(108 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a drainage catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for percutaneous biliary drainage, which is a medical procedure to remove bile from the biliary system, directly treating a medical condition.
No
A biliary drainage catheter is used to drain bile, which is a therapeutic intervention, not a diagnostic one. The "Intended Use" clearly states it is for "percutaneous biliary drainage."
No
The device description clearly states it is a physical catheter made of polyurethane with accessories like cannulas and a hub, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "percutaneous biliary drainage." This is a procedure performed directly on a patient to drain bile, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the biliary system. This is a therapeutic or interventional device, not a diagnostic reagent, instrument, or system used for testing samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used for a therapeutic procedure within the body.
N/A
Intended Use / Indications for Use
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary system
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 Skater® Biliary Drainage Catheter has been tested and compared to the predicate device. Testing included functional, leakage, catheter body tensile strength and elongation, physical dimensions and catheter body to hub tensile strength. All data gathered demonstrates the Skater® Biliary Drainage Catheter comparably to the predicate device.
The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter.
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
K070610 page 1 of 3
Section 5 - 510(k) Summary
JUN 2 1 2007
1. Applicant Contact:
Trudy D. Estridge, PhD Director of Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA CA voice: 510.742.5301 VA voice: 703.796.8927 Fax: 703.673.0061 Email: testridge@angio.com
Date Prepared: March 01, 2007
- Name of Device: Skater® Biliary Drainage Catheter Common Name: Biliary Catheter Classification Name: Catheter, Biliary, Diagnostic Regulation 21 CFR 876.5010 -- Product Code FGE
3. Identification of device(s) to which the submitted claims equivalence:
Boston Scientific Corporation, Flexima™ Biliary Catheter, K023870
4. Device Description:
The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub.
5. Intended Use of the Device:
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
1
page 2 of 2
K07061C
Section 5 - 510(k) Summary
- Technological characteristics of the device in comparison to those of the predicate device(s)
| Feature /
Technological
Characteristics | Boston Scientific
Corporation, Flexima™
Biliary Catheter
K023870
(Predicate Device) | Skater® Biliary
Drainage Catheter
(New Device) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Designed for the external and
internal percutaneous
drainage of the biliary system | Intended for percutaneous
biliary drainage |
| Characteristics | Drainage catheter with metal
stiffening cannula, flexible
stiffening cannula and luer
cap | Drainage catheter with metal
and plastic stiffening cannula
and female/male luer hub
(adapter) |
| Sizes (French) | 8, 10, 12, 14 | 8, 10, 12 |
| Length (cm) | 35 cm from hub to proximal
side of pigtail in curved
position | 40 cm from hub to distal tip
in curved position |
| Lumens | One | One |
| Distal end
configuration | 12 side holes and one end
hole, pigtail. | 8 Fr. - 12 side drainage holes
and one end drainage hole,
pigtail.
10 and 12 Fr. - 11 side
drainage holes and one end
drainage hole, pigtail. |
| Intended anatomical
location of distal end | Biliary system | Biliary system |
| Proximal end
configuration | Standard luer locking hub and
stop-cock | Female/male luer hub
(adapter) and clip |
| Materials | Polyurethane | Polyurethane |
| Coating | Hydrophilic | Hydrophilic |
2
page 3 of 3
Section 5 - 510(k) Summary
7. Safety and Performance:
The Skater® Biliary Drainage Catheter has been tested and compared to the predicate device. Testing included functional, leakage, catheter body tensile strength and elongation, physical dimensions and catheter body to hub tensile strength. All data gathered demonstrates the Skater® Biliary Drainage Catheter comparably to the predicate device.
The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter.
8. Conclusion
Based on the design, material, function and intended use discussed herein. Angiotech believes the Skater® Biliary Drainage Catheter is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
N 2 1 2007
Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech® Dulles Gateway Center 13921 Park Center Road, Suite 100 HERNDON VA 20171
Re: K070610
Trade/Device Name: Skater® Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 7. 2007 Received: June 8, 2007
Dear Dr. Estridge:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a stylized font, with the word "Centennial" written below it. Above the acronym, the years "1906-2006" are displayed, indicating a centennial celebration. The entire design is encircled by text and star symbols, forming a complete circular seal.
cling and Promoting
4
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the text "page 1 of 1" in a handwritten style. The word "page" is written in lowercase letters, followed by the number "1". The words "of" are written in lowercase letters, followed by the number "1". The text appears to be a page number or a document identifier.
Section 4 - Indications for Use Statement
510k number if known:
KO-70610
Device Name:
Skater® Biliary Drainage Catheter
Indications for Use:
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
Prescription Use 2 (Part 21 CFR 801 Subpart D)
AND/OR
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)
Heal
on Sign-Off) vision of Reproductive, Abdomina and Radiological Devices 510(k) Number