(65 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its physical characteristics and performance. There is no mention of software, algorithms, image processing, AI, ML, or data sets typically associated with AI/ML devices.
Yes
The device is intended to dilate strictures of the airway tree, which is a therapeutic intervention.
No
Explanation: The device is described as an "instrument intended to dilate strictures of the airway tree" and is a "catheter with a high pressure balloon on the distal tip." This indicates a therapeutic function (dilating strictures), not a diagnostic one (identifying or detecting a condition).
No
The device description clearly states it is a "catheter with a high pressure balloon on the distal tip," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate strictures of the airway tree." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for mechanical dilation. This is a physical intervention, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically treat a condition within the body.
N/A
Intended Use / Indications for Use
The Modified Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
The Modified Airway Balloon Catheter is a catheter with a high pressure balloon on the distal tip. The device is designed with a coaxial lumen for inflation and stylet access, if required. The Modified Airway Balloon Catheter encompasses a 18x40mm balloon catheter and reduces the deflation time specification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway tree
Indicated Patient Age Range
Not Found
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 Modified Airway Balloon Catheter and Accessories met all performance acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KII 0218
MAR 3 1 2011
Image /page/0/Picture/2 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the last part of the word, starting above the "r" and ending after the "t". The text is black against a white background.
| APPENDIX A: 510(k) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc. |
| 1525-B O'Brien Drive | |
| Menlo Park, California 94025 | |
| Contact Person: | Keri Yen |
| Regulatory Affairs Manager | |
| Phone: (650) 687-5874 | |
| Fax: (650) 687-4449 | |
| Date of Submission: | January 24, 2011 |
| Device Trade Name: | Inspira AIR Balloon Dilation System |
| Common Name: | Airway Balloon Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4680 |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| Product Code: | KTI |
| Predicate Devices: | Acclarent Airway Balloon Catheter and Accessories (K090660) |
| Boston Scientific CRE Pulmonary Balloon Dilation Catheter | |
| (K023337) | |
| Device Description: | The Modified Airway Balloon Catheter is a catheter with a high |
| pressure balloon on the distal tip. The device is designed with a coaxial | |
| lumen for inflation and stylet access, if required. The Modified Airway | |
| Balloon Catheter encompasses a 18x40mm balloon catheter and reduces | |
| the deflation time specification. | |
| Indications for Use: | The Modified Airway Balloon Catheter is an instrument intended to |
| dilate strictures of the airway tree. |
1
Technological Characteristics: The technological characteristics of the subject device are similar to its predicate devices.
| Attribute | Airway Balloon
Catheter
(K090660) | CRE Pulmonary
Balloon Dilation
Catheter
(K023337) | Modified Airway
Balloon Catheter |
|----------------------------------|-----------------------------------------|---------------------------------------------------------------------------|----------------------------------------|
| Balloon Diameters | 5 mm
7 mm
10 mm
14 mm | 8-9-10 mm
10-11-12 mm
12-13.5-15 mm
15-16.5-18 mm
18-19-20 mm | 18mm |
| Balloon Length | 24 mm
40 mm | 30 mm
55 mm | 40 mm |
| Deflation Time | ≤15 seconds
≤25 seconds | Unknown | ≤15 seconds |
| Maximum
Inflation Pressure | 10-16 ATM | 6-9 ATM | 8 ATM |
| Flexible | Yes | Yes | Yes |
| Shaft Design | Coaxial Lumen | Coaxial Lumen | Coaxial Lumen |
| Used with Stylet | Optional | Yes (Guidewire) | Optional |
| Technological
Characteristics | To dilate strictures
of airway tree | To dilate strictures
of airway tree | To dilate strictures
of airway tree |
Performance Data:
The Modified Airway Balloon Catheter and Accessories met all performance acceptance criteria.
Summary of Substantial Equivalence:
The Modified Airway Balloon Catheter is substantially equivalent to the predicate device as confirmed through relevant tests.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acclarent, Inc. c/o Ms. Keri Yen Manager, Regulatory and Clinical 1525-B O'Brien Dr. Menlo Park, CA 94025
MAR 3 1 200
Re: K110218
Trade/Device Name: Inspira AIR Balloon Dilation System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Dated: March 2, 2011 Received: March 3, 2011
Dear Ms. Yen:
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.
3
Page 2 - Ms. Keri Yen
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours.
Ridettenm f
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K110218 | |
|---|---|---|
| Trade Name: | Inspira AIR Balloon Dilation System | |
| Common Name: | Airway Balloon Catheter | |
| Indications For Use: | The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree. | |
| Prescription Use | ||
| (Part 21 CFR 801 Subpart D) | X | |
| AND/OR | Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page / of /
(Posted November 13, 2003)
Daniel C. Cepp
(Division Sign-Off)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K110218
510(k) Number