(29 days)
Not Found
No
The device description focuses on the physical components and mechanical function of feeding tubes. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
A therapeutic device is one that treats or manages a disease or condition. This device is used for enteral feeding, medication administration, or gastric decompression, which are all forms of therapy or management for patients requiring nutritional support or gastric access.
No
The device is a gastrostomy feeding tube intended for enteral feeding, medication administration, and gastric decompression, not for diagnosing medical conditions.
No
The device description clearly details physical components such as tubes, funnels, balloons, and connectors, indicating it is a hardware medical device.
Based on the provided text, 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 description clearly states that these devices are Gastrostomy Feeding Tubes. Their function is to provide a pathway for enteral feeding, medication administration, and gastric decompression directly into the stomach through an established stoma.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's health status. Its purpose is purely for delivering substances or removing contents from the stomach.
The text focuses on the physical characteristics, intended use for feeding and medication delivery, and placement of the tubes, which are all consistent with a non-IVD medical device.
N/A
Intended Use / Indications for Use
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector: The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.
Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection: The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract. The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection 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.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel Gastrostomy Feeding Tube with ENFit® connector: The Gastrostomy Feeding Tube (G-tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-tubes is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions.
Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection: The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal stoma tract (for placement and access to stomach lumen)
Indicated Patient Age Range
Adult populations (for Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes)
Adult and pediatric patients (for Entuit® Gastrostomy BR Balloon Retention Feeding Tube)
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)
Not Found
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
§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2017
Xeridiem Medical Devices Steve Murrav Regulatory Affairs Specialist 4700 S. Overland Dr. Tucson, Arizona 85714
Re: K171347
Trade/Device Name: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: May 5, 2017 Received: May 8, 2017
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. 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -S
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
4.0 Indications for Use Statement
Bi-Funnel/Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector 4.1
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K171347 |
|---|---|
| Device Name | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector |
Indications for Use (Describe)
The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric 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."
FORM FDA 3881 (8/14)
ﻟﻠﻘﻀ
3
Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® 4.2 Connection
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | |
| 510(k) Number (if known) | K171347 |
| Device Name | Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection |
| Indications for Use (Describe) | The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract. |
| The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection 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. | |
| 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 (8/14) Page 1 of 1
(End of Section)
4
Image /page/4/Picture/3 description: The image shows the logo for Xeridiem Medical Devices. The logo consists of a circular graphic with four arrows pointing in a clockwise direction, each in a different color: green, blue, red, and purple. To the right of the graphic is the company name "xeridiem" in a bold, sans-serif font, with the words "MEDICAL DEVICES" in a smaller, lighter font underneath.
5.0 510(k) SUMMARY
5.1 General Information
| Date Prepared: | May 4, 2017 |
|---|---|
| 510(k) Submitter: | Xeridiem Medical Devices |
| 4700 S. Overland Dr. | |
| Tucson, AZ 85714 |
| Contact Person: | Steve Murray, Regulatory Affairs Specialist |
|---|---|
| (520) 882-77694 ext. 178 | |
| smurray@xeridiem.com |
5.2 Device Information
5.2.1 Bundled Device 1
| Trade Name: | Bi-Funnel Gastrostomy Feeding Tube with ENFit®
connector and Tri-Funnel Gastrostomy Feeding Tube
with ENFit® connector |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Feeding Tube |
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Code PIF) |
| Classification Panel: | Gastroenterology/Urology |
5.2.2 Bundled Device 2
| Trade Name: | Entuit® Gastrostomy BR Balloon Retention Feeding
Tube with ENFit® Connection |
|-----------------------|---------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Feeding Tube |
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Code PIF) |
| Classification Panel: | Gastroenterology/Urology |
5.3 Predicate Device Information (Device Being Modified)
Bundled Device 1 5.3.1
| Trade Name: | Bi-Funnel Gastrostomy Feeding Tube and
Tri-Funnel Gastrostomy Feeding Tube |
|--------------|-------------------------------------------------------------------------------|
| Common Name: | Balloon Gastrostomy Feeding Tube |
5
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Code PIF) |
|-----------------------|------------------------------------------------------------------------------|
| Classification Panel: | Gastroenterology/Urology |
| 510(k) Number: | K142075/A001 |
5.3.2 Bundled Device 2
| Trade Name: | Entuit™ Thrive Balloon Retention Gastrostomy
Feeding Tube |
|-----------------------|------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Tube |
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Code KNT) |
| Classification Panel: | Gastroenterology/Urology |
| 510(k) Number: | K130611/A001 |
- 5.4 Device Description
Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel 5.4.1 Gastrostomy Feeding Tube with ENFit® connector
The Gastrostomy Feeding Tube (G-tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-tubes is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. The table below summarizes the device offerings for the Bi-Funnel and Tri-Funnel G-Tubes.
| Model
P/N | Device Description | French Size
Offerings
(FR) | Balloon
Recommended
Fill Volume
(mL) | Functional
Length (in) |
|--------------|-----------------------|----------------------------------|-----------------------------------------------|---------------------------|
| 70-0047 | Bi-Funnel Gastrostomy | 12 | 5 | 10 |
| | Feeding Tube | 14 | | |
| | 16 | | | |
| | | 18 | 20 | |
| | 20 | | | |
| | 22 | | | |
| | | 24 | | |
| 70-0048 | Tri-Funnel | 12 | 5 | 10 |
| | Gastrostomy Feeding | 14 | | |
| | Tube | 16 | | |
Table 5.4.1 - Device Offerings for Bi-Funnel/Tri-Funnel G-Tubes
6
| Model
P/N | Device Description | French Size
Offerings
(FR) | Balloon
Recommended
Fill Volume
(mL) | Functional
Length (in) |
|--------------|--------------------|----------------------------------|-----------------------------------------------|---------------------------|
| | | 18 | 20 | |
| | | 20 | | |
| | | 22 | | |
| | | 24 | | |
Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions.
5.4.2 Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection
The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. The table below summarizes the device offerings for the Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection.
7
| Table 5.4.2 - Device Offerings for Entuit® Gastrostomy BR Balloon Retention |
|---|
| Feeding Tube with ENFit® Connection |
| Model P/N | French Size (FR) | Recommended
Balloon Fill
Volume (mL) | Functional Length
(in) |
|-----------|------------------|--------------------------------------------|---------------------------|
| 70-0060 | 12 | 5 - 7 | 10 |
| | 14 | | |
| | 16 | | |
| | 18 | 5 - 10 | |
| | 20 | 20 | |
| | 22 | | |
| | 24 | | |
The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.
5.5 Intended Use/Indications for Use
Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel 5.5.1 Gastrostomy Feeding Tube with ENFit® connector
The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.
5.5.2 Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection
The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract.
The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication
8
K171347 Page 5 of 6
administration or decompression through an established gastrointestinal stoma tract.
5.6 Technological Characteristics - Limited Device Modification
The device modification for both devices bundled in this premarket notification is changing the ENFit connector and cap material from ABS LG HF-380 to Nylon Vydyne 21X1. Otherwise, each device and its predicate is identically the same. There is no other change in technological characteristics and no change in intended use or indications for use. The extent of the material change is summarized in the table below.
| Table 5.6 ENFit Connector Material Change | ||
|---|---|---|
| Device | Material Description | |
| Proposed | Predicate | |
| Bi-Funnel and Tri-Funnel | ||
| Gastrostomy Feeding | ||
| Tubes with ENFit® | ||
| connector | Nylon Vydyne 21X1 | |
| (MEVOPUR Violet | ||
| AB4M665085 colorant) | ABS LG HF-380 | |
| (MEVOPUR Violet | ||
| SB4M664930 colorant) | ||
| Entuit® Gastrostomy BR | ||
| Balloon Retention | ||
| Feeding Tube with | ||
| ENFit® Connection | Nylon Vydyne 21X1 | ABS LG HF-380 |
Table 5.6 - ENFit® Connector Material Change
5.6 Compliance with Design Controls
Substantial equivalence of the proposed devices with the predicate devices are by compliance to the required design control activities for the device modification. These activities are summarized in the table below.
| Table 5.6 – Design Control Activities | ||
|---|---|---|
| Design Control | ||
| Requirement | Design Control Activities | Status |
| Design and | ||
| Development Planning | Design and Development Plan – outline scope of project and | |
| major milestones, including risk management plan and | ||
| analysis | Completed | |
| Design Input | Traceability Matrix update – add new design inputs for ENFit | |
| connector robustness requirement under high torque and | ||
| certain chemical exposure conditions | Completed | |
| Design Output | Traceability Matrix update - specify design outputs for the | |
| added design inputs; update risk analysis (user and design | ||
| FMEAs) appropriately to address the change | Completed | |
| Design Review | Design reviews conducted for key milestones such as design | |
| inputs, design outputs, design verification completion, etc. | Completed | |
| Design Verification | Documented in Verification and Validation Plan, summarized | |
| in Table 12.2 | Completed |
Table 5.6 - Design Control Activities
9
| Design Control
| Requirement | Design Control Activities | Status |
|---|---|---|
| Design Validation | Subject modification does not alter ENFit connector geometry | |
| so there is no effect on validation previously conducted for | ||
| clearances K142075 and K130611 | Completed |
As summarized in the table above, required design controls activities were completed, including passing any required design verification activities.
5.6 Substantial Equivalence Conclusion
Based on successful completion of the required design control activities for the device modification that is the subject of this Special 510(k) premarket notification, it may be concluded that the following modified devices are substantially equivalent to their respective predicate devices:
Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel Gastrostomy Feeding Tube with ENFit® connector
Enuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection
(End of Section)