(30 days)
Not Found
Not Found
No
The summary describes a mechanical drainage catheter and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a catheter designed for percutaneous drainage of the biliary system, which falls under therapeutic intervention.
No
Explanation: The device is described as a drainage catheter for the biliary system, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly lists physical components like a drainage catheter, metal stiffening cannula, flexible stiffening cannula, and luer cap, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "external and internal percutaneous drainage of the biliary system." This describes a procedure performed on the patient's body to drain fluids, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a catheter and related components used for drainage, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic testing, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Flexima Biliary Catheter is a therapeutic device used for drainage, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.
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 Flexima Biliary Catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
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.
Not Found
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
Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation
DEC 2 0 2002
Summary of Safety and Effectiveness
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| General
Information | Submitter: Boston Scientific Corporation
780 Brookside Drive
Spencer, IN 47460
Contact Person: Nicholas Condakes |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Trade Name: Flexima Biliary Catheter
Classification Name: Biliary Catheter and Accessories |
| Name of
Predicate
Devices | Flexima Biliary Catheter |
| Classification | Class II |
| Performance
Standards | Performance Standards have not been established by FDA under Section 514
of the Food, Drug and Cosmetic Act |
| Intended Use
and Device
Description | The
Flexima Biliary Catheter is designed for external and internal
percutaneous drainage of the biliary system. The major components of the
Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula,
flexible stiffening cannula and luer cap. |
| Summary of
Substantial
Equivalence | The Flexima Biliary Catheters have been tested and compared to the predicate
device. All data gathered demonstrate this device as substantially equivalent.
No new issues of safety or efficacy have been raised. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and service.
Public Health Service
DEC 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nicholas Condakes Regulatory Affairs Specialist II Boston Scientific Medi-Tech® Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K023870
Trade/Device Name: Flexima™ Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 19, 2002 Received: November 20, 2002
Dear Mr. Condakes:
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. Iisting 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 (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 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.
2
Page 2
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
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
3
Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation
K023870 0-0 0 0 6 3
・
Indications For Use
| 510(k) Number (if known) | |
|---|---|
| Device Name: | Flexima™ Biliary Catheter |
| Indications for Use | The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR Over-The Counter Use (Optional Format 1-2-96) |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------- |
(Division Sign Off)
Division of Reproductive, Abdominal,
and Peripheral Devices
| 510(k) Number | K023870 |
|---|---|
| --------------- | --------- |
Confidential
Boston Scientific Corporation