(77 days)
The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.
The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.
The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.
The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.
| Test Category | Study Endpoint | Requirement | Acceptance Requirement | Reported Device Performance (aeris Balloon Dilation Catheter) |
|---|---|---|---|---|
| Functional Performance | ||||
| Balloon Working Length | Balloon pressure at 1 ATM | Balloon working length within tolerance | 5x30mm: 30 ± 1 mm9x30mm: 30 ± 0.6 mm16x40mm: 40 ± 1 mm | Pass |
| Inflation Time | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Balloon able to inflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressure at 0 ATM | Balloon able to deflate | ≤ 15 seconds | Pass |
| Catheter Fatigue | Balloon inflated 10 times to recommended use pressure | 10 cycles to recommended use pressure | No evidence of balloon leakage | Pass |
| Maximum Inflation Pressure | Balloon ruptures | Balloon failure pressure > recommended use pressure | 5x30mm & 9x30mm: Balloon failure pressure > 17 ATM16x40mm: Balloon failure pressure > 10 ATM | Pass |
| Balloon Hub Measurement | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Measure diameter of hub and working length | 5x30mm & 9x30mm: Hub diameter minus working length diameter < 1 mm16x40mm: Hub diameter minus working length diameter < 2 mm | Pass |
| Balloon Diameter | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Balloon diameter within tolerance | 5x30mm: 5 ± 0.4 mm9x30mm: 9 ± 0.4 mm16x40mm: 16 ± 0.6 mm | Pass |
| Insertability | Distal end inserted through a 10° bend in a tube with specific diameter | Distal end inserted through 10° bend in tube | No visual signs of kinking or damage done to catheter or stylet | Pass |
| Removability | Distal end withdrawn through a tube with specific diameter | Distal end withdrawn through tube | No visual signs of damage | Pass |
| Proximal Luer Fitting | Tested | Per ISO 594-1 & 594-2 | Meet acceptance criteria of ISO 594-1 & 594-2 | Pass |
| Torqueable | Catheter rotated 2 times | Catheter turned at least 2 times | No visual signs of damage | Pass |
| Luer/Catheter Shaft Connection | Connection failure | Bond tensile force per ISO 10555 | 5x30mm & 9x30mm: ≥ 10 N16x40mm: ≥ 15 N | Pass |
| Biocompatibility | ||||
| L929 MEM Elution Cytotoxicity | Test article must have a reactivity grade of mild or less (≤ 2) | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. | Pass | |
| Guinea Pig Maximization Sensitization | Test article must have a reaction sensitivity grade of no visible change (Grade 0) | There was no sensitization response (Grade 0) in the test articles. | Pass | |
| Acute Systemic Toxicity | Animals treated with test article extract must not show signs indicative of toxicity. | None of the test article extract treated animals observed with clinical signs consistent with toxicity. | Pass | |
| Intracutaneous Irritation | Tissue reaction to the test article to control dermal observation score is ≤ 1. | Differences in mean test and control scores of extract dermal operations were less than 1. | Pass | |
| Comparison to Predicate Devices | ||||
| Radiopacity | X-ray performed | The balloon will have marker bands, one under each balloon neck, that are visible under fluoroscopy | Equivalent visibility of the aeris marker bands to the predicate devices (specifically CRE Pulmonary) | Equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
The document details bench testing for various physical attributes of the device and biocompatibility testing. It does not describe a clinical "test set" in the context of diagnostic AI models (i.e., human patient data with ground truth labels).
- Bench Testing: The sample sizes for each specific bench test (e.g., number of catheters tested for inflation time, fatigue, etc.) are not explicitly stated in the provided summary tables. The results are presented as "Pass" for each test.
- Biocompatibility Testing: The number of biological samples or animals used for tests like L929 MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Acute Systemic Toxicity, and Intracutaneous Irritation are not specified.
- Data Provenance: Not applicable in the context of clinical patient data. The tests are laboratory-based bench tests and preclinical biocompatibility assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The submission is for a medical device (balloon dilation catheter) and involves physical and biological performance testing, not a diagnostic AI device requiring expert-established ground truth from clinical images or data. Bench test acceptance criteria are based on engineering specifications and regulatory standards (e.g., ISO standards).
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" involving expert review or adjudication in the context of AI/diagnostic performance described in this document.
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 is a medical device for dilating strictures of the airway, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is established by:
- Engineering Specifications: Defined tolerances for physical dimensions (e.g., balloon working length, diameter), time limits (e.g., inflation/deflation time), force requirements (e.g., bond tensile force), and operational limits (e.g., maximum inflation pressure).
- Regulatory Standards: Adherence to ISO standards (e.g., ISO 594-1 & 594-2 for luer fittings, ISO 10555 for bond tensile force).
- Visual Inspection: "No visual signs of kinking or damage" for insertability/removability, "No evidence of balloon leakage" for fatigue, "No visual signs of damage" for torqueable.
- Biocompatibility Assessment: Biological responses meeting defined safety thresholds (e.g., reactivity grade of mild or less, no sensitization response, no signs of toxicity, differences in scores less than 1).
- Equivalence to Predicate Devices: For radiopacity, the visibility of the aeris marker bands needed to be "Equivalent" to that of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for an AI/algorithm described in this document.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines extending from their faces. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2015
Bryan Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K150951
Trade/Device Name: Aeris Balloon Dilation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: June 9, 2015 Received: June 10, 2015
Dear Mr. Job:
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. 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.
{1}------------------------------------------------
Page 2 - Mr. Mark Job
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
aeris Balloon Dilation Catheter
Indications for Use (Describe)
The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of 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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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (200) 483-6740
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510(k) Summary
Bryan Medical, aeris Balloon Dilation Catheter
The assigned 510(k) number is: K150951 510(k) Owner: Andrew Georgilis Bryan Medical, Inc. 3906 Oak St. Cincinnati, OH 45227 Phone: (513) 272-1600 Fax: (513) 272-1610 Contact Person: Andy Black Medical Murray, Inc. 400 North Rand Road North Barrington, IL 60010 Phone: (847) 620-7990 Fax: (847) 620-7995 January 30, 2015 Date Prepared: Device Name and Classification Classification Name: Bronchoscope (Flexible or Rigid) and Accessories Common Name: Balloon Dilation Catheter
Name: aeris Balloon Dilation Catheter
Device Classification: Class II
Number: 21 CFR Ref. § 874.4680
Product Code: KTI
Review Panel: Ear, Nose, & Throat
Predicate Device: Acclarent Inspira AIR Balloon Dilation System (K090660)
Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337)
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Device Description
The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.
The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.
| aeris BalloonDilationCatheter Size | ProductNumber | BalloonØ (mm) | BalloonWorkingLength (mm) | RecommendedUse Pressure(ATM) | CatheterOD (mm) | CatheterLength(cm) |
|---|---|---|---|---|---|---|
| 5 x 30 mm | KG0530 | 5 | 30 | 17 | 1.55 | 55 |
| 7 x 30 mm | KG0730 | 7 | 30 | 17 | 1.55 | 55 |
| 8 x 30 mm | KG0830 | 8 | 30 | 17 | 1.55 | 55 |
| 9 x 30 mm | KG0930 | 9 | 30 | 17 | 1.55 | 55 |
| 10 x 30 mm | KG1030 | 10 | 30 | 17 | 2.34 | 55 |
| 12 x 40 mm | KG1240 | 12 | 40 | 10 | 2.34 | 55 |
| 14 x 40 mm | KG1440 | 14 | 40 | 10 | 2.34 | 55 |
| 16 x 40 mm | KG1640 | 16 | 40 | 10 | 2.34 | 55 |
Table 1: aeris Balloon Dilation Catheter sizes and corresponding characteristics.
The aeris Balloon Dilation Catheter is provided in sterile packaging and with a protective sheath covering the balloon. After removing the catheter from the packaging and protective sheath, it is wiped down with a gauze pad soaked in sterile water. The catheter should then be gently advanced into the airway, to the site of the stricture under endoscopic visualization. The balloon portion of the device is then centered across the restriction and the stylet is removed while holding the catheter securely in place. The balloon dilation catheter luer is attached to the Inflation Device and the balloon is inflated to desired pressure with sterile water. Monitor the balloon via endoscopy during inflation assessing the diameter, shape, and position of the balloon ensuring that the proximal end of the balloon remains proximal to the stricture.
The balloon can be completely deflated while maintaining an endoscopic view of the balloon using a vacuum. Once visual confirmation of the fully deflated balloon is achieved, the balloon may be removed from the airway.
Indications for Use
The aeris Balloon Dilation Catheter is intended to dilate strictures of the airway.
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Substantial Equivalence Claim
Based on comparison of device features, materials, intended use, and performance, the Bryan Medical, aeris Balloon Dilation Catheter is substantially equivalent to the commercially available predicate device Acclarent Inspira AIR approved by the FDA under 510k number K090660 and Boston Scientific CRE approved by the FDA under 510k number K023337. Table 2 shows a substantial equivalence comparison summary of the aeris Balloon Dilation Catheter compared to the predicate devices.
| Table 2. Comparison table of aeris Balloon Dilation Catheter characteristics to predicate devices | ||
|---|---|---|
| Attribute | Acclarent Inspira AIR | Boston Scientific CRE | Bryan Medical aeris |
|---|---|---|---|
| A. Intended Use | |||
| A.1 Indications forUse Statement | The Airway BalloonCatheter is an instrumentintended to dilate stricturesof the airway tree. | The CRE Pulmonary BalloonDilatation Catheter is intendedto be used endoscopically todilate strictures of the airwaytree. | The aeris Balloon DilationCatheter is intended to dilatestrictures of the airway. |
| A.2 Labeling | Equivalent in content (labelincluded in Section N) | Equivalent in content (labelincluded in Section N) | Equivalent content (labelincluded in Section N) |
| A.3 TargetPopulation | All patients meetingintended use and labelingrequirements. | All patients meeting intended useand labeling requirements. | All patients meeting intendeduse and labelingrequirements. |
| A.4 Product code& 21 CFRregulation # | KTI, 874.4680 | KTI, 874.4680 | KTI, 874.4680 |
| A.5Contraindications | • Balloon dilation iscontraindicated in anypatient whose degree ofrespiratory failure wouldnot allow the patient totolerate the manipulationrequired to accomplishballoon dilation.• Balloon dilation iscontraindicated in thepresence of:o significant activebleeding from the siteof the proposeddilationo and/or presence of aknown perforation atthe site of proposeddilationo and/or presence of aknown fistula betweenthe tracheobronchialtree and esophagus,mediastinum orpleural space. | • Balloon dilation iscontraindicated in any patientwhose general medicalcondition and degree ofrespiratory failure would notallow the patient to toleratebronchoscopy (rigid orflexible) and/or themanipulation required toaccomplish balloon dilation.• Balloon dilation iscontraindicated in thepresence of:significant active bleedingfrom the site of the proposeddilatation,and/or presence of a knownperforation at the site ofproposed dilatation,and/or presence of a knownfistula between thetracheobronchial tree andesophagus, mediastinum orpleural space unless thedilatation was beingperformed in preparation forthe placement of a stent totreat the perforation or fistula. | • Balloon dilation of theairway is contraindicated inany patient whose degreeof respiratory failure wouldnot allow the patient totolerate the manipulationrequired to accomplishballoon dilation.• Balloon dilation iscontraindicated in thepresence of:o significant activebleeding from the site ofthe proposed dilationo and/or presence of aknown perforation at thesite of proposed dilationo and/or presence of aknown fistula betweenthe tracheobronchial treeand esophagus,mediastinum or pleuralspace |
| Table 2 cont. | |||
| Attribute | Acclarent Inspira AIR | Boston Scientific CRE | Bryan Medical aeris |
| B. Technology | |||
| B.1 Balloon Shapeat < 2 ATM / Max.Inflation Pressure | Straight body and conicalends / straight body andspherical ends | Straight body and conicalends / straight body andspherical ends | Dog-bone body and conicalends / straight body withspherical ends |
| B.2 Used withStylet | Optional | Yes (Guidewire) | Optional |
| B.3 RadiopaqueMarkers | No | Yes | Yes |
| B.4 PatientContactingMaterials | Unknown | Unknown | Nylon balloon, Pebax catheter |
| B.5 BalloonDiameters | 5 mm7 mm8.5 mm10 mm12 mm14 mm16 mm | 8 – 9 – 10 mm10 – 11 – 12 mm12 – 13.5 – 15 mm15 – 16.5 – 18 mm18 – 19 – 20 mm | 5 mm7 mm8 mm9 mm10 mm12 mm14 mm16 mm |
| B.6 BalloonWorking Lengths(mm) | 24 for diameters 5, 7, & 8.540 for diameters 10, 12, 14,& 16 | 30 for diameters 8 - 1255 for diameters 12 – 18 permanufacturer's website | 30 for diameters 5 - 1040 for diameters 12 - 16 |
| B.7 CatheterOutside Diameter(mm) | 2.1 | 2.5 | 1.55 for diameters 5 - 92.34 for diameters 10 - 16 |
| B.8 CatheterLength (cm) | 45 | 75 | 55 |
| B.9 Deflation Time(Seconds) | ≤ 15 & 25 per clearanceletter for K110218 | Unknown | ≤ 15 |
| B.10 MaximumInflation Pressure | 8 – 16 ATM | 6 - 9 ATM | 10 & 17 ATM |
| B.11 Flexible | Yes | Yes | Yes |
| B.12 Shaft Design | Coaxial lumen | Coaxial lumen | Single lumen |
| B.13 Single-Use | Yes | Yes | Yes |
| B.14 Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| C. Performance Specifications | |||
| C.1 Inflation Time | Equivalent | Equivalent | ≤ 10 seconds |
| C.2 Insertability | Equivalent | Equivalent | Through equal ID tubing with 10°bend around 4.5" radius |
| C.3 Removability | Equivalent | Equivalent | Through airway ≤ 60% ofballoon diameter |
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Table 2 cont.
| Attribute | Acclarent Inspira AIR | Boston Scientific CRE | Bryan Medical aeris |
|---|---|---|---|
| C.4 Proximal LuerFitting | Yes | Yes | Yes |
| C.5 Torqueable | Equivalent | Equivalent | Min. 2 turns |
| C.6 Bond Force | Unknown | Unknown | Min. 10 N for diameters 5 - 9Min. 15 N for diameters 10 - 16 |
The intended use of the aeris Balloon Dilation Catheter is substantially equivalent to the predicate devices in intended use, contraindications, and content of labeling. All devices meet the description set forth by the FDA requlation number 21 CFR Ref. § 874.4680.
The technology incorporated into the aeris Balloon Dilation Catheter is substantially equivalent to the technology for the predicate devices. The major components of these devices include a distally located inflation balloon, a flexible catheter shaft, and proximal luer to which an inflation device may be connected. The catheter shaft can be stiffened with a stylet (guidewire) running axially in an interior lumen. Attached to the catheter shaft under each end of the inflation balloon are radiopaque marker bands similar to the Boston Scientific CRE predicate device. All materials of the aeris Balloon Dilation Catheter were tested for biocompatibility for their intended use.
The inflation balloon sizes of the aeris Balloon Dilation Catheter are equivalent to those of the predicate devices. The predicate device's catalog of sizes includes a 5 mm through 18 mm diameter balloon at inflation pressure with intermediate balloon sizes approximately every 2 millimeters.
The aeris Balloon Dilation Catheter differs from the predicate devices in the design of the balloon. The aeris Balloon Dilation Catheter has hubs proximally and distally located on the balloon which begin to take shape upon inflation creating a dog bone balloon shape. As the pressure approaches the inflation pressure, each balloon end begins to take a spherical end shape. The predicate devices' balloon ends have a conical radius shape at pressures approximately equal to or less than two atmospheres. Above two atmospheres, a spherical end shape, similar to the aeris Balloon Dilation Catheter device takes shape.
The aeris Balloon Dilation Catheter is a sinqle lumen catheter design opposed to a dual lumen design of the predicates. The predicate devices have one lumen for the stylet (quidewire) to run through and a separate inflation lumen. The single aeris Balloon Dilation Catheter lumen is able to serve both of these functions without creating any additional risk.
The performance of the aeris Balloon Dilation Catheter was compared to the predicate devices in the insertability and removability tests. A sample device of each the Acclarent Inspira AIR and Boston Scientific CRE were tested for equivalency. Each predicate device passed the tests, showing equivalency between the aeris Balloon Dilation Catheter and each of the predicates were
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applicable. The aeris Balloon Dilation Catheter also shows equivalency to performance specifications of the predicate devices in the proximal luer fitting design. Equivalency of the remaining performance specifications for both predicate devices is unknown at this time due to the specifications being unspecified by the manufactures. The aeris Balloon Dilation Catheter performance specification values confirm there are no increased risks or safety concerns introduced to the patient.
Summary of Testing
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate devices identified in this submission.
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
|---|---|---|---|---|
| BalloonWorking Length | Balloon pressureat 1 ATM | Balloon workinglength withintolerance | 30 ± 1 mm | Pass |
| Inflation Time | Balloon pressureat 17 ATM | Balloon able toinflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressureat 0 ATM | Balloon able todeflate | ≤ 15 seconds | Pass |
| CatheterFatigue | Balloon inflated10 times to 17ATM | 10 cycles torecommended usepressure | No evidence ofballoon leakage | Pass |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 17 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 17 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 1 mm | Pass |
| BalloonDiameter | Balloon pressureat 17 ATM | Balloon diameterwithin tolerance | 5 ± .4 mm | Pass |
| Insertability | Balloon located | Distal end insertedthrough 10° bend intube with 5 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted | Distal end withdrawnthrough 3 mm tube | No visual signs ofdamage | Pass |
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass |
| Torqueable | Catheter rotated2 times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass |
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | ≥ 10 N | Pass |
| Table 3. Summary of baseline bench testing for 5x30mm aeris Balloon Dilation Catheter | ||
|---|---|---|
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| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
|---|---|---|---|---|
| BalloonWorking Length | Balloon pressureat 1 ATM | Balloon workinglength withintolerance | 30 ± .6 mm | Pass |
| Inflation Time | Balloon pressureat 17 ATM | Balloon able toinflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressureat 0 ATM | Balloon able todeflate | ≤ 15 seconds | Pass |
| CatheterFatique | Balloon inflated10 times to 17ATM | 10 cycles torecommended usepressure | No evidence ofballoon leakage | Pass |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 17 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 17 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 1 mm | Pass |
| BalloonDiameter | Balloon pressureat 17 ATM | Balloon diameterwithin tolerance | 9 ± .4 mm | Pass |
| Insertability | Balloon located | Distal end insertedthrough 10° bend intube with 9 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted | Distal end withdrawnthrough 5 mm tube | No visual signs ofdamage | Pass |
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass |
| Torqueable | Catheter rotated2 times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass |
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | > 10 N | Pass |
| Table 4. Summary of baseline bench testing for 9x30mm aeris Balloon Dilation Catheter | ||||
|---|---|---|---|---|
Table 5. Summary of baseline bench testing for 16x40mm aeris Balloon Dilation Catheter
| Test | Study Endpoint | Requirement | Acceptance Requirement | Result | |
|---|---|---|---|---|---|
| BalloonWorking Length | Balloon pressure at 1 ATM | Balloon working length within tolerance | $40 ± 1 mm$ | Pass | |
| Inflation Time | Balloon pressure at 10 ATM | Balloon able to inflate | < 10 seconds | Pass | |
| Deflation Time | Balloon Pressure at 0 ATM | Balloon able to deflate | $≤ 15 seconds$ | Pass | |
| CatheterFatigue | Balloon inflated 10 times to 10 ATM | 10 cycles to recommended use pressure | No evidence of balloon leakage | Pass |
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| Table 5 cont. | ||||
|---|---|---|---|---|
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 10 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 10 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 2 mm | Pass |
| BalloonDiameter | Balloon pressureat 10 ATM | Balloon diameterwithin tolerance | $16 \pm .6$ mm | Pass |
| Insertability | Balloon located | Distal end insertedthrough 10° bend intube with 16 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted | Distal end withdrawnthrough 9.6 mm tube | No visual signs ofdamage | Pass |
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass |
| Torqueable | Catheter rotated2 times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass |
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | ≥ 15 N | Pass |
Table 6. Summary of transit & 1 year accelerated aging bench testing for 5x30mm aeris Balloon Dilation Catheter
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
|---|---|---|---|---|
| BalloonWorking Length | Balloon pressureat 1 ATM | Balloon workinglength withintolerance | 30 ± 1 mm | Pass |
| Inflation Time | Balloon pressureat 17 ATM | Balloon able toinflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressureat 0 ATM | Balloon able todeflate | ≤ 15 seconds | Pass |
| CatheterFatique | Balloon inflated10 times to 17ATM | 10 cycles torecommended usepressure | No evidence ofballoon leakage | Pass |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 17 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 17 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 1 mm | Pass |
{11}------------------------------------------------
| Test | Study Endpoint | Requirement | Acceptance Requirement | Result |
|---|---|---|---|---|
| BalloonDiameter | Balloon pressureat 17 ATM | Balloon diameterwithin tolerance | $5 \pm .4$ mm | Pass |
| Insertability | Balloon located | Distal end insertedthrough 10° bend intube with 5 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted | Distal end withdrawnthrough 3 mm tube | No visual signs ofdamage | Pass |
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass |
| Torqueable | Catheter rotated2 times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass |
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | $\geq 10$ N | Pass |
Table 7. Summary of transit & 1 year accelerated aging bench testing for 9x30mm aeris Balloon Dilation Catheter
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
|---|---|---|---|---|
| BalloonWorking Length | Balloon pressureat 1 ATM | Balloon workinglength withintolerance | $30 \pm .6$ mm | Pas |
| Inflation Time | Balloon pressureat 17 ATM | Balloon able toinflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressureat 0 ATM | Balloon able todeflate | ≤ 15 seconds | Pass |
| CatheterFatigue | Balloon inflated10 times to 17ATM | 10 cycles torecommended usepressure | No evidence ofballoon leakage | Pass |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 17 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 17 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 1 mm | Pass |
| BalloonDiameter | Balloon pressureat 17 ATM | Balloon diameterwithin tolerance | $9 \pm .4$ mm | Pass |
| Insertability | Balloon located | Distal end insertedthrough 10° bend intube with 9 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted | Distal end withdrawnthrough 5 mm tube | No visual signs ofdamage | Pass |
{12}------------------------------------------------
| Table 7 cont. | ||||||
|---|---|---|---|---|---|---|
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result | ||
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass | ||
| Torqueable | Catheter rotated2 times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass | ||
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | ≥ 10 N | Pass |
Table 8. Summary of transit & 1 year accelerated aging bench testing for 16x40mm aeris Balloon Dilation Catheter
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result |
|---|---|---|---|---|
| BalloonWorking Length | Balloon pressureat 1 ATM | Balloon workinglength withintolerance | 40 ± 1 mm | Pass |
| Inflation Time | Balloon pressureat 10 ATM | Balloon able toinflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressureat 0 ATM | Balloon able todeflate | ≤ 15 seconds | Pass |
| CatheterFatigue | Balloon inflated10 times to 10ATM | 10 cycles torecommended usepressure | No evidence ofballoon leakage | Pass |
| MaximumInflationPressure | Balloon ruptures | Balloon failurepressure >recommended usepressure | Balloon failurepressure > 10 ATM | Pass |
| Balloon HubMeasurement | Balloon pressureat 10 ATM | Measure diameter ofhub and workinglength | Hub diameter minusworking lengthdiameter < 2 mm | Pass |
| BalloonDiameter | Balloon pressureat 10 ATM | Balloon diameterwithin tolerance | 16 ± .6 mm | Pass |
| Insertability | Balloon locatedpast curve | Catheter insertedthrough 10° bend intube with 16 mmdiameter | No visual signs ofkinking or damagedone to catheter orstylet | Pass |
| Removability | Catheterretracted fromtubing | Distal end withdrawnthrough 9.6 mm tube | No visual signs ofdamage | Pass |
| Proximal LuerFitting | Tested | Per ISO 594-1 &594-2 | Meet acceptancecriteria of ISO 594-1 &594-2 | Pass |
| Torqueable | Catheter turned 2times | Catheter turned atleast 2 times | No visual signs ofdamage | Pass |
| Luer/CatheterShaftConnection | Connectionfailure | Bond tensile forceper ISO 10555 | ≥ 15 N | Pass |
{13}------------------------------------------------
Table 9. Summary of predicate devices performance testing for an 8.5x24mm Inspira AIR and 15x30mm CRE Pulmonary.
| Test | Study Endpoint | Result | |||
|---|---|---|---|---|---|
| Requirement | AcceptanceRequirement | InspiraAIR | CREPulmonary | ||
| InflationTime | Balloon pressure atmax. inflation pressure | Balloon able to inflate | < 10 seconds | Pass | Pass |
| Insertability | Balloon located pastcurve | Catheter insertedthrough 10° bend intube with balloon sizediameter | No visual signsof kinking ordamage done tocatheter or stylet | Pass | Pass |
| Removability | Catheter retractedfrom tubing | Distal end withdrawnthrough tube with ID60% of balloon size | No visual signsof damage | Pass | Pass |
| Torqueable | Catheter turned 2times | Catheter turned atleast 2 times | No visual signsof damage | Pass | Pass |
Table 10. Summary of comparison test between 9x30mm aeris Balloon Dilation Catheter 15x30mm CRE Pulmonary.
| Test | Study Endpoint | Requirement | AcceptanceRequirement | Result | |
|---|---|---|---|---|---|
| Inspira AIR | CREPulmonary | ||||
| Radiopacity | X-ray performed | The balloon willhave markerbands, one undereach balloon neck,that are visibleunder fluoroscopy | Equivalentvisibility of theaeris markerbands to thepredicate devices | N/A | Equivalent |
Table 11. All materials, biocompatibility testing summary.
| Test Description | Acceptance Criteria | Results |
|---|---|---|
| L929 MEM ElutionCytotoxicity | Test article must have areactivity grade of mild or less (≤2) | There was no biological reactivity(Grade 0) of the cells exposed to thetest article extract. |
| Guinea Pig MaximizationSensitization | Test article must have a reactionsensitivity grade of no visiblechange (Grade 0) | There was no sensitization response(Grade 0) in the test articles. |
| Acute Systemic Toxicity | Animals treated with test articleextract must not show signsindicative of toxicity. | None of the test article extract treatedanimals observed with clinical signsconsistent with toxicity. |
| Intracutaneous Irritation | Tissue reaction to the test articleto control dermal observationscore is ≤ 1. | Differences in mean test and controlscores of extract dermal operationswere less than 1. |
§ 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.