(156 days)
The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway.
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.
The provided text describes the 510(k) summary for the Trachealator (D35 Airway Dilation Catheter). It details the device, its intended use, comparison to predicate devices, and performance data. However, it explicitly states that clinical data and animal testing are "Not applicable" and "Clinical studies are not necessary to establish the substantial equivalence of this device."
Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or human expert evaluation. The performance data provided consists solely of bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy against specific acceptance criteria.
Below is a summary of the requested information based on the provided text, primarily focusing on the engineering and safety aspects for which data exists:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical acceptance criteria or corresponding clinical performance data are presented, this table will focus on the bench testing that was conducted to demonstrate device specifications and substantial equivalence. The document describes several tests performed but does not explicitly list "acceptance criteria" values for each, rather it states that "the D35 Airway Dilation Catheters performs as intended and that the catheter's meets their device specifications."
| Performance Test Category | Specific Test | Reported Device Performance / Outcome | Comments on Acceptance Criteria (as implied) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Passed | Met ISO 10993-5 standards |
| Sensitization | Passed | Met ISO 10993-10 standards | |
| Irritation/Intracutaneous Reactivity | Passed | Met ISO 10993-10 standards | |
| Acute Systemic Toxicity | Passed | Met ISO 10993-11 standards | |
| Pyrogenicity | Passed | Met relevant standards | |
| Sterilization | EO Sterilization Validation (Half cycle / over-kill) | Validated | Sterility Assurance Level (SAL) 10⁻⁶ (ISO 11135:2014) |
| Ethylene Oxide Sterilization Residuals | Verified | Met ISO 10993-7:2008 | |
| Shelf Life | Shelf-life testing | Supports a 3-year shelf life | N/A (Supports claimed shelf life) |
| Packaging Seal Strength | Tested | N/A | |
| Packaging Dye Leak | Tested | N/A | |
| Bench Testing | Visual inspection and dimensional verification | Performed | Met device specifications |
| Force to remove balloon protector | Performed | Met device specifications | |
| Crossing diameter | Performed | Met device specifications | |
| Simulated use | Performed | Performed as intended | |
| Friction on the guide wire | Performed | Met device specifications | |
| Visibility/radiopacity | Performed | Met device specifications | |
| Compliance and nominal length | Performed | Met device specifications | |
| Inflation/deflation times | Performed (2-17 seconds) | Within acceptable range, improved vs predicate | |
| Rated fatigue pressure | Performed | Met device specifications | |
| Rated burst pressure | Performed (12 atm) | Within acceptable range (within predicate/reference range) | |
| Bond strength | Performed | Met device specifications | |
| Catheter flexibility | Performed | Met device specifications | |
| Catheter kink | Performed | Met device specifications | |
| Torque strength | Performed | Met device specifications | |
| Air leak | Performed | Met device specifications | |
| Liquid leak | Performed | Met device specifications | |
| Cluster crushing | Performed | Met device specifications | |
| Radial strength | Performed | Met device specifications | |
| Dilation force | Performed | Met device specifications | |
| Tip perforation | Performed | Met device specifications | |
| High tensile load balloon deflation | Performed | Met device specifications | |
| Inter balloon area verification | Performed | Met device specifications |
(Note: "Met device specifications" is inferred as the acceptance criteria for each bench test, as specific numerical criteria are not detailed in the provided text.)
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: Not explicitly stated, but the submission is from DISA Medinotec, located in Johannesburg, South Africa. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the context of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The document explicitly states that "Clinical Data" is "Not applicable." The ground truth for bench and biocompatibility tests is established by laboratory measurements against defined standards and internal device specifications, not by human experts adjudicating clinical cases.
4. Adjudication method for the test set
- Not applicable. No expert adjudication of clinical outcomes or diagnostic interpretations was performed as no clinical studies were deemed necessary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance evaluations (biocompatibility, sterilization, bench testing), the "ground truth" implicitly refers to adherence to established international standards (e.g., ISO) and the manufacturer's internal device specifications.
8. The sample size for the training set
- Not applicable. This device is a physical medical device; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
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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
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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
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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
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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 MedinotecStand 171, Northlands Business Park,Bush Telegraph Street, Northriding,Johannesburg, 2169, South Africa+27 (0) 87 330 2301 |
|---|---|
| Contact: | Michelle NieuwoudtQuality & Regulatory Affairs ManagerDISA Medinotec+27 (0) 87 330 2301michelle@disals.co.za |
| Submission Correspondent: | Matthew KruegerSenior ConsultantBiologics Consulting Group, Inc.1555 King Street, Suite 300Alexandria, VA 22314571-777-9548mkrueger@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:
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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.
| ProductReferenceNumber | Balloon Length(mm) | BalloonDiameter (mm) | NominalPressure (atm) | MaximumPressure (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.
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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 onSimilarities/Differences | |
|---|---|---|---|---|
| 510(k) Number | TBD | K170759 | K110218 | — |
| Applicant | DISA Medinotec | Boston Scientific | Acclarent | — |
| Device Name | D35 Airway DilationCatheter(Trachealator) | CRE Pulmonary BalloonDilation Catheter | Inspira AIR Balloon System | — |
| ClassificationRegulation | 21 CFR 874.4680 | 21 CFR 874.4680 | 21 CFR 874.4680 | Identical |
| Product Code | KTI | KTI | KTI | Identical |
| Indications forUse | Indicated for use indilatation techniquesto open or expandstenosis in theairway. | Intended to be usedendoscopically to dilatestrictures of the airwaytree. | Intended to dilatestrictures of the airwaytree. | Equivalent |
| Table 2: | Technological Comparison |
|---|---|
| ---------- | -------------------------- |
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| Proposed Device | Predicate Device | Reference Device | Comments onSimilarities/Differences | |
|---|---|---|---|---|
| Guidewire/Styletlumen | Yes | Yes | Yes | Identical |
| Packaged withGuidewire orStylet | Guidewire | None | Stylet | Equivalent |
| Guidewire/StyletDiameter | Guidewire0.018" (6 - 12 mm)0.035" (14.5 -18 mm) | Guidewire≤ 0.035" (0.89 mm) | Stylet0.84 mm (tip)* | EquivalentThis difference in diameter does notsignificantly alter performance, as0.018" is also a standard guidewiresize used in hospitals, and the wire issupplied as an accessory with theTrachealator. |
| Strain relief | Yes | Yes | Yes | Identical |
| Usable CatheterLength (mm) | 650 ± 10 mm | 1100 mm | 450 mm | EquivalentThe Trachealator has a usable catheterlength similar to other devices on themarket. |
| Outer LumenCatheterDiameter (mm) | 3.0 ± 0.05 (6 - 10mm clusters)3.5 ± 0.05 (12 - 18mm clusters) | 2.5 mm | 2.15 mm (14x40)2.7 mm (16x40) | EquivalentThis small difference in diameter doesnot affect its performance. |
| Inflated BalloonCluster/ BalloonShape | Six/eight cylindricalballoons, arranged inparallel in a circularconfiguration, andbonded together attheir contact points | Straight body withspherical ends | Straight body withconical end | EquivalentThe Trachealator balloon is made of 6or 8 smaller cylindrical balloonsarranged in a circular configurationdesigned to create a center channel,which the other devices do not have.All three balloons dilate an airway in aradial manner; therefore, theirfunction is the same. |
| Effective BalloonLength (mm)(BalloonDiameter, (mm)) | 27 (6 - 10 mmdiameter clusters)37 (12 – 18 mmdiameter clusters) | 30 (8 - 12)55 (12 - 18) | 24 (5, 7, 8.5)40 (10,12,14,16) | EquivalentSmall differences in balloon lengthsexist, but the subject device lengthsare within the range of lengths for thecleared predicate and referencedevices. |
| Capable BalloonDiameter (mm) | Diameters rangingfrom 6 to 18 mm | 8-9-1010-11-1212-13.5-1515-16.5-1818-19-20 | 5, 7, 8.5,10, 12,14,16, 18 | EquivalentThe Trachaelator sizes (diameters) arewithin the range of other cleareddevices. |
| Proposed Device | Predicate Device | Reference Device | Comments onSimilarities/Differences | |
| Markers | 1 x Radiopaque1 x Visual marker | 2 x Radiopaque | No markers | EquivalentThe predicate and subject device bothprovide markers to assist invisualization of balloon. |
| Nominalpressure:atm (balloon ODmm) | 6 atm(6 - 18) | 3 atm | Only MaximumPressure Given | EquivalentPressure at which nominal diameter isachieved differs. Higher pressuresprovide a greater ability to dilate alesion, but the principle is similar. |
| Rated BurstPressure /MaximumPressure(Balloon ODmm) | 12 atm(6 - 18) | Balloon Length 55 mm:6 atm (18-19-20)7 atm (15-16.5-18)8 atm (12-13.5-15)Balloon Length 30 mm:8 atm (10-11-12;12-13.5-15)9 atm (8-9-10) | Balloon Length 24mm:16 atm (5 - 7)12 atm (8.5)Balloon Length 40mm:12 atm (10)10 atm (12 - 14)8 atm 16) | EquivalentThe subject device has a higher burstpressure rating than the predicatedevice. However, the maximum burstpressure rating is within the burstpressure rating of the reference device. |
| BalloonCompliance | Semi-compliant | Semi-Compliant | Non-compliant | Identical |
| MaximumDeflation Time(seconds) | 2-17 | 10 - 30 | ≤ 15 & 25 | EquivalentThe Trachealator provides animproved deflation time compared tothe predicate device, which is animprovement. |
| CapableBronchoscopeDiameter | Minimum workingchannel of 5 mm | 2.8 mm | The balloon dilationsystem can be usedside by side with abronchoscope.Compatibility for usewithin the workingchannel of abronchoscope has notbeen established. | EquivalentThe functionality of the subject deviceis similar to the predicate device anddoes not raise any new questions ofsafety and effectiveness. |
| Soft Tip | Yes | Yes | No* | Equivalent |
| Shaft Design | Coaxial Lumen | Coaxial Lumen | Coaxial Lumen | Identical |
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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.
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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
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- 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.
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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)
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§ 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.