(287 days)
Not Found
No
The summary describes a standard enteral feeding pump with a peristaltic pumping system and does not mention any AI or ML capabilities. The performance studies focus on traditional medical device testing like software verification, electrical safety, EMC, device performance, human factors, and biocompatibility.
Yes
The device is used to deliver nutritional formula to the gastrointestinal system for patients unable to eat, directly addressing a health need.
No.
The device is an enteral feeding pump that delivers nutritional formula, not a device used to diagnose a condition or disease.
No
The device description explicitly states it is a "rotary peristaltic pumping system," which is a hardware component. The performance studies also include electrical safety, EMC, and biocompatibility testing, all related to hardware.
Based on the provided information, the AMSure® Enteral Feeding Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering nutritional formula directly to the gastrointestinal system of patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces that it's a pump for delivering formula, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical delivery of a substance into the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AMSure® Enteral Feeding Pump does not fit this definition.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZH
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
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
Adult patients, not for pediatric use.
Intended User / Care Setting
licensed healthcare professional users only.
healthcare facilities
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 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 submissions for software contained in medical devices" for a Major Level of Concern and FDA guidance document "Infusion pump total product life cycle"
Electrical safety: The electrical safety evaluation of the medical electrical equipment was performed per standards IEC60601-1 medical electrical equipment part1: General requirements for basic safety and essential performance, IEC60601-1 Canadian and US national differences test.
EMC: The AMSure® pump was evaluated to IEC 60601-1-2: Medical electrical equipment- Part 2: General requirement for basic safety and essential performance - Collateral standard: electromagnetic compatibility - Requirements and tests.
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:
• Performance testing of essential performance attributes
• Reliability testing
• Flow rate accuracy testing across all operating conditions
• Alarm detection
Human factors: Follow FDA Guidance Applying Human Factors and Usability Engineering to 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.
Biocompatibility: The biocompatibility test reports provided were conducted per ISO10993 series standard following Good Laboratory Practices and the representative product tested passed all acceptance criteria.
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 shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
November 10, 2022
Amsino International Inc. Jane Gao VP of R&D and RA 708 Corporate Center Drive Pomona, California 91768
Re: K220230
Trade/Device Name: AMSure Enteral Feeding Pump and Feeding Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: October 12, 2022 Received: October 12, 2022
Dear Jane Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pm.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the
1
Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220230
Device Name AMSure® Enteral Feeding Pump
Indications for Use (Describe)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Preparation Date: | 11/8/2022 |
|---|---|
| Manufacturer's Name: | Amsino International Inc. |
| Correspondions official : | 708 Corporate Center Drive, Pomona, CA91768 |
| Jane Gao | |
| VP of R&D and RA of Amsino | |
| Mobile: +86 139 1614 7664 | |
| Email Address: | Jane_gao@amsino.com |
| Trade Name: | |
| Common or Usual Name: | |
| Regulation Name: | |
| Regulation Number: | |
| Product Code: | |
| Device Class: | AMSure® Enteral Feeding Pump and Feeding Set |
| Enteral Feeding Pump and Set | |
| Infusion Pump | |
| 21 CFR880.5725 | |
| LZH | |
| 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
Device: AMSure
Enteral feeding pump
K220230 | Predicate: SENTINEL Enteral
feeding pump K011587 | Discussion between subject
device and predicate |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indications for 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. | The enteral feeding pump
accurately controls the flow of
liquid feeding solution to
patients who are unable or
unwilling to consume adequate
nutrients. Liquid feedings may
consist of commercially
prepared formulas or
blenderized foods and are most
often delivered by means of
nasogastric, nasoduodenal of
nasojenjunal feeding tubes. In
some cases, a surgically placed
esophagostomy, gastrostomy or
enterostomy tube may be used.
The pump is not intended for
use with blood or blood
products. The pump is not for
intravenous delivery. | No differences |
4
| Prescription only or over the
| counter | Prescription only | Prescription only | No differences |
|---|---|---|---|
| Intended population | Adult | Adult, pediatric | Different |
| 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:
AMSure Enteral feeding pump
and feeding set | Predicate:
SENTINEL Enteral feeding
pump
K011587 | Discussion between subject
device and predicate |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. | Different.
The hardware and software are
different. The subject device
contains 2 separate MCUs, and
each MCU embeds a specific
software in order to secure the
pump's running. These
differences do not raise different
questions of safety and
effectiveness than the predicate
device. |
| Mode of Action | Tubing in tension against rotor | Tubing in tension against rotor | |
| Motor type | Stepper motor | Stepper motor | |
| Sensors and flow monitoring
alarms | The device incorporates 3
sensors.
Infrared for
• Upstream occlusion/empty bag
• Free flow
Ultrasonic for
• Air in line
Pressure sensors for
• Downstream occlusion | The device incorporates 1 sensor.
Infrared sensors for
• Upstream occlusion/empty bag
• Free flow | The subject device has added an
ultrasonic sensor to detect air in
line alarm based on bubble
accumulation calculation; also
added a pressure sensor to detect
downstream occlusion and
distinguish upstream or
downstream occlusion.
The predicate device has one
infrared sensor to monitor all the
flow related events including
occlusion/empty bag/free flow.
The alarms of subject device have
been verified and the results
passed the criteria.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Pump control alarms | • Upstream Tube Alarm
• Downstream Occlusion
• Free Flow
• Air in Line
• Feeding Complete
• Out of Battery
• Battery Error
• Motor Error
• Communication Fault
• Total power failure alarm
• Single Dose Complete
• Low Battery
• Battery Degradation
• No Operation | • Feeding complete
• Single dose complete
• Low battery
• Out of battery
• Battery error
• Motor error
• Communication fault
• No operation | Different
The subject device has more
control alarms than the predicate. |
| Display | Color 4.3" LCD touch screen | 4-digit LED | Different
The subject device has a larger |
| Characteristic | Subject Device:
AMSure Enteral feeding pump
and feeding set | Predicate:
SENTINEL Enteral feeding
pump
K011587 | Discussion between subject
device and predicate |
| | | | differences do not raise different
questions of safety and
effectiveness than the predicate
device. |
| Self-test | Automated self-tests at system
start-up | No | Different.
The self-test at system start-up to
check the functioning of major
components, motor, sensors etc.
In case of component failure, the
pump pop-up warning information
and the pump cannot be used.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Maximum occlusion pressure | 11 psi | 15 psi | Different.
The occlusion pressure of subject
device is lower than the predicate.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Electrical Safety
Standards | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 62304
IEC 62366 | UL544 | Different
The subject device is designed to
follow the currently recognized
standards. These differences do
not raise different questions of
safety and effectiveness than the
predicate device. |
| EMC/ EMI and ESD standards | IEC 60601-1-2 | IEC601-1-1-2 | Different |
| Degree of Protection against
Electrical Shock | Class 2 Type BF per IEC
Standards
Pass | Class 2 Type BF
Pass | Different |
| Degree of Protection for liquid
ingress | IPX4
Pass | IPX1
Pass | Different
The subject device has higher
level of liquid ingress protection
than the predicate. These
differences do not raise different
questions of safety and
effectiveness than the predicate
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
The subject device is using
Lithium-Ion battery. This
difference does not raise safety
and effectiveness than the
predicate device. |
| Battery life | 7 hours at 120 mL/h | 12 hours at 125 mL/h | Different
The subject device has shorter
battery life than predicates.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Characteristic | Subject Device:
AMSure Enteral feeding pump
and feeding set | Predicate:
SENTINEL Enteral feeding
pump
K011587 | Discussion between subject
device and predicate |
| Battery recharge time | 5hr | 10hr | Different
The recharge time of subject
device is much shorter than the
predicate's |
| Battery operation indicator | Yes | Yes | Different |
| Feeding mode | Both continuous mode and
intermittent mode. | No | Different
The subject device has
intermittent feed mode, but the
predicate doesn't have. These
differences do not raise different
questions of safety and
effectiveness than the predicate
device. |
| Flow range | 1-400 mL/hr in 1 mL increments | 5-295 mL/hr in 1mL increments | Different.
The subject device has a wider
flow rate range to meet the update
market needs.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Volume range | 1-9999 mL 1 mL increments | Adjustable 1-2000 mL 1 mL
increments, and 2000-9999ml in
5ml increments | Different.
The subject device has a smaller
increment. These differences do
not raise different questions of
safety and effectiveness than the
predicate device. |
| Flow rate accuracy | $\pm$ 10% of selected rate under
normal or worst-case condition | $\pm$ 10% of selected rate under
normal or worst-case condition | Different |
| Auto prime | Yes - flow rate 1200 mL/h | No | Different
The subject device has auto prime
function, but the predicate doesn't
have this function . These
differences do not raise different
questions of safety and
effectiveness than the predicate
device. |
| Pump weight | 2.38pounds | 5.2pounds | Different
The pump weight of subject
device is less than the predicate's.
These differences do not raise
different questions of safety and
effectiveness than the predicate
device. |
| Pump size | 5.2"x4.3"x6.7" | 7.5"x9"x5.2" | Different
The pump size of subject device is
less than the predicate's. These
differences do not raise different
questions of safety and
effectiveness than the predicate
device. |
| Pole clamp mountable | Yes | Yes | Different |
| RFID | Yes | No | Different
As an optional feature, the subject
device incorporates RFID
technology. These differences do
not raise different questions of
safety and effectiveness than the
predicate device. |
| KTO | Yes | No | Different
As an optional feature, KTO
feature may help maintain tube
patency during the pump stop
interval. The KTO feature has |
| Characteristic | Subject Device:
AMSure Enteral feeding pump
and feeding set | Predicate:
SENTINEL Enteral feeding
pump
K011587 | Discussion between subject
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
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 |
5
6
7
Performance Tests:
A safety assurance case as recommended by the FDA guidance document, "Infusion pumps total product life cycle" was provided for the AMSure® Enteral Feeding Pump and Feeding Set.
The stated top-level goal of the safety assurance case is the pump and set are adequately safe for its intended use.
The following specific evidence were included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices.
| Software | Software verification and validation per FDA guidance for the "Content of premarket
submissions for software contained in medical devices" for a Major Level of Concern
and FDA guidance document "Infusion pump total product life cycle" |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety | The electrical safety evaluation of the medical electrical equipment was performed
per standards IEC60601-1 medical electrical equipment part1: General requirements
for basic safety and essential performance, IEC60601-1 Canadian and US national
differences test. |
| EMC | The AMSure® pump was evaluated to IEC 60601-1-2: Medical electrical equipment-
Part 2: General requirement for basic safety and essential performance - Collateral
standard: electromagnetic compatibility - Requirements and tests. |
| 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:
• Performance testing of essential performance attributes
• Reliability testing
• Flow rate accuracy testing across all operating conditions
• Alarm detection |
| Human factors | Follow FDA Guidance Applying Human Factors and Usability Engineering to 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. |
| Biocompatibility | The biocompatibility test reports provided were conducted per ISO10993 series
standard following Good Laboratory Practices and the representative product tested
passed all acceptance criteria. |
8
Clinical Tests
Not Applicable
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The AMSure® Enteral Feeding Pump and Feeding Set is substantially equivalent to the SENTINEL Enteral Feeding pump (K011587) with respect to the indications for use, target populations, treatment method, and technological characteristics.