(211 days)
No
The device description and intended use focus on a physical stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to stent esophageal stenoses (strictures) and esophago-respiratory fistulas, and to maintain esophagus lumen patency, which describes a therapeutic intervention to treat a medical condition.
No
This device is an esophageal stent system used for treating strictures, fistulas, and maintaining lumen patency, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components like a stent made of polyester and silicone, and a delivery system with various hardware parts (delivery tube, stent loader, wire guide, etc.). This indicates 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an esophageal stent system used for the mechanical treatment of esophageal strictures and fistulas. It is implanted directly into the body to maintain lumen patency.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely therapeutic and structural.
Therefore, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Polyflex Esophageal Stent System is indicated for stenting:
- Esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures (resectable and non-resectable)
- Stenting esophago-respiratory fistulas
- Maintaining esophageal lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors
Product codes
ESW
Device Description
The Polyflex Esophageal Stent System consists of a stent and delivery system. The stent is composed of a polyester braided material encapsulated with silicone. The stent has blue (endoscopic control) and black (fluoroscopic control) markers at both ends and in the center to aid with stent positioning. The delivery system is provided unassembled and consists of the following components:
- Delivery tube. Used to deliver the stent into the esophagus
- Stent Loader. With basket for loading the stent into the Delivery tube
- Wire Guide with Dilator and stent clamp. For atraumatic introduction of the Delivery tube into the esophagus using a guidewire
- Graduated Soft Positioner. Flexible aid with inner channel to deploy the stent from the Delivery tube
- Stopper. Aid for the temporary fixation of the Polyflex stent during the loading procedure into the Delivery tube.
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)
This is a request to clarify the indication for stenting of esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures, by including resectable or non-resectable strictures. No new materials or design changes were introduced. Therefore, the performance testing presented in 510(k) K030559 was not repeated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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.”
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K080332
Page 1 of 2
Section 5 510(k) Summary
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939
Contact: Ashley Pyle Regulatory Affairs Specialist Date Prepared: February 6, 2008
2. Device
Trade Name: Polyflex Esophageal Single-Use Stent System Common Name: Prosthesis, Esophageal Classification Name: Prosthesis, Esophageal Regulation Number: 878.3610 Product Code: ESW Classification: Class II
3. Predicate Devices
Polyflex Esophageal Single-Use Stent System, K030559
4. Device Description
The Polyflex Esophageal Stent System consists of a stent and delivery system. The stent is composed of a polyester braided material encapsulated with silicone. The stent has blue (endoscopic control) and black (fluoroscopic control) markers at both ends and in the center to aid with stent positioning. The delivery system is provided unassembled and consists of the following components:
- Delivery tube. Used to deliver the stent into the esophagus ●
- Stent Loader. With basket for loading the stent into the Delivery tube ●
- Wire Guide with Dilator and stent clamp. For atraumatic introduction of . the Delivery tube into the esophagus using a guidewire
- Graduated Soft Positioner. Flexible aid with inner channel to deploy the . stent from the Delivery tube
- . Stopper. Aid for the temporary fixation of the Polyflex stent during the loading procedure into the Delivery tube.
SEP - 5 2008
1
K080332
Page 2 of 2
5. Intended Use:
The Polyflex Esophageal Stent System is indicated for stenting:
- Esophageal stenoses, such as stenting refractory benign strictures . and malignant strictures (resectable or nonresectable)
- � Stenting esophago-respiratory fistulas
- Maintaining esophageal lumen patency in esophageal strictures . caused by intrinsic or extrinsic tumors
6. Technological Characteristics:
The proposed Polyflex Esophageal Stent System has identical technological characteristics (materials, construction, manufacturing processes) as the currently marketed Polyflex Esophageal Stent System.
7. Performance Data:
This is a request to clarify the indication for stenting of esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures, by including resectable or non-resectable strictures. No new materials or design changes were introduced. Therefore, the performance testing presented in 510(k) K030559 was not repeated.
8. Conclusion:
The proposed Polyflex Esophageal Stent System is substantially equivalent to the currently marketed Polyflex Esophageal Stent System. BSC is requesting to clarify the indication for, stenting of esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures, by adding resectable and non-resectable strictures, in order define the stricture types, which are within the currently cleared indication, but not explicitly stated,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines emanating from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 5 200
Ms. Ashley Pyle Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752-1234
K080332 Re:
Trade/Device Name: Polyflex™ Single-Use Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: August 28, 2008 Received: August 29, 2008
Dear Ms. Pyle:
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 such 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.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use;
510(k) Number (if known): K080332
Device Name: Polyflex Single-Use Esophageal Stent System
Indications for Use:
Stenting:
- Esophageal stenoses (strictures), such as stenting refractory benign . strictures and/or malignant strictures (resectable and non-resectable)
- . Stenting esophago-respiratory fistulas
- Maintaining esophagus lumen patency in esophageal strictures caused by . intrinsic or extrinsic tumors
Prescription Use X (Part 21 CFR 801 Part 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)
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________