Pulmonx Chartis Tablet Console

K180011 · Pulmonx Corporation · BZG · Jul 13, 2018 · Anesthesiology

Device Facts

• Record ID: K180011
• Device Name: Pulmonx Chartis Tablet Console
• Applicant: Pulmonx Corporation
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emplysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Clartis 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.

Device Story

System measures pressure and flow in isolated lung compartments to quantify collateral ventilation; used by bronchoscopists in bronchoscopy suites. Input: airflow and pressure signals from Chartis Catheter (inserted via bronchoscope working channel). Processing: Tablet Console hardware translates catheter signals into electrical data; software analyzes and displays real-time airflow, pressure, resistance, and volume. Output: real-time graphs and metrics on touchscreen display. Two modes: Standard (spontaneous breathing) and Ventilator (mechanical ventilation). Clinical decision-making: assists physicians in assessing lung compartments for collateral ventilation. Benefits: enables targeted patient selection for lung procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-6), electromagnetic compatibility (IEC 60601-1-2), hardware verification, stress cycling, cleaning/cycling testing, usability evaluation (IEC 62366), and packaging validation (ASTM D4332, ASTM 4169).

Technological Characteristics

System comprises touchscreen computer and sensor enclosure. Connectivity: wired connection to Chartis Catheter. Materials: polymer tube with filter. Sensing: pressure and flow transducers. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 62366, ASTM D4332, ASTM 4169. Software: real-time signal processing and display. Reusable capital equipment.

Indications for Use

Indicated for adult patients with emphysema (COPD) undergoing bronchoscopy in a bronchoscopy suite to quantify collateral ventilation in isolated lung compartments.

Regulatory Classification

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.

Predicate Devices

• Chartis Console (K111764)

Reference Devices

• Chartis Catheter (K111522)

Submission Summary (Full Text)

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July 13, 2018

Pulmonx Corporation Ms. Sherry Kim Sr. Regulatory Affairs Specialist 700 Chesapeake Drive Redwood City, California 94063

Re: K180011

Trade/Device Name: Pulmonx Chartis Tablet Console Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG Dated: June 12, 2018 Received: June 13, 2018

Dear Ms. Kim:

We have reviewed vour 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.

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 of medical device-related adverse events) (21 CFR 803); good

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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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180011

Device Name Pulmonx Chartis Tablet Console

#### Indications for Use (Describe)

The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emplysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Clartis 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(K) SUMMARY

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:

Sherry Kim Email: [e-mail] Phone: [phone]

#### Device Information:

Trade Name: Regulation Name: Regulation Number: Device Class: Product Code:

Pulmonx Chartis Tablet Console Diagnostic Spirometer 21 CFR 868.1840 II BZG

### Predicate Device:

Chartis Console, K111764

#### Date Prepared:

June 7, 2018

#### Device Description:

The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. 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 Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

## 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

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compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Tablet 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 as spirometry systems in measuring pressure and/or flow to detect the presence of 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 Catheter as the Chartis System and have the same principles ● of operation.
- . Both devices have the same general device description. Both devices are comprised of a touchscreen computer, patient interface board and software.
- . Both devices display air pressure, airflow, resistance and total volume of expired air.

Whereas the predicate device is indicated for all adult patients, the indications for use for the subject device specify the intended patient population as adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD). The computer and patient interface board of the predicate device are integrated into a single unit; in the subject device they are two physically separate components. The subject device allows segmental level assessments.

The subject device additionally provides a second display option called the Ventilator Mode. The Ventilator Mode provides a display option that may be preferred when the physician selects to perform the bronchoscopy and Chartis assessment on a patient under general anesthesia with mechanical ventilation. For clarification, the term "Ventilator Mode" does not signify it is intended for use in patients that are ventilator dependent outside of the procedure. The Standard Mode, which is available in both the predicate device and the subject device, provides a display option that may be preferred when the physician selects to perform the bronchoscopy and Chartis assessment on a patient under conscious sedation with spontaneous breathing. Both modes display the flow graphs, and both modes can be used to detect the presence of collateral ventilation in isolated lung compartments. The main difference in the display of the two modes is that the Ventilator Mode does not display inspiratory pressure and resistance since these measurements are not generated when mechanical ventilation is used during the procedure.

#### Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

| Test | Results and Conclusions |
|--------------------------------------------------------------------------------------------|---------------------------------------------------|
| Software verification and validation | Test samples passed all acceptance criteria. PASS |
| Electrical safety per applicable requirements of AAMI<br>ANSI ES60601-1 and IEC 60601-1-6. | Test samples passed all acceptance criteria. PASS |
| Electromagnetic compatibility per applicable<br>requirements of IEC 60601-1-2 | Test samples passed all acceptance criteria. PASS |
| Hardware Verification Testing | Test samples passed all acceptance criteria. PASS |

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| Hardware Review | Test samples passed all acceptance criteria. PASS |
|------------------------------------------------------------------------------|---------------------------------------------------|
| Operational Temperature and Humidity Conditioning | Test samples passed all acceptance criteria. PASS |
| Stress Cycling Testing | Test samples passed all acceptance criteria. PASS |
| Repeated Cleaning and Tablet Stand Cycling Testing | Test samples passed all acceptance criteria. PASS |
| Usability Evaluation per IEC 62366 | Test samples passed all acceptance criteria. PASS |
| Packaging Validation per applicable requirements of<br>ASTM D4332, ASTM 4169 | Test samples passed all acceptance criteria. PASS |

#### Summary:

The Pulmonx Chartis Tablet Console 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 Pulmonx Chartis Tablet Console is substantially equivalent to the cleared predicate device.