(259 days)
Not Found
No
The description focuses on the mechanical and user interface aspects of a peristaltic pump and feeding set. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to deliver nutritional formula to the gastrointestinal system, which is a therapeutic intervention for patients unable to eat and swallow.
No
The device is an enteral feeding pump designed to deliver nutritional formula, not to diagnose a medical condition.
No
The device description explicitly states it consists of an "enteral feeding pump and disposable enteral feeding sets," which are hardware components. The summary also details performance studies related to hardware aspects like flow rate accuracy, occlusion detection, battery life, and electrical safety.
Based on the provided information, the PUGGLE® Enteral Feeding Pump and Feeding Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver nutritional formula directly to the gastrointestinal system of a patient. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a pump and feeding set that delivers formula. It does not perform any analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or other biological specimens, which are the hallmarks of IVD devices.
- Performance Studies and Metrics: The performance studies and metrics listed (flow rate, volume range, accuracy, battery life, etc.) are related to the mechanical and operational performance of a pump, not the analytical performance of a diagnostic test.
In summary, the PUGGLE® Enteral Feeding Pump and Feeding Set is a medical device used for providing nutrition, not for diagnosing diseases or conditions through the analysis of in vitro samples.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
infant and older who is physically unable to eat and swallow. Not for use with neonates.
Intended User / Care Setting
clinical or home care settings by users ranging from laypersons to physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Submissions for Software Contained in Medical Devices” for a Major Level of Concern FDA guidance document “Infusion Pump Total Product Life Cycle” |
|---|---|
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff,” (October 2, 2014) and the risk associated cybersecurity related hazards is determined to be low |
| Electrical Safety | Electrical Safety testing in accordance with applicable IEC standards (IEC 60601-1:2005 AAMI ES 60601- 1:2005, Medical electrical equipment-Part1: General requirements 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 and essential performance-Collateral standard: Electromagnetic compatibility Requirements and tests) |
| Administration Set Compatiblity | Verification of the pump essential performance was completed with the indicated administration sets |
| Device performance | The essential performance requirements of the device (including feeding sets) were verified through performance testing in accordance with the intended use of the device and in accordance with 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, set 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 Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use. |
| Reprocessing/Cleaning | AAMI TIR30:2011/R 2016 - A compendium of processes, materials, test methods, and acceptance 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 the medical device which may indirectly contact the patient. Stability testing evaluated the properties of the feeding set after accelerated aging in support of the labeling. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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
1
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
2
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------- |
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: | 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.
4
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
Kangaroo™ Connect Enteral Feeding
Pump and Set
K143263 | Subject Device
PUGGLE® Enteral Feeding
Pump and Feeding Set
K200051 | Discussion |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Kangaroo™ Connect Enteral
Feeding Pump with Kangaroo
Connect™ Feeding Sets is intended
to deliver nutritional formula at a
controlled rate 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 feeding pump and feeding sets
are intended to be used in clinical or
home care settings by users ranging
from laypersons to clinicians. | 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. | No differences between the
devices |
| Prescription
Only or
Over the
Counter | Prescription Only | Prescription Only | No differences between the
devices |
| Intended
Population | Adult, pediatric | Adult, pediatric | No differences between the
devices |
| Environment of
Use | Hospital, home use, ambulatory
(ground) | Hospital, home use, ambulatory
(ground) | No differences between the
devices |
| Features | Predicate Device
KangarooTM Connect Enteral Feeding
Pump and Set
K143263 | Subject device
PUGGLE® Enteral Feeding
Pump and Feeding Set K200051 | Explanation of Difference |
| Technological
Characteristics
(Pump and Set) | The feeding sets are based on peristaltic
pumping using a rotating wheel which
presses against the tubing and moves the
fluid at a controlled rate | Same. | NA |
| Design (Pump) | The pump incorporates a menu-
controlled operating system which
contains on board custom software
designed to allow the user to set feed
rates and volumes as well as other
feeding options. The device incorporates
ultrasonic sensors to detect the air and
blockages in the
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
narrower flow rate range,
but the range remains within
the predicate device range. |
| Volume range | 1-3000 mL in 1 mL increments | 1-9999 mL 1 mL increments | The subject device has a
wider volume range than the
predicate device. The
subject device maintains
performance over the full
volume range, as verified
through performance testing. |
| Motor speed | Discontinuous rotation | 2 speed modes:
Discontinuous 0 to 19 mL/h
Continuous rotation 20mL/h | The subject device maintains
adequate continuous motor
speed as verified through
performance testing. |
| Accuracy | +/- 5% or 0.5 mL/h according to IEC
Standard 60601-2-24 | +/- 5% | The subject device's flow
rate accuracy is consistent
at all flow rates as verified
through performance
testing, not just those
outlined 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 the
subject device having a
slower rate of prime than the
predicate. This does not
raise new questions of safety
and effectiveness. |
| Protocol function | Yes, 1 - 99 boluses | Yes, 1- 8 Bolus | The number of
programmable bolus
functions does not impact
the substantial equivalence
of the subject device. |
| Anti-free flow
/One-way valve | Yes (opening pressure 3.47 psi) | Yes (opening pressure 2.90 psi) | The opening pressure is
lower and was verified |
| | | | through performance testing |
| Maximum
occlusion pressure | 20 psi (138 kPa) | 16 psi (110 kPa) | The subject device in
general has a more sensitive
detection of occlusions and
raises an occlusion alarm in
a shorter period of time than
the predicate device. This
does not raise different
questions of safety or
effectiveness based on the
risk associated with an
occlusion for the intended
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
mode) | 20 hours at 120 mL/h using
normal mode9 | The subject device has a
shorter battery life than the
predicate device but both
have similar rechargeable
power sources and alarms
for battery life . |
| Rechargeable
battery | Lithium-ion | NiMH | Substantial equivalence of
different battery type
evaluated through
performance testing |
| Operating
Temperature Range | 5°-40°C (41°-104°F) at 93% R.H.
(non-condensing) | Same | NA |
| Storage
Temperature
Range | 0°- 50°C (32°-122°F) at 93% R.H.
(non-condensing) | Similar: 0°- 40°C (32°-104°F) at
93 % R.H. (non-condensing) | Similar |
| Medical and
Electrical Safety
Standards | IEC 60601-1
ANSI/AAMI ES 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-2-24
IEC 62304
IEC 62366 | IEC 60601-1
ANSI/AAMI ES 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-2-24 *not FDA
recognized
IEC 62304
IEC 62366-1 | NA |
| Degree of
Protection against
Electrical Shock | Class 2 Type BH per IEC Standards | Same | NA |
| Degree of
Protection for
liquid ingress | IP26 per IEC 60529 | IP44 per IEC 60529 | The ingress protection of
IP44 is adequate for the
intended use environment of
the subject device. |
| EMC/ EMI and
ESD standards | IEC 60601-1-2 Parts 1 and 2 | IEC 60601-2:2015 | NA |
| | The pump set incorporates 5 basic
segments:
• Fluid reservoir(s), which may be an
attached bag (500ml or 1000ml) or
a spike for connection to a formula
container | The pump set incorporates 5
basic segments:
• Fluid reservoir(s), which may
be an attached bag (500ml
or 1200ml) or a spike for
connection to a formula | Differences in design do not
raise different questions of
safety or effectiveness and
performance testing verified
that this design meets the
essential performance |
| Design (Feeding
set) | • Tubing from fluid reservoir to pump
(14inches) | container
• Tubing from fluid reservoir to | requirements. |
| | • Cassette containing pump interface
module (peristaltic tubing)
• Tubing from pump to patient
connector (66 inches) | pump (12inches)
• Cassette containing pump
interface module
(peristaltic tubing) | |
| | | • Tubing from pump to
patient connector
(59 inches) | |
| Feeding Set
Connector | Patient connector (ENFit connector
compliant to ISO 80369-3) | Patient connector (ENFit
connector compliant to ISO
80369-3) | NA |
| Pump feeding set
Materials/Chemical | Polyvinyl chloride (PVC): Feeding bags
and caps, Tubing | Polyvinyl chloride (PVC):
Feeding bags and caps, Tubing | Differences in materials
were evaluated for
substantial equivalence |
| composition | Silicone: Peristaltic tubing | Silicone: Peristaltic tubing | through performance and
biocompatibility testing. |
| | Polycarbonate: Cassette body
CoPolyester: Patient connector | ABS: Spike, Tube holder and
cap, Cassette body, Patient | |
| | ABS: Spike, Tube holder and cap
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.
5
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
6
7
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
Submissions for Software Contained in Medical Devices” for a Major Level of Concern FDA
guidance document “Infusion Pump Total Product Life Cycle” |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance “Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug
Administration Staff,” (October 2, 2014) and the risk associated cybersecurity related hazards is
determined to be low |
8
| Electrical Safety | Electrical Safety testing in accordance with applicable IEC standards (IEC 60601-
1:2005 AAMI ES 60601- 1:2005, Medical electrical equipment-Part1: General
requirements 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 and
essential performance-Collateral standard: Electromagnetic compatibility Requirements and
tests) |
| Administration Set
Compatibility | Verification of the pump essential performance was completed with the indicated administration
sets |
| Device performance | The essential performance requirements of the device (including feeding sets) were verified
through performance testing in accordance with the intended use of the device and in accordance
with 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, set
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
Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted
with the intended user population, use environment and use scenarios to simulate clinical
conditions. Results of the human factors testing demonstrate validation of the device per the
intended use. |
| Reprocessing/Cleaning | AAMI TIR30:2011/R 2016 - A compendium of processes, materials, test methods, and
acceptance 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 the
medical device which may indirectly contact the patient.
Stability testing evaluated the properties of the feeding set after accelerated aging in support of
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.