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 may include:

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

Device Description

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 mushroom type tips.

Device modification: The modification to this device is a change in balloon material formulation.

The device is packaged sterile and is marketed with a number of accessories; reference page 19 - Kit Certification, "Special" 510(k) Premarket Notification.

AI/ML Overview

The provided text describes a "Special" 510(k) premarket notification for a device modification. The modification is a change in the balloon material formulation of the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit. The submission focuses on demonstrating substantial equivalence to a predicate device, as such it relies on non-clinical data for performance evaluation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria (from predicate device)	Reported Device Performance (Proposed Device)
Material Integrity	Visual/Dimensional Inspection	Identical to predicate device	Passed inspection
Functional Performance	Balloon Burst Strength	Identical to predicate device	Met acceptance criteria
Durability	High Acid Balloon Life Study	Identical to predicate device	Met acceptance criteria

Note: The document explicitly states: "The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device." However, the specific numerical or qualitative criteria for each test are not detailed in the provided text. It only indicates that the proposed device met these unspecified criteria which were identical to the predicate.

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

The document does not specify the sample size used for the non-clinical tests (Visual/Dimensional Inspection, Balloon Burst Strength, High Acid Balloon Life Study). It mentions "the proposed MIC-KEY® 'G'™ Gastrostomy Tube" as the subject of testing, implying that samples of the modified device were used.

The data provenance is retrospective, as it refers to comparing the modified device's performance to an already legally marketed predicate device (MIC-KEY® "G"™ Low Profile Gastrostomy Tube -510(k) K922667/B). The tests were conducted "in vitro".

The country of origin for the data is implicitly the United States, as Ballard Medical Products is located in Draper, UT, and the submission is to the US FDA.

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

This information is not applicable as the study described is a non-clinical, in-vitro performance evaluation of a device modification, not a study involving human subjects or expert assessment of clinical data. The "ground truth" for these engineering tests would be the established specifications and performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

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

This information is not applicable. The device is a medical tube for enteral feeding, not an imaging or diagnostic device that would involve "human readers" or AI assistance in the context of interpretation.

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

This information is not applicable for the reasons stated in point 5.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was the established performance specifications and acceptance criteria of the legally marketed predicate device. The goal was to demonstrate that the modified device performed identically to the predicate device in terms of these engineering benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

This information is not applicable for the reasons stated in point 8.

Summary

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OCT 20 1999

Appendix F Attachment 1.0

"Special" 510(k): Device Modification Premarket Notification Summary per 807,92(c)

Monday, August 09, 1999

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"™ 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 -Keplacement Ici has been classification name is Tubes, Gastrointestinal (and Accessories) - Product Code 78KNT.
Legally marketed equivalent(s) per 807.92(a)(3): MIC-KEY® "G" 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 Replacement in is intended to be ass 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 mushroom type tips.

Device modification: The modification to this device is a change in balloon material formulation.

The device is packaged sterile and is marketed with a number of accessories; reference page 19 - Kit Certification, "Special" 510(k) Premarket Notification.

Intended Use per 807.92(a)(5): 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.
Technological Characteristics (equivalence to predicate devices) per 807.92(a)(6): . Similarly, this device and the predicate devices have commonality in their balloon and tubing material - Silicone. All device kits, market, in their kits: Gauze pads, syringe(s) and feeding sets.

Image /page/0/Picture/15 description: The image shows the logo for Allard Medical Products. The logo consists of the word "ALLARD" in large, bold, sans-serif letters, with a curved shape above the "A". Below "ALLARD" is a thick black line, and below that is the phrase "MEDICAL PRODUCTS" in smaller, sans-serif letters. A small circled R symbol is to the right of the word "PRODUCTS".

(801) 572-6800

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12050 Lone Peak Parkway Draper, Utah 84020 (801) 572-6800 Fax: (801) 572-6999

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.

I. Visual/Dimensional Inspection
1. Balloon Burst Strength
1. High Acid Balloon Life Study

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 Low Profile Gastrostomy Tube has been shown to be safe and effective for its intended use and equivalent to its predicate device, the MICKEY® "G"™ Low Profile Gastrostomy Tube -510(k) K922667/B, in performance.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 1999

Mr. E. Martin Chamberlain VP Regulatory Affairs Ballard Medical Products 12050 Lone Peak Parkway Draper, UT 84020

Re: K993138

MIC-KEY® "G"TM Low Profile Gastrostomy Replacement Kit Dated: September 16, 1999 Received: September 20, 1999 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

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 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

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Page 2 - Mr. E. Martin Chamberlain

diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions diagnotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. on the promotion and actived, "Misbranding by reference to premarket notification"(21 CFR 1100, Please net al information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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

EDICAL PRODU 12050 Lone Peak Parkw Draper, Utah 84020 (801) 572-6800 Fax: (801) 572-6999

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): unknown

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.

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
------------------	---------------------------------------	----	----------------------	--

1
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K993138
---------------	---------

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.