(28 days)
No
The summary describes a mechanical stent and delivery system, with no mention of AI or ML in its function or description.
Yes
The device is described as an implantable metallic stent intended "to restore the structure and/or function of the esophagus" by establishing patency in esophageal strictures. This restorative function directly addresses a medical condition, qualifying it as a therapeutic device.
No
The device is an esophageal stent intended for treatment (restoring structure and function), not for diagnosing medical conditions.
No
The device description explicitly states it consists of an implantable metallic stent and a disposable, flexible introducer system, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description clearly states that this is an implantable metallic stent and a delivery system intended to be placed within the esophagus to restore its structure and function. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Intended Use: The intended use is to treat esophageal strictures and fistulas, which is a therapeutic application, not a diagnostic one.
The device is a medical device, specifically an implantable therapeutic device, but it does not fit the definition of an In Vitro Diagnostic.
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 and occlusion of concurrent esophageal fistulas.
Product codes (comma separated list FDA assigned to the subject device)
ESW
Device Description
The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
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)
Performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- Deployment Test
- Deployment Force Test
- Dimensional Test
- Tensile Strength Test
The results of the performance testing described above demonstrate that the TTS Esophageal Stent is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
March 22, 2024
Taewoong Medical % Matthew Krueger Senior Consultant Biologics Consulting Group 100 Daingerfield Road, Suite 400 Alexandria, Virginia 22314
Re: K240522
Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: February 23, 2024 Received: February 23, 2024
Dear Matthew Krueger:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Shanil P. Haugen -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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 and occlusion of concurrent esophageal fistulas.
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.
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SUBMITTER INFORMATION 1.
| Applicant: | Taewoong Medical |
|---|---|
| Contact: | Yongjin Jeff Kim |
| Phone: | +82 70 4649 1543 |
| Email: | jinjeff@stent.net |
| Address: | 14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, 10022, |
| Republic of Korea |
2. CORRESPONDENT INFORMATION
| Contact: | Matthew Krueger |
|---|---|
| Title: | Senior Consultant |
| Firm: | Biologics Consulting Group |
3. DATE PREPARED: FEBRUARY 21, 2024
4. DEVICE INFORMATION
| Device Name: | Esophageal TTS Stent |
|---|---|
| Common Name: | Prosthesis, Esophageal |
| Regulation Number: | 21 C.F.R. 878.3610 |
| Regulation Name: | Esophageal prosthesis |
| Product Code: | ESW |
| Regulatory Class: | Class II |
5. PREDICATE DEVICE INFORMATION
| Device Name: | Taewoong Esophageal TTS Stent |
|---|---|
| 510(k) Number: | K221482 |
| Manufacturer: | Taewoong Medical |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION 6.
The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system
5
for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.
7. INDICATIONS FOR USE
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL 8. CHARACTERISTICS WITH THE PREDICATE DEVICE
The table below compares the intended use and the technological characteristics of the subject device and predicate device.
| | Subject Device | Predicate Device
K221482 | Comments |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Device Name | Esophageal TTS Stent | Esophageal TTS Stent | Identical |
| Common Name | Esophageal Stent | Esophageal Stent | Identical |
| Manufacturer | Taewoong Medical Co., Ltd | Taewoong Medical Co., Ltd | Identical |
| Product Code | ESW | ESW | Identical |
| Regulation | 21 CFR 878.3610
Esophageal prosthesis | 21 CFR 878.3610
Esophageal prosthesis | Identical |
| Indications for use | For use in esophageal strictures
caused by intrinsic and/or
extrinsic malignant tumors and
occlusion of concurrent
esophageal fistulas. | For use in esophageal strictures
caused by intrinsic and/or
extrinsic malignant tumors and
occlusion of concurrent
esophageal fistulas. | Identical |
Table 1: Comparator Table for Subject and Predicate Devices
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| | Subject Device | Predicate Device
K221482 | Comments |
|-------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design
(Stents) | Image: Full Covered Stent | Image: Full Covered Stent | Identical |
| | Image: Both Bare Stent | Image: Both Bare Stent | |
| | Nitinol wire in diamond shape
Lengths; 60, 80, 100, 120, 140,
150mm | Nitinol wire in diamond shape
Lengths; 60, 80, 100, 120, 140,
150mm | |
| | Body Diameter/Head Diameter:
• 18mm/26mm | Body Diameter/Head Diameter:
• 18mm/26mm | |
| | • 20mm/26mm
• 22mm/28mm | • 20mm/26mm
• 22mm/28mm | |
| | Coverage:
• Silicone Full Covered | Coverage:
• Silicone Full Covered | |
| | • Silicone Both Bare
Radiopaque Markers: 8 Pt/Ir, 2
STS 316L | • Silicone Both Bare
Radiopaque Markers: 8 Pt/Ir, 2
STS 316L | |
| | Subject Device | Predicate Device
K221482 | Comments |
| Design
(Introducer) | Image: Subject Device | Image: Predicate Device | Substantially Equivalent
Dimensionally the same
General design is identical
with the following
changes:
- Hub: Changes from
ABS to PCABS (not
patient contacting) - Replacement of Y-
Connector with a straight
connector (PCABS) (no
side port like the Y-
connector) (not patient
contacting) - 2nd Inner Catheter
material change from
Nylon to Nylon with black
pigment (not patient
contacting) - Yellow marker
changing from Nylon to
Acrylic Resin with Tampa
Pur TPU 122 (yellow
colorant) (patient
contacting) - Addition of heat
shrinkable tube at distal
end of the connector (not
patient contacting) - Soft 2nd Inner Catheter
made of Nylon 6/6 added
to provide flexibility
between the 1st and 2nd
inner catheters (patient
contacting) - Addition of lubricant to
the inner catheter to
decrease deployment force
(not patient contacting)
Performance testing and
biocompatibility testing
demonstrates that the
changes to design and
materials do not affect the
safety or effectivness |
| | Co-axial tube type
Usable Length: 180 and 220cm
Diameter: 10.5 Fr (3.5mm) | Co-axial tube type
Usable Length: 180 and 220cm
Diameter; 10.5 Fr (3.5mm) | |
| Single Use | Yes | Yes | Identical |
| Sterile | EO Sterilization | EO Sterilization | Identical |
| | Subject Device | Predicate Device
K221482 | Comments |
| Method of
Placement | Endoscopic | Endoscopic | Identical |
| Method of
Deployment | Release by pulling outer sheath | Release by pulling outer sheath | Identical |
| Packaging | PET tray with Tyvek lid placed
in a Tyvek pouch and then
placed inside of a Manila paper
box | PET tray with Tyvek lid placed
in a Tyvek pouch and then
placed inside of a Manila paper
box | Identical |
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8
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING 9.
Biocompatibility Testing
Biocompatibility testing of the stent was not repeated for this submission since the stent in this submission is identical to the stent cleared in K221482. The stent, in its final finished form, is identical to the Esophageal TTS Stent in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Patient contacting materials of the introducer:
The following parts directly contact patient tissue for |
Biocompatibility Testing Conducted Table 2:
Electrical Safety
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Electromagnetic Compatibility (EMC)
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software
Not applicable. The subject device contains no software.
Performance Testing
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- Deployment Test
- Deployment Force Test
- . Dimensional Test
- Tensile Strength Test
CONCLUSION 10.
The results of the performance testing described above demonstrate that the TTS Esophageal Stent is as safe and effective as the predicate device and supports a determination of substantial equivalence.