(242 days)
Not Found
No
The device description focuses on the physical components and mechanical properties of the stent and delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are also focused on material and mechanical properties, not algorithmic performance.
Yes
The device is described as an Esophageal Stent System intended for maintaining esophageal strictures and occluding esophageal fistulas, which is a therapeutic function.
No
The device is a stent system used to maintain esophageal strictures and occlude fistulas, which is a treatment or palliative measure, not a diagnostic one.
No
The device description clearly outlines physical components including a self-expanding metal stent, a stent introduction system, a handle, nitinol wire, a silicone membrane, and radiopaque bands. These are all hardware components, not software.
No, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this is an implantable medical device (a stent) used to treat a physical condition within the body (esophageal strictures and fistulas). It is introduced directly into the patient's esophagus.
- Intended Use: The intended use is to maintain esophageal strictures and occlude fistulas, which are therapeutic interventions performed directly on the patient, not diagnostic tests performed on samples outside the body.
The device is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Esophageal Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Product codes (comma separated list FDA assigned to the subject device)
ESW
Device Description
The Esophageal Stent System 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 ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal 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
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 biocompatibility evaluation for the 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" 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:
Biocompatibility Testing on Stent:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity
- Salmonella Reverse Mutation
- Implantation
- Toxicological Risk Assessment based on Chemical Characterization
Biocompatibility Testing on Introduction System: - Cytotoxicity
- Sensitization
- Irritation
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:
- 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
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.
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.
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.”
0
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June 21, 2018
Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director No.10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K172813 Trade/Device Name: Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 13, 2018 Received: April 17, 2018
Dear Becky Li:
This letter corrects our substantially equivalent letter of May 18, 2018.
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 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.
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,
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Jeffrey W. Cooper -S 2018.06.21 16:26:16
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Esophageal Stent System
Indications for Use (Describe)
The Esophageal Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510K Summary
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: K172813
1. Date of Preparation: 05/22/2018
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 & RA Director
Tel: +86-25-58646378
Fax: +86-25-58350006
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: 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
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4. Identification of Predicate Device
510(k) Number: K091510
Product Name: WallFlex Esophageal Fully Covered Stent System
5. Indications for Use
Esophageal Stent System 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.
6. Device Description
The Esophageal Stent System 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 ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal 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.
The detail dimension information of the proposed device is as follows:
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510K Summary
| No | Model | Diameter
of Stent
(D) | Diameter
of Stent
(D1,D2) | Length
of
Stent
(L) | Length
of
Stent
(LO) | Maximum
OD
(D) of
Delivery
System | Working
Length
(L) | Covering |
|----|------------------|-----------------------------|---------------------------------|------------------------------|-------------------------------|-----------------------------------------------|--------------------------|----------------------|
| 1 | NST01-222-18.060 | 18 | 23 | 060 | 030 | 6.7 | 650 | Partially
Covered |
| 2 | NST01-222-18.080 | 18 | 23 | 080 | 050 | 6.7 | 650 | Partially
Covered |
| 3 | NST01-222-18.100 | 18 | 23 | 100 | 070 | 6.7 | 650 | Partially
Covered |
| 4 | NST01-222-18.120 | 18 | 23 | 120 | 090 | 6.7 | 650 | Partially
Covered |
| 5 | NST01-222-18.140 | 18 | 23 | 140 | 110 | 6.7 | 650 | Partially
Covered |
| 6 | NST01-222-18.150 | 18 | 23 | 150 | 120 | 6.7 | 650 | Partially
Covered |
| 7 | NST01-222-20.060 | 20 | 25 | 060 | 030 | 6.7 | 650 | Partially
Covered |
| 8 | NST01-222-20.080 | 20 | 25 | 080 | 050 | 6.7 | 650 | Partially
Covered |
| 9 | NST01-222-20.100 | 20 | 25 | 100 | 070 | 6.7 | 650 | Partially
Covered |
| 10 | NST01-222-20.120 | 20 | 25 | 120 | 090 | 6.7 | 650 | Partially
Covered |
| 11 | NST01-222-20.140 | 20 | 25 | 140 | 110 | 6.7 | 650 | Partially
Covered |
| 12 | NST01-222-20.150 | 20 | 25 | 150 | 120 | 6.7 | 650 | Partially
Covered |
| 13 | NST01-222-22.060 | 22 | 27 | 060 | 030 | 6.7 | 650 | Partially
Covered |
| 14 | NST01-222-22.080 | 22 | 27 | 080 | 050 | 6.7 | 650 | Partially
Covered |
| 15 | NST01-222-22.100 | 22 | 27 | 100 | 070 | 6.7 | 650 | Partially
Covered |
| 16 | NST01-222-22.120 | 22 | 27 | 120 | 090 | 6.7 | 650 | Partially
Covered |
| 17 | NST01-222-22.140 | 22 | 27 | 140 | 110 | 6.7 | 650 | Partially
Covered |
| 18 | NST01-222-22.150 | 22 | 27 | 150 | 120 | 6.7 | 650 | Partially
Covered |
| | | | | | | 510K Summary | | |
| 19 | NST01-224-18.060 | 18 | 23 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 20 | NST01-224-18.080 | 18 | 23 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 21 | NST01-224-18.100 | 18 | 23 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 22 | NST01-224-18.120 | 18 | 23 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 23 | NST01-224-18.140 | 18 | 23 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 24 | NST01-224-18.150 | 18 | 23 | 150 | 120 | 6.7 | 650 | Fully Covered |
| 25 | NST01-224-20.060 | 20 | 25 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 26 | NST01-224-20.080 | 20 | 25 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 27 | NST01-224-20.100 | 20 | 25 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 28 | NST01-224-20.120 | 20 | 25 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 29 | NST01-224-20.140 | 20 | 25 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 30 | NST01-224-20.150 | 20 | 25 | 150 | 120 | 6.7 | 650 | Fully Covered |
| 31 | NST01-224-22.060 | 22 | 27 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 32 | NST01-224-22.080 | 22 | 27 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 33 | NST01-224-22.100 | 22 | 27 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 34 | NST01-224-22.120 | 22 | 27 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 35 | NST01-224-22.140 | 22 | 27 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 36 | NST01-224-22.150 | 22 | 27 | 150 | 120 | 6.7 | 650 | Fully covered |
Table 1 Dimension information of proposed device (Unit: mm)
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4/8
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510K Summary
7. Comparison of Technological Characteristics with a Predicate Device
The Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific Corporation Predicate Device, WallFlex Esophageal Fully Covered Stent System, under K091510.
The proposal device is substantially equivalent to the currently marketed devices, WallFlex Esophageal Fully Covered Stent System, K091510 cleared June 26, 2009.
The following table is the technological comparison between the proposed device and predicate device WallFlex Esophageal Fully Covered Stent System (K091510).
| ITEM | Proposed Device
Esophageal Stent System | Predicate Device (K091510)
WallFlex Esophageal Fully
Covered Stent System | Remark |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Diameter of Stent (mm) | 18,20,22 | 18,23 | One more different
diameter than
predicate device. More
diameter could provide
more choices. |
| Length of Stent (mm) | 60, 80, 100, 120, 140, 150 | 103, 123, 153
105, 125, 155 | More short lengths
than predicate device.
More length can
provide more choices
for users |
| Maximum OD (D) of
Delivery System (mm) | 6.7 | 6.17 | Different but similar |
| Working Length (mm) | 650 | 780 | Different working
length, but similar |
| Image: Logo | | | 510K Summary |
| Covering | Partially Covered, Fully
Covered | Fully Covered | The proposed device
includes partially
covered and fully
covered. The
predicate device only
has fully covered. |
| Main Stent material | Nitinol, Silicone | Nitinol, Silicone | Same |
| Main Introduction system
materials | PTFE, Pebax | PTFE, Pebax | Same |
| Indications for Use | Esophageal Stent System
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. | The WallFlex Esophageal
Fully Covered Stent System
is intended for maintaining
esophageal luminal patency
in esophageal strictures
caused by instrinsic and/or
extrinsic malignant tumors,
and occlusion of concurrent
esophageal fistula. | Same |
| Stent function | maintaining esophageal
luminal patency in
esophageal strictures | maintaining esophageal
luminal patency in
esophageal strictures | Same |
| Shelf life | 2 years | 1.5 years | Different, longer shelf
life than predicate
device |
| Principle of operation | The proposed device
consists of the stent and
delivery system. The outer
tube of the delivery system
serves to constrain the
stent before deployment
and reposition the stent, if
desired, after partial
deployment. Loosen the
safe lock, then withdraw the
front handle to deploy the
stent. Take the opposite
action to reposition the
stent | The proposed device
consists of the stent and
delivery system. The outer
tube of the delivery system
serves to constrain the stent
before deployment and
reposition the stent, if
desired, after partial
deployment. Loosen the
safe lock, then withdraw the
front handle to deploy the
stent. Take the opposite
action to reposition the stent | Same |
| Single Use | Yes | | |
| 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 | MR conditional
scanning parameters
are different |
Table 2 Technological comparison between the proposed device and predicate device
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Image /page/8/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the text "MICRO-TECH" in a similar blue font. Below the text "MICRO-TECH" are two Chinese characters.
9
Image /page/9/Picture/2 description: The image contains the logo for Micro-Tech. The logo consists of a blue stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in blue. Below the company name are two Chinese characters, also in blue. The logo appears to be for a technology-related company.
8. Performance Data
The biocompatibility evaluation for the 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" 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:
Biocompatibility Testing on Stent:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity
- Salmonella Reverse Mutation
- Implantation
- Toxicological Risk Assessment based on Chemical Characterization
Biocompatibility Testing on Introduction System:
- Cytotoxicity
- Sensitization
- Irritation
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:
- ゃ Visual Inspection
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Image /page/10/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text "MICRO-TECH" are two Chinese characters.
- や Dimension Testing
- ゃ Deployment Force Testing
- Expansion Force Testing ゃ
- ゃ Compression Force Testing
- や Corrosion Testing
- や Tensile Strength Testing
- や Sterility Testing
- ゃ Shelf Life Testing
- や MR Compatibility Testing
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 performance testing, the 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 WallFlex Esophageal Fully Covered Stent System(K091510).