(119 days)
Not Found
No
The summary describes a device that measures pressure and flow to calculate resistance and collateral ventilation. There is no mention of AI/ML algorithms, image processing, or training/test sets, which are common indicators of AI/ML use in medical devices.
No.
The device is designed to measure pressure and flow to calculate resistance to airflow and quantify collateral ventilation for diagnostic purposes, not to treat a condition.
Yes
The device is 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 diagnostic measurements for lung conditions.
No
The device description explicitly states the system is composed of a Chartis Catheter (a physical, disposable device) and a Chartis Console (a re-useable piece of capital equipment), indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided information, the Chartis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Chartis System Function: The Chartis System directly interacts with the patient's respiratory system in vivo (within the living body) during a bronchoscopy procedure. It measures pressure and flow within isolated lung compartments.
- No Specimen Collection/Analysis: The device does not collect or analyze biological specimens from the patient.
The Chartis System is a medical device used during a diagnostic procedure to gather physiological data directly from the patient's body. This falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
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 (comma separated list FDA assigned to the subject device)
CBI
Device Description
The Chartis™ Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Catheter lumen during spontaneous respiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung compartments, airway
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k) - Chartis Catheter
Image /page/0/Picture/1 description: The image shows the text "K111522" in a handwritten style. Below this, the date "May 31, 2011" is printed in a smaller, sans-serif font. The text and date appear to be part of a document or label, possibly indicating a code or reference number along with a corresponding date.
SEP 2 9 2011
510 (k) Summary
| 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. |
| 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: | May 31, 2011 |
Predicate Device:
The Chartis Catheter is substantially equivalent to the following currently marketed predicate device:
Chartis Catheter (K083883, cleared on June 25, 2009, product code CBI, regulation number 868.5740)
Device Description:
The Chartis™ Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Catheter lumen during spontaneous respiration.
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 Catheter is substantially equivalent to the predicate Chartis Catheter with regard to technological characteristics. The minor changes to materials, packaging, and shelf-life 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 Catheter 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
Mr. Hans Schulz Director of Quality Assurance Pulmonx, Incorporated 700 Chesapeake Drive Redwood City, California 94063
2 9 2011 SEP
Re: K111522
Trade/Device Name: Chartis Catheter Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: August 29, 2011 Received: August 30, 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.
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 (OS) 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.html 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.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 KIII 522 Chartis Catheter Device Name 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)
Pulmonx Inc. Confidential
OR
Over-the-Counter Use
(Division Sign-Off) 9/28/11
Division of Anesthesiology, General Hospital infection Control, Dental Devices
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510(k) Number: K111522