(178 days)
Not Found
No
The summary describes a system that measures pressure and flow to calculate resistance and quantify collateral ventilation. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with such technologies. The performance studies focus on bench testing, animal studies, and equivalence to a predicate device, not on AI/ML performance metrics.
No
The device is designed to measure pressure and flow to calculate resistance to airflow and quantify collateral ventilation for diagnostic purposes, rather than directly treating a condition.
Yes
The device is explicitly stated to be used "during a diagnostic bronchoscopy" and is "designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments," which are functions consistent with diagnostic purposes.
No
The device description explicitly states the system is composed of the Chartis Catheter and Chartis Console, and the Catheter is a patient contact component, indicating hardware is involved.
Based on the provided information, the Chartis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). The Chartis System directly interacts with the patient's lung compartments within the body (in vivo - "in the living").
- The system measures physical parameters (pressure, flow, resistance) within the lung. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for functional assessment of air pressures and flows in isolated lung compartments during a bronchoscopy. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the Chartis System falls under the category of a medical device used for physiological measurement and assessment, not an IVD.
N/A
Intended Use / Indications for Use
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of canital equipment that displays the patient information.
Product codes
CBI
Device Description
The Chartis Catheter consists of two components which are pouched separately and provided to the user in a single shelf carton with the Instructions for Use. These two components are the Chartis Catheter and the Connector Set. The Catheter is the patient contact component while the Connector Set acts to connect the Chartis Catheter to the Chartis Console (which is documented in a concurrent 510(k) submission). The system is designed to be used by experienced bronchoscopists during a diagnostic bronchoscopy in a hospital bronchoscopy suite for functional assessment of air pressures and flows in isolated lung compartments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung compartments
Indicated Patient Age Range
adult patients
Intended User / Care Setting
bronchoscopists, hospital bronchoscopy suite, bronchoscopy suite
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)
Bench test results support the performance characteristics of the device and show equivalence to the currently marketed predicate device. Design durability was tested in the laboratory and animal studies were used to validate performance of the system in a simulated clinical environment, as well as verify the performance to design specifications and the durability of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
JUN 2 5 2009
Proprietary Name: Chartis™ Catheter
Classification Name:
Tube, tracheal/bronchial, differential ventilation (w/wo connector) 21 CFR §, 868.5740 Class II Classification: CBI
Common Name: Tube, tracheal/bronchial, differential ventilation (w/wo connector)
Manufacturer: Pulmonx, Inc. 1047 Elwell Court Palo Alto, CA, 94303
Contact: Hans Schulz Director, Quality Assurance
Preparation Date: June 16, 2009
Predicate Devices:
The Chartis Catheter is substantially equivalent to the following currently marketed predicate device:
- (1) Endobronchial Blocker marketed by Cook. (K021920, cleared August 14, 2002, product code CBI, regulation number 868.5740)
Device Description:
The Chartis Catheter consists of two components which are pouched separately and provided to the user in a single shelf carton with the Instructions for Use. These two components are the Chartis Catheter and the Connector Set. The Catheter is the patient contact component while the Connector Set acts to connect the Chartis Catheter to the Chartis Console (which is documented in a concurrent 510(k) submission). The system is designed to be used by experienced bronchoscopists during a diagnostic bronchoscopy in a hospital bronchoscopy suite for functional assessment of air pressures and flows in isolated lung compartments.
1
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.
Technological Characteristics of Substantial Equivalence:
The Chartis Catheter is substantially equivalent to the Endobronchial Blocker marketed by Cook. (K021920, cleared August 14, 2002, product code CBI, regulation number 868.5740) with regard to materials, safety, efficacy and lung isolation.
Performance Data:
Bench test results support the performance characteristics of the device and show equivalence to the currently marketed predicate device. Design durability was tested in the laboratory and animal studies were used to validate performance of the system in a simulated clinical environment, as well as verify the performance to design specifications and the durability of the device.
Conclusion:
The Chartis Catheter does not raise new questions of safety or effectiveness when compared to the legally marketed predicate device, and is substantially equivalent to the referenced predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hans Schulz Director of Quality Assurance Pulmonx, Incorporated 1047 Elwell Court Palo Alto, California 94303
Re: K083883
Trade/Device Name: Chartis TM Catheter Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: June 16, 2009 Received: June 24, 2009
Dear Mr. Schulz:
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.
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 - Mr. Schulz
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/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,
Susan Junos
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) K083883/S1
510(k) Number (if known): K083883
Device Name: Chartis™ Catheter
Indications for Use:
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of canital equipment that displays the patient information.
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) Page __ of
(POSTED
L Schulla
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
10838883 510(k) Number: