MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT

K982894 · Ballard Medical Products · KNT · Sep 11, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982894
• Device Name: MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
• Applicant: Ballard Medical Products
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIC KEY® "G"TM Low Profile Gastrostomy . Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy and is designed to be a balloon - secured replacement gastrostomy tube.

Device Story

Balloon-secured replacement gastrostomy tube; used for enteral feeding, hydration, medication delivery, or gastric decompression. Features tapered distal tip for insertion through gastric tract; balloon inflated to secure placement. Device length reduced compared to predicate to allow balloon to surround distal tip. Packaged as kit including accessories (gauze, syringe, feeding sets). Used in clinical settings for patients with long-term enteral needs; operated by healthcare professionals. Benefits include reduced trauma during placement compared to skin-level tubes with obturator-placed mushroom tips.

Clinical Evidence

Bench testing only. In vitro testing performed on balloon cuff glue bond, visual/dimensional inspection, and balloon burst strength. Results demonstrated identical performance and acceptance criteria to the predicate device.

Technological Characteristics

Silicone balloon and tubing. Balloon-secured design with tapered distal tip. Kit includes gauze pads, syringe, and feeding sets. Sterile packaging.

Indications for Use

Indicated for patients requiring long-term enteral support (feeding, hydration, medication delivery, decompression) via a gastrostomy in a well-formed gastric tract. Applicable to patients with head/neck conditions including stroke, cancer, tumors, trauma, or neurological disorders causing chewing/swallowing impairment.

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

• MIC-KEY® Low Profile Gastrostomy Kit #K922667/B

Submission Summary (Full Text)

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Appendix F Attachment 1.0

## "Special" 510(k): Device Modification Premarket Notification Summary per 807.92(c)

Wednesday, August 12, 1998

Submitter Information per 807.92(a)(1): E. Martin Chamberlain Ballard Medical Products 12050 Lone Peak Parkway Draper, UT., 84020 Tel. (801) 572 - 6800 Fax. (801 572 - 6869

- Proprietary Name per 807.92(a)(2): MIC-KEY® "G"TM Low Profile Gastrostomy . Replacement Kit
- Common Name per 807.92(a)(2): Enteral Feeding Catheter Kit ●
- Classification per 807.92(a){2); MIC- KEY® "G"™ Low Profile Gastrostomy . Replacement Kit has been classified a Class II device through the Gastrointestinal -Urology Panel per 21 CFR 876.5980. Classification name is Tubes, Gastrointestinal (and Accessories) - Product Code 78KNT.
- Legally marketed equivalent(s) per 807.92(a)(3): MIC-KEY® Low Profile Gastrostomy . Kit #K922667/B.
- Description of the device 807.92(a)(4): The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy, and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with obturator placed mushroom type tips.

The balloon in this device is mounted (distal cuff) to the distal inner lumen of the feeding tube, the proximal cuff is mounted to the outer diameter of the feeding tube. While the balloon length is equivalent to the predicate MIC-KEY, the overall length of the device has been decreased to facilitate the balloon, when inflated, to surround the device distal tip.

The device is packaged sterile and is marketed with a number of accessories; reference Section 11 - Kit Certification, "Special" 510(k) Premarket Notification.

- Intended Use per 807.92(a)(5): The MIC KEY® "G"TM Low Profile Gastrostomy . Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy and is designed to be a balloon - secured replacement gastrostomy tube.
Image /page/0/Picture/14 description: The image shows the logo for Lallard Medical Products. The logo is in black and white and features the company name in a bold, sans-serif font. The words "Medical Products" are written in a smaller font below the company name. There is a line above and below the words "Medical Products".

2050 Lone Peak Pa Draper, Utah 8402 801) 572-6800 AX [phone]

.

SEP 1 1998

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Image /page/1/Picture/2 description: The image shows the logo for Lallard Medical Products. The logo is in black and white and features the word "LALLARD" in large, bold letters. Below the word "LALLARD" is the phrase "Medical Products" in smaller letters. There is a line above and below the text.

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Technological Characteristics (equivalence to predicate devices) per 807.92(a)(6): Similarly, the aforementioned devices have commonality in their balloon and tubing material - Silicone. All three device kits, market, in their kits: Gauze pads, syringe(s) and feeding sets.

Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1): The following in vitro tests were performed on the proposed MIC-KEY® "G"™ Gastrostomy Tube:

Note: The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device.

- 1. Balloon Cuff Glue Bond Inspection
- Visual/Dimensional Inspection 2.
- 3. Balloon Burst Strength
- Conclusions from non-clinical data per 807.92(b)(3): Based on the indications for use, technological characteristics, and performance testing, the MIC-KEY® "G"TM Gastrostomy Tube has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three wavy lines that form a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 1998

Mr. E. Martin Chamberlain V. P., Regulatory Affairs Ballard Medical Products 12050 Lone Peak Parkway Draper, Utah 84020

Re: K982894 Ballard Mic-Kev® "G"™ Low Profile Gastrostomy Replacement Kit Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: August 12, 1998 Received: August 17, 1998

Dear Mr. Chamberlain:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System

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#### Page 2 - Mr. E. Martin Chamberlain

Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

for

Ulind C. Stigum
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix F. Attachment 3.0

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

# Device Name: MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit

Indications for Use: The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable.

Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions include:

Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE

OR OVER-THE-COUNTER USE

Arind C. de yom

Reproductive, Abdominal. 510(k) Number

Image /page/4/Picture/13 description: The image shows the logo for Lallard Medical Products. The logo is in black and white, with the word "LALLARD" in large, bold letters. Below the word "LALLARD" is the phrase "Medical Products" in smaller letters. The logo has a registered trademark symbol.

er. Utah 840 1572-6800 AX [phone]