(449 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the stent and delivery system, with no mention of AI or ML.
Yes
The device is designed to maintain the patency of esophageal strictures caused by malignant tumors, which is a therapeutic intervention.
No
The device, HILZO Esophageal Stents, is described as a "self-expanding tubular prosthesis designed to maintain patency of esophageal strictures." Its intended use is to treat esophageal strictures caused by malignant tumors. This description indicates a therapeutic purpose (maintaining patency) rather than a diagnostic one (identifying or characterizing a condition).
No
The device description clearly outlines physical components (stents made of Nitinol wire, delivery devices) and performance testing related to these physical components (biocompatibility, expansion force, corrosion testing, etc.), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The HILZO Esophageal Stent is a physical implant designed to maintain the patency of the esophagus. It is a therapeutic device, not a diagnostic one. It does not analyze samples or provide diagnostic information.
- Intended Use: The intended use clearly states it is for treating esophageal strictures, not for diagnosing a condition.
Therefore, based on the provided information, the HILZO Esophageal Stent is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic malignant tumors.
Product codes
ESW
Device Description
The HILZO Esophageal Stents are partially covered and fully covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures. The HILZO Esophageal stents are available loaded on two styles of delivery devices, Over the Wire (OTW) and Through the Scope (TTS). The OTW delivery devices are 14Fr and the TTS is 10.5Fr to enable delivery through the working channel of an endoscope. The stents are made of Nitinol wire and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety models, diameters and lengths.
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
Prescription Use
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)
Biocompatibility:
The stent and delivery system underwent extensive biocompatibility data in accordance with guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Per the obtained results, the HILZO Esophageal Stent System was found to be biocompatible.
Non-Clinical Performance Testing:
The HILZO Esophageal Stents have undergone and successfully passed the following:
- Shelf-life and sterilization validation
- Expansion force testing
- Compression force testing
- Dimensional testing
- Corrosion testing
- Kink resistance testing
- Tensile strength testing (delivery system)
- Tensile strength test (cover material)
- Deployment force and deployment positioning testing
- Suture Loop Tensile Strength Testing
- Radiopacity testing
- MR safety
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
January 16, 2024
Thoracent, Inc. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K223266
Trade/Device Name: Hilzo Esophageal Stents Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: April 26, 2023 Received: April 26, 2023
Dear Bosmat Friedman:
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.
1
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" (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 (OS) 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 QS 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.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/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,
Sivakami Venkatachalam -S
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
3
Indications for Use
510(k) Number (if known) K223266
Device Name Hilzo Esophageal Stents
Indications for Use (Describe)
The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic malignant tumors.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K223266 Page 1 of 4
510(K) SUMMARY [as required by section 807.92(c)] HILZO Esophageal Stent 510(k) Number K223266
5.1 SUBMITTER
Applicant's Name:
Thoracent, Inc. Brian Lynch, CEO 11 Stewart Ave. Unit 1, Suite 200 Huntington, NY, USA 917-4396742 brian@thoracent.com
Contact Person:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com
Date Revised:
December 14, 2023
5.2 DEVICE
Trade Name: HILZO Esophageal Stents
| Classification Code: | Device: | Prosthesis, Esophageal |
|---|---|---|
| Product Code: | ESW | |
| Regulation No: | 878.3610 | |
| Class: | 2 | |
| Medical Specialty: | General & Plastic Surgery | |
| Review Panel: | Gastroenterology/Urology |
5.3 PREDICATE DEVICE
Primary Predicate:
- Niti-S Esophageal Stent System, manufactured by Taewoong Medical Co., . Ltd., cleared under K080782; Product Code: ESW
5
Reference devices for
- . Esophageal TTS Stent, manufactured by Taewoong Medical Co., Ltd., cleared under K123205; Product Code: ESW.
- Bonastent Esophageal, manufactured by EndoChoice, Inc. cleared under . K092144: Product Code: ESW
5.4 DEVICE DESCRIPTION
The HILZO Esophageal Stents are partially covered and fully covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures. The HILZO Esophageal stents are available loaded on two styles of delivery devices, Over the Wire (OTW) and Through the Scope (TTS). The OTW delivery devices are 14Fr and the TTS is 10.5Fr to enable delivery through the working channel of an endoscope. The stents are made of Nitinol wire and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety models, diameters and lengths.
5.5 INDICATIONS FOR USE
The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
5.6 SUBSTANTIAL EQUIVALENCE
The subject and predicate devices are both single- use, partially covered and fully covered esophageal stents indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The stent weave pattern, delivery devices as well as the available stent sizes are equivalent in design and performance.
| Feature | HILZO Esophageal Stent | Niti-S Esophageal (OTW) K080782 | Comparison to Predicate |
|---|---|---|---|
| Reg. Number | 878.3610 | 878.3610 | Same |
| Product Code | ESW | ESW | Same |
| Indication for Use | The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors | Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. | Same |
| Principle of Operation | TTS and OTW models available | OTW | Same as both devices |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | Same |
| Single use | Yes | Yes | Same |
| Feature | HILZO Esophageal Stent | Niti-S Esophageal | |
| (OTW) | |||
| K080782 | Comparison to Predicate | ||
| Sterility | Eto | Eto | Same |
| Stent material | Nitinol | Nitinol | Same |
| Covering | |||
| material | Silicone/PTFE | Silicone | Similar; biocompatibility testing |
| supports the safety and effectiveness | |||
| profile of the HILZO Esophageal Stent; | |||
| literature survey and material tensile | |||
| strength testing support the use of PTFE | |||
| cover material | |||
| Stent diameter | |||
| (mm) | 18-20 mm | 16 - 20 mm | Same; compression and expansion |
| testing support the stent diameter | |||
| difference | |||
| Stent total length | |||
| (mm) | 60-150 mm | 60-120 mm | Similar; compression and expansion |
| testing support the increased stent | |||
| length; FDA has cleared other | |||
| esophageal stents with a length of 150 | |||
| such as K172813 and K211706 | |||
| Stent head | Silicone covered and uncovered | ||
| flaring stent head design | |||
| with/without removal string | |||
| (lasso) | Silicon covered and uncovered | ||
| flaring stent head design | |||
| with/without removal string | |||
| (lasso) | Similar flaring stent head design | ||
| Delivery | |||
| Diameter | OTW - 14 Fr, 16 Fr | ||
| TTS = 10.5 Fr | OTW - 16 Fr and 20 Fr | Similar; deployment testing and tensile | |
| strength testing demonstrate delivery | |||
| device performance | |||
| MR Status | MR Conditional | MR Conditional | Same |
| Expansion force | Fully Covered: | ||
| 18X60 - Avg. 0.442 kgf | |||
| 18X150 - Avg. 0.443 kgf | |||
| 20X60 - Avg. 0.520 kgf | |||
| 20X150 - Avg. 0.460 kgf | |||
| Partial Covered: | |||
| 18X60 - Avg. 0.445 kgf | |||
| 18X150 - Avg. 0.446 kgf | |||
| 20X60 - Avg. 0.528 kgf | |||
| 20X150 - Avg.0.537 kgf | Fully Covered: | ||
| 18X60 - Avg. 0.439 kgf | |||
| 18X150 - Avg. 0.443 kgf | |||
| 20X60 - Avg. 0.521 kgf | |||
| 20X150 - Avg. 0.543 kgf | |||
| Partial Covered: | |||
| 18X60 - Avg. 0.440 kgf | |||
| 18X150 - Avg. 0.448 kgf | |||
| 20X60 - Avg. 0.530 kgf | |||
| 20X150 - Avg.0.542 kgf | Similar; all results fell within the ±5% | ||
| difference acceptance criteria. The | |||
| results support our SE claim | |||
| Compression | |||
| force | Fully Covered: | ||
| 18X60 - Avg. 3.073 kgf | |||
| 18X150-Avg. 3.189 kgf | |||
| 20X60 - Avg. 3.75 kgf | |||
| 20X150 - Avg. 3.844 kgf | |||
| Partial Covered: | |||
| 18X60 - Avg. 3.097 kgf | |||
| 18X150 - Avg. 3.176 kgf | |||
| 20X60 - Avg. 3.876 kgf | |||
| 20X150 - Avg.3.925 kgf | Fully Covered: | ||
| 18X60 - Avg. 3.093 kgf | |||
| 18X150-Avg. 3.168 kgf | |||
| 20X60 - Avg. 3.786 kgf | |||
| 20X150 - Avg. 3.889 kgf | |||
| Partial Covered: | |||
| 18X60 - Avg. 3.141 kgf | |||
| 18X150 - Avg. 3.220 kgf | |||
| 20X60 - Avg. 3.875 kgf | |||
| 20X150 - Avg.3.914 kgf | Similar; all results fell within the ±5% | ||
| difference acceptance criteria. The | |||
| results support our SE claim |
The following table provides a comparison with the predicate:
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7
Any differences in technological characteristics do not raise different questions of safety or effectiveness.
5.7 PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility:
The stent and delivery system underwent extensive biocompatibility data in accordance with guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Per the obtained results, the HILZO Esophageal Stent System was found to be biocompatible.
Non-Clinical Performance Testing:
The HILZO Esophageal Stents have undergone and successfully passed the following:
- Shelf-life and sterilization validation -
- Expansion force testing -
- Compression force testing -
- Dimensional testing -
- -Corrosion testing
- -Kink resistance testing
- -Tensile strength testing (delivery system)
- Tensile strength test (cover material) -
- Deployment force and deployment positioning testing -
- -Suture Loop Tensile Strength Testing
- Radiopacity testing -
- MR safety -
5.8 CONCLUSION
The HILZO Esophageal Stents have the same indications for use and technological characteristics as its predicates. Niti-S and Esophageal. The company has provided sufficient comparative testing between the HILZO Esophageal Stents and the predicates, as well as additional pre-clinical bench data to demonstrate our substantial equivalency claim. Consequently, it is clear that the HILZO Esophageal Stents are as safe and effective as their primary predicates without raising any new safety and/or effectiveness concerns.