(28 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 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.
This document is a 510(k) premarket notification for a medical device called the "Esophageal TTS Stent." It explains that the new device is substantially equivalent to a previously cleared device (K221482) manufactured by the same company, Taewoong Medical.
The core of the document focuses on demonstrating this substantial equivalence, noting that the stent itself is identical to the predicate device, with modifications only to the introducer system (the delivery mechanism). Therefore, much of the testing performed is related to the performance and biocompatibility of this modified introducer system.
Based on the provided document, here's a breakdown of the requested information:
This document is a marketing submission for a medical device (Esophageal Stent) that does not involve AI or software. Therefore, many of the requested criteria related to AI/software performance validation, such as "acceptance criteria for an AI model," "MRMC study," "standalone algorithm performance," "ground truth establishment for training set," are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the standard non-clinical performance and biocompatibility testing for a physical medical device, not an AI or software component.
Here's a detailed response to the applicable sections of your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and reported numerical performance for each test. Instead, it lists the types of performance tests conducted and then states a general conclusion that the device "meets its design requirements and performs as intended" and is "as safe and effective as the predicate device."
However, we can infer the types of tests and the general outcome:
| Acceptance Criteria Category | Specific Test Conducted (Implied Criteria: Meet Design Req. & Perform as Intended) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Pass (Supports SE) |
| Sensitization (ISO 10993-10:2021) | Pass (Supports SE) | |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Pass (Supports SE) | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass (Supports SE) | |
| Pyrogen Test (ISO 10993-11:2017, USP <151>) | Pass (Supports SE) | |
| Device Performance | Deployment Test | Meets design requirements |
| Deployment Force Test | Meets design requirements | |
| Dimensional Test | Meets design requirements | |
| Tensile Strength Test | Meets design requirements |
Notes on Acceptance Criteria:
- For biocompatibility tests, the acceptance criteria would be defined by the ISO standards, e.g., "non-cytotoxic," "not a sensitizer," etc.
- For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the acceptance criteria would be specific to the device's engineering specifications, such as "deployment within X seconds," "deployment force less than Y Newtons," "dimensions within Z tolerance," "tensile strength greater than W," etc. These specific numerical criteria and results are not provided in this summary document. The document only states that the testing was conducted and found to demonstrate substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- The document does not specify the sample sizes used for the non-clinical performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength).
- For biocompatibility, the sample sizes would be typical for the specific ISO test methods (e.g., a certain number of mice for acute systemic toxicity, guinea pigs for sensitization), but these are not explicitly detailed.
- Data Provenance:
- This is a submission for a medical device (stent and introducer), not data related to a clinical study or AI model.
- The testing pertains to the physical characteristics and interaction of the device components.
- The manufacturer is Taewoong Medical Co., Ltd., based in the Republic of Korea. It's highly probable the testing was conducted there or at subcontracted labs.
- The tests are prospective in nature, as they are performed on newly manufactured devices or materials to demonstrate compliance for premarket submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a physical medical device (stent and introducer system) and does not involve a diagnostic AI or imaging interpretation. Therefore, there is no "ground truth" derived from expert interpretation of images or clinical data in the context of an AI model.
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and standardized biological safety tests. The "experts" involved would be engineers, material scientists, and toxicologists/biologists conducting and interpreting the non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in machine learning contexts (e.g., for radiology readings) where there might be disagreement among human readers. Since this is a submission for a physical device based on non-clinical performance and biocompatibility testing, such adjudication methods are not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This submission is for a physical medical device (esophageal stent) and its introducer system. It does not involve AI or software, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not have an "algorithm" component. It is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on engineering specifications and established test methodologies.
- For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the ground truth is defined by the pre-defined design requirements and specifications (e.g., a stent must deploy within a certain time, or a certain force is required for deployment).
- For biocompatibility tests, the ground truth is defined by the results of standardized in vitro and in vivo biological tests as per ISO 10993 series, indicating the material's safety for contact with the body.
- It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-related devices.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device. Therefore, there is no "training set." The device's design is based on engineering principles and knowledge gained from previous device iterations (the predicate device).
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set (being a physical medical device, not an AI), there is no ground truth establishment for a training set.
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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"
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(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
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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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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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 DeviceK221482 | 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 878.3610Esophageal prosthesis | 21 CFR 878.3610Esophageal prosthesis | Identical |
| Indications for use | For use in esophageal stricturescaused by intrinsic and/orextrinsic malignant tumors andocclusion of concurrentesophageal fistulas. | For use in esophageal stricturescaused by intrinsic and/orextrinsic malignant tumors andocclusion of concurrentesophageal fistulas. | Identical |
Table 1: Comparator Table for Subject and Predicate Devices
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| Subject Device | Predicate DeviceK221482 | Comments | |
|---|---|---|---|
| Design(Stents) | Image: Full Covered Stent | Image: Full Covered Stent | Identical |
| Image: Both Bare Stent | Image: Both Bare Stent | ||
| Nitinol wire in diamond shapeLengths; 60, 80, 100, 120, 140,150mm | Nitinol wire in diamond shapeLengths; 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 BareRadiopaque Markers: 8 Pt/Ir, 2STS 316L | • Silicone Both BareRadiopaque Markers: 8 Pt/Ir, 2STS 316L | ||
| Subject Device | Predicate DeviceK221482 | Comments | |
| Design(Introducer) | Image: Subject Device | Image: Predicate Device | Substantially EquivalentDimensionally the sameGeneral design is identicalwith the followingchanges:1) Hub: Changes fromABS to PCABS (notpatient contacting)2) Replacement of Y-Connector with a straightconnector (PCABS) (noside port like the Y-connector) (not patientcontacting)3) 2nd Inner Cathetermaterial change fromNylon to Nylon with blackpigment (not patientcontacting)4) Yellow markerchanging from Nylon toAcrylic Resin with TampaPur TPU 122 (yellowcolorant) (patientcontacting)5) Addition of heatshrinkable tube at distalend of the connector (notpatient contacting)6) Soft 2nd Inner Cathetermade of Nylon 6/6 addedto provide flexibilitybetween the 1st and 2ndinner catheters (patientcontacting)7) Addition of lubricant tothe inner catheter todecrease deployment force(not patient contacting)Performance testing andbiocompatibility testingdemonstrates that thechanges to design andmaterials do not affect thesafety or effectivness |
| Co-axial tube typeUsable Length: 180 and 220cmDiameter: 10.5 Fr (3.5mm) | Co-axial tube typeUsable Length: 180 and 220cmDiameter; 10.5 Fr (3.5mm) | ||
| Single Use | Yes | Yes | Identical |
| Sterile | EO Sterilization | EO Sterilization | Identical |
| Subject Device | Predicate DeviceK221482 | Comments | |
| Method ofPlacement | Endoscopic | Endoscopic | Identical |
| Method ofDeployment | Release by pulling outer sheath | Release by pulling outer sheath | Identical |
| Packaging | PET tray with Tyvek lid placedin a Tyvek pouch and thenplaced inside of a Manila paperbox | PET tray with Tyvek lid placedin a Tyvek pouch and thenplaced inside of a Manila paperbox | Identical |
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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 ●
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| CytotoxicityMEM Extract | ISO 10993-5:2009 |
|---|---|
| SensitizationGuinea pig maximization test | ISO 10993-10:2021 |
| Intracutaneous ReactivityNew Zealand rabbit | ISO 10993-23:2021 |
| Acute Systemic ToxicityICR mice | ISO 10993-11:2017 |
| Pyrogen TestNew Zealand rabbit | ISO 10993-11:2017USP <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.
§ 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.”