(115 days)
The Bronchial Catheter System is intended to be used for foreign body removal and bronchial hemostasis.
Not Found
Here's an analysis of the provided text regarding the Bronchial Catheter System, focusing on acceptance criteria and study details.
Based on the provided document, there is no detailed information regarding specific acceptance criteria (numerical targets for performance metrics) or a comprehensive clinical study proving the device meets such criteria. The document is a 510(k) Summary for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new efficacy studies with formal acceptance criteria.
The information primarily states that the device's performance was "evaluated in vitro and shown to be equivalent to the performance of the predicate devices." This implies a comparison, but the specifics of what was measured, how it was evaluated, and the numerical thresholds for "equivalence" are not provided.
Therefore, many of the requested sections below will state that the information is not provided in the given text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy) | Reported Device Performance |
|---|---|
| Not formally defined in the document. The general criterion is "equivalence to predicate devices." | "evaluated in vitro and shown to be equivalent to the performance of the predicate devices." |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document only mentions "in vitro" evaluation, which implies laboratory tests, not human test subjects or patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The "test set" described is in vitro performance evaluation, not a clinical study requiring human ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication method is described for in vitro performance evaluation.
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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:
- No. An MRMC study was not conducted as this is a physical medical device (catheter system) for foreign body removal and hemostasis, not an AI diagnostic or assistance tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For in vitro performance, "ground truth" would typically be established by established engineering or scientific measurement standards for performance characteristics (e.g., tensile strength, flow rates, maneuverability in a model). Details on these specific standards or measurements are not provided.
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set in that context.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is mentioned.
Summary of Study Limitations based on the provided text:
The provided 510(k) summary focuses solely on demonstrating substantial equivalence to predicate devices through in vitro performance evaluation and biocompatibility testing. It explicitly states: "The performance of the Bronchial Balloon Catheter was evaluated in vitro and shown to be equivalent to the performance of the predicate devices." This means there was no clinical study described in this document with human participants, defined acceptance criteria for clinical outcomes, or the use of experts to establish clinical ground truth. The device is cleared based on its similarity in design, materials, and in vitro operational characteristics to existing, legally marketed devices.
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Bronchial Catheter System
510(k) Summary of Safety and Effectiveness 10000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MAY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K180046
Applicant Information:
| Date Prepared: | January 5, 1998 |
|---|---|
| Name: | Broncus Technologies, Inc. |
| Address: | 1400N. Shoreline BoulevardMountain View, CA 94043 |
| Contact Person: | Glendon E. French |
|---|---|
| Phone Number: | (650) 428-1600 |
| Fax Number: | (650) 428-1542 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Bronchial Catheter System |
| Classification Name: | Bronchoscope and Accessories21 CFR 874.4680 |
Equivalent Devices:
The subject device is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
- Disposable Balloon Catheters 1. Olympus
- Microvasive Gold Probe Direct Boston Scientific 2.
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- Valleylab, Inc. Force 2 Electrosurgical Generator
Intended Use:
The Bronchial Catheter System is intended to be used for foreign body removal and bronchial hemostasis.
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510(k) Summary of Safety and Effectiveness, continued
Comparison To Predicate Devices:
The Broncus Technologies Bronchial Catheter System is equivalent in intended use and operational characteristics to the Olympus Disposable Balloon Catheters and the Microvasive Gold Probe when used with the Valleylab Force 2 RF Generator.
Non-Clinical Test Results:
Performance
The performance of the Bronchial Balloon Catheter was evaluated in vitro and shown to be equivalent to the performance of the predicate devices.
Biocompatibility
The materials used in the Bronchial Balloon Catheter have proven biocompatibility.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The words are arranged on a single line and centered.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1998
Bronchus Technologies, Inc.
Mountain View, California 94043
1400 N. Shoreline Blvd. Building A. Suite 8
Glendon E. French
President and CEO
Re:
K980046 Bronchial Catheter System Dated: April 10, 1998 Received: April 13, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO 21 CFR 878.4400/Procode: 79 GEI
Dear Mr. French:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K980046 510(k) Number (if known):
Device Name:
Bronchial Catheter System
Indications for Use:
The Bronchial Catheter System is intended for foreign body removal and bronchial hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devj 510(k) Number Prescription Use OR Over- The Counter Use _______ (Per 21 CFR 801.109) -
(Optional Format 1-2-96)
§ 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.