K Number
K060557
Device Name
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
Date Cleared
2006-08-15

(166 days)

Product Code
Regulation Number
876.5010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. 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.
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.
More Information

Not Found

No
The device description focuses on the physical components and mechanical properties of a stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes

The device is indicated for "palliative treatment of biliary strictures produced by malignant neoplasms," which directly addresses and alleviates a medical condition, classifying it as a therapeutic device.

No

Explanation: The device is a stent and delivery system used for the palliative treatment of biliary strictures. It is a therapeutic device, not a diagnostic device. While it uses imaging during deployment, it does not analyze or interpret medical images to diagnose a condition.

No

The device description clearly states it is comprised of two physical components: an implantable metallic stent and a delivery system, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the palliative treatment of biliary strictures produced by malignant neoplasms. This is a therapeutic intervention performed in vivo (within the body).
  • Device Description: The device is an implantable metallic stent and a delivery system. This is a medical device used for a surgical or interventional procedure.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.

The device is clearly a therapeutic medical device used for an interventional procedure within the body.

N/A

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

FGE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

biliary strictures, 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K051379, K032457

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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 600
Houston, Texas 77058 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Timothy R. Placek
Vice 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 Stent
Delivery 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.

1

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

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Page 4 - Mr. Timothy Placek