The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication or decompression through an established gastrointestinal stoma tract.

The Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon Retention Feeding Tube.

The Entuit LP Patient Care Kit with ENFit Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube.

The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.

The PromaX LP Patient Care Kit with ENFit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a PromaX Low Profile Gastrostomy Feeding Tube.

Device Description

The proposed low profile devices are constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. At the distal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the extension set connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.

In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present.

Accessories for the proposed devices include two extension set configurations (bolus and continuous, each available in both ENFit-compatible version and non-ENFit compatible version due to ENFit market transition status), an inflation syringe, a feeding syringe (similarly available in both ENFit compatible and non-ENFit compatible versions), gauzes, and a stoma measuring device (for the Entuit offering) to facilitate device placement and use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of new medical devices to legally marketed predicate devices. As such, it does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria for an AI/ML powered medical device. The document pertains to physical medical devices (gastrostomy feeding tubes and kits).

Therefore, I cannot provide the requested information based on the given text.

The typical structure for a 510(k) submission for a physical device like a feeding tube involves demonstrating:

Substantial equivalence to a predicate device already on the market.
Performance testing (bench testing, e.g., tensile strength, leak testing, biocompatibility, sterilization validation) to show the device meets specifications and is safe and effective for its intended use.
Clinical tests (if applicable): Often not required for Class II devices like these if bench data and substantial equivalence is strong.

The document you provided outlines exactly this:

It identifies predicate and reference devices (Section 5.3, 5.4).
It describes the proposed devices and their technological characteristics, comparing them to the predicate (Section 5.5, 5.7, 5.7a).
It lists non-clinical tests performed (biocompatibility, sterilization, performance bench testing like tensile, leak, connector strength, dimensional testing per ISO standards, pinch clamp testing, and resistance to chemical exposure) (Section 5.8.1).
It explicitly states that animal and clinical tests were not required (Section 5.8.2, 5.8.3), which is common for devices demonstrating substantial equivalence through robust bench testing.

Essentially, for these types of physical devices, the "acceptance criteria" are the specifications and performance standards met during the non-clinical bench testing, and the "study that proves the device meets the acceptance criteria" refers to the results of these bench tests demonstrating compliance with the standards and equivalence to the predicate. There is no AI/ML component described, so terms like "test set," "training set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" are not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

October 18, 2018

Xeridiem Medical Devices, A Spectrum Plastics Group Company Steve Murray Regulatory Affairs Specialist 4700 S. Overland Drive Tucson, AZ 85714

Re: K180708

Trade/Device Name: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube Kit with ENFit, PromaX LP Patient Care Kit with ENFit Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF, KNT Dated: September 14, 2018 Received: September 17, 2018

Dear Steve Murray:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

{1}------------------------------------------------

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/11 description: The image shows the FDA logo. The logo is in white and is made up of the letters F, D, and A. The letters are in a bold, sans-serif font. The logo is simple and recognizable.

Jeffrey W. Cooper -5 2018.10.18 17:52:17 -04'00'

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180708

Device Name

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection

Indications for Use (Describe)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180708

Device Name Entuit LP Patient Care Kit

Indications for Use (Describe)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

{4}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180708

Device Name

Entuit LP Patient Care Kit with ENFit Connection

Indications for Use (Describe)

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ 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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

{5}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180708

Device Name

PromaX Low Profile Gastrostomy Feeding Tube Kit with ENFit

Indications for Use (Describe)

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."

{6}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180708

Device Name PromaX LP Patient Care Kit with ENFit

Indications for Use (Describe)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

{7}------------------------------------------------

510(k) SUMMARY 5.0

5.1 Submitter Information

Date Prepared:	October 16, 2018
510(k) Submitter:	Xeridiem Medical Devices,A Spectrum Plastics Group Company4700 S. Overland Dr.Tucson, AZ 85714
Contact Person:	Steve Murray, Regulatory Affairs Specialist(520) 882-7794 ext. 178

smurray@xeridiem.com

5.2 Device Information

Trade Name:	- Entuit® LP Gastrostomy BR Low Profile Balloon RetentionFeeding Tube
-------------	---------------------------------------------------------------------------

· Entuit® LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit® Connection
Entuit® LP Patient Care Kit
Entuit® LP Patient Care Kit with ENFit® Connection
PromaXTM Low Profile Gastrostomy Feeding Tube Kit with ENFit®
PromaX™ LP Patient Care Kit with ENFit®

Common Name:	Low Profile Gastrostomy Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Codes PIF, KNT)
Classification Panel:	Gastroenterology/Urology

5.3 Predicate Device Information

Trade Name:	Entuit™ Thrive LP Balloon Retention GastrostomyFeeding Tube
Common Name:	Gastrostomy Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Codes KNT)
510(k) Number:	K130674

{8}------------------------------------------------

5.4 Reference Device Information

Trade Name:	EndoVive™ 3s Low Profile Balloon KitEndoVive™ 3s Bolus Extension SetsEndoVive™ 3s Continuous Extension SetsEndoVive™ 3s Medication Extension Set
Common Name:	Gastrostomy Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Codes PIF, PIO)
510(k) Number:	K142297

*These accessories are the only part of the cleared device being used for reference considerations.

5.5 Device Description

The proposed devices are listed below in Table 5.5-1 and are described following the table.

Device PartNumber	Device Brand Name	Hereafter Referred to As
50-0423	Entuit® LP Gastrostomy BR Low ProfileBalloon Retention Feeding Tube	Entuit LP G-Tube
50-0416	Entuit® LP Patient Care Kit with ENFit®Connection	Entuit Patient Care Kit (ENFit)
50-0393	Entuit® LP Patient Care Kit	Entuit Patient Care Kit (Legacy)
70-0061	Entuit® LP Gastrostomy BR Low ProfileBalloon Retention Feeding Tube withENFit® Connection (Kit)	Entuit Low Profile Kit (ENFit)
70-0069	Entuit® LP Gastrostomy BR Low ProfileBalloon Retention Feeding Tube (Kit)	Entuit Low Profile Kit (Legacy)
50-0435	PromaX™ Low Profile GastrostomyFeeding Tube	PromaX LP G-Tube
50-0436	PromaX™ LP Patient Care Kit withENFit®	PromaX Patient Care Kit (ENFit)
70-0072	PromaX™ Low Profile GastrostomyFeeding Tube Kit with ENFit®	PromaX Low Profile Kit (ENFit)

Table 5.5-1 - Proposed Devices

The Low Profile Gastrostomy Tube Family will be comprised of two different brands of low profile gastrostomy tube kits - the Entuit Low Profile Kits (ENFit and Legacy versions) and the PromaX Low Profile Kit (ENFit), There are several minor design differences between the Entuit and PromaX offerings, including: hub strap width, extension set valve connector stem height, ENFit connector grip surface, length of ENFit feeding and Y-port stem on continuous extension set, and cap/tether configuration of the extension set for PromaX.

{9}------------------------------------------------

with radiopaque barium RTV. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the extension set connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.

The proposed low profile devices are available in the configurations shown below in Table 5.5-2.

Size	0.8	1.0	1.5	2.0	2.5	3.0	3.5	4.0	4.5	5.0
12 FR	✓	✓	✓	✓	✓	✓	✓	✓
14 FR	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
16 FR	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
18 FR	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
20 FR	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
22 FR			✓	✓	✓	✓	✓	✓	✓	✓
24 FR			✓	✓	✓	✓	✓	✓	✓	✓

Table 5.5-2 – LP G-Tube Configurations (Length [cm] for Each FR Size)

The extension sets have a valve connector end that inserts into the LP G-Tube reflux valve. For ENFit Extension Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with non-enteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. For Legacy Extension Sets (for the Entuit offering), the opposite end has a connector that can accept connection from non-ENFit catheter tip syringes and giving sets.

The ISO 80369-3 standard for enteral feeding ENFit connections was released in its final form on July 1, 2016. Progression of healthcare facilities adopting enteral devices with ENFit connectors has been slow as reported by industry organizations such as GEDSA and ECRI. As a result, both ENFit Extension Sets and Legacy Extension Sets are being made available to meet short-term patient needs.

{10}------------------------------------------------

The PromaX Low Profile Kits will only be offered in an ENFit version, targeted at the long term full market transition to ENFit connections.

5.6 Indications for Use

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube and 5.6.1 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection

The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established qastrointestinal stoma tract.

5.6.2 Entuit LP Patient Care Kit with ENFit Connection

5.6.3 Entuit LP Patient Care Kit

5.6.4 PromaX Low Profile Gastrostomy Feeding Tube Kit with ENFit

The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration, or decompression through an established gastrointestinal stoma tract.

5.6.5 PromaX LP Patient Care Kit with ENFit

5.7 Technological Characteristics

The proposed devices, as shown in Table 5.7 below with specific similarities and differences, have the same or very similar technological characteristics as the predicate device. The intended uses of the proposed devices and predicate device are the same and there are no significant differences noted in the table below that would affect the performance of the proposed devices as compared to the predicate device. The

{11}------------------------------------------------

Reference Device is used as the comparison in situations where the predicate device does not have the identified characteristic for proper comparisons (see table 5.7a below).

	PREDICATE DEVICE(K130674)	PROPOSED DEVICE 1	PROPOSED DEVICE 2
	Entuit™ Thrive LP BalloonRetention GastrostomyFeeding Tube	Entuit® LP GastrostomyBR Balloon RetentionFeeding Tube Kit (andwith ENFit® Connection)	PromaX™ Low ProfileGastrostomy FeedingTube Kit with ENFit®
Indications forUse	The Entuit™ Thrive BalloonRetention GastrostomyFeeding Tube is indicated inadult and pediatricpopulations for use inpercutaneous placement ofan enteral feeding tube forfeeding and/or administrationof medication in conjunctionwith an established GI stomatract. The replacement tubemay also be used for gastricdecompression.	The Entuit® LP GastrostomyBR Low Profile BalloonRetention Feeding Tube isindicated for use inpercutaneous placement ofan enteral feeding tube inadult and pediatric patientsthat require enteral feeding,medication administration ordecompression through anestablished gastrointestinalstoma tract.	The PromaX™ GastrostomyFeeding Tube is indicatedfor use in percutaneousplacement of an enteralfeeding tube in adult andpediatric patients thatrequire enteral feeding,medication administration ordecompression through anestablished gastrointestinalstoma tract.
User Population	Adult and Pediatric	Same as K130674	Same as K130674
OperatingPrinciple	Device tip enters through thestoma tract and into thestomach, then the device issecured in place by inflatingthe retention balloon. Oncesecured in place, theappropriate extension set isconnected to the device andit then serves as a channelfor administering nutrientsand medication into thestomach and for gastricdecompression.	Same as K130674	Same as K130674
Single Patient Use	Yes	Same as K130674	Same as K130674
Sterile	Yes (ETO) for pouch-sealedlow profile device	Same as K130674	Same as K130674
Shaft	Silicone 65D	Same as K130674	Same as K130674
Balloon	Silicone 24D	Same as K130674	Same as K130674
Balloon InflationRating	5 mL	12-16 FR tubing size: 5-7mL18-24 FR tubing size: 5-10mL	12-16 FR tubing size: 5-7mL18-24 FR tubing size: 5-10mL
Reflux Valve	Silicone dome valve	Silicone cross-slit valve	Silicone cross-slit valve
RadiopaqueMarker	Barium sulfate	Same as K130674	Same as K130674
Balloon InflationValve	Thermoplastic housing withsilicone valve	Same as K130674	Same as K130674
Inflation ValvePort	Port on Silicone 60D hubwhich houses inflation valve	Slightly smaller ID tofacilitate improvedmanufacturability	Slightly smaller ID tofacilitate improvedmanufacturability

	Table 5.7 - Device Comparison Table (Predicate Device)
--	--------------------------------------------------------	--	--	--

{12}------------------------------------------------

Low Profile Gastrostomy Tube Family
-------------------------------------

	PREDICATE DEVICE(K130674)Entuit™ Thrive LP BalloonRetention GastrostomyFeeding Tube	PROPOSED DEVICE 1Entuit® LP GastrostomyBR Balloon RetentionFeeding Tube Kit (andwith ENFit® Connection)	PROPOSED DEVICE 2PromaX™ Low ProfileGastrostomy FeedingTube Kit with ENFit®
Connectors(Extension Sets)	Valve Connector - ABS,straight (bolus) or right angle(continuous)Feeding Connector - PVC,non-ENFit	Valve Connector -Polycarbonate, straight(bolus) or right angle(continuous)Feeding Connector – Nylon(ENFit)* or PVC non-ENFit(Legacy); LegacyContinuous ES has addedmedication port adapter cap	Valve Connector -Polycarbonate, straight(bolus) or right angle(continuous)Feeding Connector - Nylon(ENFit)*
Pinch Clamps(Extension Sets)	Bolus ES - 6.8 mm ODpolypropylene pinch clamp;Continuous ES - 5.0 mm ODpolypropylene pinch clamp	Both Bolus and ContinuousES - print device warninginformation on pinch clampinstead of warning tag;Continuous ES - 3.0 mm ODpolypropylene pinch clamp(no change to pinch clampfor Bolus ES)	Both Bolus and ContinuousES - print device warninginformation on pinch clampinstead of warning tag:Continuous ES - 3.0 mmOD polypropylene pinchclamp (no change to pinchclamp for Bolus ES)
Warning Tags	Yes - for "Not for IV Use"warning	No - see pinch clampprinting above instead	No - see pinch clampprinting above instead
Kit Contents	Inflation syringe, feedingsyringe, gauze, BolusExtension Set, ContinuousExtension Set	Same as K130674	Same as K130674
PackagingSystem/ Materials	Tyvek Pouch, Polybag, IFU,Corrugate Case & Shipper	Same as K130674	Same as K130674

*The Reference Device is used here as a comparison, since the predicate device does not have this characteristic.

Table 5.7a - Device Comparison Table (Reference Device)

	REFERENCE DEVICE(K142297)	PROPOSED DEVICE 1	PROPOSED DEVICE 2
	EndoVive™ 3s Bolus andContinuous ExtensionSets	Entuit® LP Patient CareKit and Entuit® LP PatientCare Kit with ENFit®Connection	PromaX™ LP PatientCare Kit with ENFit®
Indications forUse (applicable toextension sets)	The EndoVive™ 3sExtension Set is indicated forthe delivery of nutrition,hydration and/or medicationinto the stomach through alow profile balloon and alsoprovides a mechanism forgastric decompression.	The Entuit® LP Patient CareKit is indicated for use inadult and pediatric patientsthat require enteral feeding,medication administration ordecompression through anEntuit® LP Gastrostomy BRBalloon Retention FeedingTube	The PromaX™ LP PatientCare Kit with ENFit® isindicated for use in adultand pediatric patients thatrequire enteral feeding,medication administration,or decompression through aPromaX™ Low ProfileGastrostomy Feeding Tube

{13}------------------------------------------------

Low Profile Gastrostomy Tube Family

	REFERENCE DEVICE(K142297)	PROPOSED DEVICE 1	PROPOSED DEVICE 2
	EndoVive™ 3s Bolus andContinuous ExtensionSets	Entuit® LP Patient CareKit and Entuit® LP PatientCare Kit with ENFit®Connection	PromaX™ LP PatientCare Kit with ENFit®
Connectors(Extension Sets)	Valve Connector -Polycarbonate, straight(bolus) or right angle(continuous)	Valve Connector -Polycarbonate, straight(bolus) or right angle(continuous)Feeding Connector - Nylon	Valve Connector -Polycarbonate, straight(bolus) or right angle(continuous)
	Feeding Connector - NylonENFit	(ENFit) or PVC (Legacy)	Feeding Connector - Nylon(ENFit)

As can be seen from the above table, the changes are limited in scope and many characteristics are unchanged from the predicate device. The limited differences are as follows:

The indications for use, while slightly changed in wording, does specify the same o intended use and therefore does support substantial equivalence;
The balloon inflation volume rating change from a fixed value to a range does not change functionality nor use of the device but only provides flexibility in meeting individual patient needs for device retention;
. The new reflux valve design (cross-slit) performs the same function as the predicate device's reflux valve and is shown to be equivalent or better based on performance testing, including creating an effective seal to the extension set valve connector;
The inflation valve port has a minor dimensional change for improved manufacturability:
. The extension connectors similarly perform the same function as those of the predicate but incorporates a material change for improved strength of the valve connector and ISO 80369-3 (ENFit) compliance for the feeding connector (latter for the ENFit version only on both Entuit and PromaX);
. The new pinch clamp for the Continuous Extension Set performs the same function as the predicate but enables improved pinch clamp performance;
Certain warning information is simply transferred from a warning tag to printing ● on the extension set pinch clamp itself;
o Entuit legacy Continuous Extension Set has an added medication port adapter cap (instructions provided in related IFU);
o In addition. PromaX valve connector has minor aesthetic differences (compared to Entuit) for market differentiation, including a slightly shorter stem.

Any differences noted above do not raise new or different questions of safety or effectiveness as compared to the predicate device. The proposed devices are deemed substantially equivalent.

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5.8 Performance Data

5.8.1 Non-Clinical Tests

Based on detailed analysis of the proposed devices as compared to the predicate device and considering previous testing on materials in not only the predicate device but also other devices cleared for Xeridiem Medical Devices, required Verification and Validation Testing was decided upon for the proposed devices. It was found that the proposed devices are in compliance with design and performance requirements according to ISO 80369-3:2016 Small-bore connectors for liquids and qases in healthcare applications – Part 3: Connectors for enteral applications (for the ENFitcompatible devices). EN1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors: Design and testing, and biocompatibility requirements assessed per ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

The following testing was conducted to support substantial equivalence of the proposed devices:

Biocompatibility

Based on ISO 10993-1:2009 assessment, confirming cytotoxicity testing was ● performed per ISO 10993-5:2009
Sterilization
Based on sterilization adoption assessment, confirming EO residuals testing was 0 performed per ISO 10993-7:2008
Performance Testing - Bench
Resistance to device migration (hub or balloon) ●
Enteral feeding devices (with a retention balloon) testing per ASTM F2528-06 0
o Tensile testing per EN1615:2000 and EN 1618:1997
Leak testing per EN1615:2000 and EN 1618:1997 ●
Connector insertion/removal force testing per EN1615:2000 and EN 1618:1997 ●
o Low profile device-valve connector torque testing
Dimensional testing of ENFit connectors per ISO 80369-3 ●
o Extension set pinch clamp testing (able to stop fluid flow)
o Testing for resistance to expected chemical exposure
. Distribution simulation testing
o Design validation testing per simulated use conditions, including blenderized diet

Results from all the above tests met the acceptance criteria for each test.

5.8.2 Animal Tests

Animal tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.7.1.

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5.8.3 Clinical Tests

Clinical tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.7.3.

5.9 Conclusion

The conclusions drawn from the device comparison for technological characteristics and results of the non-clinical testing demonstrate that the proposed devices in the Low Profile Gastrostomy Tube Family are as safe, effective, and perform as well or better than the legally marketed predicate device identified in 5.3, and/or the legally marketed reference device identified in 5.4.

(End of Section)

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.