(143 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a biliary stent, with no mention of AI or ML.
Yes
The device, a biliary stent, is placed to drain obstructed ducts, which is a direct treatment for a medical condition.
No
This device is a stent, used for drainage of obstructed ducts, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical biliary stent made of materials and includes performance testing related to physical properties and biocompatibility, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Endoscopic biliary stent placement for biliary drainage of obstructed ducts". This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is a physical stent designed to be implanted in the biliary duct. It facilitates drainage by providing a physical pathway.
- Lack of In Vitro Activity: IVD devices are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Anatomical Site: The device is placed in the "Biliary duct," which is an internal anatomical structure.
- Input Imaging Modality: Fluoroscopic monitoring is used to guide the placement of the device in vivo.
The device is a medical device used for a therapeutic intervention, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7).
The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic monitoring
Anatomical Site
Biliary duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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 biocompatibility evaluation for the subject device, was conducted in accordance with ISO 10993-1: 2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (September 2020). The following Biocompatibility tests were performed: Cytotoxicity, irritation, sensitization, acute systemic toxicity, systemic toxicity following subcutaneous implantation – 13 Week, muscle implantation study – 4 Week, muscle implantation study - 13 Week, mouse lymphoma assay, material mediated USP rabbit pyrogen study and bacterial reverse mutation study.
Testing was completed to Cook Ireland's design control system. Performance testing included simulated use, dimensional and visual testing, tensile strength testing, MRI conditional testing, radiopacity, flow rate and shelf-life testing.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 9, 2022
Cook Ireland LTD Kieran Casey, Regulatory Affairs Specialist O'Halloran Road. National Technology Park, Limerick. IRELAND
Re: K213946
Trade/Device Name: Compass BDS Biliary Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: April 12, 2022 Received: April 15, 2022
Dear Kieran Casey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213946
Device Name Compass BDS® Biliary Stent
Indications for Use (Describe)
Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.
| 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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Section 5: 510(k) Summary
I. SUBMITTER
Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Persons: Kieran Casey, Regulatory Affairs Specialist Jane Kennedy, Lead Regulatory Engineer
Phone: +353 61 334440 Fax: +353 61 239293
Date Prepared: December 10th, 2021
II. DEVICE
Trade Name of Device:
-
Compass BDS® Biliary Stent
Model numbers: -
= CBBSO-7-5
-
CBBSO-7-10
-
CBBSO-7-15
Classification Name: Biliary catheter and accessories (21 CFR 876.5010)
Regulatory Class: Class: II, Sterile
Product Code: FGE
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III. PREDICATE DEVICE
Predicate: The Zimmon biliary stent, cleared under K172044 on February 27th, 2018
IV. DEVICE DESCRIPTION
The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7).
The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.
V. INDICATIONS FOR USE
Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A PREDICATE DEVICE
The subject device is substantially equivalent to the currently marketed device, Cook Zimmon biliary stent (7Fr ZSO), cleared under K172044 on February 27th, 2018
In brief, the subject device has the same technological characteristics as the predicate, with respect to the following:
- The subject device and predicate device are for use in the biliary duct. .
- The subject device and predicate device have the same intended use ●
-
Biliary stents use to drain obstructed biliary ducts.
-
- The subject device and predicate device are intended for single use only. ●
- The subject device and predicate device are supplied sterile
- The subject device and predicate device are sterilised using ethylene oxide. ●
- The subject device and predicate device are for professional use only. ●
- The subject device and predicate device require a 0.035" wire guide and endoscope to perform the therapeutic procedure.
5
- . The subject device and predicate device are placed within the body endoscopically using fluoroscopic monitoring.
- . The subject device and predicate device are supplied as stent only with pigtail straightener.
- The subject device and predicate device are both double pigtail stents, both are made ● from Ethylene-Vinyl-Acetate (EVA) co-polymer and both contain multiple side ports with no flaps.
Differences between the predicate devices and subject devices can be summarized as follows:
- Stent marker bands
- Additional sideports
- Bidirectional stent ends ●
Reference devices cleared under K172044, K172057 and K180868 were used to support biocompatibility and reference devices cleared under K172044 and K172057 were used to support device performance.
VII. PERFORMANCE DATA
The biocompatibility evaluation for the subject device, was conducted in accordance with ISO 10993-1: 2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (September 2020). The following Biocompatibility tests were performed: Cytotoxicity, irritation, sensitization, acute systemic toxicity, systemic toxicity following subcutaneous implantation – 13 Week, muscle implantation study – 4 Week, muscle implantation study - 13 Week, mouse lymphoma assay, material mediated USP rabbit pyrogen study and bacterial reverse mutation study.
Testing was completed to Cook Ireland's design control system. Performance testing included simulated use, dimensional and visual testing, tensile strength testing, MRI conditional testing, radiopacity, flow rate and shelf-life testing.
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CONCLUSIONS VIII.
The subject device has indications for use and technological characteristics that are similar to the predicate devices. The results of the non-clinical testing demonstrate that the subject device met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence of the subject device to the predicate device.