The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

Device Description

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 introducer needles with pre-loaded suture anchors and a wire guide. A notch is located on the distal tip of the introducer needle. The coil anchor is placed in the notch prior to placement. The proximal end of the suture anchor contains the suture retention mechanism.

The retention mechanism of the Entuit Secure Gastrointestinal Suture Anchor consists of an extension spring which is glued on the proximal end within a suture retention housing. The suture is threaded through the coils of the extension spring. When the suture retention mechanism is pushed towards the anchor, tension is applied to the spring, which causes the coils of the spring to open. This allows the suture to slide through the spring and allows the retention mechanism to slide along the suture. When the retention mechanism is pulled away from the anchor, the coils of the spring compress and clamp down on the suture. This does not allow the suture to slide through the spring and maintains tension on the suture anchor.

The adjustable suture retention mechanism of the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set consists of a suture retention housing, a compression spring, a compression jaw, and a removable adjustable tab. The suture is threaded through the suture retention housing and held in place by the compression jaws and the compression spring. The adjustable tab must be compressed for the suture to be adjusted. When the adjustable tab is compressed, the spring and compression jaws do not contact the suture. This allows the suture retention mechanism to slide along the suture. Once the suture retention mechanism is in place, the compression jaws will maintain tension on the suture anchor, and the adjustable tab can be removed.

Both of the proposed devices are supplied sterile and are intended for one-time use.

AI/ML Overview

The provided text describes a 510(k) summary for the Entuit™ Secure Gastrointestinal Suture Anchor Set and its adjustable counterpart. This summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Based on the document, here's what can be extracted and inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":

The "device" in this context refers to the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the devices met predetermined acceptance criteria for various tests. However, the specific numerical acceptance criteria themselves are not provided, nor are precise quantitative performance results. Instead, it offers qualitative statements about meeting these criteria.

Acceptance Criterion	Reported Device Performance
Tensile Testing	Device met all predetermined acceptance criteria. Testing shows that the tensile strength during proper clinical use should be capable of maintaining the proper tensile force requirements to anchor the anterior wall of the stomach to the abdominal wall.
Fatigue Testing	Testing shows that under normal clinical use of the devices there should be no mechanism or suture failure.
Biocompatibility Testing	In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met. Testing (i.e., cytotoxicity, sensitization, intracutaneous and systemic toxicity, and pyrogenicity) shows that the devices are biocompatible.
Torque Testing (for Adjustable Set only)	Testing shows that the device can withstand the torsional forces seen during proper clinical use.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the tensile, fatigue, biocompatibility, or torque testing. It also does not mention country of origin of data or whether the studies were retrospective or prospective, as these are typically bench tests or in-vitro tests for a device of this nature, not clinical studies involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological tests (tensile, fatigue, biocompatibility, torque) on the device components or the entire device, not clinical evaluations that require expert interpretation of results or ground truth established by medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where multiple expert opinions are reconciled, typically in clinical evaluations or image interpretation. The tests described are objective, physical measurements.

5. 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

An MRMC comparative effectiveness study was not done, as this device is a medical instrument (suture anchor set) and not an AI-powered diagnostic or interpretive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was not done, as this device is a medical instrument and does not involve any algorithms or AI.

7. The Type of Ground Truth Used

For the engineering tests (tensile, fatigue, torque), the "ground truth" would be defined by engineering specifications and standards (e.g., minimum tensile strength required for anchoring the stomach wall, acceptable levels of fatigue over a certain number of cycles, biocompatibility standards per ISO 10993-1). These are objective, measurable criteria. For biocompatibility, it's about meeting established biological safety levels.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/algorithm and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This section is not applicable as the device is not an AI/algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, outlined letters at the top. Below that, the word "MEDICAL" is in smaller, bold letters.

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

K131201 Page 1 of 3 A I

510(k) Summary

Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set 21 CFR 8876.5010 Date Prepared: June 19, 2013

Submitted By:

Applicant: Address:

Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Phone Number: Fax Number:

1(800) 468-1379 (812) 332-0281

Erum B. Nasir

OCT 07 2013

Contact: Contact Address:

Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 (ext 2607) (812) 332-0281

Contact Phone Number: Contact Fax Number:

Device Information:

Trade Name:

Common Name: Proposed Classification: Regulation: Product Code:

Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set Suture Anchor Set | I 21 CFR §876.5010 FGE

Intended Use:

The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

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Predicate Devices:

Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adju strointestinal Suture Anchor Set are substantially equivalent to the Connex Gastrointestinal ture Anchor Set, subject of Premarket Notification K090133, manufactured by Cook corporated and cleared for commercial distribution on January 20, 2009.

omparison to Predicate Device:

omponents of the predicate, Connex Gastrointestinal Suture Anchor Set and th components on the predicate, Connex Gastronitestinal Suture Anchor Set and diustable Gastrointestinal Suture Anchor Set are identical, and consist of the wire guides, introducer needles, suture, and the suture anchors.

the proposed devices are substantially equivalent to the predicate in terms of in increation, the proposed as rises and such in the mical location, and method of sterilization.

ence in the technological characteristic of the predicate device and the proposed d the suture anchoring mechanism. The predicate, Connex Gastrointestinal Suture Anchor Set intine suture anonoming moonamants The produced. Connell wall by an anchoring mechanism aich consists of disks and crimp beads.

e suture retention mechanism of the Entuit™ Secure Gastrointestinal Suture Anchor Set
intains the retention of the suture anchor to the abdominal wall by passing the suture t extension spring inside the suture retention mechanism housing. Whereas, the Entuit™ Secure divisiable Gastrointestinal Suture Anchor Set maintains the retention of the suture anchor to the ominal wall by threading the suture through the retention housing with the suture held in ce by a compression jaw and spring. The adjustable tab is removable and can be used to adjust the suture.

evice Description:

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure A astrointestinal Suture Anchor Set consist of 2 or 3 introducer needles with pre-loaded suture nors and a wire guide. A notch is located on the distal tip of the introducer needle. The coil chor is placed in the notch prior to placement. The proximal end of the suture anchor ntains the suture retention mechanism.

e retention mechanism of the Entuit Secure Gastrointestinal Suture Anchor consists of an
ension spring which is glued on the proximal end within a suture retention housing. T ture is threaded through the coils of the extension spring. When the suture retention echanism is pushed towards the anchor, tension is applied to the spring, which causes the coils he spring to open. This allows the suture to slide through the spring and allows the retention echanism to slide along the suture. When the retention mechanism is pulled away from the

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anchor, the coils of the spring compress and clamp down on the suture. This does not allow the suture to slide through the spring and maintains tension on the suture anchor.

Both of the proposed devices are supplied sterile and are intended for one-time use.

Comparison of Technological Characteristics:

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set were subjected to the following tests to assure reliable design and performance under the specified testing parameters:

1. Tensile Testing Testing shows that the tensile strength during proper clinical use of the devices should be capable of maintaining the proper tensile force requirements to anchor the anterior wall of the stomach to the abdominal wall. Testing demonstrated that the device met all predetermined acceptance criteria.
1. Fatigue Testing Testing shows that under normal clinical use of the devices there should be no mechanism or suture failure.
1. Biocompatibility Testing Testing (i.e., cytotoxicity, sensitization, intracutaneous and systemic toxicity, and pyrogenicity) shows that the devices are biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

The Entuit 110 Secure Adjustable Gastrointestinal Suture Anchor Set was also subjected to torque testing. Testing shows that the device can withstand the torsional forces seen during proper clinical use.

Testing demonstrated that the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set met all predetermined acceptance criteria.

Conclusions Drawn from the Tests:

The results of these tests provide reasonable assurance that the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set are as safe and effective as the predicate device and support a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.

Public Health Service

Food and Drug Administration 19903 New Hamoshire Avenue Document Control Center - WObo-Gold Silver Spring, MID 20993-0002

October 7. 2013

Cook. Inc. % Erum B. Nasir Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404

Re: K131201

Trade/Device Name: Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Il Product Code: FGE Dated: August 30, 2013 Received: September 3. 2013

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. Iisting 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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.

Sincerely yours,

Benjamin R. Fisher -S

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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Special 510(k) Premarket Notification Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set Cook Incorporated April 26, 2013

K131201 510(k) Number (if known):

Device Name: Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set

Indications for Use:

The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C) 5

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.10.07 16:47:37 -04'00'

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.