(179 days)
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.
The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.
Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.
Table 1: Non-Clinical Testing Performance
| Test Item | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Tensile strength | Pass |
| Guidewire pass-through ability | Pass |
| Dilation ability | Pass |
| Slide durability | Pass |
| Radio-detectability | Pass |
| Corrosion resistance | Pass |
| Polyurethane strength | Pass |
| Guide wire trackability | Pass |
| Kink resistance | Pass |
| Dimension measurement | Pass |
| Simulated use and (torsional strength) | Pass |
Table 2: Biocompatibility Testing Acceptance Criteria and Results
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity MEM Elution Test | ISO 10993-5 (No deviations) | The test system is considered suitable if no signs of cellular reactivity (Grade 0) are noted for both the negative control article and the medium control. | Non-cytotoxic |
| Sensitization KLIGMAN Maximization Test | ISO 10993-10 (No deviations) | The extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation Intracutaneous Injection Test | ISO 10993-10 (No deviations) | The test extract and the negative control must exhibit similar edema and erythema scores. | Non-Irritant |
| Systemic Toxicity Acute System Toxicity Test | ISO 10993-11 (No deviations) | The test article must not show significantly greater biological activity than the control. | Non-toxic |
| Systemic Toxicity Rabbit Pyrogen Test (material mediated) | ISO 10993-11 (No deviations) | The test article should not increase the rectal temperature of any of the animals by more than 0.5 degrees Celsius. | Non-pyrogenic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.
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. The testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of ground truth in clinical data, not bench testing.
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 document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 17, 2024
ASAHI Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants 1783 Forest Drive Suite 254 Annapolis, Maryland 21401
Re: K241801
Trade/Device Name: Tornus ES Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: November 15, 2024 Received: November 18, 2024
Dear Candace Cederman:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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,
Anthony Lee -S
Anthony Lee, Ph.D., M.B.A. 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
Tornus ES
Indications for Use (Describe)
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
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}------------------------------------------------
510(k) Summary [as required by 21 CFR 807.92(c)]
Tornus ES 510(k) K241801
| DATE PREPARED: | December 10, 2024 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD.3-100 Akatsuki-cho, SetoAichi 489-0071Japan |
| CONTACT | Yoshi TeraiPresident/CEOASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, CA 92780 USTel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com |
| TRADE NAME: | Tornus ES |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §876.5010 |
| CLASSIFICATION NAME: | Biliary catheter and accessories |
| PRODUCT CODE | FGE |
| PREDICATE DEVICE: | Soehendra Biliary Dilatation Catheter (K171548) |
| REFERENCE DEVICE: | Cook Dilator Sets (K183036)Zimmon Pancreatic Stent Sets (K172057)Soehendra Stent Retriever (K161203)Cysto-Gastro Sets (K211909) |
INDICATIONS FOR USE:
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
{5}------------------------------------------------
DETAILED DESCRIPTION
The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings.
The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together.
The Tornus ES is available for prescription use only.
DILATION SEGMENT
The coil of the Dilation portion of the device is a dual coil design consisting of an upper laver Wire coil and a Rope coil under layer. The distal side of the dilation segment is tapered, and the surface is coated with Resin and a Hydrophilic coating.
A tapered metal tip is welded to the tip of the coil. This metal tip is available in two applicable guidewire diameters: 0.018 inch and 0.025 inch.
SHAFT
The Shaft coil is also a dual coil design consisting of a rope coil in both the upper and under lavers.
The proximal end of the coil is coated with polyurethane, and a grip is bonded to it using an adhesive.
Principal of Operation
The Tornus ES is advanced as the physician rotates the grip, in a fashion similar to that of a screw, due to the spiral-wound wire coil design. Once the target site is reached, the site is expanded via the outer diameter of the device's tapered shape.
COMPARISON WITH PREDICATE DEVICES:
The subject device has similar intended use and indication for use as compared with the predicate device. The subject device has similar technological characteristics as the predicate devices. While differences exist between the subject and predicate device, with respect to the access point, those differences do not raise different/new questions of safety and/or effectiveness
{6}------------------------------------------------
Comparison with Predicate Device
| Subject | Predicate | Reference | Subject | Predicate | Reference | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Name | Tornus ES | Soehendra BiliaryDilation Catheter | Cook Dilator Sets | ZimmonPancreatic StentSets | Soehendra StentRetriever | Cysto-Gastro Sets | Device Name | Tornus ES | Soehendra BiliaryDilation Catheter | Cook Dilator Sets | ZimmonPancreatic StentSets | Soehendra StentRetriever | Cysto-Gastro Sets |
| Manufacturer | ASAHI INTECC | Wilson-Cook Medical | Cook Incorporated | Cook Ireland Ltd. | Wilson-CookMedical | G-Flex Europe SPRL | DesignFeature/MainComponents | Rope coilResin coatingHydrophilic coatingMetal tipGrip | Catheter shaftMarker ringLuer lock hub | Dilator shaft,coating(hydrophilic),guidewireport | Stent Introducer | HandleRope coilTapered threadedscrew type distaltip | Metal TipNeedle(Depends on lineup)Catheter Handlewith electrode |
| 510(k) | K241801 | K171548 | K183036 | K172057 | K161203 | K211909 | Material | Stainless Steel,Polyurethaneelastomer, Acrylicresin, PVP,Nitrocellulose,Polypropylene | Unknown | ResinHydrophilic coating | PolyethyleneEVA | Stainless SteelResin | Stainless Steel,Teflon,POM + MABS |
| ClassificationPanel | Gastroenterology/Urology | Gastroenterology/Urology | Cardiovascular/Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology | O.D.(Dilation)^ | 7 Fr(2.62 mm) | 6 — 10 Fr(2.0 - 3.3 mm) | 3.0 - 26.0 Fr(1.0 - 8.7 mm) | 3 - 11.5 Fr(1.66 - 2.66 mm) | 8 Fr(2.70 mm) | 6, 8.5 and 10 Fr(2.0 - 3.3 mm) |
| Regulation | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 870.131021 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.4300 | EffectiveLength | 195 cm | 200 cm | 6 – 65 cm | Stent length:2 – 15 cmIntroducer length:170cm | 168 cm | 180 and 210 cm |
| CommonName | Dilatation Catheter | Dilatation Catheter | Dilator, vessel, forpercutaneouscatheterization /stents, drains anddilators for thebiliary ducts | Drainage Catheter | Stent Retriever | Endoscopicelectrosurgery device | GuidewireDiameter (in) | 0.018" | 0.035" | Unknown | 0.035" | 0.018" | 0.035" |
| Product Code | FGE | FGE | DRE, FGE | FGE | FGE | KNS | 0.025" | 0.035" | |||||
| Class | Class II | Class II | Class II | Class II | Class II | Class II | Sterilization | EO | Unknown | EO | EO | EO | EO |
| Indication forUse | This device is usedto dilate strictures inthe pancreatobiliarysystems and todilate openings viathe transgastric ortransduodenal wall.This device isindicated for adultuse only. | Soehendra BiliaryDilatation Cathetersare used to dilatebiliary strictures.These devices areindicated for adultuse only | Intended to beused for dilatingpuncture sites orcatheter tracts forpercutaneousplacement ofdevices for vascularand non-vascularapplications suchas in the venous,arterial, biliary andrenal systems. | Zimmon PancreaticStent sets are usedto drain obstructedpancreatic ducts | Used to removestents from thebiliary andpancreatic duct(s)while maintainingwire guideplacement | Cysto-Gastro Setsare intended to beused toelectrosurgicallycannulate pancreaticpseudo-cystsendoscopically (viathe transgastric ortransduodenal wall)as an alternative tosurgical orpercutaneoustreatment | Shelf Life | 3 years | Unknown | 3 years | 3 years | 3 years | 3years |
{7}------------------------------------------------
^ The shaft O.D of the Tornus ES is 2.64mm, with a Tip ID of either 0.018" or 0.025"
{8}------------------------------------------------
Non Clinical testing / Performance Data:
| Test item | Test Results |
|---|---|
| Appearance | Pass |
| Tensile strength | Pass |
| Guidewire pass-through ability | Pass |
| Dilation ability | Pass |
| Slide durability | Pass |
| Radio-detectability | Pass |
| Corrosion resistance | Pass |
| Polyurethane strength | Pass |
| Guide wire trackability | Pass |
| Kink resistance | Pass |
| Dimension measurement | Pass |
| Simulated use and (torsional strength) | Pass |
Non clinical laboratory testing was performed on the Tornus ES to determine substantial equivalence. The following testing/assessments were performed:
The in vitro bench tests demonstrated that the Tornus ES met all acceptance criteria. Performance data demonstrate that the device functions as intended and is substantially equivalent to the predicate and reference devices.
BIOCOMPATIBILITY:
The Tornus ES was tested in accordance with ISO 10993 and found to be biocompatible. The following tests were performed:
| Test Method | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| CytotoxicityMEM Elution Test | ISO 10993-5No deviations | The test system is considered suitable if no signs ofcellular reactivity (Grade 0) are noted for both thenegative control article and the medium control. | Non-cytotoxic |
| SensitizationKLIGMANMaximization Test | ISO 10993-10No deviations | The extracts should show no evidence of causingdelayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| IrritationIntracutaneousInjection Test | ISO 10993-10No deviations | The test extract and the negative control must exhibitsimilar edema and erythema scores. | Non-Irritant |
| Systemic ToxicityAcute SystemToxicity Test | ISO 10993-11No deviations | The test article must not show significantly greaterbiological activity than the control. | Non-toxic |
| Systemic ToxicityRabbit Pyrogen Test(material mediated) | ISO 10993-11No deviations | The test article should not increase the rectaltemperature of any of the animals by more than 0.5degrees Celsius. | Non-pyrogenic |
{9}------------------------------------------------
Sterilization and Shelf Life:
The Tornus ES sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135: 2014 to achieve a sterility assurance level (SAL) of 10-9. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008.
Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 3-year shelf-life.
CONCLUSION:
The Tornus ES have the similar intended use and indications, and the same or similar technological characteristics such as design, materials, sterilization method, performance, and operating principles as the predicate and reference device. Performance data demonstrates that the device functions as intended.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.