ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285

K083685 · Mri Manufacturing and Research, Inc. · KNT · Jun 25, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083685
• Device Name: ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
• Applicant: Mri Manufacturing and Research, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.

Device Story

EndoVive™ Low Profile Replacement Gastrostomy Tube is a silicone-based catheter for enteral feeding, medication delivery, or gastric decompression. Device features a tri-port funnel overmolded onto a bi-lumen shaft, with a bonded silicone balloon at the proximal end and a sliding retention bolster. In clinical use, the balloon is inserted into an established stoma tract, inflated with 3 mL saline, and the bolster is adjusted against the skin to secure the tube. Available in straight and right-angle bolster configurations. Used in clinical settings by healthcare providers to maintain access to the GI tract for patients requiring nutritional support or decompression.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Constructed primarily of silicone. Features a tri-port funnel, bi-lumen shaft, and retention bolster. Shaft contains radiopaque barium RTV. Balloon bonded with silicone RTV. Mechanical device; no energy source or software.

Indications for Use

Indicated for adult and pediatric patients requiring percutaneous enteral feeding, medication administration, or gastric decompression via an established GI 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

• Microvasive Balloon Gastrostomy Tube Kit (K962375)
• EndoVive™ Low Profile Button Replacement Gastrostomy Tube (K014297)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary of Safety and Effectiveness

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: | Manufacturing and Research, Inc. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Submitter Address : | 4700 S. Overland Dr., Tucson, AZ 85714 |
| Contact Person: | Suzanne Dew |
| Phone Number: | 520-882-7794 x109 |
| Fax Number: | 520-882-6849 |
| Date Prepared: | November, 2008 |
| Device Trade Name: | EndoVive™ Low Profile Replacement GastrostomyTube |
| Device Common Name: | Tube, Gastro-enterostomy |
| Classification Name: | Tube, Gastro-enterostomy, product code KNT |
| Predicate device: | Microvasive Balloon Gastrostomy Tube Kit, K962375<br>EndoVive™ Low Profile Button Replacement Gastrostomy Tube,<br>K014297 |
| Reason for submission: | Not previously marketed in the USA |

#### Device Description and Materials:

The EndoVive™ Low Profile Replacement GastrostomyTube 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 a silicone RTV. The shaft is filled with a radiopague barium 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

#### Intended Use:

The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.

#### Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):

The EndoVive™ Low Profile 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™ Low Profile 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™ Low Profile Replacement Gastrostomy Tube and the specified predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 25 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MRI Manufacturing and Research, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

Re: K083685

Trade/Device Name: EndoVive Low Profile Replacement Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 8, 2009 Received: June 10, 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 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 (reporting of medical

{2}------------------------------------------------

Page 2

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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

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

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number:

Device Name: EndoVive™ Low Profile Replacement Gastrostomy Tube

### Indications For Use:

The EndoVive™ Low Profile 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. The replacement tube may also be used for decompression.

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)

Tsai Mhong

(Division Sign-Off) (Division Sign-Off) ()
Division of Reproductive, Abdominal and Radiological Devices K083685 510(k) Number --

Page 1 of ...

A-2