(188 days)
Not Found
No
The device description focuses on mechanical components and functionality for dilation, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to dilate strictures in the alimentary tract and Sphincter of Oddi, which directly treats a medical condition.
No
The device is indicated for dilating strictures, which is a therapeutic intervention, not a diagnostic one.
No
The device is a physical medical device consisting of a catheter with an inflatable balloon, guidewire lumen, and radiopaque markers. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MultiStage Balloon Dilatation Catheter is a medical device used within the body (in vivo) to physically dilate strictures in the alimentary tract and Sphincter of Oddi. It is a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "to endoscopically dilate strictures," which is a physical intervention, not a diagnostic process.
- Device Description: The description details the physical components and mechanism of action (inflatable balloon, catheter, guidewire, radiopaque markers) which are consistent with an interventional medical device.
Therefore, the MultiStage Balloon Dilatation Catheter is a therapeutic medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Product codes
FGE
Device Description
The MultiStage Balloon Dilatation Catheters are indicated for use to endoscopically dilate strictures of the alimentary tract and the Sphincter of Oddi with or without prior sphincterotomy. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation and passage of a guidewire.
The MultiStage balloon is designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon is made of Pebax material. The MultiStage Balloon Dilatation is designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through an minimum working channel of a 2.8mm alimentary tract, or a 3.7mm biliary tract. The hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. Accordingly, product models, are divided into those with a wireguided (MSW) and non-wireguided (MSO) component.
The MSW model allows the guidewire and catheter to be introduced into the endoscope together. The MSO model as a traditional operation method, the guidewire is first inserted into the endoscope for positioning and then the catheter is inserted through the guidewire for good passability. The physician can choose the model as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, Sphincter of Oddi
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
Not Found
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)
No clinical study is included in this submission.
Non-clinical tests performed:
- Biocompatibility evaluation (ISO 10993-1): Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity test (ISO 10993-10). All tests were passed.
- Shelf life test (ASTM F1980). All tests were passed.
- Sterile barrier systems evaluation (ISO 11607-1:2019).
- Sterilization Process validation (ISO 11135:2014). The MultiStage Balloon Dilatation Catheter is sterile with a validation of the sterilization process that demonstrates achievement of the required SAL of 10% and is in accordance with the half cycle overkill approach.
- Technological characteristics tests: Visual Inspection, Bacteriostasis performance of pouch, Dye penetration (Pouch), Tension test, Guidewire compatibility test, Channel compatibility, Product Dimensional Inspection, Compliance (deployed balloon dimensional analysis), Balloon fatigue (No leakage and damage when inflation), Balloon rated burst pressure (RBP), Peak tensile, Kink resistance, Leakage Test, Hydratability, Hub (Corrosion resistance), X-ray detectability, Chemical properties. All tests were passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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March 9, 2023
Dongguan TT Medical, Inc. % Mingzi Hussey Principal Regulatory Consultant Zi-medical. Inc. 93 Springs Rd Bedford, MA 01730
Re: K222663
Trade/Device Name: MultiStage Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: February 10, 2023 Received: February 10, 2023
Dear Mingzi Hussey:
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
1
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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Image /page/1/Picture/5 description: The image contains the text "Je An -S" in a large, sans-serif font. The letters are black and bolded, and they are arranged horizontally. The background is white, with a faint watermark-like design in a light blue color.
Je Hi An, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222663
Device Name MultiStage Balloon Dilatation Catheter
Indications for Use (Describe)
The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Repackaging (Part 201.22(a) Subject Shipment) Own-Use Controlled (201.22(a) Subject Shipment) | Repackaging (Part 201.22(a) Subject Shipment) | Own-Use Controlled (201.22(a) Subject Shipment) |
| Repackaging (Part 201.22(a) Subject Shipment) | ||
| Own-Use Controlled (201.22(a) Subject Shipment) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Sponsor
Dongguan TT Medical, Inc. Address: BLD#1, 1 Taoyuan Road, Songshan Lake, Dongguan, Guangdong, 523808 China Phone: +86 15553341910 Contact: Yuying Bi, Regulatory Affairs Specialist Email: ybi @ttmedicalinc.com
2. Submission Correspondent
Mingzi Hussey Zi-medical, Inc. Address: 93 Springs Rd, Bedford, MA 01730 US Phone: 206-981-0675 Email: mingzi@zi-medical.com
3. Date Prepared
Aug 10th, 2022
4. Device Identification
Trade Name: MultiStage Balloon Dilatation Catheter Regulation name: Biliary Catheter And Accessories Product Code: FGE Regulation Number: 21 CFR 876.5010 Regulation Class: Class II Review Panel: Gastroenterology/Urology
5. Predicate Devices
The proposed device is substantially equivalent to the following predicate device:
| Applicant | Device name | 510(k) Number | Product code |
|---|---|---|---|
| Boston Scientific | |||
| Corp | CRETM Wireguided Balloon | ||
| Dilatation Catheter | K112994 | FGE |
6. Device Description
The MultiStage Balloon Dilatation Catheters are indicated for use to endoscopically dilate strictures of the alimentary tract and the Sphincter of Oddi with or without prior sphincterotomy. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation and passage of a guidewire.
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The MultiStage balloon is designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon is made of Pebax material. The MultiStage Balloon Dilatation is designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through an minimum working channel of a 2.8mm alimentary tract, or a 3.7mm biliary tract. The hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. Accordingly, product models, are divided into those with a wireguided (MSW) and non-wireguided (MSO) component.
The MSW model allows the guidewire and catheter to be introduced into the endoscope together. The MSO model as a traditional operation method, the guidewire is first inserted into the endoscope for positioning and then the catheter is inserted through the guidewire for good passability. The physician can choose the model as needed.
7. Indication for Use Statement
The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
8. Comparison of Technological Characteristics
The proposed device is compared with the predicate devices in terms of intended use, technological characteristics and principles of operation. The proposed device shares the similar indications for use, similar materials, same device operation, and same overall technical capabilities as the predicate device. The MSW model has same components with the predicate device while the MSO model does not contain a guidewire for the users to install a guidewire by their choice. The proposed device also has the same standards and requirements as the predicate device, and has been verified for its safety and effectiveness to establish substantially equivalence.
| Nominal Balloon Diameter | ||||||
|---|---|---|---|---|---|---|
| Nominal | ||||||
| Length | 6mm | 8mm | 10mm | 12mm | 15mm | 18mm |
| 30mm | MSO063008 | MSO083008 | MSO103008 | MSO123008 | MSO153008 | MSO183008 |
| 30mm | MSO063017 | MSO083017 | MSO103017 | MSO123017 | MSO153017 | MSO183017 |
| 30mm | MSO063023 | MSO083023 | MSO103023 | MSO123023 | MSO153023 | MSO183023 |
| 55mm | MSO065508 | MSO085508 | MSO105508 | MSO125508 | MSO155508 | MSO185508 |
| 55mm | MSO065517 | MSO085517 | MSO105517 | MSO125517 | MSO155517 | MSO185517 |
| 55mm | MSO065523 | MSO085523 | MSO105523 | MSO125523 | MSO155523 | MSO185523 |
| 30mm | MSW063008 | MSW083008 | MSW103008 | MSW123008 | MSW153008 | MSW183008 |
| 30mm | MSW063017 | MSW083017 | MSW103017 | MSW123017 | MSW153017 | MSW183017 |
MultiStage Balloon Dilatation Catheter has 72 models:
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| 30mm | MSW063023 | MSW083023 | MSW103023 | MSW123023 | MSW153023 | MSW183023 |
|---|---|---|---|---|---|---|
| 55mm | MSW065508 | MSW085508 | MSW105508 | MSW125508 | MSW155508 | MSW185508 |
| 55mm | MSW065517 | MSW085517 | MSW105517 | MSW125517 | MSW155517 | MSW185517 |
| 55mm | MSW065523 | MSW085523 | MSW105523 | MSW125523 | MSW155523 | MSW185523 |
9. Description of Non-clinical Testing
The non-clinical tests of the subject device and predicate device are in compliance with the following standards and guidance.
The biocompatibility evaluation for MultiStage Balloon Dilatation Catheter was conducted in accordance with ISO 10993-1.
- · Cytotoxicity (ISO 10993-5)
- · Sensitization (ISO 10993-10)
- · Intracutaneous reactivity test (ISO 10993-10)
Result: All tests were passed.
Shelf life for MultiStage Balloon Dilatation Catheter test is conducted based on ASTM F1980: · Shelf life test report
- Shell life test report
Result: All tests were passed.
Sterile barrier systems for MultiStage Balloon Dilatation Catheter were evaluated in accordance with ISO 11607-1:2019.
Sterilization Process has been validated accordance with ISO 11135:2014.
Result: The MultiStage Balloon Dilatation Catheter is sterile with a validation of
of the sterilization process that demonstrates achievement of the required SAL of 10% and is in accordance with the half cycle overkill approach.
Technological characteristics for MultiStage Balloon Dilatation Catheter have been tested for its functions as intended including verification of performance characteristics per performances characteristics relevant to functions as intended:
- · Visual Inspection
- · Bacteriostasis performance of pouch
- · Dye penetration
- Pouch
- · Tension test
- · Guidewire compatibility test
- · Channel compatibility
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- Product Dimensional Inspection
- . Compliance (deployed balloon dimensional analysis)
- Balloon fatigue; No leakage and damage when inflation .
- · Balloon rated burst pressure (RBP)
- · Peak tensile
- · Kink resistance
- Leakage Test
- · Hydratability
- Hub
- · Corrosion resistance
- · X-ray detectability
- · Chemical properties
Result: All tests were passed.
The results of Non-Clinical Performance testing demonstrate that the MultiStage Balloon Dilatation Catheter is considered as safe and effective as the predicate.
10. Performance Data-Clinical
No clinical study is included in this submission.
11. Conclusion
The differences in technological characteristics between the proposed device and the predicate device do not raise any different questions of safety or effectiveness. Performance testing and compliance with voluntary standards demonstrate the subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
Therefore, the proposed devices are determined to be substantially equivalent to the referenced predicate device.