← Product Code [KTI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI) · K150951
# aeris Balloon Dialation Catheter (K150951)
_Bryan Medical, Inc. · KTI · Jun 25, 2015 · Ear, Nose, Throat · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K150951
## Device Facts
- **Applicant:** Bryan Medical, Inc.
- **Product Code:** [KTI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI.md)
- **Decision Date:** Jun 25, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic, Pediatric, 3rd-Party Reviewed
## Intended Use
The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.
## Device Story
Single lumen balloon dilation catheter; high-pressure balloon at distal tip; includes stylet for advancement; luer lock for inflation/stylet placement; radiopaque markers for fluoroscopic placement. Used in clinical settings under endoscopic visualization; physician-operated. Device advanced to stricture site; stylet removed; balloon inflated with sterile water to dilate airway; monitored via endoscopy; deflated via vacuum for removal. Benefits include mechanical dilation of airway strictures to improve patency.
## Clinical Evidence
Bench testing only. Testing included balloon working length, inflation/deflation times, fatigue (10 cycles), burst pressure, hub measurement, insertability, removability, luer fitting, torque, and bond strength. Transit and 1-year accelerated aging tests performed. Biocompatibility testing (cytotoxicity, sensitization, systemic toxicity, irritation) confirmed safety.
## Technological Characteristics
Materials: Nylon balloon, Pebax catheter. Energy: Hydraulic (sterile water inflation). Dimensions: 5-16mm diameter, 30-40mm length, 55cm catheter length. Connectivity: None. Sterilization: Ethylene Oxide. Standards: ISO 594-1/2 (luer), ISO 10555 (bond strength). Single lumen design.
## Regulatory 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.
## Predicate Devices
- Acclarent Inspira AIR Balloon Dilation System ([K090660](/device/K090660.md))
- Boston Scientific CRE Pulmonary Balloon Dilation Catheter ([K023337](/device/K023337.md))
## Submission Summary (Full Text)
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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 (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)
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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 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 < 2 ATM / Max.
Inflation Pressure | Straight body and conical
ends / straight body and
spherical ends | Straight body and conical
ends / straight body and
spherical ends | Dog-bone body and conical
ends / straight body with
spherical ends |
| B.2 Used with
Stylet | Optional | Yes (Guidewire) | Optional |
| B.3 Radiopaque
Markers | No | Yes | Yes |
| B.4 Patient
Contacting
Materials | Unknown | Unknown | Nylon balloon, Pebax catheter |
| B.5 Balloon
Diameters | 5 mm
7 mm
8.5 mm
10 mm
12 mm
14 mm
16 mm | 8 – 9 – 10 mm
10 – 11 – 12 mm
12 – 13.5 – 15 mm
15 – 16.5 – 18 mm
18 – 19 – 20 mm | 5 mm
7 mm
8 mm
9 mm
10 mm
12 mm
14 mm
16 mm |
| B.6 Balloon
Working Lengths
(mm) | 24 for diameters 5, 7, & 8.5
40 for diameters 10, 12, 14,
& 16 | 30 for diameters 8 - 12
55 for diameters 12 – 18 per
manufacturer's website | 30 for diameters 5 - 10
40 for diameters 12 - 16 |
| B.7 Catheter
Outside Diameter
(mm) | 2.1 | 2.5 | 1.55 for diameters 5 - 9
2.34 for diameters 10 - 16 |
| B.8 Catheter
Length (cm) | 45 | 75 | 55 |
| B.9 Deflation Time
(Seconds) | ≤ 15 & 25 per clearance
letter for K110218 | Unknown | ≤ 15 |
| B.10 Maximum
Inflation 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% of
balloon diameter |
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Table 2 cont.
| Attribute | Acclarent Inspira AIR | Boston Scientific CRE | Bryan Medical aeris |
|------------------------------|-----------------------|-----------------------|------------------------------------------------------------------|
| C.4 Proximal Luer
Fitting | Yes | Yes | Yes |
| C.5 Torqueable | Equivalent | Equivalent | Min. 2 turns |
| C.6 Bond Force | Unknown | Unknown | Min. 10 N for diameters 5 - 9
Min. 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 | Acceptance
Requirement | Result |
|--------------------------------------|-------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------|
| Balloon
Working Length | Balloon pressure
at 1 ATM | Balloon working
length within
tolerance | 30 ± 1 mm | Pass |
| Inflation Time | Balloon pressure
at 17 ATM | 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 17
ATM | 10 cycles to
recommended use
pressure | No evidence of
balloon leakage | Pass |
| Maximum
Inflation
Pressure | Balloon ruptures | Balloon failure
pressure >
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 < 1 mm | Pass |
| Balloon
Diameter | Balloon pressure
at 17 ATM | Balloon diameter
within tolerance | 5 ± .4 mm | Pass |
| Insertability | Balloon located | Distal end inserted
through 10° bend in
tube with 5 mm
diameter | No visual signs of
kinking or damage
done to catheter or
stylet | Pass |
| Removability | Catheter
retracted | Distal end withdrawn
through 3 mm 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 | ≥ 10 N | Pass |
| | | Table 3. Summary of baseline bench testing for 5x30mm aeris Balloon Dilation Catheter |
|--|--|---------------------------------------------------------------------------------------|
| | | |
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| Test | Study Endpoint | Requirement | Acceptance
Requirement | Result |
|--------------------------------------|-------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------|
| Balloon
Working Length | Balloon pressure
at 1 ATM | Balloon working
length within
tolerance | 30 ± .6 mm | Pass |
| Inflation Time | Balloon pressure
at 17 ATM | Balloon able to
inflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressure
at 0 ATM | Balloon able to
deflate | ≤ 15 seconds | Pass |
| Catheter
Fatique | Balloon inflated
10 times to 17
ATM | 10 cycles to
recommended use
pressure | No evidence of
balloon leakage | Pass |
| Maximum
Inflation
Pressure | Balloon ruptures | Balloon failure
pressure >
recommended use
pressure | Balloon failure
pressure > 17 ATM | Pass |
| Balloon Hu…
---
**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K150951](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K150951)
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