(140 days)
Not Found
No
The description focuses on measuring pressure and flow to calculate resistance and quantify collateral ventilation, with the console analyzing and displaying this data in real time. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as measuring pressure and flow to calculate airflow resistance and quantify collateral ventilation for diagnostic purposes, not for treating a condition.
Yes
The device is "indicated for use by bronchoscopists 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". These actions are performed to aid in diagnosis.
No
The device description explicitly states the system is composed of a Chartis Catheter and a Chartis Console, both of which are hardware components. The Console is described as a "re-useable piece of capital equipment" and the Catheter is used through a bronchoscope.
Based on the provided information, the Chartis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Chartis System measures pressure and flow within the lung compartments of a living patient during a bronchoscopy. It's interacting directly with the patient's physiology, not analyzing a sample removed from the body.
- The intended use is for a diagnostic bronchoscopy. This is a procedure performed directly on the patient.
- The device description details the measurement of airflow and pressure in real time from the isolated lung compartment. This further reinforces that it's a direct physiological measurement, not an analysis of a biological sample.
The Chartis System is a device used in vivo (within the living body) to gather physiological data during a medical procedure.
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 capital equipment that displays the patient information.
Product codes
BZG
Device Description
The Chartis Console is an integrated, self-contained, 12 VDC powered system designed to be used in the bronchoscopy suite in conjunction with the Chartis Catheter. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Cathter isolates the lung compartment of interest. The hardware components of the Console translate air flow and pressure detected through the Chartis Catheter into electrical signals. The Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
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, 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)
Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate 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
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Special 510(k) - Chartis Console
June 22, 2011
NOV 1 0 2011
K 111764
510 (k) Summary
| Proprietary Name: | Chartis ™ Console |
|---|---|
| Classification Name: | Spirometer, Diagnostic |
| 21 CFR 868.1840 Class II | |
| Classification: BZG | |
| Common Name: | Spirometer, Diagnostic |
| Manufacturer: | Pulmonx, Inc. |
| 700 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| 650-364-0400 (phone) | |
| 650-364-0403 (fax) | |
| Contact: | Rich Ferrick |
| VP, Regulatory Compliance and Quality Assurance | |
| Preparation Date: | June 22, 2011 |
Predicate Device:
The Chartis Console is substantially equivalent to the following currently marketed predicate device:
Chartis Console (K083199, cleared on June 25, 2009, product code BZG, regulation number 868.1840)
Device Description:
The Chartis Console is an integrated, self-contained, 12 VDC powered system designed to be used in the bronchoscopy suite in conjunction with the Chartis Catheter. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Cathter isolates the lung compartment of interest. The hardware components of the Console translate air flow and pressure detected through the Chartis Catheter into electrical signals. The Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
1
Intended 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 capital equipment that displays the patient information.
Technological Characteristics:
The modified Chartis Console is substantially equivalent to the predicate Chartis Console with regard to technological characteristics. The minor changes to graphic display, hardware, software, packaging and service/calibration do not raise new types of safety or effectiveness questions.
Performance Data:
Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device.
Conclusion:
The Chartis Console is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Mr. Hans Schulz Director, Quality Assurance Pulmonx, Incorporated 700 Chesapeake Drive Redwood City, California 94063
Re: K111764
Trade/Device Name: Chartis" Console Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: October 10, 2011 Received: October 12, 2011
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. 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.
DEPARTMENT OF HEALTH &
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/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.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number | Not known K111764 |
|---|---|
| Device Name | Chartis Console |
| 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 capital equipment that displays the patient information. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per CFR 801.109)
OR Y Schultheis
Over-the-Counter Use
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
Pulmonx Inc. Confidential
510(k) Number: K111764