(421 days)
No
The summary describes a physical medical device (a stent) and its delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on the physical properties and function of the stent.
Yes
The device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula, which directly treats or alleviates a medical condition.
No
The device is a stent used to maintain patency and seal fistulas, which serves a therapeutic or palliative function rather than diagnosing a condition.
No
The device description explicitly states it is a "nonsterile, disposable device" and includes "Coated Metal Expandable stents in varying lengths and components to facilitate stent delivery," 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 is to maintain patency of esophageal strictures and/or seal tracheoesophageal fistulas. This is a therapeutic and structural function performed within the body.
- Device Description: The device is a stent, which is an implantable medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is used for treatment and structural support within the body.
N/A
Intended Use / Indications for Use
Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula.
Product codes
79 ESW
Device Description
The Esophageal Z-Stent with Dua Anti-Reflux Valve is a nonsterile, disposable device, used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula. The product line includes Coated Metal Expandable stents in varying lengths and components to facilitate stent delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
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)
Design Control, Risk Analysis, Design Verification and Validation activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The Design Control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The Risk Analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element to eliminate, the potential to detect and our recommended actions were also documented. Additional testing to support the modifications to the predicate stent and introduction system has been conducted. During Design Verification and Validation, visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification and Validation met our predetermined acceptance criteria for this product line. Data from this testing has been documented and retained in our files.
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
RE: 510(k): DEVICE MODIFICATION, ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE (K011591)
510(k) Summary of Safety & Effectiveness
Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Blvd. Winston-Salem, NC 27105
Device Description: The Esophageal Z-Stent with Dua Anti-Reflux Valve is a nonsterile, disposable device, used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula. The product line includes Coated Metal Expandable stents in varying lengths and components to facilitate stent delivery.
| Trade Name: | Esophageal Z-Stent with Dua Anti-Reflux Valve |
|---|---|
| Classification Name/Code: | Prosthesis, Esophageal/79 ESW |
Classification: FDA has classified similar devices as Class II as per 21 CFR §878.3610 This device falls within the purview of the General and Plastic Surgery Device Panel.
Common/Usual Name: Esophageal Prosthesis
Establishment Registration Number: 1037905
Sterility: The Esophageal Z-Stent with Dua Anti-Reflux Valve is a non-sterile, disposable device.
Performance Standards: Performance standards applicable to Esophageal Prostheses have not been established by the Food and Drug Administration.
Intended Use: Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula.
Predicate Device(s):
| Predicate Device | Manufacturer | Document Control
Number |
|---------------------------------|--------------------------|----------------------------|
| Covered Esophageal Z-
Stent | Wilson-Cook Medical Inc. | K920218 |
| Wilson-Cook Colonic Z-
Stent | Wilson-Cook Medical Inc. | K990034 |
Substantial Equivalence:
The modified Esophageal Z-Stent with Dua Anti-Reflux Valve is substantially equivalent to the referenced predicate devices in that it is similar or identical with respect to technological characteristics, materials of construction and intended use.
1
K011.597-52
RE: 510(k): DEVICE MODIFICATION, ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE (K011591)
| Characteristic | Esophageal Z-Stent
with Dua Anti-Reflux
Valve[Subject of
"Special" 510(k)] | Predicate Wilson-Cook
Coated Esophageal Z-
Stent (K920218) | Predicate Wilson-
Cook Colonic Z-
Stent (K990034) | | |
|----------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to maintain
patency of malignant
esophageal strictures
and/or to seal
tracheoesophageal
fistula. | Used to maintain patency
of malignant esophageal
strictures and/or to seal
tracheoesophageal fistula | Used to maintain
patency of malignant
colonic strictures in
patients having high
operative risk and/or
advanced disease. | | |
| | Sterility | Non-Sterile,
Disposable | Non-Sterile, Disposable | Non-Sterile,
Disposable | |
| | | Prostheses
Configuration | Metal expandable Z-
Stent Fully and
Partially Coated | Metal expandable
Covered Z-Stent | Metal expandable Z-
Stent |
| | Introduction
System | | Radiopaque coaxial
catheter, Dilator Tip,
Loading Funnel,
Locking Ring, Thumb
Ring w/String, Guiding
Catheter and Wire
Guide | Radiopaque coaxial
catheter, Wire Guide | Radiopaque coaxial
catheter, Dilator Tip,
Loading Funnel,
Locking Ring, Thumb
Ring w/String,
Guiding Catheter
and Wire Guide |
| | | | Stent
Construction | Stent: Stainless Steel,
Suture, Solder
Coating:
Polyurethane | Stent: Stainless Steel,
Suture, Solder Coating:
Polyurethane |
| | | Stent Sizes | | 25 mm flared distal
ends, 18 mm shaft
Lengths: 8-14 cm | 18, 21 & 25 mm flared
distal ends, 15, 18 mm
shaft. Lengths: 6-14 cm |
510(k) Summary of Safety & Effectiveness (continued)
Reasonable assurance of biocompatibility for the patient Biocompatibility: contacting materials has been established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results.
Design Control/Risk Analysis/Design Verification/Validation:
Design Control, Risk Analysis, Design Verification and Validation activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The Design Control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The Risk Analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element to eliminate, the potential to detect and our recommended actions were also documented. Additional testing to support the modifications to the predicate stent and introduction system has been conducted. During Design Verification and Validation, visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification and Validation met our predetermined acceptance criteria for this product line. Data from this testing has been documented and retained in our files.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2002
Re: K011591
Ms. Paula Joyce Vice President, QA/RA Wilson-Cook® Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Trade/Device Name: Wilson-Cook® Esophageal Z-Stent with Dua Anti-Reflux Valve Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 79 ESW Dated: April 19, 2002 Received: April 22, 2002
Dear Ms. Joyce:
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.
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 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 this 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" (21 CFR Part 807.97). 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/cdrh/dsma/dsmamain.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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Wilson-Cook Esophageal Z-Stent with Dua Anti-Reflux Valve
Indications for Use:
Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.
(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 of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011591
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)