(299 days)
The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.
Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.
Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.
Kimberly-Clark* MIC-KEY* SF Patient Starter Kit is indicated to provide necessary components to begin enteral feeding after placement of the Kimberly-Clark* MIC-KEY* SF Gastrostomy Tube.
Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression for single patient use.
The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube external feeding head, feeding catheter, and disc-shaped retention balloon are manufactured with polyurethane. The feeding catheter is inserted into the stomach through a secured or formed stoma and is held in place with a retention balloon that is filled with sterile or distilled water. The device is provided with feeding catheter outer diameters that range from 10Fr to 24Fr, and with feeding tube lengths that range from 0.8cm to 6.0cm to fit different stoma diameters and lengths, respectively. The device incorporates a balloon fill indicator to alert the user when the balloon is not optimally inflated and incorporates an extension set connector that snaps with an audible double click that helps confirm that the connection of the extension set is secure. In addition, the feeding port includes a one-way dome valve that does not require a closure cap/strap.
The Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set and Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set engage to the feeding port using a snap-in connector and are made from DEHP-free materials. The feed valve and extension set ports have been designed to help prevent misconnections with Luer style connectors in alignment with ISO 80369-1 requirements.
The Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device consists of a head, catheter, retention balloon, that are composed of polvurethane.
The provided text describes a 510(k) summary for the Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories. It outlines the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "All results of testing met acceptance criteria." However, it does not explicitly list the specific acceptance criteria for each test performed. It only lists the standards to which the device was tested.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not explicitly stated for each test, but generally: Conformance to applicable sections of listed standards. | All results of testing met acceptance criteria. |
The following standards were used for testing:
- ISO 10993-1: 2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-3: 2009 Biological Evaluation of Medical Devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6: 2007 Biological Evaluation of Medical Devices-Part 6: Test for Local Effects After Implantation
- ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and delayed-type Hypersensitivity
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- ISO 10993-12: 2007 Biological Evaluation of Medical Devices-Part 12: Sample Preparation and Reference Materials
- ANSI/AAMI/ISO 11607-1 (2006) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11135-7: 2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
- ASTM F640-07 - Standard Test Methods for Determining Radiopacity for Medical Use
Missing Information:
The provided text does not contain any of the following information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document only states "Summary of Testing" and lists standards without detailing specific test methodologies, sample sizes, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device for feeding tubes, not an AI or diagnostic imaging device requiring expert ground truth for interpretation. The testing focuses on biological safety and performance against established engineering standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described (biocompatibility, sterilization, physical performance).
- 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: Not applicable, as this is a medical device (gastrostomy tube), not an AI or diagnostic imaging system.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is based on conformance to the established national and international standards listed, which often involve specific physical, chemical, and biological tests with predefined pass/fail criteria.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
In summary: The document confirms that the Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories underwent a series of tests to ensure compliance with relevant medical device standards (primarily ISO and AAMI/ANSI). All tests met acceptance criteria, concluding that the device is substantially equivalent to its predicate devices in terms of design, biocompatibility, performance, and principles of operation. However, the specific details of the acceptance criteria for each test and the methodologies (like sample size) are not elaborated in this 510(k) summary. The nature of the device (a physical medical implant/accessory) means that many of the AI/diagnostic-specific questions are not relevant.
§ 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.