(140 days)
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.
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.
This 510(k) submission (K111764) describes a
Special 510(k) for the Chartis™ Console,
which is a modification of an already cleared device (K083199). As such, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel clinical effectiveness through extensive new studies.
Here's an analysis of the provided information regarding acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a Special 510(k) for device modifications, the "acceptance criteria" here refer to demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The submission explicitly states:
"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."
"Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: The modified Chartis Console must demonstrate substantial equivalence to the predicate Chartis Console (K083199) regarding technological characteristics, and its changes must not raise new questions of safety or effectiveness. | "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." "Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device." |
| Performance Characteristics: The modified device's performance characteristics must be supported by verification and validation test results. | "Verification and validation test results support the performance characteristics of the modified device." |
Note: The document does not provide specific numerical performance metrics, such as accuracy, sensitivity, or specificity, as it's a Special 510(k) focused on demonstrating equivalence of modifications to an already cleared device. The "performance data" mentioned are likely internal verification and validation testing to ensure the modified components function as intended and do not degrade the overall system's performance compared to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a "test set" or detail data provenance in the context of a clinical study or a comparative study against a ground truth. The submission refers to "verification and validation test results," which are typically internal engineering and performance tests on the device itself, rather than clinical data from patients.
This type of submission often relies on:
- Engineering bench testing: To confirm the functionality and accuracy of the modified hardware and software components.
- Software validation: To ensure the software changes do not introduce errors and perform as designed.
- System integration testing: To verify that all components work together correctly.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided document does not mention the use of experts to establish ground truth for a test set. This is consistent with a Special 510(k) for device modification, where the focus is on the device's functional equivalence rather than a new clinical claim requiring expert-adjudicated clinical endpoints.
4. Adjudication Method
The document does not specify an adjudication method. This is because the submission does not detail a clinical study where expert review and adjudication would be necessary to establish a "ground truth" for patient cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Such studies are typically performed for devices that involve human interpretation (e.g., imaging devices) to assess the impact of AI on human reader performance. The Chartis Console is a diagnostic spirometer that measures physical parameters (pressure, flow) and displays them, not a device requiring human interpretation of complex visual data in the same way an imaging AI would.
6. Standalone (Algorithm Only) Performance
The document does not present data on standalone (algorithm only without human-in-the-loop) performance. The Chartis Console is described as displaying real-time data for a bronchoscopist, implying it's always used with a human in the loop for clinical decision-making. The device itself is the "algorithm" that calculates and displays pressure and flow, so its "standalone performance" would be its accuracy in measuring and calculating these physical parameters. The "verification and validation test results" likely cover this aspect without detailing specific metrics in the summary.
7. Type of Ground Truth Used
The type of ground truth used here would be physical and engineering measurements to confirm the accuracy and calibration of the device's sensors and algorithms for measuring pressure and flow, and its ability to quantify collateral ventilation. It would not be expert consensus, pathology, or outcomes data, as these are typically associated with clinical efficacy studies for new devices or new indications.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This type of device, which measures physical parameters, typically does not rely on machine learning or AI models that require extensive training data in the same way an image recognition algorithm would. The "algorithm" here is likely based on established physiological principles and formulas for calculating resistance and flow, embedded in the software.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or specific machine learning algorithms that require one, the document does not describe how ground truth for a training set was established. The "ground truth" for the device's functionality would be established through engineering standards, calibration procedures using known accurate references, and verification against physiological models or simulations.
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Special 510(k) - Chartis Console
June 22, 2011
NOV 1 0 2011
K 111764
510 (k) Summary
| Proprietary Name: | Chartis ™ Console |
|---|---|
| Classification Name: | Spirometer, Diagnostic21 CFR 868.1840 Class IIClassification: BZG |
| Common Name: | Spirometer, Diagnostic |
| Manufacturer: | Pulmonx, Inc.700 Chesapeake DriveRedwood City, CA 94063650-364-0400 (phone)650-364-0403 (fax) |
| Contact: | Rich FerrickVP, 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.
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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.
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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 &
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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
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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
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Pulmonx Inc. Confidential
510(k) Number: K111764
§ 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).