(129 days)
Not Found
K 982614
No
The 510(k) summary describes a mechanical stent and its delivery system, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is intended to treat esophageal stenoses and fistulas, which are medical conditions, and maintains lumen patency, thus providing a therapeutic effect.
No
This device is a stent used to maintain lumen patency in the esophagus, which is a therapeutic function, not a diagnostic one.
No
The device description clearly lists multiple hardware components (Stent, Introducer Sleeve, Stent Loader, Insertion Tube, etc.), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for treating conditions within the esophagus (stenting strictures, maintaining lumen patency, treating fistulas). This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device components are all related to the physical placement and function of a stent within the esophagus. There are no components related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or prognosis
Therefore, the Rüsch Polyflex Stent for the Esophagus is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rüsch Polyflex Stent for the Esophagus with Introducer System intended for use with Esophageal Stenoses, indications are: Stenting: Esophageal stenoses (strictures), such as stenting refractory benign and/or malignant strictures. Esophageal-respiratory-fistula. Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors.
Product codes (comma separated list FDA assigned to the subject device)
79ESW
Device Description
The Rüsch Polyflex Stent for the Esophagus with Introducer System consists of the Polyflex Stent, Introducer Sleeve, Stent Loader, Insertion Tube with Dilator, Soft Positioner, Stopper and Stent Clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
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.
Not Found
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.
K 982614
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
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”
0
JUN 3 0 2003
Image /page/0/Picture/1 description: The image shows a document with the text "K030559" at the top, which appears to be a document or reference number. Below that, it says "page 1 of 2", indicating that this is the first page of a two-page document. The word "RUSCH" is prominently displayed in a bold, stylized font, followed by "INTERNATIONAL" and "Group Regulatory Affairs" in smaller fonts. The text "A Subsidiary of Teleflex incorporated (USA)" is at the bottom of the image.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510 (k) Summary
Submitter Name, Address, and Date of Submission. 1.
Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone: Facsimile: (603) 532-6207
Contact: Same as above
2 . Name of the Device, Common, Proprietary (if Known), and Classification.
Classification:
Class II, Product Code 79ESW, 21 CFR 878.3610
Common Name:
Esophageal Stent
Proprietary Name:
Rüsch Polyflex Stent for the Esophaqus with Introducer/Delivery System
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Rüsch Polyflex Stent for the Esophagus with Introducer System is substantially equivalent to the Hood Esophageal Prosthesis, Boston Scientific Ultraflex™, Boston Scientific Wall Stent, Cook, Inc. Esophageal Z-Stent, and the Wilson-Cook Esophageal Prosthesis Set.
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K030559", and the text below reads "page 2 of 2". The handwriting is in black ink and appears to be clear and legible.
page 2
Description of the Device. 4 .
The Rüsch Polyflex Stent for the Esophagus with Introducer System consists of the Polyflex Stent, Introducer Sleeve, Stent Loader, Insertion Tube with Dilator, Soft Positioner, Stopper and Stent Clamp.
Intended Use of the Device. 5.
The Rüsch Polyflex Stent for the Esophagus with Introducer System intended for use with Esophageal Stenoses, indications are: Stenting: Esophageal stenoses (strictures), such as stenting refractory benign and/or malignant strictures. Esophageal-respiratory-fistula. Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors.
Summary of Technological Characteristics. 6.
The following technological characteristics are the same as or equivalent to predicate devices:
The stent is constructed with an integral polyester braid, which is surrounded by medical grade silicone. This is the same construction as Rüsch Polyflex Stent Kit, which was cleared under K 982614.
The product is delivered through the mouth via a delivery system as is the Wilson Cook Esophageal Prosthesis, the Boston Scientific Ultraflex or Hood Prosthesis.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2003
Ms. Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park JAFFREY NH 03452
Re: K030559
Trade/Device Name: Rüsch Polyflex Stent for the Esophagus with Introducer/Delivery System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 79 ESW Dated: June 6, 2003 Received: June 10, 2003
Dear Ms. Brozowski:
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 application (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. Iisting 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 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.
3
This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. 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/cdrf/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K030559
Device Name: Rüsch Polyflex Stent for the Esophagus with Introducer System
Indications for Use:
Stenting:
Esophaqeal stenoses (strictures), such as stenting refractory beniqn strictures and/or malignant strictures
Esophageal-respiratory-fistula
Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
David A. Seagram
510k) N