(30 days)
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Not Found
No
The summary describes a physical medical device (a stent) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the management of biliary obstruction and to prevent or relieve symptoms, which are therapeutic functions.
No
The device, a Biliary Stent, is used for treatment (management of biliary obstruction, prevention/relief of sepsis/pruritis, maintaining bile flow) rather than for identifying or diagnosing a condition.
No
The device description explicitly states "Silicone Biliary Stent," indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body to manage biliary obstruction. This is an in vivo application.
- Device Description: A silicone biliary stent is a physical implant used to maintain a pathway for bile flow. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are devices used in vitro (outside the body) to perform tests on biological samples. This device is clearly used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function.
The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases to the porta hepatis, and other malignant conditions causing obstructive jaundice.
The stent can also be used in cases of benign biliary obstruction such as strictures secondary to primary or iatrogenic trauma pancreatitis, biliary calculi, or biliary leaks.
Product codes
78 FGE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
biliary
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, arranged in a way that suggests a sense of unity or support. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 1997
Ms. T. Jan Varner President and CEO Specialty Surgical Products 302 North First Street Hamilton, Montana 59840 Re: K973114
Silicone Biliary Stent Dated: August 5, 1997 Received: August 20, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE
Dear Ms. Varner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Silicone Biliary Stent
Indications For Use:
Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function.
The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases to the porta hepatis, and other malignant conditions causing obstructive jaundice.
The stent can also be used in cases of benign biliary obstruction such as strictures secondary to primary or iatrogenic trauma pancreatitis, biliary calculi, or biliary leaks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter R. Sitting
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 9731 i 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)