(30 days)
Not Found
No
The summary describes a mechanical device (suture anchor set) and its performance testing, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as a "Gastrointestinal Suture Anchor Set" intended for "anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters." Its function is structural anchoring, a preparatory step, rather than directly treating a disease or therapeutic condition.
No
The device is described as a "Suture Anchor Set" intended for "anchoring the anterior wall of the stomach to the abdominal wall," which is a therapeutic or interventional function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it consists of physical components (introducer needles, anchors, guidewire) and is supplied sterile, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Connex Gastrointestinal Suture Anchor Set is a surgical device used to physically anchor the stomach to the abdominal wall. It is used within the body (in vivo) during a procedure.
- Intended Use: The intended use clearly describes a surgical procedure for anchoring tissue, not for testing biological samples.
- Device Description: The description details needles, anchors, and a guidewire – components of a surgical device, not an IVD.
- Performance Studies: The performance studies listed (Tensile Testing, Insertion Testing, Biocompatibility Testing) are relevant to the physical and biological properties of a surgical implant, not the analytical performance of an IVD.
Therefore, based on the provided information, the Connex Gastrointestinal Suture Anchor Set is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FGE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior wall of the stomach; abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
-
- Insertion Testing
-
- 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.
2
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.
3
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) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 (800) 638-2041 or (240) 276-3150 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
4
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