CHARTIS CATHETER MODEL CHR-CA-12.0

K111522 · Pulmonx, Inc. · CBI · Sep 29, 2011 · Anesthesiology

Device Facts

• Record ID: K111522
• Device Name: CHARTIS CATHETER MODEL CHR-CA-12.0
• Applicant: Pulmonx, Inc.
• Product Code: CBI · Anesthesiology
• Decision Date: Sep 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5740
• Device Class: Class 2

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.

Device Story

Single-use, sterile, disposable catheter; inserted through working channel of standard video/fiber bronchoscope. Distal tip features compliant balloon; inflation seals/isolates target lung segment. Air flows from isolated compartment through central catheter lumen; device measures pressure and flow during spontaneous respiration. Used in bronchoscopy suite by bronchoscopists. Connects to reusable Chartis Console; console displays patient information. Enables assessment of collateral ventilation; aids clinical decision-making regarding lung compartment isolation.

Clinical Evidence

Bench testing only. Verification and validation test results support performance characteristics and demonstrate equivalence to the predicate device.

Technological Characteristics

Single-use, sterile, disposable catheter with compliant distal balloon. Connects to reusable Chartis Console. Technological characteristics are substantially equivalent to predicate; minor changes to materials, packaging, and shelf-life.

Indications for Use

Indicated for adult patients undergoing diagnostic bronchoscopy in a bronchoscopy suite to measure pressure and flow for calculating airflow resistance and quantifying collateral ventilation in isolated lung compartments.

Regulatory Classification

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.

Predicate Devices

• Chartis Catheter (K083883)

Submission Summary (Full Text)

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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)<br>21 CFR 868.5740 Class II<br>Classification: CBI |
| Common Name: | Tube, tracheal/bronchial, differential ventilation (w/wo connector) |
| Manufacturer: | Pulmonx, Inc.<br>700 Chesapeake Drive<br>Redwood City, CA 94063<br>650-364-0400 (phone)<br>650-364-0403 (fax) |
| Contact: | Rich Ferrick<br>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.

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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 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.

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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

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.

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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 (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 [phone] or [phone] 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

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## 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