The EndoVive™ Standard Replacement Gastrostomy 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. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression. Note: Only the 20F tube is indicated for jejunal replacement.

Device Description

The EndoVive™ Standard Replacement GastrostomyTube is constructed primarily of silcone. 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 a silicone RTV. The shaft is filled with a radiopague banum RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle

AI/ML Overview

The provided text describes a 510(k) summary for the "EndoVive™ Standard Replacement Gastrostomy Tube." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

The submission relies on bench test results to demonstrate that "there was no difference in the performance, safety, or effectiveness between the EndoVive™ Standard Replacement Gastrostomy Tube and the specified predicate devices." This is a common approach for devices seeking 510(k) clearance where the new device is technologically similar to previously cleared devices.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and expert involvement are not explicitly stated or applicable in the context of this 510(k) submission as it's presented.

Here's a breakdown based on the provided information, noting where details are not available:

1. Table of Acceptance Criteria and Reported Device Performance

As the submission relies on bench testing for substantial equivalence, specific numerical "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy are not provided. The acceptance criterion is implied as "no difference in performance, safety, or effectiveness" compared to predicate devices based on bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
No difference in performance compared to predicate devices	Bench tests demonstrated no difference in performance.
No difference in safety compared to predicate devices	Bench tests demonstrated no difference in safety.
No difference in effectiveness compared to predicate devices	Bench tests demonstrated no difference in effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The submission refers to "bench test results," which typically involve a limited number of device samples rather than human subjects.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Bench testing is conducted in a laboratory setting, not typically patient-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" would be engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human expert disagreements in image interpretation or clinical diagnosis. This submission describes bench testing of a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

MRMC Study: No, an MRMC study was not done.
Effect Size of AI Assistance: Not applicable. This device is a gastrostomy tube, not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "bench test results," the ground truth would be established engineering specifications, material properties, and the known performance characteristics of the legally marketed predicate devices (Microvasive Balloon Gastrostomy Tube Kit, K962375, and EndoVive™ Low Profile Button Replacement Gastrostomy Tube, K014297).

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission describes a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As described above, the concept of a training set and its ground truth is not relevant to this device's premarket submission.

Summary

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K083684
Page 1 of 1

510(k) Summary of Safety and Effectiveness

B - 5 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter Name:
Submitter Address :
Contact Person:
Phone Number:
Fax Number:
Date Prepared:
Device Trade Name:
Device Common Name:
Classification Name:
Predicate device:

Manufacturing and Research, Inc. 4700 S. Overland Dr., Tucson, AZ 85714 Suzanne Dew 520-882-7794 x109 520-882-6849 November, 2008 EndoVive TM Standard Replacement GastrostomyTube Tube, Gastro-enterostomy Tube, Gastro-enterostomy, product code KNT Microvasive Balloon Gastrostomy Tube Kit, K962375 Endo/ive™ Low Profile Button Replacement Gastrostomy Tube, K014297 Not previously marketed in the USA

Reason for submission:

Device Description and Materials:

Intended Use:

The EndoVive™ Standard Replacement Gastrostomy Tube is indicated in adult and pediations for use in perculaneous placement of an Enteral feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression. Note: Only the 20F tube is indicated for jejunal replacement.

Substantial Equivalencel Device - Technological Characteristics and Comparison to Predicate Device(s):

The EndoVive™ Standard Replacement Gastrostomy Tube is substantially equivalent to the Microvasive Balloon Gastrostomy Tube Kit, K962375 and EndoVive™ Low Profile Button Replacement Gastrostomy Tube, K014297

Among the information and data presented in the 510(k) submission to support the substantial equivalency of the EndoVive™ Standard Replacement Gastrostomy Tube to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the EndoVive™ Standard Replacement Gastrostomy Tube and the specified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 an abstract symbol resembling an eagle or bird with three stylized lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2009

MRI Medical, Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1395 25th Street, N.W. BUFFALO MN 55313

K083684 Re:

Trade/Device Name: EndoVive™ Standard Replacement Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 16, 2009 Received: January 21, 2009

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Lamme B. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K083684 510(k) Number:

Device Name: EndoVive™ Standard Replacement Gastrostomy Tube

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulstemen

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

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