Trachealator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 9, 2021 DISA Medinotec % Matthew Krueger Senior Consultant Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, Virginia 22314 Re: K211894 Trade/Device Name: Trachealator Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dear Matthew Krueger: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 11/24/2021. Specifically, FDA is updating this SE Letter for a typo in the Sponsor name, from "DISA Medintec" to "DISA Medinotec" as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6481, shu-chen.peng(@fda.hhs.gov. Sincerely, Shuchen Peng -S 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 24, 2021 DISA Medintec % Matthew Krueger Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 Alexandria, Virginia 22314 Re: K211894 Trade/Device Name: Trachealator Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: October 27, 2021 Received: October 28, 2021 Dear Matthew Krueger: 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 {2}------------------------------------------------ requirements, including, but not limited to: registration and listing (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-continung-education/cdrl-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-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, # Shuchen Peng -S 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 {3}------------------------------------------------ In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the D35 Airway Dilation Catheter (Trachealator) is provided below. #### 1. SUBMITTER | Applicant: | DISA Medinotec<br>Stand 171, Northlands Business Park,<br>Bush Telegraph Street, Northriding,<br>Johannesburg, 2169, South Africa<br>+27 (0) 87 330 2301 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Michelle Nieuwoudt<br>Quality & Regulatory Affairs Manager<br>DISA Medinotec<br>+27 (0) 87 330 2301<br>michelle@disals.co.za | | Submission Correspondent: | Matthew Krueger<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>1555 King Street, Suite 300<br>Alexandria, VA 22314<br>571-777-9548<br>mkrueger@biologicsconsulting.com | | Date Prepared: | October 26, 2021 | #### 2. DEVICE | Device Trade Name: | Trachealator | |---------------------|------------------------------------------------------| | Device Common Name: | D35 Airway Dilation Catheter | | Classification Name | 21CFR 874.4680, Bronchoscope (flexible or rigid) and | | | accessories | | Regulatory Class: | Class II | | Product Code: | KTI | #### 3. PREDICATE DEVICE K170759 – CRE Pulmonary Balloon Dilatation Catheter (Boston Predicate Device: Scientific) K110218 - Inspira AIR Balloon Dilation System (Acclarent, Inc.) Reference Device: {4}------------------------------------------------ #### DEVICE DESCRIPTION 4. The D35 Airway Dilation Catheter (marketing name: Trachealator) is a sterile single-use device used during airway dilatation procedures. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for airflow. Thus, airway occlusion is avoided. The D35 Airway Dilation Catheter is also packaged with a double-ended PTFE-coated stainlesssteel guidewire. The guidewire consists of a two-tip configuration with a length of 1500 mm. One end has a straight tip configuration, while the other end consists of a J-tip with a 6 mm diameter. The catheter is also used with an inflation device that is not provided with the catheter. The D35 Airway Dilation Catheter is provided in nine models. The only differences between the models are the balloon length and diameter. Refer to Table 1 for the specifications for each of the 9 models. | Product<br>Reference<br>Number | Balloon Length<br>(mm) | Balloon<br>Diameter (mm) | Nominal<br>Pressure (atm) | Maximum<br>Pressure (atm) | |--------------------------------|------------------------|--------------------------|---------------------------|---------------------------| | TRD1-06030 | 30 | 6.0 | 6 | 12 | | TRD1-07030 | 30 | 7.0 | 6 | 12 | | TRD1-08030 | 30 | 8.0 | 6 | 12 | | TRD1-09030 | 30 | 9.0 | 6 | 12 | | TRD1-10030 | 30 | 10.0 | 6 | 12 | | TRD1-12040 | 40 | 12.0 | 6 | 12 | | TRD1-14540 | 40 | 14.5 | 6 | 12 | | TRD1-16040 | 40 | 16.0 | 6 | 12 | | TRD1-18040 | 40 | 18.0 | 6 | 12 | Table 1: Catheter Models and Balloon Specifications #### 5. INTENDED USE/INDICATIONS FOR USE The device is indicated for use in dilatation techniques to open or expand stenosis in the airway. {5}------------------------------------------------ #### SUBSTANTIAL EQUIVALENCE 6. ### Comparison of Indications #### Predicate Device Indications for Use K170759 - Boston Scientific CRE Pulmonary Balloon Dilatation Catheter The CRE Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. #### Subject Device Indications for Use The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway. The intended use of the Trachealator (internal device name: D35 Airway Dilation Catheter) is the same as that of the predicate Boston Scientific CRE Pulmonary Balloon Dilation Catheter. The proposed Indications for Use statement is similar to the predicate IFU but uses slightly different wording. Despite the difference in wording, both Indications for Use statements convey the same clinical use of the device. ### Technological Comparisons The table below compares the key technological feature of the subject device to the predicate device (CRE Pulmonary Balloon Dilatation Catheter-Boston Scientific [K170759]) and the reference device (Inspira AIR Balloon Dilation System-Acclarent, Inc. [K110218]). The reference device is used because the Inspira device helps to better define the "box" of device attributes that are cleared to demonstrate that the Trachealator's key parameters fall within the range of cleared devices. | | Proposed Device | Predicate Device | Reference Device | Comments on<br>Similarities/Differences | |------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------| | 510(k) Number | TBD | K170759 | K110218 | — | | Applicant | DISA Medinotec | Boston Scientific | Acclarent | — | | Device Name | D35 Airway Dilation<br>Catheter<br>(Trachealator) | CRE Pulmonary Balloon<br>Dilation Catheter | Inspira AIR Balloon System | — | | Classification<br>Regulation | 21 CFR 874.4680 | 21 CFR 874.4680 | 21 CFR 874.4680 | Identical | | Product Code | KTI | KTI | KTI | Identical | | Indications for<br>Use | Indicated for use in<br>dilatation techniques<br>to open or expand<br>stenosis in the<br>airway. | Intended to be used<br>endoscopically to dilate<br>strictures of the airway<br>tree. | Intended to dilate<br>strictures of the airway<br>tree. | Equivalent | | Table 2: | Technological Comparison | |----------|--------------------------| |----------|--------------------------| {6}------------------------------------------------ | | Proposed Device | Predicate Device | Reference Device | Comments on<br>Similarities/Differences | |------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Guidewire/Stylet<br>lumen | Yes | Yes | Yes | Identical | | Packaged with<br>Guidewire or<br>Stylet | Guidewire | None | Stylet | Equivalent | | Guidewire/Stylet<br>Diameter | Guidewire<br>0.018" (6 - 12 mm)<br>0.035" (14.5 -<br>18 mm) | Guidewire<br>≤ 0.035" (0.89 mm) | Stylet<br>0.84 mm (tip)* | Equivalent<br>This difference in diameter does not<br>significantly alter performance, as<br>0.018" is also a standard guidewire<br>size used in hospitals, and the wire is<br>supplied as an accessory with the<br>Trachealator. | | Strain relief | Yes | Yes | Yes | Identical | | Usable Catheter<br>Length (mm) | 650 ± 10 mm | 1100 mm | 450 mm | Equivalent<br>The Trachealator has a usable catheter<br>length similar to other devices on the<br>market. | | Outer Lumen<br>Catheter<br>Diameter (mm) | 3.0 ± 0.05 (6 - 10<br>mm clusters)<br>3.5 ± 0.05 (12 - 18<br>mm clusters) | 2.5 mm | 2.15 mm (14x40)*<br>2.7 mm (16x40)* | Equivalent<br>This small difference in diameter does<br>not affect its performance. | | Inflated Balloon<br>Cluster/ Balloon<br>Shape | Six/eight cylindrical<br>balloons, arranged in<br>parallel in a circular<br>configuration, and<br>bonded together at<br>their contact points | Straight body with<br>spherical ends | Straight body with<br>conical end | Equivalent<br>The Trachealator balloon is made of 6<br>or 8 smaller cylindrical balloons<br>arranged in a circular configuration<br>designed to create a center channel,<br>which the other devices do not have.<br>All three balloons dilate an airway in a<br>radial manner; therefore, their<br>function is the same. | | Effective Balloon<br>Length (mm)<br>(Balloon<br>Diameter, (mm)) | 27 (6 - 10 mm<br>diameter clusters)<br>37 (12 – 18 mm<br>diameter clusters) | 30 (8 - 12)<br>55 (12 - 18) | 24 (5, 7, 8.5)<br>40 (10,12,14,16) | Equivalent<br>Small differences in balloon lengths<br>exist, but the subject device lengths<br>are within the range of lengths for the<br>cleared predicate and reference<br>devices. | | Capable Balloon<br>Diameter (mm) | Diameters ranging<br>from 6 to 18 mm | 8-9-10<br>10-11-12<br>12-13.5-15<br>15-16.5-18<br>18-19-20 | 5, 7, 8.5,10, 12,<br>14,16, 18 | Equivalent<br>The Trachaelator sizes (diameters) are<br>within the range of other cleared<br>devices. | | | Proposed Device | Predicate Device | Reference Device | Comments on<br>Similarities/Differences | | Markers | 1 x Radiopaque<br>1 x Visual marker | 2 x Radiopaque | No markers | Equivalent<br>The predicate and subject device both<br>provide markers to assist in<br>visualization of balloon. | | Nominal<br>pressure:<br>atm (balloon OD<br>mm) | 6 atm<br>(6 - 18) | 3 atm | Only Maximum<br>Pressure Given | Equivalent<br>Pressure at which nominal diameter is<br>achieved differs. Higher pressures<br>provide a greater ability to dilate a<br>lesion, but the principle is similar. | | Rated Burst<br>Pressure /<br>Maximum<br>Pressure<br>(Balloon OD<br>mm) | 12 atm<br>(6 - 18) | Balloon Length 55 mm:<br>6 atm (18-19-20)<br>7 atm (15-16.5-18)<br>8 atm (12-13.5-15)<br>Balloon Length 30 mm:<br>8 atm (10-11-12;12-13.5-<br>15)<br>9 atm (8-9-10) | Balloon Length 24<br>mm:<br>16 atm (5 - 7)<br>12 atm (8.5)<br>Balloon Length 40<br>mm:<br>12 atm (10)<br>10 atm (12 - 14)<br>8 atm 16) | Equivalent<br>The subject device has a higher burst<br>pressure rating than the predicate<br>device. However, the maximum burst<br>pressure rating is within the burst<br>pressure rating of the reference device. | | Balloon<br>Compliance | Semi-compliant | Semi-Compliant | Non-compliant | Identical | | Maximum<br>Deflation Time<br>(seconds) | 2-17 | 10 - 30 | ≤ 15 & 25 | Equivalent<br>The Trachealator provides an<br>improved deflation time compared to<br>the predicate device, which is an<br>improvement. | | Capable<br>Bronchoscope<br>Diameter | Minimum working<br>channel of 5 mm | 2.8 mm | The balloon dilation<br>system can be used<br>side by side with a<br>bronchoscope.<br>Compatibility for use<br>within the working<br>channel of a<br>bronchoscope has not<br>been established. | Equivalent<br>The functionality of the subject device<br>is similar to the predicate device and<br>does not raise any new questions of<br>safety and effectiveness. | | Soft Tip | Yes | Yes | No* | Equivalent | | Shaft Design | Coaxial Lumen | Coaxial Lumen | Coaxial Lumen | Identical | {7}------------------------------------------------ As shown in the table above, the fundamental design and technology of the Trachealator is equivalent or identical to the predicate CRE Pulmonary Balloon and/or the reference Inspira AIR Balloon. The minor differences between the subject device and predicate device does not raise questions of safety and effectiveness. Performance testing supports substantial equivalence, that the subject device performs as intended and that the subject device meets the device specifications. {8}------------------------------------------------ #### 7. PERFORMANCE DATA ### Biocompatibility Testing The balloons and the outer shaft are direct patient contacting devices classified as a surface device, in contact with tissue, with limited contact duration (≤24h) based on the intended use. Other parts of the catheter (inner lumen shaft and tip, radiopaque marker, film on the inner surface of the balloon cluster, and adhesive bonds and the guidewire provided with the device. may be positioned in the patient's airway and therefore encounter blood, mucous, or phlegm and thereby indirectly contact patient's tissues. These are an indirect patient contacting device classified as a surface device, in contact with tissue, with limited contact duration (≤24h). Biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and pyrogenicity) was performed in accordance with the following standards: ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-11:2018, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials The D35 Airway Dilation Catheter passed all biocompatibility testing. ### Sterilization and Shelf Life The device is EO sterilization, validated by a half cycle / over-kill approach in accordance with ISO 11135:2014. The sterility assurance level is 106. The D35 Airway Dilation Catheters have been verified according to ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals". Shelf-life testing was conducted to support a 3 year shelf life. Packaging was tested for seal strength and dye leak. # Electrical Safety and Electromagnetic Compatibility (EMC) Not applicable. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type. ### Software Verification and Validation Testing Not applicable. The device contains no software. # Bench Testing The following performance testing supports substantial equivalence, that the D35 Airway Dilation Catheters performs as intended and that the catheter's meets their device specifications: - . Visual inspection and dimensional verification {9}------------------------------------------------ - Force to remove balloon protector ● - Crossing diameter ● - Simulated use - Friction on the guide wire ● - Visibility/radiopacity - Compliance and nominal length - Inflation/deflation times - Rated fatigue pressure ● - Rated burst pressure - Bond strength - Catheter flexibility - Catheter kink - Torque strength - Air leak - Liquid leak - Cluster crushing - Radial strength ● - Dilation force - Tip perforation ● - High tensile load balloon deflation ● - Inter balloon area verification ● ### Animal Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. ### Clinical Data Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device. #### CONCLUSION 8. Based on the detailed comparison to the predicate device and the performance testing, the D35 Airway Dilation Catheter can be found substantially equivalent to the predicate device. {10}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211894 Device Name Trachealator Indications for Use (Describe) The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway. 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. 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