(65 days)
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
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.
The provided document is a 510(k) summary for the Acclarent Inspira AIR Balloon Dilation System, an airway balloon catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than being a clinical study report of an AI/ML diagnostic device. Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this type of submission.
However, I can extract the acceptance criteria and reported performance for the Modified Airway Balloon Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (from predicate devices) | Reported Device Performance (Modified Airway Balloon Catheter) |
|---|---|---|
| Balloon Diameters | 5 mm, 7 mm, 10 mm, 14 mm (for predicate K090660); Various (for K023337) | 18 mm |
| Balloon Length | 24 mm, 40 mm (for predicate K090660); 30 mm, 55 mm (for K023337) | 40 mm |
| Deflation Time | ≤15 seconds, ≤25 seconds (for predicate K090660); Unknown (for K023337) | ≤15 seconds |
| Maximum Inflation Pressure | 10-16 ATM (for predicate K090660); 6-9 ATM (for K023337) | 8 ATM |
| Flexible | Yes (for both predicates) | Yes |
| Shaft Design | Coaxial Lumen (for both predicates) | Coaxial Lumen |
| Used with Stylet | Optional (for K090660); Yes (Guidewire) (for K023337) | Optional |
| Technological Characteristics | To dilate strictures of airway tree (for both predicates) | To dilate strictures of airway tree |
Study Proving Device Meets Acceptance Criteria:
The document states: "The Modified Airway Balloon Catheter and Accessories met all performance acceptance criteria." This indicates that internal testing was conducted to verify against the established specifications which are based on the predicate devices. The specifics of these tests (e.g., number of units tested, precise methodology of deflection time measurement, etc.) are not detailed in this summary document, which is typical for a 510(k) summary rather than a full study report.
Relevant Missing Information (Not applicable or not typically included in a 510(k) summary for this type of device):
- Sample size used for the test set and the data provenance: Not specified. This is a medical device approval based on technological characteristics and performance specifications for a balloon catheter, not an AI/ML diagnostic device using a dataset. The "test set" here refers to physical device testing rather than a data set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic algorithms (e.g., consensus reads, pathology) is not relevant for evaluating the physical performance specifications of a balloon catheter.
- Adjudication method for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic algorithms. For the physical device, the "ground truth" is measured physical properties and performance against engineering specifications.
- The sample size for the training set: Not applicable. There is no algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
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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 DriveMenlo Park, California 94025 |
| Contact Person: | Keri YenRegulatory Affairs ManagerPhone: (650) 687-5874Fax: (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 highpressure balloon on the distal tip. The device is designed with a coaxiallumen for inflation and stylet access, if required. The Modified AirwayBalloon Catheter encompasses a 18x40mm balloon catheter and reducesthe deflation time specification. |
| Indications for Use: | The Modified Airway Balloon Catheter is an instrument intended todilate strictures of the airway tree. |
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Technological Characteristics: The technological characteristics of the subject device are similar to its predicate devices.
| Attribute | Airway BalloonCatheter(K090660) | CRE PulmonaryBalloon DilationCatheter(K023337) | Modified AirwayBalloon Catheter |
|---|---|---|---|
| Balloon Diameters | 5 mm7 mm10 mm14 mm | 8-9-10 mm10-11-12 mm12-13.5-15 mm15-16.5-18 mm18-19-20 mm | 18mm |
| Balloon Length | 24 mm40 mm | 30 mm55 mm | 40 mm |
| Deflation Time | ≤15 seconds≤25 seconds | Unknown | ≤15 seconds |
| MaximumInflation 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 |
| TechnologicalCharacteristics | To dilate stricturesof airway tree | To dilate stricturesof airway tree | To dilate stricturesof 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.
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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.
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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
§ 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.