Esophageal TTS Stent

K240522 · Taewoong Medical · ESW · Mar 22, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240522
• Device Name: Esophageal TTS Stent
• Applicant: Taewoong Medical
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Mar 22, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Esophageal TTS Stent is an implantable, flexible, tubular metallic stent made of Nitinol wire; used to restore esophageal structure/function by exerting outward radial force on the luminal surface. Device includes a disposable, flexible, co-axial introducer system for endoscopic delivery and deployment. Physician operates the introducer to position the stent at the target site; deployment occurs by pulling the outer sheath. Stent remains in the esophagus to maintain patency. Benefits include relief of strictures and occlusion of fistulas. Subject device is a modification of the predicate introducer system; stent design remains identical.

Clinical Evidence

Bench testing only. Performance testing included deployment tests, deployment force tests, dimensional tests, and tensile strength tests. Biocompatibility testing was conducted on patient-contacting components of the introducer system per ISO 10993 standards (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity).

Technological Characteristics

Stent: Nitinol wire, diamond-shaped mesh, silicone-covered or bare, lengths 60-150mm, diameters 18-22mm. Radiopaque markers: Pt/Ir and STS 316L. Introducer: Co-axial tube, 10.5 Fr (3.5mm) diameter, 180/220cm length. Materials include PCABS, Nylon, Nylon 6/6, Acrylic Resin, and TPU. Sterilization: Ethylene Oxide (EO). No electrical or software components.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Taewoong Esophageal TTS Stent (K221482)

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

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)

K240522

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.

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."

{4}------------------------------------------------

#### SUBMITTER INFORMATION 1.

| Applicant: | Taewoong Medical |
|------------|----------------------------------------------------------------------------------|
| Contact: | Yongjin Jeff Kim |
| Phone: | [phone] |
| Email: | [e-mail] |
| Address: | 14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, 10022,<br>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<br>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<br>Esophageal prosthesis | 21 CFR 878.3610<br>Esophageal prosthesis | Identical |
| Indications for use | For use in esophageal strictures<br>caused by intrinsic and/or<br>extrinsic malignant tumors and<br>occlusion of concurrent<br>esophageal fistulas. | For use in esophageal strictures<br>caused by intrinsic and/or<br>extrinsic malignant tumors and<br>occlusion of concurrent<br>esophageal fistulas. | Identical |

Table 1: Comparator Table for Subject and Predicate Devices

{6}------------------------------------------------

| | Subject Device | Predicate Device<br>K221482 | Comments |
|-------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design<br>(Stents) | Image: Full Covered Stent | Image: Full Covered Stent | Identical |
| | Image: Both Bare Stent | Image: Both Bare Stent | |
| | Nitinol wire in diamond shape<br>Lengths; 60, 80, 100, 120, 140,<br>150mm | Nitinol wire in diamond shape<br>Lengths; 60, 80, 100, 120, 140,<br>150mm | |
| | Body Diameter/Head Diameter:<br>• 18mm/26mm | Body Diameter/Head Diameter:<br>• 18mm/26mm | |
| | • 20mm/26mm<br>• 22mm/28mm | • 20mm/26mm<br>• 22mm/28mm | |
| | Coverage:<br>• Silicone Full Covered | Coverage:<br>• Silicone Full Covered | |
| | • Silicone Both Bare<br>Radiopaque Markers: 8 Pt/Ir, 2<br>STS 316L | • Silicone Both Bare<br>Radiopaque Markers: 8 Pt/Ir, 2<br>STS 316L | |
| | Subject Device | Predicate Device<br>K221482 | Comments |
| Design<br>(Introducer) | Image: Subject Device | Image: Predicate Device | Substantially Equivalent<br>Dimensionally the same<br>General design is identical<br>with the following<br>changes:<br>1) Hub: Changes from<br>ABS to PCABS (not<br>patient contacting)<br>2) Replacement of Y-<br>Connector with a straight<br>connector (PCABS) (no<br>side port like the Y-<br>connector) (not patient<br>contacting)<br>3) 2nd Inner Catheter<br>material change from<br>Nylon to Nylon with black<br>pigment (not patient<br>contacting)<br>4) Yellow marker<br>changing from Nylon to<br>Acrylic Resin with Tampa<br>Pur TPU 122 (yellow<br>colorant) (patient<br>contacting)<br>5) Addition of heat<br>shrinkable tube at distal<br>end of the connector (not<br>patient contacting)<br>6) Soft 2nd Inner Catheter<br>made of Nylon 6/6 added<br>to provide flexibility<br>between the 1st and 2nd<br>inner catheters (patient<br>contacting)<br>7) Addition of lubricant to<br>the inner catheter to<br>decrease deployment force<br>(not patient contacting)<br>Performance testing and<br>biocompatibility testing<br>demonstrates that the<br>changes to design and<br>materials do not affect the<br>safety or effectivness |
| | Co-axial tube type<br>Usable Length: 180 and 220cm<br>Diameter: 10.5 Fr (3.5mm) | Co-axial tube type<br>Usable Length: 180 and 220cm<br>Diameter; 10.5 Fr (3.5mm) | |
| Single Use | Yes | Yes | Identical |
| Sterile | EO Sterilization | EO Sterilization | Identical |
| | Subject Device | Predicate Device<br>K221482 | Comments |
| Method of<br>Placement | Endoscopic | Endoscopic | Identical |
| Method of<br>Deployment | Release by pulling outer sheath | Release by pulling outer sheath | Identical |
| Packaging | PET tray with Tyvek lid placed<br>in a Tyvek pouch and then<br>placed inside of a Manila paper<br>box | PET tray with Tyvek lid placed<br>in a Tyvek pouch and then<br>placed inside of a Manila paper<br>box | Identical |

{7}------------------------------------------------

{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 <24 hours:

- outer sheath
- soft 2nd inner catheter ●
- yellow marker ●
- proximal/center/distal X-ray markers ●
- holder
- 1st inner catheter ●
- tip ●

{9}------------------------------------------------

| Cytotoxicity<br>MEM Extract | ISO 10993-5:2009 |
|-------------------------------------------------|--------------------------------|
| Sensitization<br>Guinea pig maximization test | ISO 10993-10:2021 |
| Intracutaneous Reactivity<br>New Zealand rabbit | ISO 10993-23:2021 |
| Acute Systemic Toxicity<br>ICR mice | ISO 10993-11:2017 |
| Pyrogen Test<br>New Zealand rabbit | ISO 10993-11:2017<br>USP <151> |

#### 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.