Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

K152524 · Cook Incorporated · FGE · Sep 30, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152524
• Device Name: Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
• Applicant: Cook Incorporated
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Sep 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2

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.

Device Story

The Entuit Secure and Entuit Secure Adjustable Gastrointestinal Suture Anchor Sets are used in gastropexy procedures to anchor the stomach wall to the abdominal wall. The sets consist of 2 or 3 stainless steel introducer needles pre-loaded with suture anchors, a wire guide, and (for the adjustable version) a sterile red adjustable plunger. The needles feature a silicone lubricant coating to reduce insertion force. The device is used by clinicians in a clinical setting to prepare the site for subsequent interventional catheter placement. The device is supplied sterile for single-use only.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1, insertion force testing, and ease of insertion testing were performed to validate the addition of the silicone lubricant coating.

Technological Characteristics

Materials: Stainless steel needles with silicone lubricant coating. Components: 2-3 introducer needles, pre-loaded suture anchors, wire guide, and adjustable plunger (adjustable set only). Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for anchoring the anterior wall of the stomach to the abdominal wall to facilitate the introduction of interventional catheters.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Entuit Secure Gastrointestinal Suture Anchor Set and the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (K131201)

Submission Summary (Full Text)

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

September 30, 2015

Cook Incorporated Erum B. Nasir, MS Regulatory Affairs Specialist 750 Daniels Wav Bloomington, IN 47404

Re: K152524

> 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: II Product Code: FGE Dated: September 2, 2015 Received: September 3, 2015

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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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)

K152524

Device Name

Entuit Secure Gastrointestinal Suture Anchor Set Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

#### Indications for Use (Describe)

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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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EF

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#### 10.0 510(k) SUMMARY

## Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set 21 CFR §876.5010 Date Prepared: 2 September 2015

Cook Incorporated Erum B. Nasir, MS Cook Incorporated 750 Daniels Way

[phone]

Bloomington, IN 47404

[phone] x102607

### Submitted By:

| Applicant: | |
|--------------------|--|
| Contact: | |
| Applicant Address: | |

Contact Phone Number: Contact Fax Number:

# Device Information:

Trade Name:

Common Name: Classification Name: Regulation: Product Code

Entuit™ Secure Gastrointestinal Suture Anchor Set Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set Biliary Catheter and Accessories Catheter, Biliary, Diagnostic 21 CFR §876.5010 FGE

## Predicate Device:

- K131201, Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure 0 Adjustable Gastrointestinal Suture Anchor Set
## Device Description:

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set are used in gastropexy procedures. The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 stainless steel silicone coated introducer needles with pre-loaded suture anchors and a wire guide. An additional sterile prepackaged red adjustable plunger is packaged with the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set.

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set are supplied sterile and are intended for one-time use.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters on a red background.

# Indications for Use:

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

# Comparison to Predicates:

It has been demonstrated that the subject devices are substantially equivalent to the predicate devices, the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set (K131201), in that these devices have similar designs, methods of construction and operation, and indications for use. A coating of silicone lubricant has been added to the outer surface of the stainless steel introducer needles, a component of the subject devices. The safety and effectiveness of the modification is supported by testing.

# Technological Characteristics:

The following tests were performed to demonstrate that the subject devices met applicable design and performance requirements and support a determination of substantial equivalence.

- 0 Biocompatibility Testing - Testing showed that the devices met the requirements of ISO 10993-1.
- Insertion Force Testing Testing showed that applying silicone to the outer surface of the . needle reduced the insertion force to less than 1.5 N. The acceptance criterion was met.
- . Ease of Insertion Testing - Testing showed that needles coated with silicone lubricant are easier to advance. The acceptance criterion was met.

## Conclusion:

The results of this testing support a conclusion that the proposed devices met the design input requirements based on the intended use and these devices do not raise new questions of safety or effectiveness as compared to the predicate and are therefore substantially equivalent to the predicate devices, the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set (K131201).