ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE

K130674 · Xeridiem Medical Devices · KNT · Jan 13, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K130674
• Device Name: ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
• Applicant: Xeridiem Medical Devices
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediatric populations for use in percutaneous placement of an enteral feeding and/or administration of medication in conjunction with an established gastrointestinal stoma tract. The replacement tube may also be used for gastric decompression.

Device Story

Low-profile balloon retention gastrostomy feeding tube; constructed of silicone with radiopaque barium RTV tip. Device inserted through established gastrointestinal stoma tract into stomach lumen; balloon inflated with 5mL sterile/distilled water for securement. Used for enteral feeding, medication administration, or gastric decompression. Operated by healthcare professionals in clinical settings. Accessories include extension sets, inflation/catheter tip syringes, and stoma measuring device. Output is physical delivery of nutrition/medication or decompression of stomach contents. Benefits include secure, low-profile access for long-term enteral support.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2528-06 (Procedures A-G) including flow rate, balloon burst volume, volume maintenance, concentricity, over-shaft size, integrity, and integrity in simulated gastric fluid. Results confirmed candidate device met all requirements and performed equivalent to or better than the predicate device.

Technological Characteristics

Silicone construction (65 durometer shaft); radiopaque barium sulfate tip. Balloon retention mechanism; 5cc inflation volume. Low-profile hub with thermoplastic/silicone feeding and inflation valves. Dimensions: 12-24 FR, 0.8-5.0 cm length. Non-powered, mechanical device. Sterilization method not specified. Complies with ASTM F2528-06.

Indications for Use

Indicated for adult and pediatric patients requiring percutaneous enteral feeding, medication administration, or gastric decompression via an established gastrointestinal stoma tract.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• EndoVive™ Low Profile Replacement Gastrostomy Tube (K083685)

Submission Summary (Full Text)

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JAN 13 2014

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# 510(k) Summary

As required by 21 CFR 807.92, this "510(k) Summary" provides a basis for the substantial equivalence determination of the device listed below.

## General Information

| Date Prepared: | February 26, 2013 |
|--------------------|---------------------------------------------|
| Submitter Name: | Xeridiem Medical Devices |
| | [formerly Manufacturing and Research, Inc.] |
| Submitter Address: | 4700 S. Overland Dr. |
| | Tucson, Az 85714 |
| Contact Person: | Michelle Lott, RAC |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information

| Trade Name: | Entuit™ Thrive LP Balloon Retention Gastrostomy Feeding Tube |
|-----------------------|-------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Tube Kit (low profile) |
| Classification Name: | Tubes, gastrointestinal (and accessories) [21 CFR 876.5980, Product Code KNT] |
| Classification Panel: | Gastroenterology/Urology |

#### Predicate Device Information

| Trade Name: | EndoVive™ Low Profile Replacement Gastrostomy Tube (K083685) |
|-----------------------|----------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Tube Kit (low profile) |
| Classification Name: | Tubes, gastrointestinal (and accessories)<br>[21 CFR 876.5980, Product Code KNT] |
| Classification Panel: | Gastroenterology/Urology |

#### Device Description

The Entuit™ Thrive I.P Balloon Retention Gastrostomy Feeding Tube is constructed primarily of silicone. The low profile device consists of a hub which is overmolded onto a previously extruded bilumen shaft. At the proximal end, a silicone balloon is bonded to the shaft using a 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 with 5mL sterile or distilled water to secure the device in place. Accessories for the Low Profile device include two extension set configurations, an inflation syringe, a catheter tip syringe, gauzes and a stoma measuring device to facilitate device placement and use.

============================================================================================================================================================================== Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube Xeridiem Special 510(k) Application Appendix B Page 1 of 3

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# Intended Use/Indications for Use

Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediatric populations for use in percutaneous placement of an enteral feeding and/or administration of medication in conjunction with an established gastrointestinal stoma tract. The replacement tube may also be used for gastric decompression.

### Technological Characteristics

The table below provides a general summary of the technological characteristics of the Entui™ Thrive LP Balloon Retention Gastrostomy Feeding Tube compared to the predicate device.

| Technological Characteristics | | |
|---------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | EntuitTM Thrive LP Balloon<br>Retention Gastrostomy Feeding<br>Tube (Submitted device) | EndoViveTM Low Profile<br>Replacement Gastrostomy Tube<br>(Predicate Device)<br>K083685 |
| Product Range<br>(FR size) | 12 - 24 FR | 12 - 28 FR |
| Product Range<br>(Length) | 0.8 - 5.0 cm | 1.0 - 5.5 cm |
| Product Range<br>(Balloon Size) | 5 cc for all FR sizes | 4 cc for 12 FR device<br>6 cc for 14 - 28 FR devices |
| Hub | Same as K083685 | Silicone with 2 ports: one for<br>feeding and the other for balloon<br>inflation |
| Inflation valve | Same as K083685 | Thermoplastic housing with<br>silicone valve |
| Balloon | Same materials as K083685,<br>different balloon profile | Silicone balloon |
| Reflux (feeding)<br>valve | Thermoplastic housing with<br>silicone valve - different profile as<br>K083685 | Thermoplastic housing with<br>silicone valve |
| Shaft | Silicone 65 duro | Silicone 60 duro |
| Barium stripe | Barium sulfate | Barium sulfate with blue colorant |
| Kit Contents | Inflation syringe, feeding syringe,<br>gauze, Bolus Extension Set,<br>Continuous Extension Set | Inflation syringe, feeding syringe,<br>gauze, lubricating jelly, Bolus<br>Feeding Set, Continuous Feeding<br>Set |
| Packaging<br>System/Materials | Same as K083685 | Tyvek Pouch, Polybag, IFU,<br>Corrugate Case & Shipper |

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## Performance Characteristics

The table below provides a general summary of the performance testing that was conducted for the Entuit™ Thrive LP Balloon Retention Gastrostomy Feeding Tube.

## Test Method Conclusion

| Test | Method | Conclusion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -Flow rate<br>-Balloon Burst Volume<br>-Balloon Volume Maintenance<br>-Balloon Concentricity<br>-Balloon Over Shaft Size<br>-Balloon Integrity<br>-Balloon Integrity in simulated gastric fluid | All in accordance to ASTM<br>F2528-06<br>(Procedures A through G) | Candidate device met all<br>performance requirements.<br>Where acceptance criteria<br>were not defined in the<br>standard, the candidate device<br>performed equivalent to or<br>better than the predicate<br>device. |

In all instances the Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube performed as intended.

# Substantial Equivalence – Comparison to Predicate Device

Among the information and summary tables presented in the 510(k) submission to support substantial equivalence of the Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube to the legally marketed predicate device are: 1.) device description, 2.) indications for use, 3.) device compaging tables, 4.) material information, 5.) bench test results, and 6.) labeling. In particular, bench testing democrates that there was no difference in the performance, safety, or effectiveness between the Entuisitation Balloon Retention Gastrostomy Feeding Tube and the Endo Vive™ Low Profile Replacement Gastrostomy Tube.

The Entuit ™ Thrive LP Balloon Retention Gastrostomy Feeding Tube is substantially equivalent to the EndoVive™ Low Profile Replacement Gastrostomy Tube (K083685)

The subject device and predicate device have the same intended use and similar indications, technological characteristics and principles of operation. The minor differences in technological characteritics have been identified and do not present any new issues of safety or effectiveness. Thus, the ve LP Balloon Retention Gastrostomy Feeding Tube is substantially equivalent to the EndoVive™ Low Profile Replacement Gastrostomy Tube (K083685).

Entuit "M Thrive LP Balloon Retention Gastrostomy Feeding Tube Xeridiem Special 510(k) Application Appendix B Page 3 of 3

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2014

Xeridiem Medical Devices Michelle Lott RA/QA Director, RAC 4700 South Overland Drive Tucson, AZ 85714

K130674 Re:

> Trade/Device Name: Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: December 3, 2013 Received: December 6, 2013

Dear Michelle Lott,

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.

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.

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Page 2 - Michelle Lott

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/4/Picture/7 description: The image shows the name "Benjamin Fisher-S" in a bold, sans-serif font. The letters are black against a white background. The letters "FDA" are in the middle of the name, with a logo around them.

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

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# Indications for Use

510(k) Number (if known): K130674

Device Name: Entuit ™ Thrive Balloon Retention Gastrostomy Feeding Tube

Indications For Use:

The Entuit The Thrive Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding tube for feeding tube feeding and/or administration of medication in conjunction with an established GI stoma to act The replacement tube may also be used for gastric decompression.

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S
2014.01.13 15:29:18 -05'00'

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