(30 days)
K922667/B
Not Found
No
The 510(k) summary describes a physical medical device (a gastrostomy tube) with a material modification. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are in vitro tests of the device's physical properties.
Yes
Explanation: The device is a Gastrostomy tube used for long-term enteral support, including feeding, hydrating, medication delivery and decompressing, which are therapeutic interventions.
No
This device is a replacement gastrostomy tube used for enteral support (feeding, hydrating, medication delivery, decompressing). It is a therapeutic/supportive device, not one that identifies, diagnoses, or predicts a medical condition. Its purpose is to deliver substances or decompress the gastric tract, not to analyze or interpret physiological data for diagnostic purposes.
No
The device description clearly states it is a physical gastrostomy tube with a balloon, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement gastrostomy tube used for enteral support (feeding, hydrating, medication delivery, decompressing) directly into the gastric tract. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of the tube for insertion and secure placement within the gastric tract. It does not describe any components or processes for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis of samples," "in vitro," or "laboratory testing."
- Performance Studies: The performance studies described are related to the physical integrity and function of the tube (burst strength, balloon life), not to the accuracy or reliability of a diagnostic test.
In summary, the MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is a medical device used for delivering substances directly into the stomach, which is a therapeutic and supportive function, not a diagnostic one performed in vitro.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
78KNT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following in vitro tests were performed on the proposed MIC-KEY® "G"™ Gastrostomy Tube:
- I. Visual/Dimensional Inspection
-
- Balloon Burst Strength
-
- High Acid Balloon Life Study
Note: The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K922667/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
2
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
-
- Balloon Burst Strength
-
- 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.
2
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
4
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.
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.
(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 |
|---|---|
| --------------- | --------- |