(306 days)
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.
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.
This document describes the 510(k) submission for the Entuit™ Thrive LP Balloon Retention Gastrostomy Feeding Tube, comparing it to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to a single performance test with multiple sub-components. The acceptance criteria were primarily based on a standard, and where not explicitly defined, the device's performance was compared to the predicate device.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow rate | In accordance to ASTM F2528-06 (Procedure A) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Burst Volume | In accordance to ASTM F2528-06 (Procedure B) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Volume Maintenance | In accordance to ASTM F2528-06 (Procedure C) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Concentricity | In accordance to ASTM F2528-06 (Procedure D) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Over Shaft Size | In accordance to ASTM F2528-06 (Procedure E) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Integrity | In accordance to ASTM F2528-06 (Procedure F) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Integrity in simulated gastric fluid | In accordance to ASTM F2528-06 (Procedure G) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Overall Conclusion | Device performs as intended. | Candidate device met all performance requirements. Where acceptance criteria were not defined in the standard, the candidate device performed equivalent to or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the test set used for performance testing (e.g., number of devices tested for each parameter). The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective, but it is clear that these were bench tests conducted in a laboratory setting as part of the 510(k) submission, not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The performance testing described is bench testing against an ASTM standard and comparison to a predicate device, not clinical evaluation requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
Not applicable. This is a medical device (gastrostomy feeding tube), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. As noted above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for the performance testing was adherence to the specified ASTM F2528-06 standard and comparative performance against a legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering and design of a gastrostomy tube.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as above).
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Image /page/0/Picture/1 description: The image shows the word "xeridiem" in a bold, serif font. To the left of the word is a circular logo with four curved shapes pointing inward. A small registered trademark symbol is located to the right of the word.
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: | (520) 882-7794 |
| Fax Number: | (520) 882-6894 |
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)[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 BalloonRetention Gastrostomy FeedingTube (Submitted device) | EndoViveTM Low ProfileReplacement Gastrostomy Tube(Predicate Device)K083685 | |
| Product Range(FR size) | 12 - 24 FR | 12 - 28 FR |
| Product Range(Length) | 0.8 - 5.0 cm | 1.0 - 5.5 cm |
| Product Range(Balloon Size) | 5 cc for all FR sizes | 4 cc for 12 FR device6 cc for 14 - 28 FR devices |
| Hub | Same as K083685 | Silicone with 2 ports: one forfeeding and the other for ballooninflation |
| Inflation valve | Same as K083685 | Thermoplastic housing withsilicone valve |
| Balloon | Same materials as K083685,different balloon profile | Silicone balloon |
| Reflux (feeding)valve | Thermoplastic housing withsilicone valve - different profile asK083685 | Thermoplastic housing withsilicone valve |
| Shaft | Silicone 65 duro | Silicone 60 duro |
| Barium stripe | Barium sulfate | Barium sulfate with blue colorant |
| Kit Contents | Inflation syringe, feeding syringe,gauze, Bolus Extension Set,Continuous Extension Set | Inflation syringe, feeding syringe,gauze, lubricating jelly, BolusFeeding Set, Continuous FeedingSet |
| PackagingSystem/Materials | Same as K083685 | Tyvek Pouch, Polybag, IFU,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-Balloon Burst Volume-Balloon Volume Maintenance-Balloon Concentricity-Balloon Over Shaft Size-Balloon Integrity-Balloon Integrity in simulated gastric fluid | All in accordance to ASTMF2528-06(Procedures A through G) | Candidate device met allperformance requirements.Where acceptance criteriawere not defined in thestandard, the candidate deviceperformed equivalent to orbetter than the predicatedevice. |
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 (800) 638-2041 or (301) 796-7100 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'
Page 1 of
§ 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.