(299 days)
Not Found
No
The device description and intended use focus on the mechanical and material properties of a gastrostomy tube and its accessories. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is described as a "low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression." Delivering nutrition and medication, and performing gastric decompression are all therapeutic functions.
No
The described devices, including the gastrostomy tubes, extension sets, and stoma measuring device, are all involved in the delivery of nutrition/medication or the measurement for tube placement, rather than the diagnosis of a medical condition.
No
The device description clearly details physical components made of polyurethane, such as the feeding tube, catheter, and balloon, and mentions accessories like extension sets and a measuring device, all of which are hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used for delivering nutrition, medication, and for gastric decompression directly into the stomach through a stoma. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a physical tube and accessories designed for insertion into the body to facilitate feeding and decompression. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
The device is a medical device used for patient care and management, specifically related to enteral feeding and gastric decompression.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach, stoma
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 Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tubes and Accessories have been tested for conformance to the applicable sections of the following standards.
- ISO 10993-1: 2009 Biological Evaluation of Medical t 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
All results of testing met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K122653 Page 1 of 4
JUN 2 6 2013
Section 3 - 510K Summary
Date Summary was June 04, 2012 Prepared:
510(k) Submitter: David M. Lee, JD Associate Director, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.7167 FAX: 920.225.4784 Email: David.Lee@kcc.com
this 510(k) Submission:
Primary Contact for David Lee Associate Director of Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.7167 FAX: 920.225.4784 Email: David.Lee@kcc.com Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube Device Trade Name: and Accessories Device Common Gastrointestinal FeedingTubes names: Device Product KNT Class II Codes and 21 CFR 876.5980 Classification Names: Gastrointestinal tube and accessories Predicate Devices: The Kimberly-Clark* MIC-KEY Low Profile Gastrostomy Tube and accessories cleared under K043114 and K993138. Device Description: Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression for single patient use. Intended Use: 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
Section 3 - 510K Summary
Page 1
:
1
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.
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.
Section 3 - 510K Summary
Technological
Characteristics:
2
Summary of Testing:
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 Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tubes and Accessories have been tested for conformance to the applicable sections of the following standards.
- ISO 10993-1: 2009 Biological Evaluation of Medical t 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
All results of testing met acceptance criteria.
Conclusion:
Based upon the results of the performance testing conducted, the Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are substantially equivalent to the predicate devices cleared under K043114 and K993138 in intended use,
Section 3 - 510K Summary
3
.
design, biocompatibility, performance, and principles of operation.
、
.
:
Section 3 – 510K Summary
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2013
Kimberly-Clark Corporation % Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
K122653 Re:
Trade/Device Name: Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 11, 2013 Received: June 12, 2013
Dear Mr. Devine
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. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
5
Page 2 - Mr. Ned Devine
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 of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Section 2 - Indications for Use
510(k) Number (if known): __K.122653
Device Name: Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories
Indications for Use:
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.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
Section 2 - Indications for Use
Page 6 of 127