(29 days)
Not Found
No
The summary describes a physical medical device (a stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a stent used to palliate malignant neoplasms in the biliary tree, which directly addresses a medical condition for treatment or relief.
No
Explanation: The device is a stent used for palliation of malignant neoplasms in the biliary tree, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components made of materials like Nickel Titanium alloy, indicating it is a hardware device (a stent and delivery system) and 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 "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a stent and a delivery system. This is a medical device designed for implantation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The Precise™ Nitinol Stent Transhepatic Biliary System (6F) is intended for use in the palliation of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The device description of the proposed Precise™ Nitinol Stent Transhepatic Biliary System (6F) is as follows.
• 5 / 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy;
• Expanded stent diameters 8, 9, and 10 mm;
• Stent lengths: 20, 30, and 40 mm;
• Stent delivery system usable length 135 cm; and
• Guidewire lumen 0.018".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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 equivalence was confirmed through pre-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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OCT - 5 2001
Image /page/0/Picture/1 description: The image shows the text "K012993 Page 1 of 1". The text appears to be handwritten. The first line contains a series of numbers and letters, while the second line indicates that it is page 1 of 1.
510(k) Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Precise™ Nitinol Stent Transhepatic | ||
| Biliary System (6F) | Biliary Stent | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| • Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445 – | ||
| May 16, 2001). | ||
| Classification | Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under section | |
| 514 of the Food, Drug and Cosmetic Act. | ||
| Indications | ||
| for Use | The Precise™ Nitinol Stent Transhepatic Biliary System (6F) is intended | |
| for use in the palliation of malignant neoplasms in the biliary tree. | ||
| Device | ||
| Description | The device description of the proposed Precise™ Nitinol Stent | |
| Transhepatic Biliary System (6F) is as follows. | ||
| • 5 / 6 French stent delivery system profile; | ||
| • Stent material – Nickel Titanium alloy; | ||
| • Expanded stent diameters 8, 9, and 10 mm; | ||
| • Stent lengths: 20, 30, and 40 mm; | ||
| • Stent delivery system usable length 135 cm; and | ||
| • Guidewire lumen 0.018". | ||
| Biocompatibility | All materials used in the Precise™ Nitinol Stent Transhepatic Biliary | |
| System (6F) are biocompatible. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | The Precise™ Nitinol Stent Transhepatic Biliary System (6F) is | |
| substantially equivalent to the predicate device. The equivalence was | ||
| confirmed through pre-clinical testing. | ||
| Precise™ Nitinol Stent Transhepatic Biliary System (6F) | ||
| Special 510(k) |
Special 510(k)
September 5, 2001
1
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes extending upwards and to the right. The bird's body is suggested by a curved line, and there are two curved lines below, possibly representing the tail feathers or the base of the bird.
5 2001 OCT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam A. Mirza Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K012993
Trade/Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 5, 2001 Received: September 6, 2001
Dear Mr. Mirza:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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
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Page 2 - Mr. Sam Mirza
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 requirements, as set forth in the Quality System Regulation (QS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally §809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 §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/dsma/dsmamain.html".
Sincerely yours,
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K012993
Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F)
FDA's Statement of the Indications For Use for device:
Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for The use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use_
Colin M. Pollard
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