(92 days)
Not Found
No
The summary describes a mechanical device (balloon catheter and inflation device) for dilating airway strictures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as an "instrument intended to dilate strictures of the airway tree," which is a medical intervention aimed at treating a health condition (strictures) and restoring proper function (airflow), fitting the definition of a therapeutic device.
No
The device is described as an instrument intended to dilate strictures of the airway tree, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly mentions a "catheter with a high pressure balloon on the distal tip" and an "Inflation Device," which are physical hardware components.
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 a patient's body.
- Device Description: The device is a catheter with a balloon, designed for physical intervention within the airway.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.
Product codes (comma separated list FDA assigned to the subject device)
KTI, LRC
Device Description
The 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 guidewire access, if required. There are two accessories for the Airway Balloon Catheter: Inflation Device and Relieva Vigor Guidewire (optional).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway tree, sinus
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 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
Acclarent
APPENDIX A: 510(k) SUMMARY
Sponsor/Submitter:
Contact Person:
Acclarent, Inc. 1525-B O'Brien Drive Menlo Park, California 94025
Keri Yen Sr. Regulatory Affairs Specialist Phone: (650) 687-5874 Fax: (650) 687-4449
Airway Balloon Catheter and Accessories
Airway Balloon Catheter (21 CFR 874.4680)
Relieva Inflation Device (21 CFR 874.4420)
Bronchoscope (flexible or rigid) and accessories Ear, nose, and throat manual surgical instrument
Airway Balloon Catheter (Class II)
Relieva Inflation Device (Class I)
Date of Submission:
March 11, 2009
TBD
Device Trade Name:
Common Name:
Device Classification:
Regulation Number:
Classification Name:
Product Code:
Predicate Devices:
Device Description:
KTI LRC
Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337) Acclarent Relieva Sinus Balloon Catheter (K073041) Acclarent Relieva Sinus Inflation Device (K052198) Boston Scientific Alliance II Inflation System (K Number Unknown)
The 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 guidewire access, if required. There are two accessories for the Airway Balloon Catheter: Inflation Device and Relieva Vigor Guidewire (optional).
JUN 122009
1
| Indications for Use: | The Airway Balloon Catheter is an instrument intended to
dilate strictures of the airway tree.
The Inflation Device is an instrument intended to inflate,
deflate and monitor pressure in balloon catheters used in sinus
procedures and dilation of the airway tree. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The Airway Balloon Catheter and Accessories enlarge
strictures in the airway tree. The technological characteristics
of the subject device are similar to its predicate devices. |
| Performance Data: | The Airway Balloon Catheter and Accessories met all
performance acceptance criteria. |
| Summary of Substantial
Equivalence: | The Airway Balloon Catheter is substantially equivalent to the
predicate device as confirmed through relevant tests. |
- September 19.
. .
:
:
and the state of the state of the states of the states
.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acclarent, Inc. c/o Debra Cogan Sr. Regulatory Affairs Manager 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K090660
Trade/Device Name: Airway Balloon Catheter Inflation Device Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and Accessories Regulatory Class: II Product Code: KTI Dated: May 21, 2009 Received: May 22, 2009
Dear Ms. Cogan:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUN 1 2 2009
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.
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.
3
Page 2 – Ms. Debra Cogan
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander 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
4
Acclarent
090660
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
TBD
Common Name:
Airway Balloon Catheter Inflation Device
Indications For Use:
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Amalul
(Division Sign-Off) (Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K096660
Page _ of _
(Posted November 13, 2003)