(98 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a self-expanding stent, with no mention of AI or ML technologies.
Yes
The device is intended for the palliation of malignant strictures in the biliary tree, which is a therapeutic intervention aimed at relieving symptoms and improving patient comfort, even if it's not a cure.
No
The device is a stent used for palliation of malignant strictures, which is a treatment not a diagnostic function.
No
The device description explicitly states it consists of a self-expanding Nitinol stent mounted on a catheter delivery system, which are hardware components.
Based on the provided information, the JOSTENT SelfX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "palliation of malignant strictures in the biliary tree." This describes a therapeutic intervention performed within the body (in vivo) to treat a medical condition.
- Device Description: The device is a "self-expanding Nitinol stent mounted on a catheter delivery system." This is a physical implantable device used to open up blockages.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or treatment decisions. The JOSTENT SelfX does not perform this function.
Therefore, the JOSTENT SelfX is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.
Product codes
78 FGE
Device Description
The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.
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
The safety and effectiveness of the JOSTENT SelfX has been demonstrated through the data collected in bench and biocompatibility testing.
Key Metrics
Not Found
Predicate Device(s)
K002143, K001222, K983008, K964688
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.
0
JOMED
MAR 31 2003
510K) Summary of Safety and Effectiveness
| Date Prepared: | January 23, 2003 |
|---|---|
| Submitter Name: | JOMED AG |
| Submitter Address: | Ampthauptstrasse |
| Postlach | |
| CH-8222 Beringen | |
| Switzerland | |
| Contact Person: | Rudi Ott |
| Vice President Regulatory and Clinical Affairs | |
| Phone Number: | 41 52 674 8505 |
| Fax Number: | 41 52 674 8404 |
| Device Trade Name: | JOSTENT® SelfX |
| Device Common Name: | Biliary Stent |
| Device Classification | |
| Name and Class: | Biliary Catheter; Class II |
| Predicate Devices: | Guidant DYNALINK™ Biliary Self Expanding Stent System (K002143) |
| Guidant OTW MEGALINK™ SDS Biliary Stent System (K001222) | |
| Peripheral AVE Biliary Stent System (K983008) | |
| Cordis Long Medium PALMAZ-SCHATZ Balloon Expandable Stent (K964688) |
Device Description:
The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.
·
Intended Use:
The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.
1
510(k) Summary (cont'd)
Device Technological Characteristics and Comparison to Predicate Device:
The JOSTENT SelfX is constrained within an outer catheter and is deployed in the biliary tree by retracting the outer catheter until the stent is unconstrained.
The stent material is substantially equivalent to currently marketed Nitinol Biliary stents and the catheter materials are substantially equivalent to currently marketed stent delivery systems and PTA catheters.
The range of device lengths and diameters are equivalent to currently marketed Biliary stent/catheter systems.
Performance Data:
The safety and effectiveness of the JOSTENT SelfX has been demonstrated through the data collected in bench and biocompatibility testing.
Conclusion:
The JOSTENT SelfX is substantially equivalent to the claimed predicate devices and other currently marketed biliary stent systems.
K030053 Premarket Notification [510(k)] Number
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
MAR 3 1 2003
Ms. Terry Schultz Regulatory Affairs Manager JOMED Inc. 15330 Avenue of Science, Suite 200 SAN DIEGO CA 92128
Re: K030053
Trade/Device Name: JOSTENT® SelfX Biliary Stent Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 21, 2003 Received: March 24, 2003
Dear Ms. Schultz:
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). 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 marufacturing 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.
3
Page 2 -- Ms. Terry Schultz
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.
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 Section 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 Part 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 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,
Daniel Schultz, M.D.
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K030053
Device Name: JOSTENT® SelfX Biliary Stent
FDA's Statement of the Indications for Use for device:
The JOSTENT SelfX Biliary Stent is intended for use in the palliation of malignant strictues in the biliary tree.
Prescription Use V Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
David A. Ingram
(Division Sim Division in aboutinglys. roceminal and Radiotogram Covi 510(k) Number