(259 days)
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.
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.
The provided text is a 510(k) summary for the PUGGLE® Enteral Feeding Pump and Feeding Set. It outlines the device's technical characteristics and how it compares to a predicate device (Kangaroo™ Connect Enteral Feeding Pump and Set K143263). The document primarily focuses on demonstrating substantial equivalence to the predicate, rather than detailing a specific clinical study with acceptance criteria and device performance in the way a traditional clinical trial report would.
However, based on the Performance Testing section, we can extract information regarding acceptance criteria in the form of standards and general performance attributes, and the "reported device performance" is indicated by the statement that the device was verified and validated to meet these requirements.
Here's an attempt to structure the information based on your request, acknowledging that some fields may not be directly available in the provided document:
1. Table of Acceptance Criteria (based on standards and essential performance) and an indication of Device Performance
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance (as stated in the document) |
|---|---|
| Software Verification & Validation per FDA Guidances | Software verification and validation were successfully performed for a Major Level of Concern, in accordance with FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices" and "Infusion Pump Total Product Life Cycle." |
| Cybersecurity Evaluation per FDA Guidances | Cybersecurity was evaluated, and the risk associated with cybersecurity-related hazards was determined to be low, following FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Electrical Safety per IEC 60601-1 | Electrical Safety testing was successfully completed in accordance with IEC 60601-1:2005 AAMI ES 60601-1:2005. |
| EMC per IEC 60601-1-2:2014 | Electromagnetic compatibility evaluation was successfully performed against IEC 60601-1-2:2014. |
| Administration Set Compatibility | Verification of essential pump performance was completed with the indicated administration sets. |
| Essential Performance Requirements (e.g., Flow Rate Accuracy, Occlusion Detection, Alarms) | The essential performance requirements (including feeding sets) were verified through performance testing in accordance with the intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle." This included: System V&V, Performance testing of essential attributes, Stability testing of feeding set, Flow Rate Accuracy testing across all operating conditions, Downstream Occlusion Detection, Pump Alarms (Air presence, upstream/downstream occlusions, set dislodged, rotor stuck, cassette error). |
| The device's flow rate accuracy is +/- 5%. (Compared to predicate's +/-5% or 0.5 mL/h according to IEC standard 60601-2-24, where the subject device confirmed +/-5% for "all flow rates" not just those in the standard). | |
| The maximum occlusion pressure is 16 psi (110 kPa), and the device has a more sensitive detection of occlusions and raises an alarm in a shorter period compared to the predicate's 20 psi (138 kPa). | |
| Battery Safety per IEC 62133 | NiMH battery safety was successfully tested per IEC 62133. |
| Human Factors per FDA Guidance | Human factors studies were conducted with the intended user population, use environment, and scenarios to simulate clinical conditions. The results demonstrate validation of the device per its intended use, in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Reprocessing/Cleaning per AAMI TIR30 | Compliance with AAMI TIR30:2011/R 2016 for cleaning reusable medical devices. (Implies successful verification). |
| Biocompatibility per ISO-10993 (FDA Guidance) | Biocompatibility testing demonstrated the biological safety of parts of the medical device that may indirectly contact the patient, as outlined in FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
The study that proves the device meets the acceptance criteria is detailed under the "Performance Testing" section within the 510(k) summary. It describes a "safety assurance case" approach.
Detailed Information about the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a numerical sample size for individual performance tests (e.g., how many pumps or feeding sets were tested). It refers to "performance testing of essential performance attributes" and "stability testing of feeding set" but doesn't give a number of units tested.
- Data Provenance: Not specified in the document. It does not mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for bench performance testing of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is Not Applicable (N/A) in this context. The testing described is primarily bench and engineering validation (e.g., electrical safety, EMC, flow rate accuracy). "Ground truth" established by experts, as in clinical image interpretation, is not relevant here. The "ground truth" for these tests would be the measured physical parameters against defined engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of medical images. For engineering performance testing, the results are typically objectively measured against pre-defined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is an enteral feeding pump, not an AI-assisted diagnostic device. Therefore, MRMC studies or human reader improvement with AI are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is partially applicable in the sense that the device's technical functions (e.g., pump mechanism, sensors, alarms) were tested in isolation (standalone performance) against technical specifications. The "Performance Testing" section confirms that the "essential performance requirements of the device (including feeding sets) were verified through performance testing". This implies testing the device's inherent functionality. However, this is not "algorithm only" in the context of AI but rather the entire device's automated functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests is based on established engineering specifications, national and international standards (e.g., IEC standards), and regulatory guidance documents (e.g., FDA guidance for Infusion Pumps). For example, flow rate accuracy is measured against a defined percentage deviation. Occlusion detection is measured against specified pressure thresholds and response times.
8. The sample size for the training set
- N/A. As an enteral feeding pump, there is no "training set" in the context of machine learning or AI that would require a data sample for training. The device operates based on programmed logic and hardware, not a learned model from a dataset.
9. How the ground truth for the training set was established
- N/A. Since there is no training set, this question is not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| 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: | 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: +86 139 1614 7664 |
| Email Address: | Jane_gao@amsino.com |
| 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 DeviceKangaroo™ Connect Enteral FeedingPump and SetK143263 | Subject DevicePUGGLE® Enteral FeedingPump and Feeding SetK200051 | Discussion |
|---|---|---|---|
| Indications forUse | The Kangaroo™ Connect EnteralFeeding Pump with KangarooConnect™ Feeding Sets is intendedto deliver nutritional formula at acontrolled rate to the gastrointestinalsystem of a patient age infant andolder who is physically unable to eatand swallow. Not for use withneonates.The feeding pump and feeding setsare intended to be used in clinical orhome care settings by users rangingfrom laypersons to clinicians. | The PUGGLE® EnteralFeeding Pump andFeeding Set areintended to delivernutritional formula tothe gastrointestinalsystem of a patient ageinfant and older who isphysically unable to eatand swallow. Not foruse with neonates.The PUGGLE® EnteralFeeding Pump andFeeding Set are intendedto be used in clinical orhome care settings byusers ranging fromlaypersons to physicians.The PUGGLE® EnteralFeeding Pump and FeedingSet shall be used togetheronly. | No differences between thedevices |
| PrescriptionOnly orOver theCounter | Prescription Only | Prescription Only | No differences between thedevices |
| IntendedPopulation | Adult, pediatric | Adult, pediatric | No differences between thedevices |
| Environment ofUse | Hospital, home use, ambulatory(ground) | Hospital, home use, ambulatory(ground) | No differences between thedevices |
| Features | Predicate DeviceKangarooTM Connect Enteral FeedingPump and SetK143263 | Subject devicePUGGLE® Enteral FeedingPump and Feeding Set K200051 | Explanation of Difference |
| TechnologicalCharacteristics(Pump and Set) | The feeding sets are based on peristalticpumping using a rotating wheel whichpresses against the tubing and moves thefluid at a controlled rate | Same. | NA |
| Design (Pump) | The pump incorporates a menu-controlled operating system whichcontains on board custom softwaredesigned to allow the user to set feedrates and volumes as well as otherfeeding options. The device incorporatesultrasonic sensors to detect the air andblockages in thefeeding set | Same. | NA |
| Flow range | 1-600 mL/hour in 1 mL increments | 1-400 mL/hour 1 mL increments | The subject device has anarrower flow rate range,but the range remains withinthe predicate device range. |
| Volume range | 1-3000 mL in 1 mL increments | 1-9999 mL 1 mL increments | The subject device has awider volume range than thepredicate device. Thesubject device maintainsperformance over the fullvolume range, as verifiedthrough performance testing. |
| Motor speed | Discontinuous rotation | 2 speed modes:Discontinuous 0 to 19 mL/hContinuous rotation 20mL/h | The subject device maintainsadequate continuous motorspeed as verified throughperformance testing. |
| Accuracy | +/- 5% or 0.5 mL/h according to IECStandard 60601-2-24 | +/- 5% | The subject device's flowrate accuracy is consistentat all flow rates as verifiedthrough performancetesting, not just thoseoutlined in IEC 60601-2-24. |
| Auto prime | Yes - flow rate 1200 mL/h | Yes - flow rate 600 mL/h | Both devices have auto-prime functionality, with thesubject device having aslower rate of prime than thepredicate. This does notraise new questions of safetyand effectiveness. |
| Protocol function | Yes, 1 - 99 boluses | Yes, 1- 8 Bolus | The number ofprogrammable bolusfunctions does not impactthe substantial equivalenceof the subject device. |
| Anti-free flow/One-way valve | Yes (opening pressure 3.47 psi) | Yes (opening pressure 2.90 psi) | The opening pressure islower and was verified |
| through performance testing | |||
| Maximumocclusion pressure | 20 psi (138 kPa) | 16 psi (110 kPa) | The subject device ingeneral has a more sensitivedetection of occlusions andraises an occlusion alarm ina shorter period of time thanthe predicate device. Thisdoes not raise differentquestions of safety oreffectiveness based on therisk associated with anocclusion for the intendeduse 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 safemode) | 20 hours at 120 mL/h usingnormal mode9 | The subject device has ashorter battery life than thepredicate device but bothhave similar rechargeablepower sources and alarmsfor battery life . |
| Rechargeablebattery | Lithium-ion | NiMH | Substantial equivalence ofdifferent battery typeevaluated throughperformance testing |
| OperatingTemperature Range | 5°-40°C (41°-104°F) at 93% R.H.(non-condensing) | Same | NA |
| StorageTemperatureRange | 0°- 50°C (32°-122°F) at 93% R.H.(non-condensing) | Similar: 0°- 40°C (32°-104°F) at93 % R.H. (non-condensing) | Similar |
| Medical andElectrical SafetyStandards | IEC 60601-1ANSI/AAMI ES 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 60601-1-11IEC 60601-2-24IEC 62304IEC 62366 | IEC 60601-1ANSI/AAMI ES 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 60601-1-11IEC 60601-2-24 *not FDArecognizedIEC 62304IEC 62366-1 | NA |
| Degree ofProtection againstElectrical Shock | Class 2 Type BH per IEC Standards | Same | NA |
| Degree ofProtection forliquid ingress | IP26 per IEC 60529 | IP44 per IEC 60529 | The ingress protection ofIP44 is adequate for theintended use environment ofthe subject device. |
| EMC/ EMI andESD standards | IEC 60601-1-2 Parts 1 and 2 | IEC 60601-2:2015 | NA |
| The pump set incorporates 5 basicsegments:• Fluid reservoir(s), which may be anattached bag (500ml or 1000ml) ora spike for connection to a formulacontainer | The pump set incorporates 5basic segments:• Fluid reservoir(s), which maybe an attached bag (500mlor 1200ml) or a spike forconnection to a formula | Differences in design do notraise different questions ofsafety or effectiveness andperformance testing verifiedthat this design meets theessential performance | |
| Design (Feedingset) | • Tubing from fluid reservoir to pump(14inches) | container• Tubing from fluid reservoir to | requirements. |
| • Cassette containing pump interfacemodule (peristaltic tubing)• Tubing from pump to patientconnector (66 inches) | pump (12inches)• Cassette containing pumpinterface module(peristaltic tubing) | ||
| • Tubing from pump topatient connector(59 inches) | |||
| Feeding SetConnector | Patient connector (ENFit connectorcompliant to ISO 80369-3) | Patient connector (ENFitconnector compliant to ISO80369-3) | NA |
| Pump feeding setMaterials/Chemical | Polyvinyl chloride (PVC): Feeding bagsand caps, Tubing | Polyvinyl chloride (PVC):Feeding bags and caps, Tubing | Differences in materialswere evaluated forsubstantial equivalence |
| composition | Silicone: Peristaltic tubing | Silicone: Peristaltic tubing | through performance andbiocompatibility testing. |
| Polycarbonate: Cassette bodyCoPolyester: Patient connector | ABS: Spike, Tube holder andcap, Cassette body, Patient | ||
| ABS: Spike, Tube holder and capStrontium 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 PremarketSubmissions for Software Contained in Medical Devices” for a Major Level of Concern FDAguidance document “Infusion Pump Total Product Life Cycle” |
|---|---|
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices Guidance for Industry and Food and DrugAdministration Staff,” (October 2, 2014) and the risk associated cybersecurity related hazards isdetermined to be low |
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| Electrical Safety | Electrical Safety testing in accordance with applicable IEC standards (IEC 60601-1:2005 AAMI ES 60601- 1:2005, Medical electrical equipment-Part1: Generalrequirements for basic safety and essential performance) |
|---|---|
| EMC | Electromagnetic compatibility evaluation in accordance with applicable standards (IEC 60601-1-2:2014, Medical electrical equipment-Part 1-2: General requirements for basic safety andessential performance-Collateral standard: Electromagnetic compatibility Requirements andtests) |
| Administration SetCompatibility | Verification of the pump essential performance was completed with the indicated administrationsets |
| Device performance | The essential performance requirements of the device (including feeding sets) were verifiedthrough performance testing in accordance with the intended use of the device and in accordancewith the FDA Guidance "Infusion Pumps Total Product Life Cycle" including: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, setdislodged, 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 UsabilityEngineering to Medical Devices (February 3, 2016). The human factors studies were conductedwith the intended user population, use environment and use scenarios to simulate clinicalconditions. Results of the human factors testing demonstrate validation of the device per theintended use. |
| Reprocessing/Cleaning | AAMI TIR30:2011/R 2016 - A compendium of processes, materials, test methods, andacceptance criteria for cleaning reusable medical devices. |
| Biocompatibility | Biocompatibility testing as outlined in the FDA Guidance, "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces#G87-1 #8294) (blue book memo)" has demonstrated the biological safety of parts of themedical device which may indirectly contact the patient.Stability testing evaluated the properties of the feeding set after accelerated aging in support ofthe 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.
§ 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).