(26 days)
Not Found
No
The device description and performance studies focus on mechanical components and their function, with no mention of AI or ML.
No.
The device is an introducer kit designed to facilitate the placement of feeding tubes, not to treat a condition itself.
No
The device is an introducer kit intended to facilitate the primary placement of gastrostomy and jejunal feeding tubes, which is a procedural/interventional use, not diagnostic.
No
The device description explicitly lists multiple physical components (Gastropexy, Dilator, Syringe, etc.) that are part of the kit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes." This describes a surgical or procedural device used to insert a feeding tube into the body.
- Device Description: The components listed (Gastropexy, Dilator, Syringe, Hemostat, Introducer Needle, Seeking Catheter, Scalpel, Guidewire, Stoma Measuring Device) are all instruments used in a medical procedure for placement, not for analyzing biological samples.
- Anatomical Site: The anatomical sites mentioned are the "Gastric wall, anterior abdominal wall," which are locations within the body where the procedure is performed.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not perform any such examination of specimens.
The device is clearly intended for a medical procedure involving the insertion of a feeding tube, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
| Kit Configuration | Indications for Use Statement |
|---|---|
| For the Kimberly-Clark* MIC*G Introducer Kit | The Kimberly-Clark* MIC* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes. |
| For the Kimberly-Clark* MIC-KEY*G Introducer Kit | The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding Tubes. |
| For the Kimberly-Clark* MIC*J-TJ Introducer Kit | The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC* Jejunal Feeding Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal Feeding Tube. |
| For the Kimberly-Clark* MIC-KEY*J-TJ Introducer Kit | The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark* MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC-KEY* Low-Profile Jejunal Feeding Tube and the Kimberly-Clark* MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. |
Product codes (comma separated list FDA assigned to the subject device)
KNT, KGC
Device Description
The Introducer Kits consists of a group of essential components required to facilitate placement of a balloon-retained enteral feeding tube. The kit contains these essential components in an easy to use tray and is configured for use in an interventional radiology and /or endoscopy suite.
This device consists of the following components and accessories:
-
- Gastropexy
-
- Dilator with Peel-away sheath
-
- Syringe
-
- Hemostat
-
- Introducer Needle
-
- Seeking Catheter
-
- Scalpel
-
- Guidewire
-
- Stoma Measuring Device
The device consists of the following main components and accessories: list components and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interventional radiology and /or endoscopy suite
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)
All components that come in direct contact with the patient have a history of use in medical devices and are biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans.
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
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Kimberly-Clark*
1400 Holcomb Bridge Road
Roswell, GA 30076 | FEB 26 2008 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|
| OFFICIAL
CORRESPONDENT | Sherry Saurini
Associate Director, Regulatory Affairs
Tel: 770.587.8502
Fax: 920.969.3455
email: sherry.saurini@kcc.com | |
| TRADE NAME: | KIMBERLY-CLARK* Introducer Kits | |
| CLASSIFICATION
NAME: | Gastrointestinal tube and accessories | |
| DEVICE
CLASSIFICATION
AND PRODUCT
CODE | Class II per 21 CFR §876.5980
Product Code - KNT | |
SUBSTANTIAL EQUIVALENCE:
The new Kimberly-Clark* Introducer Kits are substantially equivalent to the MIC* Gastrostomy Tube Percutaneous Insertion Kit cleared under K852363, the MIC* Gastro-Enterostomy Tube Modification cleared under K921370 and the MIC* Transgastric Jejunal Tube Kit cleared under K926581. Both the Kimberly-Clark* Introducer Kits and the predicate kit have the same intended use and basic scientific technology.
Both kits have the same intended use, and utilize the same scientific principles, dilation and attachment of the gastric wall to the anterior abdominal wall. Bench testing has demonstrated that the new Kimberly-Clark* Introducer Kits performs the same function as the predicate kits, and that any minor differences between the modified device and the predicate device do not affect safety or efficacy.
1
Image /page/1/Picture/0 description: The image shows the text "K080253" in a bold, sans-serif font. The characters are large and take up most of the frame. The text appears to be a code or identifier, with a mix of letters and numbers.
SUMMARY OF SAFETY & EFFECTIVE
DESCRIPTION OF THE DEVICE:
The Introducer Kits consists of a group of essential components required to facilitate placement of a balloon-retained enteral feeding tube. The kit contains these essential components in an easy to use tray and is configured for use in an interventional radiology and /or endoscopy suite.
This device consists of the following components and accessories:
-
- Gastropexy
-
- Dilator with Peel-away sheath
-
- Syringe
-
- Hemostat
-
- Introducer Needle
-
- Seeking Catheter
-
- Scalpel
-
- Guidewire
-
- Stoma Measuring Device
The device consists of the following main components and accessories: list components and accessories.
2
Image /page/2/Picture/0 description: The image shows a sequence of alphanumeric characters, seemingly handwritten. The sequence starts with the letter 'K', followed by the number '0', then '80253'. The characters are bold and dark, contrasting with the background.
SUMMARY OF SAFETY & EFFECTIVENESS
INDICATIONS FOR USE:
| Kit Configuration | Indications for Use Statement |
|---|---|
| For the Kimberly- | |
| Clark* MIC*G | |
| Introducer Kit | The Kimberly-Clark* MIC* G Introducer Kits are intended to |
| facilitate primary placement of Kimberly-Clark* and Kimberly- | |
| Clark* MIC* brand of Gastrostomy Feeding Tubes. | |
| For the Kimberly- | |
| Clark* MIC-KEY*G | |
| Introducer Kit | The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended |
| to facilitate primary placement of Kimberly-Clark* and | |
| Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding | |
| Tubes. | |
| For the Kimberly- | |
| Clark* MIC*J-TJ | |
| Introducer Kit | The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC* |
| Transgastric-Jejunal Introducer Kit is intended to facilitate | |
| primary placement of Kimberly-Clark* MIC* Jejunal Feeding | |
| Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal | |
| Feeding Tube. | |
| For the Kimberly- | |
| Clark* MIC-KEY*J- | |
| TJ Introducer Kit | The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark* |
| MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to | |
| facilitate primary placement of Kimberly-Clark* MIC-KEY* | |
| Low-Profile Jejunal Feeding Tube and the Kimberly-Clark* | |
| MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. |
PERFORMANCE DATA:
All components that come in direct contact with the patient have a history of use in medical devices and are biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans. Biocompatibility summaries can be found in Attachment D.
3
Image /page/3/Picture/0 description: The image contains the number 8 followed by a period. The number is written in a bold, sans-serif font. The number is black and is set against a white background. The period is the same color and font as the number.
Summary of Safety & E
CONCLUSION:
Based on the performance testing, it can be concluded that the new Kimberly-Clark* Introducer Kits are equivalent to the predicates MIC* Gastrostomy Tube Percutaneous Insertion Kit (K852363), MIC* Enterostomy Tube Modification (K921370) and MIC* Transgastric Jejunal Tube Kit (K926581) with respect to intended use and technological characteristics.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is a symbol of the United States, and its presence on the seal indicates the department's role in protecting the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2008
Ms. Sherry Saurini Associate Director, Regulatory Affairs Kimberly-Clark* Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076
Re: K080253
Trade/Device Name: Kimberly-Clark* MIC* G, MIC-KEY* G, MIC* Jejunal, MIC* Transgastric-Jejunal, MIC-KEY* Jejunal and MIC-KEY* Transgastric-Jejunal Introducer Kits Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KGC Dated: January 30, 2008 Received: January 31, 2008
Dear Ms. Saurini:
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 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 (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.
5
Page 2 -- Ms. Sherry Saurini
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. B. rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
K080253
1 of 1
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K080253
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
| Kit Configuration | Indications for Use Statement |
|---|---|
| For the Kimberly- | |
| Clark* MIC*G | |
| Introducer Kit | The Kimberly-Clark* MIC* G Introducer Kits are intended to |
| facilitate primary placement of Kimberly-Clark* and Kimberly- | |
| Clark* MIC* brand of Gastrostomy Feeding Tubes. | |
| For the Kimberly- | |
| Clark* MIC-KEY*G | |
| Introducer Kit | The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended |
| to facilitate primary placement of Kimberly-Clark* and | |
| Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding | |
| Tubes. | |
| For the Kimberly- | |
| Clark* MIC*J-TJ | |
| Introducer Kit | The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC* |
| Transgastric-Jejunal Introducer Kit is intended to facilitate | |
| primary placement of Kimberly-Clark* MIC* Jejunal Feeding | |
| Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal | |
| Feeding Tube. | |
| For the Kimberly- | |
| Clark* MIC-KEY*J- | |
| TJ Introducer Kit | The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark* |
| MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to | |
| facilitate primary placement of Kimberly-Clark* MIC-KEY* | |
| Low-Profile Jejunal Feeding Tube and the Kimberly-Clark* | |
| MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. |
Prescription Use × (Part 21 CFR 801 Subpart D) ANDYOR
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)
Nancy C. Brogdon
(Division Sign-t Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number,
Page 1 of ____________________________________________________________________________________________________________________________________________________________________