device and in accordance<br>with the FDA Guidance "Infusion Pumps Total Product Life Cycle" including:<br>System Verification and Validation activities Performance testing of essential performance attributes Stability testing of feeding set Flow Rate Accuracy testing across all operating conditions Downstream Occlusion Detection Pump Alarms (Air presence, upstream and downstream occlusions, set<br>dislodged, rotor stuck, cassette error) |
| Battery testing | NiMH battery safety successfully tested per IEC 62133 |
| Human Factors | Human factors studies per the FDA Guidance Applying Human Factors and Usability<br>Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted<br>with the intended user population, use environment and use scenarios to simulate clinical<br>conditions. Results of the human factors testing demonstrate validation of the device per the<br>intended use. |
| Reprocessing/Cleaning | AAMI TIR30:2011/R 2016 - A compendium of processes, materials, test methods, and<br>acceptance criteria for cleaning reusable medical devices. |
| Biocompatibility | Biocompatibility testing as outlined in the FDA Guidance, "Use of International Standard ISO-<br>10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces<br>#G87-1 #8294) (blue book memo)" has demonstrated the biological safety of parts of the<br>medical device which may indirectly contact the patient.<br><br>Stability testing evaluated the properties of the feeding set after accelerated aging in support of<br>the labeling. |

# 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 PUGGLE® Enteral Feeding Pump and Feeding Set is substantially equivalent to the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets cleared under K143263 with respect to the indications for use, target populations, treatment method, and technological characteristics.