(83 days)
Not Found
No
The device description focuses on the mechanical properties and materials of the stent and its delivery system, with no mention of AI or ML capabilities.
Yes
The device is a stent used to maintain patency of malignant esophageal strictures and to seal tracheoesophageal fistulas, which are therapeutic interventions.
No
The device is a stent used to maintain patency and seal fistulas, which are treatment functions, not diagnostic ones.
No
The device description clearly details a physical, self-expanding metal stent and a stent introduction system, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (stent) and its delivery system. It is designed to be placed within the esophagus.
- Mechanism of Action: The stent physically opens the stricture or seals the fistula. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.
Product codes
ESW
Device Description
The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment.
The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional
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)
The biocompatibility evaluation for the Evolution® Esophageal Stent System - Partially Covered was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016), the following tests were conducted:
- Cytotoxicity
- Irritation
- Sensitization
- Acute Systemic Toxicity
- Implantation (with Histopathology Report)
The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998, the following tests were conducted for the subject device:
- Simulated Use (Including Deployment, Repositioning, Dimensional)
- Corrosion Testing
- Tensile Strength Testing
- Shelf Life Testing (Visual Inspection, Radial Force, Simulated Use, Tensile Strength)
- Visual Inspection
- Torque Testing
- MR Compatibility Testing
The non-clinical data supports the safety of the subject device and demonstrates that the Evolution® Esophageal Stent System - Partially Covered is safe and effective and should perform as intended in the specified use conditions. This non-clinical data supports the substantial equivalence of the Evolution® Esophageal Stent System – Partially Covered to the predicate devices.
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
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
Image /page/0/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, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Cook Ireland Ltd. Jane Kennedy Regulatory Affairs Specialist O'halloran Road, National Technology Park Limerick Ireland
Re: K162717 Trade/Device Name: Evolution® Esophageal Stent System - Partially Covered Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: October 4, 2016 Received: October 6, 2016
Dear Jane Kennedy:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K162717
Device Name
Evolution® Esophageal Stent System - Partially Covered
Indications for Use (Describe)
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5: 510(k) Summary
I. SUBMITTER
Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Persons: Jane Kennedy, Senior Regulatory Affairs Specialist Jacinta Kilmartin, Regulatory Affairs Manager
Phone: +353 61 334440 Fax: +353 61 239293
Date Prepared: December 05, 2016
II. DEVICE
Trade Name of Device: Evolution® Esophageal Stent System – Partially Covered The model numbers are EVO-20-25-8-E, EVO-20-25-10-E, EVO-20-25-12.5-E and EVO-20-25-15-E.
Common or Usual Name: Esophageal Stent
Classification Name: Esophageal Prosthesis (21 CFR 878.3610)
Regulatory Class: II
Product Code: ESW
4
III. PREDICATE DEVICE
Primary Predicate: Evolution™ Esophageal Stent System, K080359 cleared May 09, 2008. Second Predicate: Evolution™ Esophageal Stent System - Fully Covered, K093619 cleared on June 17th, 2010.
The predicate devices detailed above have never been subject to a design related recall.
DEVICE DESCRIPTION IV.
The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment.
The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
V. INDICATIONS FOR USE
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.
The intended use of the subject and predicate devices are identical.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A VI. PREDICATE DEVICE
The subject device is substantially equivalent to the currently marketed devices, the Evolution® Esophageal Stent System, K080359 cleared May 09, 2008 and the Evolution™ Esophageal Stent System – Fully Covered, K093619 cleared on June 17th, 2010.
In brief, the subject device is identical to/ within the range of the Evolution® Esophageal Stent System, K080359, primary predicate device, and the Evolution™ Esophageal Stent System -Fully Covered, K093619, with respect to the following:
- । Stent material
- Stent dimensions ।
- । Stent function
- -Introduction system dimensions
- -Introduction system materials
- । Shelf life
- -Principle of operation
- -For professional use
- For single use
- -Sterility (Ethylene oxide, EO)
The following technological differences exist between the subject device and the Evolution Esophageal Stent System, K080359, primary predicate device, and the Evolution™ Esophageal Stent System - Fully Covered, K093619:
- । Materials and configuration of the stent lasso loop.
- MRI Information ।
PERFORMANCE DATA VII.
The biocompatibility evaluation for the Evolution® Esophageal Stent System - Partially Covered was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016), the following tests were conducted:
- Cytotoxicity -
- -Irritation
- Sensitization -
- Acute Systemic Toxicity -
6
-
-Implantation (with Histopathology Report)
The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998, the following tests were conducted for the subject device: -
Simulated Use (Including Deployment, Repositioning, Dimensional) -
-
। Corrosion Testing
-
-Tensile Strength Testing
-
Shelf Life Testing (Visual Inspection, Radial Force, Simulated Use, Tensile Strength) |
-
-Visual Inspection
-
Torque Testing -
-
-MR Compatibility Testing
CONCLUSIONS VIII.
The non-clinical data supports the safety of the subject device and demonstrates that the Evolution® Esophageal Stent System - Partially Covered is safe and effective and should perform as intended in the specified use conditions. This non-clinical data supports the substantial equivalence of the Evolution® Esophageal Stent System – Partially Covered to the predicate devices.