(30 days)
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.
The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of 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.
The provided document is a 510(k) premarket notification for the Taewoong Medical Co., Ltd. Esophageal TTS Stent. It states that the device is "substantially equivalent" to previously cleared predicate devices (K211706, K123205, K113551) with the "exception of a modification to the Indications for Use statement."
As such, this document does not contain acceptance criteria for this specific submission with new performance data to prove the device meets these criteria. Instead, it relies on the previous clearances and argues that the change in indication does not affect safety and efficacy, therefore no additional performance data is required for this 510(k).
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from this document. The document explicitly states:
- No additional biocompatibility information is required.
- Not applicable for Electrical safety and electromagnetic compatibility (EMC) as it contains no electrical components.
- Not applicable for Software Verification and Validation Testing as it contains no software.
- No additional performance data is required for Bench Testing because no design modifications were made.
- Not applicable for Animal Testing.
- Not applicable for Clinical Data.
The 510(k) submission relies on the substantial equivalence principle, asserting that since the new device is identical in design and materials to previously cleared devices, and the change in indication does not introduce new risks, the prior performance data of the predicate devices is sufficient.
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June 22, 2022
Taewoong Medical Co., Ltd. % Matthew Krueger Senior Consultant, Medical Devices Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314
Re: K221482
Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: May 19, 2022 Received: May 23, 2022
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 (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
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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 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 (QS) 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
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Indications for Use
510(k) Number (if known) K221482
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) |
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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, Gyeonggido, Korea, 10022TEL: +82-31-996-0641 |
|---|---|
| Contact: | Yongjin Jeff KimInternational Regulatory Affairs ManagerPhone: +82 70 4649 1543E-mail: jinjeff@stent.net |
| Submission Correspondent: | Matthew KruegerSenior Consultant, Medical DevicesBiologics Consulting Group, Inc.Phone: (667) 352-2578Email: mkrueger@biologicsconsulting.com |
| Date Prepared: | June 22, 2022 |
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 AND REFERENCE DEVICES
Predicate Devices 3.1.
K211706: Taewoong Esophageal TTS Stent
K123205: Taewoong Esophageal TTS Stent
K113551: Taewoong Esophageal TTS Stent
3.2. Reference Device
K200860: HANAROSTENT Esophagus TTS (CCC) and HANAROSTENT Esophagus TTS (NCN)
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DEVICE DESCRIPTION 4.
The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K211706, K123205, and K113551, with the exception of a modification to the Indications for Use statement. The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of 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.
5. 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.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
| Table 1: | Indications for Use Comparison | |
|---|---|---|
| Subject Device | Predicate Device (K21170) |
| Subject Device | Predicate Device (K211706) | Explanation of Differences |
|---|---|---|
| The Esophageal TTS Stent isintended for use in esophagealstrictures caused by intrinsicand/or extrinsic malignanttumors and occlusion ofconcurrent esophageal fistulas. | The Esophageal TTS Stent isintended for use in esophagealstrictures caused by intrinsicand/or extrinsic malignanttumors. | Similar to predicate and isnearly identical to the referencedevice K200860 which used theTaewoong TTS Stent(K123205) as its predicate.This addition to the Indicationsfor Use does not affect thesafety and efficacy of thedevice because the devicedesign and intended use isidentical to the predicate. |
| Subject Device | Predicate | |
| K211706 | ||
| (K123205 and K113551) | ||
| Device Name | Esophageal TTS Stent | Esophageal TTS Stent |
| CommonName | Esophageal Stent | Esophageal Stent |
| Manufacturer | Taewoong Medical Co., Ltd | Taewoong Medical Co., Ltd |
| ClassificationRegulation | 878.3610 | 878.3610 |
| Product Code | ESW | ESW |
| Indicationsfor use | For use in esophageal strictures caused byintrinsic and/or extrinsic malignant tumorsand occlusion of concurrent esophagealfistulas. | For use in esophageal strictures caused byintrinsic and/or extrinsic malignant tumors. |
| Design(Stents) | ||
| Image: Full Covered Stent | Image: Full Covered Stent | |
| Image: Both Bare Stent | Image: Both Bare Stent | |
| Nitinol wire in diamond shape | Nitinol wire in diamond shape | |
| Lengths; 60, 80, 100, 120, 140, 150mm | Lengths; 60, 80, 100, 120, 140, 150mm | |
| Body Diameter/Head Diameter: | Body Diameter/Head Diameter: | |
| ・ 18mm/26mm | ・ 18mm/26mm | |
| ・20mm/26mm | ・ 20mm/26mm | |
| ・ 22mm/28mm | ・ 22mm/28mm | |
| Coverage: | Coverage: | |
| · Silicone Full Covered | · Silicone Full Covered | |
| • Silicone Both Bare | • Silicone Both Bare | |
| Radiopaque Markers: 8 Pt/Ir, 2 STS 316L | Radiopaque Markers: 8 Pt/Ir, 2 STS 316L | |
| Subject Device | Predicate | |
| K211706 | ||
| (K123205 and K113551) | ||
| Design(Introducer) | Image: Subject Device | Image: Predicate K211706 |
| Co-axial tube type | Co-axial tube type | |
| Usable Length: | Usable Length; | |
| · 180cm (for diameter 22mm stent) | · 180cm (for diameter 22mm stent) | |
| · 220cm (for diameter 18, 20 & 22 mm stent) | · 220cm (for diameter 18, 20 & 22 mm stent) | |
| Diameter; 10.5 Fr (3.5mm) | Diameter; 10.5 Fr (3.5mm) | |
| Single Use | Yes | Yes |
| Sterile | EO Sterilization | EO Sterilization |
| Method ofPlacement | Endoscopic | Endoscopic |
| Method ofDeployment | Release by pulling outer sheath | Release by pulling outer sheath |
| Materials | Stent - Nitinol, Pt/Ir, STS316L | Stent - Nitinol, Pt/Ir, STS316L |
| Cover – Silicone | Cover – Silicone | |
| Introducer – Teflon, PE, ABS | Introducer – Teflon, PE, ABS |
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate device (Taewoong Esophageal TTS Stent, K211706).
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Table 2: Technological Comparison
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7. PERFORMANCE DATA
Biocompatibility Testing
The subject device in its final finished form is identical to the Esophageal TTS Stent cleared in K211706, K123205, and K113551, in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Therefore, no additional biocompatibility information is required to establish substantial equivalence.
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.
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Bench Testing
No design modifications have been made to the cleared Esophageal TTS Stent. The only change is to the Indications for Use. An assessment of the change was performed, and it was determined that the modified Indications for Use do not introduce any new risks. Thus, testing previously performed for the Esophageal TTS Stent is appropriate and sufficient for the modified Indications for Use. The testing on the Esophageal TTS Stent is consistent with the testing performed on the reference device which uses this identical Indications for Use statement. Therefore, no additional performance data is required.
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.
Based on the modified Indications for Use, the technological characteristics and materials of construction, the Esophageal TTS Stent can be found substantially equivalent to the identified predicate device.
§ 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.”