Passio Pump Drainage System

K190292 · Bearpac Medical · DWM · Jul 25, 2019 · Cardiovascular

Device Facts

• Record ID: K190292
• Device Name: Passio Pump Drainage System
• Applicant: Bearpac Medical
• Product Code: DWM · Cardiovascular
• Decision Date: Jul 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

Device Story

Passio Pump Drainage System provides long-term access to pleural cavity for intermittent drainage of recurrent, symptomatic pleural effusions. Device facilitates relief of dyspnea and chest discomfort. System components include a catheter for pleural access. Used in clinical or home settings to manage fluid accumulation. Healthcare providers or patients (following training) operate the system to drain fluid. Output is the removal of pleural fluid, which directly alleviates patient symptoms and improves quality of life.

Indications for Use

Indicated for patients with recurrent and symptomatic pleural effusions, including malignant pleural effusions, requiring intermittent drainage for symptom relief (dyspnea, chest discomfort).

Regulatory Classification

Identification

A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

Submission Summary (Full Text)

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July 25, 2019

Bearpac Medical Jay Zimmerman President 124 West Point Road Moultonborough, New Hampshire 03254

Re: K190292

Trade/Device Name: Passio Pump Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient care suction apparatus Regulatory Class: Class II Product Code: DWM Dated: June 21, 2019 Received: June 25, 2019

Dear Jay Zimmerman:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James Lee Assistant Director DHT1C: Division of ENT, 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K190292

Device Name Passio Pump Drainage System

#### Indications for Use (Describe)

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

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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