The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

Device Description

The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.

AI/ML Overview

This document describes the Cook Incorporated Entuit Start Initial Placement Gastrostomy Set, but it does not contain information about software or AI devices, nor does it conduct a study on device performance against acceptance criteria in the manner you described.

The document is a 510(k) premarket notification for a medical device that assists with the initial placement of feeding tubes. It focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical characteristics and the results of various engineering and biocompatibility tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/software device. The document details the following for a physical medical device:

1. Table of acceptance criteria and reported device performance:
The document lists various mechanical and biocompatibility tests performed. It states that "The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. For example, it lists "Wire Guide Tensile" but does not state the minimum tensile strength required (acceptance criteria) or the measured tensile strength (reported performance).

2. Sample size used for the test set and the data provenance:
This information is not provided. The document generally refers to "applicable testing" but does not detail the methodology, sample sizes, or data provenance for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this is not a study requiring expert-established ground truth. The tests are engineering and biocompatibility tests for a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable.

5. If a multi-reader multicase (MRMC) comparative effectiveness study was done:
No, this type of study was not performed or described. This is a 510(k) submission for a physical device, not an AI or imaging device requiring human reader assessment.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the engineering tests would be the established engineering and safety standards.

8. The sample size for the training set:
Not applicable as there is no training set for an AI/software device.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available information from the document (relevant to a physical device):

The document details the device, its intended use, a comparison to a predicate device, and a list of various physical, mechanical, and biocompatibility tests that were performed. The conclusion states that the device "met the design input requirements."

Specific tests listed:

Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
Wire Guide Tensile
Wire Guide Corrosion
Wire Guide Flex
Wire Guide Fracture
Dilator Shaft Tensile
Dilator Hub-to-Shaft Tensile
Peel-Away Introducer Shaft Tensile
Peel-Away Introducer Knob-to-Shaft Tensile
Peel Force Testing
Radiopacity Testing
Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 14, 2017

Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

K170323 Re:

Trade/Device Name: Entuit Start Initial Placement Gastrostomy Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KGC Dated: August 8, 2017 Received: August 9, 2017

Dear Erum B. Nasir:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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.

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.

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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 (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 Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education (DICE) 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.

Joyce M. Whang-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

Enclosure

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Indications for Use

510(k) Number (if known) K170323

Device Name

Entuit Start Initial Placement Gastrostomy Set

Indications for Use (Describe)

The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

1.0 510(k) SUMMARY

Entuit™ Start Initial Placement Gastrostomy Set As required by 21 CFR §807.92 Date Prepared: September 14, 2017

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact:	Erum B. Nasir
Email:	RegSubmissions@CookMedical.com
Contact Phone Number:	(812) 335-3575 x102607
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Entuit™ Start Initial Placement Gastrostomy Set
Common Name:	Gastrointestinal tube and accessories
Classification Name:	Tube, Gastro-Enterostomy
Regulation:	21 CFR §876.5980
Product Code:	KGC
Device Class:	II
Classification Panel:	Gastroenterology/Urology

Predicate Device:

The Entuit™ Start Initial Placement Gastrostomy Set is substantially equivalent to the Kimberly-Clark Introducer Kits (K080253), cleared by FDA on February 26, 2008.

Device Description:

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Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017

may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.

Intended Use:

The Entuit™ Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

Comparison to Predicate Device:

The Entuit™ Start Initial Placement Gastrostomy Set and the predicate device, the Kimberly-Clark Introducer Kits (K080253), are substantially equivalent in that these devices are similar in intended use and principles of operation. The differences between the subject device and the predicate device, including the materials, dimensions, and components within the sets, do not raise any new issues of safety and effectiveness. The substantial equivalence comparison of the subject device to the predicate device is provided in the table below.

		Kimberly-Clark Introducer Kits(K080253)	Entuit™ Start Initial PlacementGastrostomy Set(Subject of this submission)
	Regulation Number	21 CFR §876.5980	Identical
Product Code		KGC	Identical
Classification		Class II	Identical
	Intended Use	The Kimberly-Clark Introducer Kits areintended to facilitate primary placementof Kimberly-Clark, Kimberly-ClarkMIC and Kimberly-Clark MIC-KEYbrand of gastrostomy feeding tubes.	The Entuit Start Initial PlacementGastrostomy Set is intended to assistthe physician with the initial placementof feeding tubes while performing agastrostomy in adult patients only.
	Material	Unknown	Stainless Steel
WireGuide	Diameter(inch)	0.035	0.038
	Length(cm)	Unknown	100
Dilator	Diameter(Fr)	Not included	12, 14, 16, 18, 20, 22, 24
	Length (cm)	Not included	20
	ShaftMaterial	Not included	Polyethylene (12 Fr Dilator),Polyvinyl chloride (14 - 24 Fr dilators)
	HydrophilicCoating	Unknown	Yes

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		Kimberly-Clark Introducer Kits(K080253)	Entuit™ Start Initial PlacementGastrostomy Set(Subject of this submission)
Peel-AwayIntroducer(SheathandDilator)	Diameter(Fr)	16, 18, 20, 22, 24*	16, 18, 20, 22, 26
	SheathMaterial	NA	Polytetrafluoroethylene (PTFE)
	SheathLength (cm)	N/A	15.5 (for 16 & 18 Fr)13 (for 20 - 24 Fr)
	Dilator ShaftMaterial	Unknown	Polyvinyl chloride
	DilatorLength (cm)	N/A	20
	Compatible Gastrostomytube size (Fr)	12, 14, 16, 18, 20	12, 14, 16, 18, 20, 22, 24
Gastrointestinal AnchorSet		Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners	Not included with set - FDA cleared(K131201and K152524), soldseparately
Accessory components		18 g Safety introducer needleSafety Scalpel No.11 Blade12 ml syringeHemostatStoma Measuring Device	18 g entry access needleSafety Scalpel No.11 Blade6cc syringeGauze**
	Packaging	Unknown	Tray: Polyethylene terephthalatePouch: Polyethylene, TyvekSpiral Holder: Polyethylene
	Sterilization	Ethylene oxide	Identical
	Sterility Assurance Level(SAL)	Unknown	10-6

*Device includes serial dilators with varying size increments.

**Stoma measuring device is cleared under K130674 and is sold separately.

Technological Characteristics:

The subject Entuit™ Start Initial Placement Gastrostomy Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

. Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
Wire Guide Tensile ●
Wire Guide Corrosion
Wire Guide Flex ●
Wire Guide Fracture .
Dilator Shaft Tensile ●
. Dilator Hub-to-Shaft Tensile

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Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017

. Peel-Away Introducer Shaft Tensile
Peel-Away Introducer Knob-to-Shaft Tensile
. Peel Force Testing
Radiopacity Testing
Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for ● cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.

Conclusion:

The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence.

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.