Multistage Balloon Dilatation Catheter
Device Facts
| Record ID | K222187 |
|---|---|
| Device Name | Multistage Balloon Dilatation Catheter |
| Applicant | Dongguan TT Medical, Inc. |
| Product Code | KTI · Ear, Nose, Throat |
| Decision Date | Mar 1, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
Device Story
The MultiStage Balloon Dilatation Catheter is a single-use endoscopic device designed to dilate airway strictures. It features a three-in-one balloon design allowing for successive, gradual radial expansion to three distinct diameters. The catheter is inserted through a bronchoscope (minimum 2.8mm working channel) and tracked over a 0.035in guidewire. Two radiopaque tantalum marker bands on the balloon shoulders provide fluoroscopic visualization for precise positioning within the stricture. The device is operated by a physician during endoscopic procedures. By inflating the balloon to controlled pressures, the device mechanically dilates the stricture, potentially improving airway patency for the patient. The device is supplied sterile and is intended for single use.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, -10), shelf-life (ASTM F1980), sterilization validation (ISO 11135), and functional performance testing (visual inspection, balloon fatigue, burst pressure, leakage, tensile strength, and guidewire/channel compatibility).
Technological Characteristics
Materials: Pebax (tip, balloon, inner tube), Pebax/blue additive (outer tube), HDPE/white additive (strain relief), Polycarbonate/bonding agent (hub), HDPE (sheath), Polyformaldehyde (mandrel), Tantalum (marker bands). Energy: Mechanical inflation. Connectivity: None. Sterilization: Ethylene Oxide (EO). Form factor: Catheter with 3-stage balloon, 90mm/180mm working lengths, 0.89mm guidewire lumen.
Indications for Use
Indicated for patients requiring endoscopic dilation of strictures within the airway tree.
Regulatory Classification
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Predicate Devices
- CRE Pulmonary Balloon Dilatation Catheter (K170759)
Submission Summary (Full Text)
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March 1, 2023
Dongguan TT Medical, Inc. % Mingzi Hussey Principal Regulatory Consultant Zi-medical, Inc. 93 Springs Rd Bedford, Massachusetts 01730
Re: K222187
Trade/Device Name: MultiStage Balloon Dilatation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: February 2, 2023 Received: February 2, 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 Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (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-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,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K222187
Device Name MultiStage Balloon Dilatation Catheter
Indications for Use (Describe)
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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
May 5th, 2022
## 4. Device Identification
510(k) Number: K222187 Trade Name: MultiStage Balloon Dilatation Catheter Common Name/Classification Name: Balloon Dilatation Catheter Product Code: KTI Regulation Number: 21 CFR 874.4680 Regulation Class: Class II Review Panel: Ear Nose & Throat (ENT)
# 5. Predicate Device
The proposed device is substantially equivalent to the following predicate device:
| Applicant | Device name | 510(k) Number | Product code |
|---------------------------|----------------------------------------------|---------------|--------------|
| Boston Scientific<br>Corp | CRE Pulmonary Balloon Dilatation<br>Catheter | K170759 | KTI |
## 6. Device Description
The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter
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Image /page/4/Picture/1 description: The image shows a logo for t-MED. The logo features a large, orange triangle with a circle behind it. The triangle is the most prominent element of the logo, and the circle adds a sense of completeness. Below the triangle, the text "t-MED" is written in a simple, sans-serif font.
designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter 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.
# 7. Indication for Use
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
# 8. Comparison of Technological Characteristics
The following table compares the proposed device with the predicate device in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.
| ITEM | Proposed Device | Predicate Device | Comments |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | MultiStage Balloon Dilatation<br>Catheter | CRE Pulmonary Balloon<br>Dilatation Catheter | / |
| 510(K)<br>Submitter | Dongguan TT Medical, Inc. | Boston Scientific Corp | / |
| 510(K) Number | K222187 | K170759 | / |
| Classification<br>Regulation | 21 CFR 874.4680 | 21 CFR 874.4680 | Same |
| Classification<br>and Product Code | Class II,<br>KTI | Class II,<br>KTI | Same |
| Common name | Balloon Dilatation Catheter | Balloon Dilatation Catheter | Same |
| Bronchoscope | Single-Use | Single-Use | Same |
| Intended Use | MultiStage balloon dilatation<br>catheter is intended to be used to<br>dilate strictures located in the<br>airway tree. | CRETM Pulmonary Balloon Dilator<br>Catheters is Intended to be used to<br>endoscopically dilate strictures of<br>the airway tree. | MultiStage Balloon<br>Dilatation Catheter and<br>the predicate device are<br>same in terms of<br>indication for use. They<br>are both to be used to<br>dilate strictures located<br>in the airway tree. |
| Anatomical<br>Locations | Airway tree | Airway tree | Same |
| Components | 1. Tip 2. Balloon 3. Marker<br>Band 4. Inner Tube 5. Outer<br>Tube 6. Strain Relief 7. Hub<br>8. Protective Sheath 9. Mandrel | 1. Tip 2. Balloon 3. Marker Band<br>4. Inner Tube 5. Outer Tube<br>6. Stress Relief 7. Hub<br>8. Protective Sheath 9. Mandrel | Same |
| Principle of<br>Operation | MultiStage balloon dilatation<br>catheter used to access the<br>airway tree via a bronchoscope | The CRETM Pulmonary Balloon<br>Dilatation Catheter is used to<br>access the airway tree via a | The only different is the<br>working channel<br>diameter: MultiStage |
General Comparison
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# Premarket Notification – Traditional 510(k)
510(k) Summarv
Image /page/5/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized letter "A" in orange, with a circular shape behind it. The text "t-MED" is written in a smaller font below the "A". The logo has a clean and modern design.
| 510(k) Summary | | | | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | for the purpose of dilating<br>strictures. It is designed to pass<br>over a 0.035in (0.89mm)<br>guidewire through its guidewire<br>lumen or through a minimum 2.8<br>mm working channel<br>bronchoscope, balloon is capable<br>of 3 distinct and progressively<br>larger size diameters via controlled<br>radial expansion | bronchoscope for the purpose of<br>dilating strictures. It is designed to<br>pass over a 0.035in (0.89mm)<br>guidewire through its guidewire<br>lumen or through a minimum 5.0<br>mm working channel<br>bronchoscope, balloon is capable<br>of 3 distinct and progressively<br>larger size diameters via<br>controlled radial expansion | balloon dilatation<br>catheter has a minimum<br>2.8mm working channel,<br>which is better than<br>predicate device's<br>minimum 5.0mm<br>working channel. The<br>difference won't<br>increase any new safety<br>and efficacy risk. | | |
| Marker<br>Band/Location | Two radiopaque mark are placed<br>under the balloon segment of the<br>catheter to provide visual<br>reference points fluoroscopically<br>for balloon positioning within the<br>stricture. | Two radiopaque mark are placed<br>under the balloon segment of the<br>catheter to provide visual reference<br>points fluoroscopically for balloon<br>positioning within the<br>stricture. | Same | | |
| How Supplied | Sterile, Single use only | Sterile, Single use only | Same | | |
| Sterilization<br>method | EO | EO | Same | | |
| Outer shaft<br>diameter | 2.5mm | 2.5mm | Same | | |
| Working<br>length(mm) | 90, 180 | 110 | Different Multistage<br>Balloon Dilatation<br>Catheter has two type of<br>working length 90mm<br>and 180mm, while the<br>predicate device only has<br>one working length,<br>which<br>is 110mm. | | |
| Guiding wire<br>channel | 0.89mm | 0.89mm | Same | | |
| Inflated Balloon<br>OD | Inflated<br>Balloon<br>OD (mm)<br>6-7-8<br>8-9-10<br>10-11-12<br>12-13.5-15<br>15-16.5-18 | Inflation<br>Pressure<br>(ATM)<br>3-6-10<br>3-5.5-9<br>3-5-8<br>3-4.5-8<br>3.4.5-7 | Inflated Balloon<br>OD (mm)<br>8-9-10<br>10-11-12<br>12-13.5-15<br>15-16.5-18<br>18-19-20 | Inflation<br>Pressure<br>(ATM)<br>3-5.5-9<br>3-5-8<br>3-4.5-8<br>3.4.5-7<br>3-4.5-6 | Multistage Balloon<br>Dilatation Catheter has<br>more model to select in<br>balloon OD and<br>pressure. |
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Premarket Notification – Traditional 510(k) 510(k) Summary
Image /page/6/Picture/1 description: The image shows a logo for "t-MED". The logo is primarily orange and features a stylized letter "A" with a circle behind it. The text "t-MED" is written in a smaller font below the "A" symbol.
| Balloon Dilation<br>length | 30mm, 55mm | 30mm, 55mm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------|
| Inflation pressure | Inflated Balloon OD (mm) Inflation Pressure (ATM) 6-7-8 3-6-10 8-9-10 3-5.5-9 10-11-12 3-5-8 12-13.5-15 3-4.5-8 15-16.5-18 3.4.5-7 18-19-20 3-4.5-6 | | | | | | | | | | | | | | | Inflated Balloon OD (mm) Inflation Pressure (ATM) 8-9-10 3-5.5-9 10-11-12 3-5-8 12-13.5-15 3-4.5-8 15-16.5-18 3.4.5-7 18-19-20 3-4.5-6 | | | | | | | | | | | | | Multistage Balloon<br>Dilatation Catheter has<br>more model to select in<br>balloon OD and<br>pressure. |
| Applicable tunnel | ≥15 Fr (2.8 mm) | ≥15Fr (5.0 mm) | Different<br>MultiStage balloon<br>dilatation catheter has<br>a minimum 2.8mm<br>working channel,<br>which is better than<br>predicate device's<br>minimum 5.0mm<br>working channel. The<br>difference won't<br>increase any new safety<br>and efficacy risk. | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Materials | 1. Tip: 100% Pebax<br>2. Balloon: 100% Pebax<br>3. Marker band: Tantalum<br>4. Inner tube: 100% Pebax<br>5. Outer tube: 99.8%Pebax: 0.2%<br>Blue color additives<br>6. Strain relief: 99.8% HDPE:<br>0.2% White color additives<br>7. Hub: 95% Polycarbonate:<br>5% Bonding agent (Ethylene<br>propylene UV binder )<br>8. Protective Sheath: 100%<br>HDPE<br>9. Mandrel: 100%<br>Polyformaldehyde | 1. Balloon: 100% Pebax<br>2. Marker band: Platinum iridium | Similar Compared with<br>predicate device marker<br>band material is<br>different, the marker<br>band does not touch the<br>human body. Difference<br>do not raise new<br>questions of safety and<br>efficacy. | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Storage<br>condition and<br>Shipping<br>condition | Store in a cool, dry, dark place.<br>Rotate inventory so that those<br>catheters are used prior to the<br>expiration date on the package<br>label | Store in a cool, dry, dark place.<br>Rotate inventory so that those<br>catheters are used prior to the<br>expiration date on the package<br>label | Same | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Packaging | Sterile single package. The | Sterile single package. Predicate | Same | | | | | | | | | | | | | | | | | | | | | | | | | | |
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Image /page/7/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized orange triangle with a circle behind it. The text "t-MED" is written in black below the triangle.
| | product is inserted into the<br>dispenser, and put in sterile pouch,<br>the sterile pouch material: PET12/<br>SPE-250 (LK)<br>composite film and Tyvek 1073B<br>dialysis paper, finally put into<br>the carton. | Device is inserted into HDPE Die-<br>cut insert card, and put in<br>sterile pouch, the sterile pouch<br>material: PET12/ SPE-250 (LK)<br>composite film and Tyvek 1073B<br>dialysis paper. | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Shelf-life | 3 | 3 | Same |
| Cytotoxicity | Comply with ISO10993-5, no<br>cytotoxicity effect | Comply with ISO10993-5, no<br>cytotoxicity effect | Same |
| Irritation | Comply with ISO10993-10, not an<br>irritant | Comply with ISO10993-10, not an<br>irritant | Same |
| Sensitization | Comply with ISO10993-10, not a<br>sensitizer. | Comply with ISO10993-10, not a<br>sensitizer. | Same |
MultiStage Balloon Dilatation Catheter has 24 models:
| | Nominal Balloon Diameter | | | | | |
|-------------------|--------------------------|-----------|-----------|-----------|-----------|-----------|
| Nominal<br>Length | 6mm | 8mm | 10mm | 12mm | 15mm | 18mm |
| 30mm | MSO063009 | MSO083009 | MSO103009 | MSO123009 | MSO153009 | MSO183009 |
| 30mm | MSO063018 | MSO083018 | MSO103018 | MSO123018 | MSO153018 | MSO183018 |
| 55mm | MSO065509 | MSO085509 | MSO105509 | MSO125509 | MSO155509 | MSO185509 |
| 55mm | MSO065518 | MSO085518 | MSO105518 | MSO125518 | MSO155518 | MSO185518 |
The differences between those models have been described in 012 Device Description in this 510K submission.
The proposed device shares the similar indications for use, same device operation, and overall technical and functional capabilities as the predicate device. It also has the same standards and requirements as the predicate device.
#### 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.
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Image /page/8/Picture/1 description: The image shows a logo for "t-MED". The logo features a stylized letter "A" in orange, with a circular shape behind it. The text "t-MED" is written in black below the "A".
Shelf life for MultiStage Balloon Dilatation Catheter test is conducted based on ASTM F1980:
• Shelf 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 determination of the sterilization process to demonstrate achievement of the required SAL of 10° is in accordance to 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
- Product Dimensional Inspection
- Compliance
- . Balloon fatigue; No leakage and damage when inflation
- Balloon inflation and deflation time .
- Balloon rated burst pressure (RBP) .
- Peak tensile
- · Leakage Test
- Hydratability
- •
- · Corrosion resistance
- · X-ray detectability
- · Torsion test
The results of Non-Clinical Performance testing demonstrate that the MultiStage Balloon Dilatation Catheter is considered safe and effective for its intended use.
## 10. Performance Data-Clinical
No clinical study is included in this submission.
## 11. Conclusion
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Image /page/9/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized letter 'A' in orange, with a circular arc behind it, also in orange. Below the 'A', the text 't-MED' is written in a smaller, sans-serif font, also in orange. The overall design is simple and modern, with a focus on the letter 'A' as the central element.
It has been shown in this 510(k) submission that the differences between the proposed device and the predicate device do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed 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 device is determined to be substantially equivalent to the referenced predicate device.
