(92 days)
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.
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).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Acclarent Airway Balloon Catheter and Accessories (K090660):
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided 510(k) summary (K090660) does not explicitly list the specific acceptance criteria for the Airway Balloon Catheter and Accessories. It only states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly listed | "The Airway Balloon Catheter and Accessories met all performance acceptance criteria." |
This is a common characteristic of 510(k) summaries, where the detailed test protocols and acceptance criteria are part of the full submission but are not always fully redacted into the public summary. The summary notes that the device demonstrated substantial equivalence to predicate devices through "relevant tests."
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include any information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically found in the detailed test reports within the 510(k) submission, not the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not include any information about the number of experts used to establish ground truth or their qualifications. This information would be relevant if clinical studies involving expert interpretation were conducted, but the summary focuses on technical and performance testing against predicate devices.
4. Adjudication Method for the Test Set
The provided text does not include any information about an adjudication method. Adjudication is usually relevant for studies involving human interpretation or subjective assessments, which are not detailed in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence through performance data and technological characteristics, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
This device is a medical instrument (catheter, inflation device), not an Artificial Intelligence (AI) algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission.
7. Type of Ground Truth Used
Given that this is a physical medical device (catheter and inflation device), the "ground truth" for its performance would typically involve:
- Engineering specifications and standards: Confirming the balloon inflates to specified pressures, maintains integrity, fits through lumens, etc.
- Biocompatibility testing: Ensuring the materials are safe for use in the human body.
- Mechanical testing: Evaluating tensile strength, burst pressure, fatigue, etc.
- Bench testing: Simulating clinical use in a controlled environment.
- Animal studies (potentially): To assess in-vivo performance and safety if novel aspects are present.
The summary simply states it "met all performance acceptance criteria," implying these types of objective measures were used. It does not mention expert consensus, pathology, or outcomes data in the context of establishing ground truth for the core device performance.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable. The device's design and manufacturing processes are validated, not "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense, this question is not applicable. The ground truth for the device's design and performance validation would be established through engineering principles, material science, applicable medical device standards, and in vitro and potentially in vivo testing to ensure it meets its intended use and safety profile.
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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
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| Indications for Use: | The Airway Balloon Catheter is an instrument intended todilate strictures of the airway tree.The Inflation Device is an instrument intended to inflate,deflate and monitor pressure in balloon catheters used in sinusprocedures and dilation of the airway tree. |
|---|---|
| TechnologicalCharacteristics: | The Airway Balloon Catheter and Accessories enlargestrictures in the airway tree. The technological characteristicsof the subject device are similar to its predicate devices. |
| Performance Data: | The Airway Balloon Catheter and Accessories met allperformance acceptance criteria. |
| Summary of SubstantialEquivalence: | The Airway Balloon Catheter is substantially equivalent to thepredicate device as confirmed through relevant tests. |
- September 19.
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:
and the state of the state of the states of the states
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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.
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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
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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)
§ 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.