(120 days)
No
The summary describes a system that measures pressure and flow to calculate resistance and quantify collateral ventilation. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on physical measurements and calculations.
No
The device is described as measuring pressure and flow to calculate resistance to airflow and quantify collateral ventilation, which are diagnostic functions, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is "designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments," and the "Device Description" section states it's for use "during a diagnostic bronchoscopy procedure." These functions align with the process of gathering information to identify or characterize a medical condition.
No
The device description explicitly states that the Chartis System is composed of the Chartis Catheter and Chartis Console, and the subject 510(k) is for the Chartis Precision Catheter, which is a physical, single-use, sterile, disposable device. This indicates the device includes hardware components.
Based on the provided information, the Chartis System, including the Chartis Catheter and Chartis Console, 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 the diagnosis, treatment, or prevention of disease.
- 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 to assess airflow resistance and collateral ventilation. This is a physiological measurement taken directly from the patient, not an analysis of a specimen collected from the patient.
Therefore, the Chartis System falls under the category of a medical device used for physiological measurement and assessment in vivo, rather than an IVD device used for analyzing in vitro specimens.
N/A
Intended Use / Indications for Use
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), 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 capital equipment that is reusable and displays the patient information.
Product codes
CBI
Device Description
The Chartis Precision 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 Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision 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 Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
isolated 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 tests have been performed in accordance with Design Controls as per 21 CFR §820.30. The following performance testing was completed to demonstrate safety and efficacy in support of substantial equivalence determination:
- Functional testing
- Shelf-life testing
- Packaging validation testing
- Biocompatibility testing
- Sterilization validation testing
Functional Testing: The Chartis Precision Catheter completed the following functional testing after being subjected to sterilization, conditioning and distribution:
- Balloon inflation, deflation and balloon burst testing
- Tensile testing of all fittings and joints of catheter, obturator, and connector set
- Airway resistance testing
- Bronchoscope deflection angle testing
- Obturator removal force testing
- Torque transmission and kink testing
- Leak testing
- Catheter insertion and withdrawal force testing
- Dimensional and visual inspection verifications
- Simulated use testing
Shelf-life Testing: The Chartis Precision Catheter successfully completed repeated functional testing and pouch seal tensile strength testing after sterilization and accelerated aging to validate its shelf-life in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Packaging Validation Testing: The Chartis Precision Catheter successfully completed packaging validation testing including visual inspection, bubble leak testing and pouch seal tensile strength testing after sterilization, conditioning and distribution in accordance with the following standards:
- ASTM D4332-2014, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D4169-2016, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F2096-11(R19), Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
- ASTM F88/F88M-2021. Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1886/F1886M-2016 Standard Test Method for Determining Integrity of Seal for Flexible Packaging by Visual Inspection
- ISO 11607-1:2019, Packaging for Terminally Sterilized Medical Devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices, Part 2: Validation requirements for forming, sealing and assembly processes
Biocompatibility Testing: The Chartis Precision Catheter is categorized per ISO 10993-1: 2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, as a surface device with limited (≤ 24 hours) mucosal membrane contact. The following biological effects were evaluated:
- Cytotoxicity at time zero and at end of shelf-life
- Sensitization
- Irritation or Intracutaneous Reactivity
- Gas Pathway Testing, including:
- Particulate Matter
- Volatile Organic Components
- Toxicological Risk Assessment
The results of these evaluations support the conclusion that the Chartis Precision Catheter is biocompatible for its intended use.
Sterilization Validation Testing: The Chartis Precision Catheter is sterilized using electron beam radiation. A three lot validation study substantiated the sterilization dose for the electron beam irradiation process at a sterility assurance level (SAL) of 10th per validation method VDmax 3 from the ISO 11137 series. The sterilization validation testing was successfully completed in accordance with the standards below:
- ANSI/AAMI/ISO 11137-1:2006(R2015) & A1:2013 & A2:2019, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-2:2013(R2019), Sterilization of health care products -. Radiation - Part 2: Establishing the sterilization dose
- ANSI/AAMI/ISO 11137-3:2017, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
- ANSI/AAMI/ISO 11737-1:2018, Sterilization of medical devices Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ANSI/AAMI/ISO 11737-2:2019, Sterilization of medical devices Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Key Results: Performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the subject device, Chartis Precision Catheter, is substantially equivalent to the cleared predicate device, Chartis Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Chartis Catheter, K111522
Reference Device(s)
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).
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December 1, 2022
Pulmonx Corporation Aniket Khakhadiya Principal Regulatory Affairs Specialist 700 Chesapeake Road Redwood City, California 94063
Re: K222340
Trade/Device Name: Chartis Precision Catheter Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: October 27, 2022 Received: October 28, 2022
Dear Aniket Khakhadiya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222340
Device Name Chartis Precision Catheter
Indications for Use (Describe)
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), 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 is capital equipment that is reusable and displays the patient information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
K222340
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant Information:
Pulmonx Corporation 700 Chesapeake Drive Redwood City, California 94063
Contact Person:
Aniket Khakhadiya Email: akhakhadiya@pulmonx.com Phone: (650) 216-0168 Ext. 268
Device Information:
| Trade Name: | Chartis Precision Catheter |
|---|---|
| Regulation Name: | Tube, tracheal/bronchial, differential ventilation (w/wo connector) |
| Device Class: | II |
| Product Code: | CBI |
Predicate Device:
Chartis Catheter, K111522, Pulmonx
Date Prepared:
July 29, 2022
Device Description:
The Chartis Precision 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 Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision 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 Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical
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Image /page/4/Picture/0 description: The image contains the word "pulmonX" in purple font. The "X" is stylized with a teal infinity symbol around it. The word "pulmon" is in lowercase letters, while the "X" is in uppercase. The image is likely a logo for a company or product called PulmonX.
ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.
Indications for Use:
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), 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 capital equipment that is reusable and displays the patient information.
Comparison of Intended Use and Technological Characteristics with the Predicate Device:
The subject and the predicate devices have the same intended use in measuring pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments.
The subject and predicate device are based on the following same technological elements:
- Both devices operate with the Chartis Console as the Chartis System and have the same . principles of operation.
- . Both devices have the same general device description and are single use, sterile, disposable devices designed to be inserted through a 2.8 mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure.
The subject and predicate device have minor differences that do not raise new types of safety or effectiveness questions:
- . The subject device is sterilized using E-beam radiation whereas the predicate device is sterilized using ethylene oxide.
- The subject device is packaged with the 3 mL and 10 mL syringes together in the same . package whereas the predicate device does not include the 3 mL and 10 mL syringes.
- In the subject device, the 1-way stopcock and 3-way stopcock have been integrated into . the Chartis handle and the Chartis Connector set, respectively. In the predicate device, the 1-way and 3-way stopcocks were provided separately.
- The subject device has a balloon working volume of up to 6 mL, airway diameter range . of 5-15mm and burst requirement of at least 9 mL whereas the predicate device has a working volume of up to 3 mL, airway diameter range of 5-12mm and burst requirement of at least 6 mL. The balloon material is identical for the subject and predicate device.
- The subject device has a shorter overall length, longer connector set length and reduced . catheter profile when compared to the predicate device.
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Image /page/5/Picture/0 description: The image shows the word "pulmonx" in a stylized font. The word "pulmon" is in a dark purple color, while the "x" is in the same color but is also part of a light blue infinity symbol. The infinity symbol is behind the "x" and extends to the right of the word.
- Material changes do not introduce new risks and have been shown to be biocompatible. ●
Non-clinical Testing / Performance Data:
Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. The following performance testing was completed to demonstrate safety and efficacy in support of substantial equivalence determination:
- . Functional testing
- Shelf-life testing ●
- . Packaging validation testing
- . Biocompatibility testing
- Sterilization validation testing .
Functional Testing
The Chartis Precision Catheter completed the following functional testing after being subjected to sterilization, conditioning and distribution:
- . Balloon inflation, deflation and balloon burst testing
- Tensile testing of all fittings and joints of catheter, obturator, and connector set ●
- Airway resistance testing
- Bronchoscope deflection angle testing
- Obturator removal force testing
- Torque transmission and kink testing
- . Leak testing
- Catheter insertion and withdrawal force testing
- Dimensional and visual inspection verifications
- Simulated use testing ●
Shelf-life Testing
The Chartis Precision Catheter successfully completed repeated functional testing and pouch seal tensile strength testing after sterilization and accelerated aging to validate its shelf-life in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Packaging Validation Testing
The Chartis Precision Catheter successfully completed packaging validation testing including visual inspection, bubble leak testing and pouch seal tensile strength testing after sterilization, conditioning and distribution in accordance with the following standards:
- ASTM D4332-2014, Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
6
Image /page/6/Picture/0 description: The image shows the word "pulmonx" in purple font. The "x" in pulmonx is stylized with a light blue infinity symbol around it. The word pulmonx is written in lowercase letters.
- ASTM D4169-2016, Standard Practice for Performance Testing of Shipping Containers . and Systems
- . ASTM F2096-11(R19), Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
- ASTM F88/F88M-2021. Standard Test Method for Seal Strength of Flexible Barrier . Materials
- . ASTM F1886/F1886M-2016 Standard Test Method for Determining Integrity of Seal for Flexible Packaging by Visual Inspection
- ISO 11607-1:2019, Packaging for Terminally Sterilized Medical Devices, Part 1: . Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices, Part 2: Validation requirements for forming, sealing and assembly processes
Biocompatibility Testing
The Chartis Precision Catheter is categorized per ISO 10993-1: 2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, as a surface device with limited (≤ 24 hours) mucosal membrane contact. Based on the device categorization, the following biological effects were evaluated for the Chartis Precision Catheter:
- . Cytotoxicity at time zero and at end of shelf-life
- . Sensitization
- Irritation or Intracutaneous Reactivity ●
- Gas Pathway Testing, including: ●
- 0 Particulate Matter
- o Volatile Organic Components
- Toxicological Risk Assessment O
The results of these evaluations support the conclusion that the Chartis Precision Catheter is biocompatible for its intended use.
Sterilization Validation Testing
The Chartis Precision Catheter is sterilized using electron beam radiation. A three lot validation study substantiated the sterilization dose for the electron beam irradiation process at a sterility assurance level (SAL) of 10th per validation method VDmax 3 from the ISO 11137 series. The sterilization validation testing was successfully completed in accordance with the standards below:
- . ANSI/AAMI/ISO 11137-1:2006(R2015) & A1:2013 & A2:2019, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-2:2013(R2019), Sterilization of health care products -. Radiation - Part 2: Establishing the sterilization dose
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Image /page/7/Picture/0 description: The image shows the word "pulmonx" in purple font. The "x" in pulmonx is stylized with a teal infinity symbol behind it. The infinity symbol is slightly offset to the right of the "x".
- ANSI/AAMI/ISO 11137-3:2017, Sterilization of health care products Radiation Part ● 3: Guidance on dosimetric aspects of development, validation and routine control
- ANSI/AAMI/ISO 11737-1:2018, Sterilization of medical devices Microbiological . methods - Part 1: Determination of a population of microorganisms on products
- ANSI/AAMI/ISO 11737-2:2019, Sterilization of medical devices Microbiological . methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Summarv:
The Chartis Precision Catheter has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the subject device, Chartis Precision Catheter, is substantially equivalent to the cleared predicate device, Chartis Catheter.