(57 days)
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No
The document describes a mechanical stent and its insertion tools, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device addresses medical conditions like "Airway complications such as anastomosis and stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus))". These are medical conditions, and a device used to treat or alleviate them is a therapeutic device. The "Device Description" also refers to it as a "stent," which is a common therapeutic implant.
No
The "Intended Use / Indications for Use" section lists airway complications like anastomosis, stenosis, and fistulas that the device treats or manages, rather than diagnoses. The "Device Description" explains it is a stent kit for insertion into the human body, consistent with a therapeutic or palliative device.
No
The device description explicitly states it is a "Rusch Polyflex Stent Kit" consisting of a medical silicone stent and components for insertion, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes treating physical conditions within the body (airway complications, strictures, fistulas) by inserting a device. This is a therapeutic or interventional use, not a diagnostic one.
- Device Description: The device is a stent kit designed to be inserted into the human body to support airways. This is a physical implantable device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The indications for use for the Polyflex Stent Kit are as follows: Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .
Product codes (comma separated list FDA assigned to the subject device)
NYT
Device Description
The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper. This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
airway, trachea, main bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Boston Scientific Ultraflex®, Schneider Wall Stent, Cook Gianturco-Wallace Tracheobronchial "2" Stent, Bryan Dumon Tracheal Bronchial Stent, Hood Tracheal Bronchial Stent, Hood Westaby Stent
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).
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§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
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RUSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
NOV 2 7 2001
510 (k) Summary
Submitter Name, Address, and Date of Submission. 1.
Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone: (603) 532-8211 Facsimile:
Contact: Same as above
Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Tracheal Prosthesis
Common Name: Tracheal Bronchial Stent
Proprietary Name: Rüsch Polyflex Stent Kit
Identification of the legally marketed device to which the 3. submitter claims equivalence.
The Rusch Polyflex Stent is substantially equivalent to the Boston Scientific Ultraflex®, Schneider Wall Stent, the Cook Gianturco-Wallace Tracheobronchial "2" Stent, and Bryan Dumon Tracheal Bronchial Stent-,Hood Tracheal Bronchial Stent, and Hood Westaby Stent
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Description of the Device. 4 .
The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.
Intended Use of the Device. 5 .
The indications for use for the Polyflex Stent Kit are as follows:
Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .
Summary of Technological Characteristics. 6.
The following technological characteristics are the same as fic for equivalent to the predicate device, the Boston Scientific Ultraflex® and the Schneider Wall Stent. The primary material of the Rüsch Polyflex Stent is medical grade silicone surrounding the braided polyester woven seenforcement. This is equivalent to the proprietary polymer surrounding the superalloy braided monofilament metal reenforcement of the Schneider Stent. moth Stents are supplied with Stent insertion accessories, which allow for placement of the Stent into the body.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name written around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566
Re: K013266
Trade/Device Name: Rusch Polyflex Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: NYT Dated: September 27, 2001 Received: October 1, 2001
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of November 27, 2001.
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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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
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Page 2 - Ms. Angela Byland
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Huber Lemur
L. Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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