(166 days)
The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SureSave " Self-Expandable Biliary Nitinol Stent and Precision" Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.
The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is comprised of two components; the implantable SureSave™ metallic stent and the Precision™ delivery system. The stent, provided pre-mounted on the delivery system, is a woven wire is constructed from a biomedical superalloy wire, braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, self-expanding and can withstand strong radial force. The delivery system consists of an inner and outer catheter. The exterior catheter serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. The inner catheter contains a central lumen which will accommodate a 0.018" guidewire.
The provided text describes a 510(k) submission for a medical device called the SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter. This document is a regulatory approval letter from the FDA, not a detailed study report. As such, it does not contain the acceptance criteria or the specifics of a study that proves the device meets those criteria, nor any of the detailed information about sample sizes, ground truth establishment, or expert involvement that you requested.
The information provided is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance, rather than a clinical trial demonstrating performance against specific, quantifiable acceptance criteria.
Therefore, I cannot fulfill most of your request from the given text.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document states: "The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through preclinical testing." It does not provide specific performance metrics or acceptance criteria for that preclinical testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The document mentions "preclinical testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/available. The device is a physical stent and delivery system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/available. The device is a physical stent and delivery system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This information is not available in the provided document beyond the general statement of "preclinical testing" for substantial equivalence.
8. The sample size for the training set:
This information is not applicable/not available. The device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not available. The device is a physical medical device, not a machine learning model.
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IDev® Technologies, Inc. SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter
510(k) Notification
AUG 1 5 2006
SureSave™M
Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter 510(k) Summary
| Submitter: | IDev Technologies, Inc.1120 NASA Road One, Suite 600Houston, Texas 77058 |
|---|---|
| Contact Person: | Timothy R. PlacekVice President, Regulatory Affairs, Clinical Affairs and Quality(281) 333-1998 (Phone)(281) 333-4008 (Fax) |
| Date Prepared: | March 1, 2006 |
| Trade Name: | SureSaveTM Self-Expandable Biliary Nitinol Stent and PrecisionTM StentDelivery Catheter |
| Product Code: | FGE |
| Predicate Device: | Protege® GPSTM Self-Expanding Nitinol Stent - Biliary (K051379)SMARTTM ControlTM Nitinol Stent Transhepatic - Biliary (K032457) |
Device Description:
The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is comprised of two components; the implantable SureSave™ metallic stent and the Precision™ delivery system. The stent, provided pre-mounted on the delivery system, is a woven wire is constructed from a biomedical superalloy wire, braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, self-expanding and can withstand strong radial force. The delivery system consists of an inner and outer catheter. The exterior catheter serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. The inner catheter contains a central lumen which will accommodate a 0.018" guidewire.
Intended Use:
The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Technological Characteristics Compared to Predicate
The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through preclinical testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Public Health Service
AUG 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy R. Placek VP of Regulatory Affairs, Clinical Affairs and Quality Systems Official Correspondent IDev Technologies, Inc. 1120 NASA Road One, Suite 600 HOUSTON TX 77058
Re: K060557
Trade/Device Name: SureSave" Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: July 7, 2006 Received: July 10, 2006
Dear Mr. Placek:
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 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.
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Page 2 - Mr. Timothy Placek
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.
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 described above is added to your labeling.
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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060557
SureSave " Self-Expandable Biliary Nitinol Stent and Precision™ Stent Device Name: Delivery Catheter
FDA Indications For Use: The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision" Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number__ KO6055
Page 1 of 1
Page 4 - Mr. Timothy Placek
§ 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.