aeris Balloon Dialation Catheter

• K Number: K150951
• Device Name: aeris Balloon Dialation Catheter
• Manufacturer: Bryan Medical , Inc.
• Date Cleared: 2015-06-25 ( 77 days)
• Product Code: KTI
• Regulation Number: 874.4680

Intended Use

The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.

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.

Predicate Devices

K090660, K023337

Reference Devices

Acclarent Inspira AIR Balloon Dilation System (K090660), Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337)

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and function of a balloon dilation catheter, with no mention of AI or ML.

Therapeutic

Yes
The device is described as an "aeris Balloon Dilation Catheter" intended "to dilate strictures of the airway," which is a direct therapeutic intervention.

Diagnostic

No

The device is described as a "Balloon Dilation Catheter" whose intended use is "to dilate strictures of the airway," indicating a therapeutic purpose rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with a balloon, stylet, and luer lock, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "dilate strictures of the airway." This is a therapeutic procedure performed directly on the patient's body.
• Device Description: The device is a physical catheter with a balloon designed for mechanical dilation.
• Mechanism of Action: The device works by physically expanding a balloon within the airway to widen a stricture.
• Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not interact with specimens in this way.

The aeris Balloon Dilation Catheter is a therapeutic medical device used for a surgical or interventional procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.

Product codes

KTI

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy, endoscopy

Anatomical Site

airway

Indicated Patient Age Range

adult and pediations

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 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.

Bench testing was conducted for various sizes of the aeris Balloon Dilation Catheter (5x30mm, 9x30mm, 16x40mm) and included tests for:

• Balloon Working Length: Pass (within tolerance)
• Inflation Time: Pass ( recommended use pressure)
• Balloon Hub Measurement: Pass (Hub diameter minus working length diameter

Regulation Number and Section

§ 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.

Summary

0

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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: [phone] Fax: [phone] Contact Person: Andy Black Medical Murray, Inc. 400 North Rand Road North Barrington, IL 60010 Phone: [phone] Fax: [phone] 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 Balloon
Dilation
Catheter Size | Product
Number | Balloon
Ø (mm) | Balloon
Working
Length (mm) | Recommended
Use Pressure
(ATM) | Catheter
OD (mm) | Catheter
Length
(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 for
Use Statement	The Airway Balloon
Catheter is an instrument
intended to dilate strictures
of the airway tree.	The CRE Pulmonary Balloon
Dilatation Catheter is intended
to be used endoscopically to
dilate strictures of the airway
tree.	The aeris Balloon Dilation
Catheter is intended to dilate
strictures of the airway.
A.2 Labeling	Equivalent in content (label
included in Section N)	Equivalent in content (label
included in Section N)	Equivalent content (label
included in Section N)
A.3 Target
Population	All patients meeting
intended use and labeling
requirements.	All patients meeting intended use
and labeling requirements.	All patients meeting intended
use and labeling
requirements.
A.4 Product code
& 21 CFR
regulation #	KTI, 874.4680	KTI, 874.4680	KTI, 874.4680
A.5
Contraindications	• Balloon dilation is
contraindicated in any
patient whose degree of
respiratory failure would
not allow the patient to
tolerate the manipulation
required to accomplish
balloon dilation.
• Balloon dilation is
contraindicated in the
presence of:
o significant active
bleeding from the site
of the proposed
dilation
o and/or presence of a
known perforation at
the site of proposed
dilation
o and/or presence of a
known fistula between
the tracheobronchial
tree and esophagus,
mediastinum or
pleural space.	• Balloon dilation is
contraindicated in any patient
whose general medical
condition and degree of
respiratory failure would not
allow the patient to tolerate
bronchoscopy (rigid or
flexible) and/or the
manipulation required to
accomplish balloon dilation.
• Balloon dilation is
contraindicated in the
presence of:
significant active bleeding
from the site of the proposed
dilatation,
and/or presence of a known
perforation at the site of
proposed dilatation,
and/or presence of a known
fistula between the
tracheobronchial tree and
esophagus, mediastinum or
pleural space unless the
dilatation was being
performed in preparation for
the placement of a stent to
treat the perforation or fistula.	• Balloon dilation of the
airway is contraindicated in
any patient whose degree
of respiratory failure would
not allow the patient to
tolerate the manipulation
required to accomplish
balloon dilation.
• Balloon dilation is
contraindicated in the
presence of:
o significant active
bleeding from the site of
the proposed dilation
o and/or presence of a
known perforation at the
site of proposed dilation
o and/or presence of a
known fistula between
the tracheobronchial tree
and esophagus,
mediastinum or pleural
space
Table 2 cont.
Attribute	Acclarent Inspira AIR	Boston Scientific CRE	Bryan Medical aeris
B. Technology
B.1 Balloon Shape
at
recommended use
pressure	Balloon failure
pressure > 17 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 17 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter
recommended use
pressure	Balloon failure
pressure > 17 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 17 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter 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
Balloon
Working 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
recommended use
pressure	Balloon failure
pressure > 10 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 10 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter
recommended use
pressure	Balloon failure
pressure > 17 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 17 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter
recommended use
pressure	Balloon failure
pressure > 17 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 17 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter
recommended use
pressure	Balloon failure
pressure > 10 ATM	Pass
Balloon Hub
Measurement	Balloon pressure
at 10 ATM	Measure diameter of
hub and working
length	Hub diameter minus
working length
diameter