(127 days)
No
The description focuses on the mechanical properties and deployment mechanism of a physical stent and its introducer system. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
Explanation: The device is intended to treat esophageal strictures caused by malignant tumors by implanting a metallic stent, which directly addresses a medical condition.
No
The device is described as an implantable metallic stent used to treat esophageal strictures, not to diagnose them. It's a therapeutic device.
No
The device description clearly outlines physical components (metallic stent, introducer system, Nitinol wire, silicone covering) and mentions bench testing for physical properties, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The Esophageal TTS Stent is an implantable medical device designed to be placed inside the esophagus to treat strictures. It is a physical prosthesis, not a test performed on a sample.
- Intended Use: The intended use is to treat esophageal strictures caused by malignant tumors, which is a therapeutic intervention, not a diagnostic test.
- Input Modality: The input modality is fluoroscopy, which is an imaging technique used for guidance during the placement of the device, not for analyzing a biological sample.
The device is a therapeutic medical device, specifically a stent, used to physically open up a narrowed passage in the esophagus.
N/A
Intended Use / Indications for Use
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Product codes
ESW
Device Description
The Esophageal TTS Stent consists of the implantable metallic stent and introducer system.
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare).
The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy (for guidance)
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
Bench Testing: To establish the substantial equivalence of the Esophageal TTS Stent, bench testing was conducted on both the 22mm diameter size and the 220cm length to validate the performance of the device. The following tests were conducted:
- Deployment Test
- Deployment Force Test
- Expansion Force Test
- Compression Force Test
- Dimensional Test
- . Tensile Strength Test (Introducer System)
- Corrosion Test.
The following tests were also conducted: - Packaging Adhesive Force Test
- MR Compatibility.
The results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate and reference devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Taewoong Medical Co., Ltd % Jennifer Moyer Consultant, Medical Devices Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314
Re: K211706
Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: June 1, 2021 Received: June 3, 2021
Dear Jennifer Moyer:
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. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Shanil P. Haugen, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211706
Device Name Esophageal TTS Stent
Indications for Use (Describe)
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K211706 Page 1 of 5
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Esophageal TTS Stent is provided below.
1. SUBMITTER
| Applicant: | Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeongg
do, Korea, 10022
Phone: +82-31-996-0641
Fax: +82-31-996-0645 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Yonjin Jeff Kim
Regulatory Affairs / Quality Management Dept
Phone: +82-31-993-0641-4 (Ext.# 125)
Fax: 82-31-996-0645-6
E-mail: jinjeff@stent.net |
| Submission Correspondent: | Jennifer Moyer
Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: (571) 279-5811
Email: jmoyer@biologicsconsulting.com |
| Date Prepared: | August 24, 2021 |
2. DEVICE
| Device Trade Name: | Esophageal TTS Stent |
|---|---|
| Device Common Name: | Esophageal Stent |
| Classification Name | 878.3610, Prosthesis, Esophageal |
| Regulatory Class: | Class II |
| Product Code: | ESW |
3. PREDICATE DEVICE
| Primary Predicate Device: | K113551, Taewoong Esophageal TTS Stent |
|---|---|
| Additional Predicate Device: | K123205, Taewoong Esophageal TTS Stent |
| Reference Device: | K180144, Boston Scientific Agile Esophageal Stent System |
| Reference Device: | K200860, M.I. Tech HANAROSTENT Esophagus TTS |
| (CCC) and HANAROSTENT Esophagus TTS (NCN) |
4
DEVICE DESCRIPTION 4.
The Esophageal TTS Stent consists of the implantable metallic stent and introducer system.
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare).
| Type | Shape | Model Numbers* |
|---|---|---|
| Full Covered Type | Image: Stent Shape | ESTxxyyF |
| Both Bare Type | Image: Stent Shape | ESTxxyyB |
Image /page/4/Figure/6 description: This image shows a medical device with several labeled parts. The device includes a hub, pusher, and a Y-connector on the left side. Moving towards the right, there is a locking knob, an outer sheath, a yellow marker, and a stent, with proximal, center, and distal X-ray markers along the stent, and a tip at the far right end.
Image /page/4/Figure/7 description: The image shows the text "Figure 1: Introducer". The text is in black font and is centered on the page. The words "Figure 1:" are in a smaller font size than the word "Introducer". The text is likely a title or heading for a document or presentation.
The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.
5. INTENDED USE/INDICATIONS FOR USE
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Subject Device Indication for Use: For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Primary Predicate Device (Taewoong Esophageal TTS Stent: K113551) Indication for Use: For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Additional Predicate Device (Taewoong Esophageal TTS Stent: K123205) Indication for Use: For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
5
Technological Comparisons
Table 1 below compares the key technological feature of the subject devices to the primary predicate device (Taewoong Esophageal TTS Stent: K113551) and the additional predicate (Taewoong Esophageal TTS Stent: K123205).
| Proposed Device | Primary Predicate Device | Additional Predicate | |
|---|---|---|---|
| 510(k) Number | TBD | K113551 | K123205 |
| Applicant | Taewoong Medical Co., Ltd. | Taewoong Medical Co., Ltd. | Taewoong Medical Co., Ltd. |
| Device Name | Esophageal TTS Stent | Esophageal TTS Stent | Esophageal TTS Stent |
| Classification | |||
| Regulation | 878.3610 | 878.3610 | 878.3610 |
| Product Code | ESW | ESW | ESW |
| Indications for Use | For use in esophageal | ||
| strictures caused by intrinsic | |||
| and/or extrinsic malignant | |||
| tumors. | For use in esophageal | ||
| strictures caused by intrinsic | |||
| and/or extrinsic malignant | |||
| tumors. | For use in esophageal strictures | ||
| caused by intrinsic and/or | |||
| extrinsic malignant tumors. | |||
| Design (Stent) | Image: Stent | Image: Stent | Image: Stent |
| Nitinol wire | |||
| Diamond shape | |||
| Length; 60, 80, 100, 120, 140, | |||
| 150mm | |||
| Body Diameter/Head | |||
| Diameter; | |||
| • 18mm/26mm | |||
| • 20mm/26mm | |||
| • 22mm/28mm | |||
| Coverage : | |||
| • Silicone Full Covered | |||
| • Silicone Both Bare | |||
| Radiopaque Markers: 8 Pt/Ir, 2 | |||
| STS 316L | Nitinol wire | ||
| Diamond shape | |||
| Length; 60, 80, 100, 120, 140, | |||
| 150 mm | |||
| Body Diameter/Head | |||
| Diameter; 18mm/26mm | |||
| Coverage : | |||
| • Silicone Full Covered | |||
| • Silicone Both Bare | |||
| Radiopaque Markers: 8 Pt/Ir, 2 | |||
| STS 316L | Nitinol wire | ||
| Diamond shape | |||
| Length; 60, 80, 100, 120, 140, | |||
| 150 mm | |||
| Body Diameter/Head Diameter; | |||
| 20mm/26mm | |||
| Coverage : | |||
| • Silicone Full Covered | |||
| • Silicone Both Bare | |||
| Radiopaque Markers: 8 Pt/Ir, 2 | |||
| STS 316L |
Table 1: Technological Comparison – Predicate Devices
6
| Proposed Device | Primary Predicate Device | Additional Predicate | |
|---|---|---|---|
| Design (Introducer) | Image: Proposed Device | Image: Primary Predicate Device | Image: Additional Predicate |
| Co-axial tube type | |||
| Usable Length; | |||
| · 180cm (for diameter 22mm | |||
| stent) | |||
| · 220cm (for diameter 18, 20 & | |||
| 22 mm stent) | |||
| Diameter; 10.5 Fr (3.5mm) | Co-axial tube type | ||
| Usable Length; | |||
| · 180cm (for diameter 18mm | |||
| stent) | |||
| Diameter; 10.5 Fr (3.5mm) | Co-axial tube type | ||
| Usable Length; | |||
| · 180cm (for diameter 18mm | |||
| stent) | |||
| Diameter; 10.5 Fr (3.5mm) | |||
| Single Use | Yes | Yes | Yes |
| Sterile | EO Sterilization | EO Sterilization | EO Sterilization |
| Method of Placement | Endoscopic | Endoscopic | Endoscopic |
| Method of | |||
| Deployment | Release by pulling outer | ||
| sheath | Release by pulling outer | ||
| sheath | Release by pulling outer sheath | ||
| Materials | Stent - Nitinol, Pt/Ir, | ||
| STS316L | |||
| Cover – Silicone | |||
| Introducer – Teflon, PE, ABS | Stent - Nitinol, Pt/Ir, | ||
| STS316L | |||
| Cover – Silicone | |||
| Introducer - Teflon, PE, ABS | Stent - Nitinol, Pt/Ir, STS316L | ||
| Cover – Silicone | |||
| Introducer – Teflon, PE, ABS |
7. PERFORMANCE DATA
Biocompatibility Testing
The Esophageal TTS Stent was evaluated according to the FDA's guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluating and testing within a risk management process" and it has been determined that no additional biocompatibility testing is required due to the device modification described in this submission.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Not applicable. The device contains no software.
7
Bench Testing
To establish the substantial equivalence of the Esophageal TTS Stent, bench testing was conducted on both the 22mm diameter size and the 220cm length to validate the performance of the device. The following tests were conducted:
- Deployment Test, ●
- Deployment Force Test,
- Expansion Force Test, ●
- Compression Force Test, ●
- Dimensional Test, ●
- . Tensile Strength Test (Introducer System),
- Corrosion Test.
The following tests were also conducted:
- Packaging Adhesive Force Test,
- MR Compatibility.
The results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate and reference devices.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSION 8.
Performance testing was conducted on all key performance attributes of the device. All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device.