(213 days)
No
The device description and performance studies focus on the mechanical and material properties of a feeding tube and its accessories, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is indicated for enteral feeding, medication administration, and decompression, which are therapeutic interventions.
No
Explanation: The device is a feeding tube and related accessories for administering enteral feeding, medication, or decompression. While its placement can be confirmed using fluoroscopy (a diagnostic imaging technique), the device itself does not perform any diagnostic function. Its primary role is therapeutic/supportive.
No
The device description clearly details physical components made of silicone, including a hub, shaft, balloon, and ports. It also mentions accessories like syringes and gauzes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a feeding tube and associated accessories used for delivering nutrition, medication, or for decompression directly into the gastrointestinal tract through an established stoma.
- Intended Use: The intended use clearly states the purpose is for "percutaneous placement of an enteral feeding tube" and "enteral feeding, medication administration or decompression." This involves direct interaction with the body for therapeutic or supportive purposes, not for analyzing samples outside the body.
- Device Description: The description focuses on the physical construction and function of the tube and its accessories for insertion and delivery.
- Performance Studies: The performance studies listed are related to the physical and functional integrity of the device (tensile strength, leak testing, connector testing, etc.) and its ability to perform its intended function in a simulated environment. There are no studies related to analyzing biological samples.
In summary, the device is a medical device used for direct patient care and intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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.
Product codes
PIF, KNT
Device Description
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.
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.
The proposed low profile devices are available in the configurations shown below in Table 5.5-2.
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. The PromaX Low Profile Kits will only be offered in an ENFit version, targeted at the long term full market transition to ENFit connections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal stoma tract / stomach
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
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)
Non-Clinical Tests:
The proposed devices are in compliance with design and performance requirements according to ISO 80369-3:2016 Small-bore connectors for liquids and gases 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 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
- 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
- Low profile device-valve connector torque testing
- Dimensional testing of ENFit connectors per ISO 80369-3
- Extension set pinch clamp testing (able to stop fluid flow)
- Testing for resistance to expected chemical exposure
- Distribution simulation testing
- Design validation testing per simulated use conditions, including blenderized diet
Key results: Results from all the above tests met the acceptance criteria for each test.
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.
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.
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.
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
§ 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.
0
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)
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.
| 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)
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.
| 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)
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.
| 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
"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)
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.
| 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
"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)
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.
| 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
"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 Company | |
| 4700 S. Overland Dr. | |
| Tucson, AZ 85714 | |
| Contact Person: | Steve Murray, Regulatory Affairs Specialist |
| (520) 882-7794 ext. 178 |
5.2 Device Information
| Trade 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
- 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 Gastrostomy
Feeding 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 Kit
EndoVive™ 3s Bolus Extension Sets*
EndoVive™ 3s Continuous Extension Sets*
EndoVive™ 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 Part
| Number | Device Brand Name | Hereafter Referred to As |
|---|---|---|
| 50-0423 | Entuit® LP Gastrostomy BR Low Profile | |
| Balloon 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 Profile | |
| Balloon Retention Feeding Tube with | ||
| ENFit® Connection (Kit) | Entuit Low Profile Kit (ENFit) | |
| 70-0069 | Entuit® LP Gastrostomy BR Low Profile | |
| Balloon Retention Feeding Tube (Kit) | Entuit Low Profile Kit (Legacy) | |
| 50-0435 | PromaX™ Low Profile Gastrostomy | |
| Feeding Tube | PromaX LP G-Tube | |
| 50-0436 | PromaX™ LP Patient Care Kit with | |
| ENFit® | PromaX Patient Care Kit (ENFit) | |
| 70-0072 | PromaX™ Low Profile Gastrostomy | |
| Feeding 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.
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
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.
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.
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
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.
5.6.3 Entuit LP Patient Care Kit
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 Low Profile Balloon Retention Feeding Tube.
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
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.
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
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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 Balloon
Retention Gastrostomy
Feeding Tube | Entuit® LP Gastrostomy
BR Balloon Retention
Feeding Tube Kit (and
with ENFit® Connection) | PromaX™ Low Profile
Gastrostomy Feeding
Tube Kit with ENFit® |
| Indications for
Use | The Entuit™ Thrive Balloon
Retention Gastrostomy
Feeding Tube is indicated in
adult and pediatric
populations for use in
percutaneous placement of
an enteral feeding tube for
feeding and/or administration
of medication in conjunction
with an established GI stoma
tract. The replacement tube
may also be used for gastric
decompression. | The Entuit® LP Gastrostomy
BR Low Profile Balloon
Retention 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. | The PromaX™ Gastrostomy
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. |
| User Population | Adult and Pediatric | Same as K130674 | Same as K130674 |
| Operating
Principle | Device tip enters through the
stoma tract and into the
stomach, then the device is
secured in place by inflating
the retention balloon. Once
secured in place, the
appropriate extension set is
connected to the device and
it then serves as a channel
for administering nutrients
and medication into the
stomach and for gastric
decompression. | Same as K130674 | Same as K130674 |
| Single Patient Use | Yes | Same as K130674 | Same as K130674 |
| Sterile | Yes (ETO) for pouch-sealed
low 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 Inflation
Rating | 5 mL | 12-16 FR tubing size: 5-7
mL
18-24 FR tubing size: 5-10
mL | 12-16 FR tubing size: 5-7
mL
18-24 FR tubing size: 5-10
mL |
| Reflux Valve | Silicone dome valve | Silicone cross-slit valve | Silicone cross-slit valve |
| Radiopaque
Marker | Barium sulfate | Same as K130674 | Same as K130674 |
| Balloon Inflation
Valve | Thermoplastic housing with
silicone valve | Same as K130674 | Same as K130674 |
| Inflation Valve
Port | Port on Silicone 60D hub
which houses inflation valve | Slightly smaller ID to
facilitate improved
manufacturability | Slightly smaller ID to
facilitate improved
manufacturability |
| Table 5.7 - Device Comparison Table (Predicate Device) | ||||
|---|---|---|---|---|
| -- | -------------------------------------------------------- | -- | -- | -- |
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| Low Profile Gastrostomy Tube Family |
|---|
| ------------------------------------- |
| | PREDICATE DEVICE
(K130674)
Entuit™ Thrive LP Balloon
Retention Gastrostomy
Feeding Tube | PROPOSED DEVICE 1
Entuit® LP Gastrostomy
BR Balloon Retention
Feeding Tube Kit (and
with ENFit® Connection) | PROPOSED DEVICE 2
PromaX™ Low Profile
Gastrostomy Feeding
Tube 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); Legacy
Continuous ES has added
medication 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 OD
polypropylene pinch clamp;
Continuous ES - 5.0 mm OD
polypropylene pinch clamp | Both Bolus and Continuous
ES - print device warning
information on pinch clamp
instead of warning tag;
Continuous ES - 3.0 mm OD
polypropylene pinch clamp
(no change to pinch clamp
for Bolus ES) | Both Bolus and Continuous
ES - print device warning
information on pinch clamp
instead of warning tag:
Continuous ES - 3.0 mm
OD polypropylene pinch
clamp (no change to pinch
clamp for Bolus ES) |
| Warning Tags | Yes - for "Not for IV Use"
warning | No - see pinch clamp
printing above instead | No - see pinch clamp
printing above instead |
| Kit Contents | Inflation syringe, feeding
syringe, gauze, Bolus
Extension Set, Continuous
Extension Set | Same as K130674 | Same as K130674 |
| Packaging
System/ 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 and
Continuous Extension
Sets | Entuit® LP Patient Care
Kit and Entuit® LP Patient
Care Kit with ENFit®
Connection | PromaX™ LP Patient
Care Kit with ENFit® |
| Indications for
Use (applicable to
extension sets) | The EndoVive™ 3s
Extension Set is indicated for
the delivery of nutrition,
hydration and/or medication
into the stomach through a
low profile balloon and also
provides a mechanism for
gastric decompression. | 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 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 |
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Low Profile Gastrostomy Tube Family
| | REFERENCE DEVICE
(K142297) | PROPOSED DEVICE 1 | PROPOSED DEVICE 2 |
|--------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | EndoVive™ 3s Bolus and
Continuous Extension
Sets | Entuit® LP Patient Care
Kit and Entuit® LP Patient
Care Kit with ENFit®
Connection | PromaX™ LP Patient
Care 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 - Nylon
ENFit | (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)