(227 days)
The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is indicated for use with the 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter was designed and is manufactured by IDev Technologies, Inc. for use with the FDA 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in the palliation of malignant strictures (neoplasms) in the biliary tree. It shares the same indication for use and design features as the Precision™ Stent Delivery Catheter (K060557) with the exception of modifications that do not significantly affect the function and/or safety of the device.
Please refer to Figure 1. The SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is a 7 Fr, 0.018" guide wire compatible, multi-lumen sheath based delivery system comprised of an Outer Sheath (1) attached proximally to a Handle (2); a radiopaque Marker Band (3) located on the Outer Sheath that can be visualized under fluoroscopy to assist in system placement/SUPERA™ stent deployment; a Thumb Slide (4) connected internally to a means for advancing the SUPERA™ stent out of the Outer Sheath as the Outer Sheath moves proximally in a de-coupled fashion; a Stopcock (5) for flushing the central lumen of the device and for contrast injection; a Retention Cable (6) connected to the proximal end of a stent to assist in resheathing/repositioning the stent; a Resheath Collar (7) that can be actuated to allow for resheathing or deployment of a stent; a Torquer (8) connected to the Retention Cable for external visualization of the deployment process, a dedicated Guidewire Lumen (9) for traversing over an 0.018" guidewire with a radiopaque Flexible Tip (10) and Guidewire Luer Fitting (11), used for flushing the Guidewire Lumen, located on the distal and of the Guidewire Lumen, respectively; a Hemostasis Valve (12) that can be tightened to eliminate relative motion of the Flexible Tip with respect to the Outer Sheath; a Y-Port (13) housing the Retention Cable and serving as a point of reference for deployment; an introducer Valve Defeater (14); a Re-Sheathing Indicator (15); and a Packaging Mandrel (16).
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific acceptance criteria with numerical performance metrics for the device itself (SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter). Instead, it states that the device is "substantially equivalent" to a predicate device based on preclinical testing.
Therefore, a table of specific numerical acceptance criteria and reported device performance from the provided document cannot be generated.
However, based on the narrative, the implicit acceptance criterion is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557).
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "preclinical testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing, animal studies, or a combination, but the details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth. Preclinical testing for a device like a stent delivery catheter often focuses on engineering specifications, mechanical properties, and functional performance in simulated environments or animal models. Expert adjudication is more common in diagnostic or image-interpretation devices.
4. Adjudication Method for the Test Set
As there's no mention of experts establishing ground truth, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or is not mentioned in the provided text. The evaluation method focused on preclinical testing for substantial equivalence, not human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a medical instrument (stent delivery catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device itself performs its function.
7. The Type of Ground Truth Used
The text doesn't explicitly state the "type of ground truth" using terms like "pathology" or "outcomes data." However, given it's a medical device, the ground truth for preclinical testing would likely involve:
- Engineering specifications and measurements: Verifying dimensions, material properties, deployment forces, etc.
- Functional performance in simulated environments: Assessing the catheter's ability to navigate, deliver, and resheath a stent under controlled conditions.
- Animal study observations (if conducted): Direct observation of successful stent delivery and performance in an in-vivo model, potentially with histological evaluation or imaging to confirm proper placement and tissue response.
8. The Sample Size for the Training Set
Not Applicable (N/A). This device is not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Acceptance Criteria and Study (Based on Substantial Equivalence):
The primary acceptance criterion described is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557). This equivalence was confirmed through preclinical testing. While the details of this testing (specific tests, sample sizes, metrics) are not provided, the implication is that the tests demonstrated that the modified features of the new device "do not significantly affect the function and/or safety of the device" compared to the predicate. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for IDEV. The logo consists of the letters IDEV in a bold, sans-serif font. A series of concentric arcs encircle the letters, creating a globe-like effect. Below the letters, the words "inspiration, innovation, intervention" are written in a smaller font, separated by bullet points.
Image /page/0/Picture/1 description: The image shows the text "K071646 pg 1 of 3 000018". The text is written in a simple, sans-serif font. The numbers are clearly legible. The text appears to be part of a document or label.
JAN 31 2008
510(k) Summary of Safety and Effectiveness
| Submitter: | IDev® Technologies, Inc.1120 NASA Parkway, Suite 600Houston, Texas 77058FDA Establishment Registration Number: 3005325609 |
|---|---|
| Contact Person: | Timothy R. PlacekVice President, Regulatory Affairs, Clinical Affairs and Quality Systems(281) 333-1998 (Phone)(281) 333-4008 (Fax) |
| Date Prepared: | June 8, 2007 |
| Trade Name: | SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent DeliveryCatheter |
| Common Name: | Biliary Stent Delivery Catheter |
| Product Class/Code: | Class II/FGE |
| Predicate Device: | Precision™ Stent Delivery Catheter (K060557) |
Device Description:
The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter was designed and is manufactured by IDev Technologies, Inc. for use with the FDA 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in the palliation of malignant strictures (neoplasms) in the biliary tree. It shares the same indication for use and design features as the Precision™ Stent Delivery Catheter (K060557) with the exception of modifications that do not significantly affect the function and/or safety of the device.
Please refer to Figure 1. The SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is a 7 Fr, 0.018" guide wire compatible, multi-lumen sheath based delivery system comprised of an Outer Sheath (1) attached proximally to a Handle (2); a radiopaque Marker Band (3) located on the Outer Sheath that can be visualized under fluoroscopy to assist in system placement/SUPERA™ stent deployment; a Thumb Slide (4) connected internally to a means for advancing the SUPERA™ stent out of the Outer Sheath as the Outer Sheath moves proximally in a de-coupled fashion; a Stopcock (5) for flushing the central lumen of the device
{1}------------------------------------------------
Dev Technologies, Inc. Special 510(k) Notification SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter
and for contrast injection; a Retention Cable (6) connected to the proximal end of a stent to assist in resheathing/repositioning the stent; a Resheath Collar (7) that can be actuated to allow for resheathing or deployment of a stent; a Torquer (8) connected to the Retention Cable for external visualization of the deployment process, a dedicated Guidewire Lumen (9) for traversing over an 0.018" guidewire with a radiopaque Flexible Tip (10) and Guidewire Luer Fitting (11), used for flushing the Guidewire Lumen, located on the distal and of the Guidewire Lumen, respectively; a Hemostasis Valve (12) that can be tightened to eliminate relative motion of the Flexible Tip with respect to the Outer Sheath; a Y-Port (13) housing the Retention Cable and serving as a point of reference for deployment; an introducer Valve Defeater (14); a Re-Sheathing Indicator (15); and a Packaging Mandrel (16).
Stent deployment is accomplished by advancing the Thumb Slide distally, while holding the Handle stationary, until the Thumb Slide reaches the Resheath Collar. This distal motion of the Thumb Slide will introduce a small segment of stent into the biliary duct as the Outer Sheath moves proximally in a de-coupled fashion. Following location confirmation, the Thumb Slide is moved back into the proximal position to engage another portion of the stent and then advanced distally, once again, until it reaches the Resheath Collar. Thumb Slide proximal to distal motion will continue until only a small portion of the stent remains within the Outer Sheath, as visualized by the Torquer approaching the Y-Port, at which time an election to deploy or resheath/reposition the stent is made.
If deployment is desired the:
- a) Thumb slide is placed in the proximal most position:
- Resheath Collar is rotated clockwise allowing for the Thumb slide to move into a b) position distal to the Resheath Collar;
- Thumb Slide is moved into the distal most position: c)
- deployment is confirmed under fluoroscopy; and d)
- e) SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is removed.
If resheathing/repositioning is desired the:
- Resheath Collar is rotated clockwise allowing for the Thumb slide to move into a a) position distal to the Resheath Collar;
- b) Thumb Slide is advanced distally without moving it into the proximal most position;
- Guidewire Luer fitting is moved proximally; c)
- d) Torquer is pulled proximally until the stent is resheathed; and
- e) Thumb Slide is moved into the proximal most position.
Intended Use:
The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is indicated . for use with the 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent
{2}------------------------------------------------
IDev® Technologies, Inc. 000020 Special 510(k) Notification SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter
(K060557), a.k.a. SUPERA™ biliary nitinol stent, in palliative treatment of biliary strictures produced by malignant neoplasms.
Technological Characteristics Compared to Predicate
The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is substantially equivalent to the predicate device. The equivalence was confirmed through preclinical testing.
Image /page/2/Figure/4 description: Figure 1 shows a diagram of a device with multiple labeled parts. The device has a long, thin tube (1) that extends from a central body (2). The central body has several components attached to it, including a valve (4), a connector (5), and a pressure gauge (12). Other labeled parts include (3, 6-11, 13-15).
SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter
ಿ ಹಿಡಿಗಾರಿ ಹಾಸ ಹಾಗೂ ಪ್ರದಾನಿಗಳು ಬಿಡಿದ್ದಾರೆ. ಇವ
: : :
COTICAL
5 3 - 43
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
JAN 31 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy R. Placek Vice President, Regulatory Affairs, Clinical Affairs and Quality Systems IDEV® Technologies, Inc. 1120 NASA Parkway, Suite 600 HOUSTON TX 77058
Re: K071646 Trade/Device Name: SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 28, 2007 Received: December 28, 2007
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.
{4}------------------------------------------------
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,
onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K071646
SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter Device Name:
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)
0
avenc
ision Sign-Off)
sion of Reproductive, Abdominal,
and Radiological Devices
Radiological Devices
510(k) Number K071646
Page 1 of 1
§ 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.