(149 days)
No
The summary describes a mechanical device for stent placement and drainage, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended to treat obstructed biliary ducts by draining them and reducing duodenal content reflux, which directly addresses a medical condition.
No.
The device is a biliary stent intended for therapeutic purposes (draining obstructed biliary ducts and reducing duodenal content reflux), not for diagnosing a condition.
No
The device description clearly describes a physical medical device (a biliary stent with a soft sock) intended for endoscopic placement, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the placement of a biliary stent to drain obstructed ducts. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a stent and a delivery system, designed for mechanical intervention within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.
Product codes
FGE
Device Description
The Marathon Stent with Fusion Technology is designed to place its preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. A soft sock is attached to the proximal end of a traditional biliary stent that reduces duodenal content reflux without compromising antegrade flow. The stent is 10 Fr and will be offered in variable lengths of 5, 7, 9 and 12 cm between the flaps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts
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
Non-clinical testing was carried out on the stent to determine the equivalence of the Marathon stent with Fusion Technology to the predicate devices and to verify the safety and effectiveness of the stent. The following is a summary of the testing carried out: verification of Endoscope and wire guide compatibility, validation of stent deployment, sock to stent Security, antegrade flow tests (with simulated bile), retrograde flow tests.
Clinical data in support of the claim of substantial equivalence and the intended use of the Marathon stent with Fusion Technology has been collected and presented within this submission. This prospective, randomized clinical study showed that the Marathon Stent with Fusion Technology was as effective as a standard plastic stent, and no new or increased risks related to safety and effectiveness were likely to be raised when compared to risks experienced with similar marketed devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K060624 page 1 of 2
510(k) Summary
| AUG -- 4 2006 | |
|---|---|
| Name: | Cook Ireland |
| Address: | O'Halloran Road |
| National Technological Park | |
| Limerick, Ireland | |
| Phone: | 353 61 334440 |
| Fax: | 353 61 334441 |
| Contact Person: | Emmett Devereux, Quality & RegulatoryManager |
| Sinead Burke, Regulatory Affairs Specialist | |
| Date: | July 28, 2006 |
| Trade Name: | Marathon Stent with Fusion Technology |
| Common Name: | Stent Introducer with Biliary Stent |
| Classification Name: | Catheter, Biliary, Diagnostic (21 CFR 876.5010 |
| Product Code FGE) | |
| Legally Marketed | |
| Devices: | Olympus PBD Stents (K933200) |
| Wilson-Cook Zimmon Biliary Stent Set (K851962/A) | |
| Wilson-Cook OASIS Biliary Stent Introduction | |
| System (K040151) | |
| Description of the device: | The Marathon Stent with Fusion Technology is |
| designed to place its preloaded biliary stent to drain | |
| obstructed biliary ducts and reduce duodenal content | |
| reflux. A soft sock is attached to the proximal end of a | |
| traditional biliary stent that reduces duodenal content | |
| reflux without compromising antegrade flow. The stent | |
| is 10 Fr and will be offered in variable lengths of 5, 7, 9 | |
| and 12 cm between the flaps. |
1
K06024 page 2 of 2
Intended Use:
Comparison of Characteristics: This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.
We believe the proposed device to be substantially equivalent to currently marketed predicate devices as cleared by K933200, K851962/A and K040151, in terms of intended use, indications for use, performance characteristics, anatomical sites and biocompatibility.
Performance Data:
Non-clinical testing was carried out on the stent to determine the equivalence of the Marathon stent with Fusion Technology to the predicate devices and to verify the safety and effectiveness of the stent. The following is a summary of the testing carried out: verification of Endoscope and wire guide compatibility, validation of stent deployment, sock to stent Security, antegrade flow tests (with simulated bile), retrograde flow tests.
Clinical data in support of the claim of substantial equivalence and the intended use of the Marathon stent with Fusion Technology has been collected and presented within this submission. This prospective, randomized clinical study showed that the Marathon Stent with Fusion Technology was as effective as a standard plastic stent, and no new or increased risks related to safety and effectiveness were likely to be raised when compared to risks experienced with similar marketed devices.
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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 4 2006
Ms. Sinead Burke Regulatory Affairs Specialist Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick IRELAND
Re: K060624
Trade/Device Name: Marathon Stent with Fusion Technology Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 12, 2006 Received: July 17, 2006
Dear Ms. Burke:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave reviewed your Doctor on (t) project is substantially equivalent (for the indications for recented in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreate) to regardy inter of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic have been rochassified in accerantoval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, bagfor to annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket it your device is elassiliar (600 and additional controls. Existing major regulations affecting your Apployal), it may be subject to set Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters FDA in the center. The text "Centennial" is below the letters. The text "d Promoting Public Ho" is also visible at the bottom of the image.
3
Page 2 -
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 of 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Cook Ireland and Cook Endoscopy Marathon Stent with Fusion Technology
Page 5 of 40
Indications for Use
510(k) Number (if known): Koleolo24
Device Name: Marathon Stent with Fusion Technology
Indications for Use:
This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Henson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number
Page 1 of 1