CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS

K090133 · Cook, Inc. · FGE · Feb 20, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090133
• Device Name: CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
• Applicant: Cook, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Connex 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

Connex Gastrointestinal Suture Anchor Set facilitates gastropexy by anchoring the anterior stomach wall to the abdominal wall. The device consists of two introducer needles with preloaded anchors and a .018/.035 inch wire with a spring coil tip. It is a sterile, single-use device. The clinician uses the set to secure the stomach wall, creating a stable access point for subsequent interventional catheter procedures. This anchoring process helps prevent stomach wall displacement during catheter insertion, potentially reducing procedural complications and improving patient safety during gastrointestinal interventions.

Clinical Evidence

Bench testing only. Testing included tensile testing, insertion testing, and biocompatibility testing to ensure design performance and safety.

Technological Characteristics

Device consists of two introducer needles with preloaded anchors and a .018/.035 inch wire with a spring coil tip. Supplied sterile for single-use. No electronic components or software.

Indications for Use

Indicated for anchoring the anterior wall of the stomach to the abdominal wall prior to 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

• Cope Suture Anchor (K873606)

Submission Summary (Full Text)

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K890133
Page 1 of 2

Special 510{k} Premarket Notification Cope Suture Anchor COOK INCORPORATED January 16, 2009

#### 510(k) Summary

FEB 2 0 2009

Submitted By:

Karen Bradburn Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

#### Device:

Trade Name: Proposed Classification: Connex Gastrointestinal Suture Anchor Set Catheter, Biliary, Diagnostic 21 CFR §876.5010

#### Indications for Use:

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

#### Predicate Devices:

The Connex Gastrointestinal Suture Anchor Set is similar to the predicate Cope Suture Anchor in terms of intended use, materials of construction and technological characteristics.

#### Device Description:

The Connex Gastrointestinal Suture Anchor Set consists of 2 introducer needles with preloaded anchors and a .018/.035 inch with a spring coil tip. It is supplied sterile and is intended for one-time use.

#### Substantial Equivalence:

. The proposed Connex Gastrointestinal Suture Anchor Set is substantial equivalence to the predicate device, Cope Suture Anchor, K873606. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the device support a determination of substantial equivalency.

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Special 510(k) Premarket Notification Cope Suture Anchor COOK INCORPORATED January 16, 2009

K090133
page 2 of 2

### Test Data:

The Connex Gastrointestinal Suture Anchor Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Tensile Testing 1.
- 2. Insertion Testing
- 3. Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a suture anchor.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# EB 2 0 2009

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K090133

> Trade/Device Name: Connex Gastrointestinal Suture Anchor Set Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: January 16, 2009 Received: January 21, 2009

Dear Ms. Bradburn:

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 Ast include requirements for annual registration, listing of devices, good manufacturing practice, tabeling, 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 such 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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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 os 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification Cope Suture Anchor COOK INCORPORATED January 16, 2009

510(k) Number (if known): k090133

Device Name: Connex Gastrointestinal Suture Anchor Set

Indications for Use:

The Connex 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) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number