(224 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of the stent and delivery system. There is no mention of AI, ML, or any software component that would utilize such technologies for analysis, diagnosis, or treatment.
Yes
The device (Segmented Esophageal Stent System) is intended for "maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula." This indicates it is used for treating a medical condition for direct patient benefit, which aligns with the definition of a therapeutic device.
No
This device, an esophageal stent, is intended for maintaining luminal patency in strictures and occluding fistulas. It is a therapeutic device inserted into the body, not a device used to diagnose a medical condition.
No
The device description clearly details a physical stent made of Nitinol wire and PTFE, a delivery system, and mentions bench testing related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for maintaining esophageal luminal patency and occluding fistulas in patients with malignant tumors. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical stent designed to be implanted in the esophagus. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's function is mechanical support and occlusion, not the detection or measurement of substances or characteristics in a sample to diagnose a condition.
- Performance Studies: The performance studies focus on biocompatibility and mechanical properties of the device, which are relevant for an implantable medical device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This esophageal stent does not fit that description.
N/A
Intended Use / Indications for Use
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.
Product codes
ESW
Device Description
The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. 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. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. 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
Esophagus
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 Segmented Esophageal Stent System was conducted in accordance with, ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", ISO 11135 'Sterilization of Health Care Products-Ethylene Oxide-Part 1:Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices', and FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices7: Ethylene Oxide Sterilization Residuals', the following tests were conducted:
Stent Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogen
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- Muscle Implant
Delivery System Biocompatibility Testing: - Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
The device specific guidance document was consulted in preparing this premarket submission, VIII Performance testing-Bench of 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: - Visual Inspection
- Dimension Testing
- Deployment Force Testing
- Expansion Force Testing
- Compression Force Testing
- Corrosion Testing
- Tensile Strength Testing
- Sterility Testing
- Shelf Life Testing
- MR Compatibility Testing
The testing performed demonstrated that the proposed device and predicate device are equivalent.
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
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May 29, 2019
Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K182910
Trade/Device Name: Segmented Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 29, 2019 Received: May 2, 2019
Dear Becky Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Shani P. Haugen, Ph.D. Acting, Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182910
Device Name Segmented Esophageal Stent System
Indications for Use (Describe)
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.
| 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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Image /page/3/Picture/2 description: The image shows a logo with the letters "MT" in a stylized, blocky font, colored in blue. A horizontal line is placed beneath the logo. Below the line, the text "Tab 2" is written in a large, bold font. The logo appears to be a trademarked symbol, indicated by the circled 'R' symbol in the upper right corner.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K182910
Date of Preparation: 1.
2019-05-22
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development
Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Becky Li
Position: Quality & Regulatory Affairs Director
Tel: +86-25-58646378
Fax: +86-25-58350006
Email: Beckyli_mt@outlook.com
3. ldentification of Proposed Device
Trade Name: Segmented Esophageal Stent System
Common Name: Prosthesis, Esophageal
Regulatory Information
Classification Name: Esophageal Prosthesis
Classification: 2
Product Code: ESW
Regulation Number: 878.3610
Review Panel: Gastroenterology/Urology
ldentification of Predicate Device 4.
510(k) Number: K072094
Product Name: CHOOSTENT™ Covered Esophageal Stent
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Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, with the "M" slightly overlapping the "T". A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
510K Summary-2019-05-29 updated
Manufacturer: M. I. Tech Co., Ltd.
5. Indications for Use
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
6. Device Description
The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. 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. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. 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.
7. Comparison of Technological Characteristics with a Predicate Device
The Segmented Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and features the same intended use with the predicate device, namely the Esophageal Stent System manufactured by M. I. Tech Co., Ltd., under K072094.
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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern look.
The proposal device is substantially equivalent to the currently marketed devices, CHOOSTENT™ covered esophageal stent, K072094.
The following table is the technological comparison between the proposed device and predicate device CHOOSTENT™ covered esophageal stent (K072094).
Table 2 Technological comparison between the proposed device and predicate device
| ITEM | Proposed Device
Segmented
Esophageal Stent
System | Predicate Device
(K072094)
CHOOSTENTTM covered
esophageal stent | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | ESW | ESW | Same |
| Regulation No. | 878.3610 | 878.3610 | Same |
| Class | 2 | 2 | Same |
| Configuration | Stent and delivery
system | Stent and delivery system | Same |
| Indications for
Use | Segmented
Esophageal Stent
System is intended
for maintaining
esophageal luminal
patency in
esophageal strictures
caused by intrinsic,
or extrinsic malignant
tumors only, and
occlusion of
concurrent
esophageal fistula. | The CHOOSTENTTM
covered esophageal stent
is intended for
maintaining esophageal
luminal patency in
esophageal strictures
caused by intrinsic and or
extrinsic malignant
tumors only and
occlusion of concurrent
esophageal fistula. | Same |
| Single Use | Yes | Yes | Same |
| Diameter of
Stent (mm) | 18,20,22 | 18 | Different |
| Length of
Stent (mm) | 60, 80, 100, 120, 140 | 80, 110, 140, 170 | Different |
| Maximum OD
(D) of Delivery
System (mm) | 6.7 | 6.0 | Different |
| Working
Length (mm) | 650 | 700 | Different |
| ITEM | Proposed Device
Segmented
Esophageal Stent
System | Predicate Device
(K072094)
CHOOSTENT™ covered
esophageal stent | Remark |
| Covering | Fully Covered | Fully Covered | Same |
| Shelf life | 2 years | 3 years | Different |
| Packaging | EO sterilized pouch
with one device per
pouch | EO sterilized pouch with
one device per pouch | Same |
| Biocompatibility | Conform to ISO
10993-1 | Conform to ISO 10993-1 | Same |
| Sterilization | EO Sterilized,
SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| MRI
information | Comply with ASTM F
2503, ASTM F 2052,
ASTM F2119, ASTM
F2182, ASTM F2213 | Comply with ASTM F
2503, ASTM F 2052,
ASTM F2119, ASTM
F2182, ASTM F2213 | Same |
| Labeling | Conform to 21 CFR
part 801 | Conform to 21 CFR part
801 | Same |
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Image /page/6/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional design. The "M" is formed by two angled lines that meet at a point, and the "T" is a vertical line with a horizontal line across the top. The logo has a three-dimensional effect, with the letters appearing to be raised and angled slightly. A circled "R" symbol is located in the upper right corner of the logo, indicating that it is a registered trademark.
510K Summary-2019-05-29 updated
8. Performance Data
The Segmented Esophageal Stent System was conducted in accordance with, ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", ISO 11135 'Sterilization of Health Care Products-Ethylene Oxide-Part 1:Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices', and FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices7: Ethylene Oxide Sterilization Residuals', the following tests were conducted:
Stent Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
7
Image /page/7/Picture/1 description: The image shows a blue logo with the letters 'MT' stacked on top of each other in a stylized, three-dimensional font. The 'M' is on the bottom and the 'T' is on the top. The logo has a registered trademark symbol '®' in the upper right corner. The logo appears to be for a company or organization with the initials 'MT'.
- Pyrogen ●
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- Muscle Implant
Delivery System Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
The device specific guidance document was consulted in preparing this premarket submission, VIII Performance testing-Bench of 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:
- ゃ Visual Inspection
- ゃ Dimension Testing
- ゃ Deployment Force Testing
- ゃ Expansion Force Testing
- ゃ Compression Force Testing
- ゃ Corrosion Testing
- や Tensile Strength Testing
- や Sterility Testing
- ゃ Shelf Life Testing
- ゃ MR Compatibility Testing
The testing performed demonstrated that the proposed device and predicate device are equivalent.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and
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Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional design. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
510K Summary-2019-05-29 updated
performance testing, the Segmented Esophageal Stent System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the CHOOSTENT™ Covered Esophageal Stent (K072094).