(423 days)
Not Found
No
The description focuses on the physical characteristics and function of a self-expanding stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for maintaining esophageal luminal patency in esophageal strictures, which directly treats a medical condition.
No
The device is an esophageal stent designed to maintain patency in esophageal strictures and occluded fistulas, which is a treatment function, not a diagnostic one.
No
The device description clearly describes a physical, self-expanding tubular prosthesis (a stent) made of materials like gold wires and a membrane. It is implanted in the esophagus, which is a hardware component, 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. These tests are performed outside of the body.
- Device Description: The CHOOSTENT™ is a physical, self-expanding stent designed to be implanted inside the esophagus to maintain its patency. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to treat esophageal strictures and fistulas by providing structural support, not to diagnose a condition through laboratory testing.
Therefore, based on the provided information, the CHOOSTENT™ is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CHOOSTENT™ 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.
Product codes
ESW
Device Description
This stent is a self-expanding tubular prosthesis designed to maintain patency of esophageal stricture caused by malignant tumors. The unique structure of the membrane connects the several segments to increase the flexibility of the stent and to prevent migration and tumor in-growth. Since the both ends of stent have larger bands, the stent can be fixed firmly within the esophagus. There are totally 12 excellent radiopaque markers made of gold wires; 4 each on both ends of the stents and another 4 at the center. Two retrieval lassos attached to the both ends play a role in removing the stent when necessary or pulling the stent up to the right position in case the stent has been deployed deeply down the stricture. The fully expanded diameter is 18mm for the body and 24mm for both larger bands. There are four standard lengths: 80mm, 110mm, 140mm, 170mm.
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
The results of bench and test laboratory testing indicates that the new device is as safe and effective as the predicate devices. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of M. I. Tech Co., Ltd. that the CHOOSTENT™ covered Esophageal Stent is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
Key Metrics
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.”
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510(K) Summary M. I. Tech Co., Ltd. 241-3 Habuk-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do 451-864 KOREA Tel.) 82 31 662 5645 Fax) 82 31 662 5648 www.mitech.co.kr Date Prepared: July 7, 2007 Aeyoung Heo, Regulatory Affairs Manager Contact:
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- Identification of the Device: Proprietary-Trade Name: CHOOSTENT™ covered Esophageal Stent Classification Name: Prosthesis, esophageal Product Code ESW Common/Usual Name: Esophageal Stent
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- Equivalent legally marketed devices: Ultraflex™ Esophageal Stent System (K012883, Boston scientific corporation)
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- Indications for Use (intended use) The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patcncy in esophageal strictures caused by intrinsic and or extrinsic malignant turnors only and occlusion of concurrent esophageal fistula.
-
- Description of the Device:. This stent is a self-expanding tubular prosthesis designed to maintain patency of esophageal stricture caused by malignant tumors. The unique structure of the membrane connects the several segments to increase the flexibility of the stent and to prevent migration and tumor in-growth. Since the both ends of stent have larger bands, the stent can be fixed firmly within the esophagus. There are totally 12 excellent radiopaque markers made of gold wires; 4 each on both ends of the stents and another 4 at the center. Two retrieval lassos attached to the both ends play a role in removing the stent when necessary or pulling the stent up to the right position in case the stent has been deployed deeply down the stricture. The fully expanded diameter is 18mm for the body and 24mm for both larger bands. There are four standard lengths: 80mm, 110mm, 140mm, 170mm.
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- Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory testing indicates that the new device is as safe and effective as the predicate devices.
1
| Manufacturer | Boston Scientific | M. I. Tech Co., Ltd. |
|---|---|---|
| Product Name | Ultraflex™ | CHOOSTENT™ |
| 510(k) | K012883 | -- |
| Indication for use | The proposed Ultraflex Esophageal Stent | |
| System is intended for use in esophageal | ||
| strictures caused by intrinsic and/or | ||
| extrinsic malignant tumors. | The CHOOSTENT™ 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. | ||
| Specification comparison | ||
| Deployment time | 21 Sec | 11-17 Sec |
| Expansion force | 0.81 lb. | 0.83 lb. |
| Compression force | 2 lb | 2 lb |
| Dimension: diameter | 18 mm | 18 mm |
| Corrosion (in simulated | ||
| gastric fluid) | No corrosion after 90 days | SAME |
| Tensile strength | >90 lb (more than adequate for safe | |
| removal) | >15 lb. (more than adequate for safe | |
| removal) | ||
| Construction materials | Nitinol wire and Polyurethane | Nitinol wire, gold, and Nusil silicone |
6. Substantial Equivalence Chart
- Conclusion After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of M. I. Tech Co., Ltd. that the CHOOSTENT™ covered Esophageal Stent is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP % 5 2008
M.I. Tech Co., Ltd. c/o Daniel Kamm. P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K072094
Trade/Device Name: CHOOSTENT™ covered Esophageal Stent Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: July 11, 2008 Received: July 21, 2008
Dear Mr. Kamm:
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 such additional controls. Bxisting 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.
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Page 2
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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/odrh/industry/support/index.html.
Sincerely vours.
Jozue M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: CHOOSTENT™ covered Esophageal Stent
Indications For Use:
The CHOOSTENT™ 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.
Prescription Use X (Part 21 CFR 801 Subpart 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)
Hakeh Lewin
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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