(119 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™ 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.
The provided document, K111522 for the Chartis Catheter, is a Special 510(k) submission. Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or alter the fundamental scientific technology of the device.
Therefore, the "acceptance criteria" and "study" described in such a submission typically focus on demonstrating that the modifications to the device do not raise new questions of safety or effectiveness and that the modified device performs equivalently to the predicate device. It is not a study to prove initial clinical effectiveness or diagnostic accuracy in the way an AI/ML device might be evaluated.
Based on the provided text, here's a breakdown of the information requested, with an emphasis on what's available and what's not for a Special 510(k):
1. A table of acceptance criteria and the reported device performance
The document states: "Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device."
This implies that the acceptance criteria for this Special 510(k) were based on demonstrating equivalence of the modified device to the predicate device in terms of performance characteristics. Specific quantitative criteria and detailed performance results are not provided in this summary. Instead, the general conclusion is that the modified device meets the implied acceptance criteria of equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a Special 510(k) focused on minor material, packaging, and shelf-life changes, the "test set" would likely refer to engineering and bench testing rather than a clinical dataset.
3. 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)
This information is not applicable and therefore not provided. This 510(k) is not about diagnostic accuracy where expert ground truth would be established. It's about demonstrating that modifications to an existing device (Chartis Catheter) do not negatively impact its performance or raise new safety/effectiveness concerns.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies for diagnostic devices to establish ground truth or resolve discrepancies, which is not the purpose of this Special 510(k).
5. 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
This information is not applicable and therefore not provided. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and therefore not provided. This 510(k) is not about establishing ground truth for a diagnostic condition but rather confirming equivalence of the modified catheter to its predicate.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is a physical medical device (catheter), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As above, this is a physical device, not an AI/ML algorithm requiring a training set with established ground truth.
In summary, for K111522 Chartis Catheter (a Special 510(k)):
The core of this submission is demonstrating that minor changes to materials, packaging, and shelf-life of the Chartis Catheter do not raise new types of safety or effectiveness questions and that the modified device remains substantially equivalent to its predicate. The "performance data" refers to verification and validation tests for these modifications, not a clinical study to establish diagnostic accuracy or clinical effectiveness against a "ground truth" in the way an AI/ML device would. The detailed specifications of these tests (e.g., sample size, specific criteria, methodologies) are not included in this summary document but would have been part of the full 510(k) submission.
{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 IIClassification: CBI |
| Common Name: | Tube, tracheal/bronchial, differential ventilation (w/wo connector) |
| 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: | 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
Page 1 of 1
510(k) Number: K111522
§ 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).