K Number
K222187
Device Name
Multistage Balloon Dilatation Catheter
Date Cleared
2023-03-01

(222 days)

Product Code
Regulation Number
874.4680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
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 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.
More Information

Not Found

No
The 510(k) summary describes a mechanical device (balloon catheter) and its physical properties and performance. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Yes
The device is intended to be used to dilate strictures in the airway, which is a therapeutic intervention.

No

This device is a therapeutic device intended to dilate strictures in the airway, not to diagnose a condition.

No

The device description clearly outlines a physical medical device (catheter, balloon, guidewire lumen, hub, marker bands) made of specific materials (Pebax, polycarbonate, tantalum). The performance studies focus on the physical and material properties of the device, not software functionality.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "dilate strictures located in the airway tree." This is a therapeutic procedure performed directly on the patient's body.
  • Device Description: The description details a physical catheter with a balloon designed for mechanical dilation. It is used endoscopically and over a guidewire.
  • Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is a therapeutic tool used for a physical intervention.

N/A

Intended Use / Indications for Use

MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.

Product codes

KTI

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway tree

Indicated Patient Age Range

Not Found

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)

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

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 10-6 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.
No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170759

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.

0

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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

1

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

2

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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Image /page/3/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. The text "t-MED" is positioned below the "A", with "t-" in a smaller font size than "MED". The overall design is simple and modern, using a bold color to draw attention.

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:

ApplicantDevice name510(k) NumberProduct code
Boston Scientific
CorpCRE Pulmonary Balloon Dilatation
CatheterK170759KTI

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

4

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.

ITEMProposed DevicePredicate DeviceComments
Trade nameMultiStage Balloon Dilatation
CatheterCRE Pulmonary Balloon
Dilatation Catheter/
510(K)
SubmitterDongguan TT Medical, Inc.Boston Scientific Corp/
510(K) NumberK222187K170759/
Classification
Regulation21 CFR 874.468021 CFR 874.4680Same
Classification
and Product CodeClass II,
KTIClass II,
KTISame
Common nameBalloon Dilatation CatheterBalloon Dilatation CatheterSame
BronchoscopeSingle-UseSingle-UseSame
Intended UseMultiStage balloon dilatation
catheter is intended to be used to
dilate strictures located in the
airway tree.CRETM Pulmonary Balloon Dilator
Catheters is Intended to be used to
endoscopically dilate strictures of
the airway tree.MultiStage Balloon
Dilatation Catheter and
the predicate device are
same in terms of
indication for use. They
are both to be used to
dilate strictures located
in the airway tree.
Anatomical
LocationsAirway treeAirway treeSame
Components1. Tip 2. Balloon 3. Marker
Band 4. Inner Tube 5. Outer
Tube 6. Strain Relief 7. Hub
  1. Protective Sheath 9. Mandrel | 1. Tip 2. Balloon 3. Marker Band
  2. Inner Tube 5. Outer Tube
  3. Stress Relief 7. Hub
  4. Protective Sheath 9. Mandrel | Same |
    | Principle of
    Operation | MultiStage balloon dilatation
    catheter used to access the
    airway tree via a bronchoscope | The CRETM Pulmonary Balloon
    Dilatation Catheter is used to
    access the airway tree via a | The only different is the
    working channel
    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
strictures. It is designed to pass
over a 0.035in (0.89mm)
guidewire through its guidewire
lumen or through a minimum 2.8
mm working channel
bronchoscope, balloon is capable
of 3 distinct and progressively
larger size diameters via controlled
radial expansionbronchoscope for the purpose of
dilating strictures. It is designed to
pass over a 0.035in (0.89mm)
guidewire through its guidewire
lumen or through a minimum 5.0
mm working channel
bronchoscope, balloon is capable
of 3 distinct and progressively
larger size diameters via
controlled radial expansionballoon dilatation
catheter has a minimum
2.8mm working channel,
which is better than
predicate device's
minimum 5.0mm
working channel. The
difference won't
increase any new safety
and efficacy risk.
Marker
Band/LocationTwo radiopaque mark are placed
under the balloon segment of the
catheter to provide visual
reference points fluoroscopically
for balloon positioning within the
stricture.Two radiopaque mark are placed
under the balloon segment of the
catheter to provide visual reference
points fluoroscopically for balloon
positioning within the
stricture.Same
How SuppliedSterile, Single use onlySterile, Single use onlySame
Sterilization
methodEOEOSame
Outer shaft
diameter2.5mm2.5mmSame
Working
length(mm)90, 180110Different Multistage
Balloon Dilatation
Catheter has two type of
working length 90mm
and 180mm, while the
predicate device only has
one working length,
which
is 110mm.
Guiding wire
channel0.89mm0.89mmSame
Inflated Balloon
ODInflated
Balloon
OD (mm)
6-7-8
8-9-10
10-11-12
12-13.5-15
15-16.5-18Inflation
Pressure
(ATM)
3-6-10
3-5.5-9
3-5-8
3-4.5-8
3.4.5-7Inflated Balloon
OD (mm)
8-9-10
10-11-12
12-13.5-15
15-16.5-18
18-19-20Inflation
Pressure
(ATM)
3-5.5-9
3-5-8
3-4.5-8
3.4.5-7
3-4.5-6Multistage Balloon
Dilatation Catheter has
more model to select in
balloon OD and
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

length30mm, 55mm30mm, 55mmSame
Inflation pressureInflated 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 3-4.5-6Inflated 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 3-4.5-6Multistage Balloon
Dilatation Catheter has
more model to select in
balloon OD and
pressure.
Applicable tunnel≥15 Fr (2.8 mm)≥15Fr (5.0 mm)Different
MultiStage balloon
dilatation catheter has
a minimum 2.8mm
working channel,
which is better than
predicate device's
minimum 5.0mm
working channel. The
difference won't
increase any new safety
and efficacy risk.
Materials1. Tip: 100% Pebax
  1. Balloon: 100% Pebax
  2. Marker band: Tantalum
  3. Inner tube: 100% Pebax
  4. Outer tube: 99.8%Pebax: 0.2%
    Blue color additives
  5. Strain relief: 99.8% HDPE:
    0.2% White color additives
  6. Hub: 95% Polycarbonate:
    5% Bonding agent (Ethylene
    propylene UV binder )
  7. Protective Sheath: 100%
    HDPE
  8. Mandrel: 100%
    Polyformaldehyde | 1. Balloon: 100% Pebax
  9. Marker band: Platinum iridium | Similar Compared with
    predicate device marker
    band material is
    different, the marker
    band does not touch the
    human body. Difference
    do not raise new
    questions of safety and
    efficacy. | | | | | | | | | | | | | | | | | | | | | | | | | | |
    | Storage
    condition and
    Shipping
    condition | Store in a cool, dry, dark place.
    Rotate inventory so that those
    catheters are used prior to the
    expiration date on the package
    label | Store in a cool, dry, dark place.
    Rotate inventory so that those
    catheters are used prior to the
    expiration date on the package
    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
dispenser, and put in sterile pouch,
the sterile pouch material: PET12/
SPE-250 (LK)
composite film and Tyvek 1073B
dialysis paper, finally put into
the carton. | Device is inserted into HDPE Die-
cut insert card, and put in
sterile pouch, the sterile pouch
material: PET12/ SPE-250 (LK)
composite film and Tyvek 1073B
dialysis paper. | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Shelf-life | 3 | 3 | Same |
| Cytotoxicity | Comply with ISO10993-5, no
cytotoxicity effect | Comply with ISO10993-5, no
cytotoxicity effect | Same |
| Irritation | Comply with ISO10993-10, not an
irritant | Comply with ISO10993-10, not an
irritant | Same |
| Sensitization | Comply with ISO10993-10, not a
sensitizer. | Comply with ISO10993-10, not a
sensitizer. | Same |

MultiStage Balloon Dilatation Catheter has 24 models:

Nominal Balloon Diameter
Nominal
Length6mm8mm10mm12mm15mm18mm
30mmMSO063009MSO083009MSO103009MSO123009MSO153009MSO183009
30mmMSO063018MSO083018MSO103018MSO123018MSO153018MSO183018
55mmMSO065509MSO085509MSO105509MSO125509MSO155509MSO185509
55mmMSO065518MSO085518MSO105518MSO125518MSO155518MSO185518

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.

8

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.