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.
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.
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.
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.

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:

1. Gastropexy
1. Dilator with Peel-away sheath
1. Syringe
1. Hemostat
1. Introducer Needle
1. Seeking Catheter
1. Scalpel
1. Guidewire
1. Stoma Measuring Device

AI/ML Overview

The provided text describes a 510(k) submission for Kimberly-Clark* Introducer Kits, asserting substantial equivalence to previously cleared devices. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria.

Here's why and what information is available:

No Acceptance Criteria or Device Performance Table: The document explicitly states, "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." It also mentions, "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." However, it does not provide specific numerical acceptance criteria (e.g., a "failure rate of less than X%") or a table comparing the device's measured performance against such criteria.
No Standalone Study details: The document discusses "performance testing" and "bench testing," but it does not describe a formal study with a defined sample size, data provenance, ground truth establishment, or expert involvement as would be required for an AI/device performance study.
No MRMC Comparative Effectiveness Study: The submission is for an introducer kit, which is a physical medical device, not an AI software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and not mentioned.

Information that can be extracted or inferred (though not directly addressing all your questions):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The device performs the same function as the predicate kits, and any minor differences do not affect safety or efficacy. Biocompatibility, sterilization, and functional test results must demonstrate safety and effectiveness.
- Reported Device Performance:
  - "Bench testing has demonstrated that the new Kimberly-Clark* Introducer Kits performs the same function as the predicate kits."
  - "Biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans."
  - (No specific quantitative performance metrics are provided in the summary.)
Sample size used for the test set and the data provenance: Not specified. The document mentions "bench testing" and "performance testing" but does not detail the 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/specified. This type of device relies on engineering and biological testing, not expert interpretation of outputs to establish ground truth in the way AI models do.
Adjudication method for the test set: Not applicable/specified for this type of device testing.
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: No, this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "bench testing" and "functional test results" which are forms of standalone testing for a physical device, but no specific study details are provided.
The type of ground truth used:
- Implied Ground Truth: Engineering specifications, established performance characteristics of predicate devices, and biological safety standards (e.g., for biocompatibility and sterilization).
The sample size for the training set: Not applicable for a physical device.
How the ground truth for the training set was established: Not applicable for a physical device.

In summary, the provided text describes a 510(k) submission for a physical medical device (introducer kits) and focuses on establishing substantial equivalence through bench testing and functional comparisons to predicate devices, rather than a clinical or AI-driven performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be relevant for software or AI medical devices.

Summary

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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 RoadRoswell, GA 30076	FEB 26 2008
OFFICIALCORRESPONDENT	Sherry SauriniAssociate Director, Regulatory AffairsTel: 770.587.8502Fax: 920.969.3455email: sherry.saurini@kcc.com
TRADE NAME:	KIMBERLY-CLARK* Introducer Kits
CLASSIFICATIONNAME:	Gastrointestinal tube and accessories
DEVICECLASSIFICATIONAND PRODUCTCODE	Class II per 21 CFR §876.5980Product 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.

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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:

This device consists of the following components and accessories:

1. Gastropexy
1. Dilator with Peel-away sheath
1. Syringe
1. Hemostat
1. Introducer Needle
1. Seeking Catheter
1. Scalpel
1. Guidewire
1. Stoma Measuring Device

The device consists of the following main components and accessories: list components and accessories.

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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*GIntroducer Kit	The Kimberly-Clark* MIC* G Introducer Kits are intended tofacilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes.
For the Kimberly-Clark* MIC-KEY*GIntroducer Kit	The Kimberly-Clark* MIC-KEY* G Introducer Kits are intendedto facilitate primary placement of Kimberly-Clark* andKimberly-Clark* MIC-KEY* brand of Gastrostomy FeedingTubes.
For the Kimberly-Clark* MIC*J-TJIntroducer Kit	The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MICTransgastric-Jejunal Introducer Kit is intended to facilitateprimary placement of Kimberly-Clark MIC* Jejunal FeedingTube and the Kimberly-Clark* MIC* Transgastric-JejunalFeeding Tube.
For the Kimberly-Clark* MIC-KEY*J-TJ Introducer Kit	The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-ClarkMIC-KEY Transgastric-Jejunal Introducer Kit is intended tofacilitate primary placement of Kimberly-Clark* MIC-KEYLow-Profile Jejunal Feeding Tube and the Kimberly-ClarkMIC-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.

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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.

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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.

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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

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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*GIntroducer Kit	The Kimberly-Clark* MIC* G Introducer Kits are intended tofacilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes.
For the Kimberly-Clark* MIC-KEY*GIntroducer Kit	The Kimberly-Clark* MIC-KEY* G Introducer Kits are intendedto facilitate primary placement of Kimberly-Clark* andKimberly-Clark* MIC-KEY* brand of Gastrostomy FeedingTubes.
For the Kimberly-Clark* MIC*J-TJIntroducer Kit	The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MICTransgastric-Jejunal Introducer Kit is intended to facilitateprimary placement of Kimberly-Clark MIC* Jejunal FeedingTube and the Kimberly-Clark* MIC* Transgastric-JejunalFeeding Tube.
For the Kimberly-Clark* MIC-KEY*J-TJ Introducer Kit	The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-ClarkMIC-KEY Transgastric-Jejunal Introducer Kit is intended tofacilitate primary placement of Kimberly-Clark* MIC-KEYLow-Profile Jejunal Feeding Tube and the Kimberly-ClarkMIC-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 ____________________________________________________________________________________________________________________________________________________________________

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.