Aspira Pleural Drainage System
Device Facts
| Record ID | K212696 |
|---|---|
| Device Name | Aspira Pleural Drainage System |
| Applicant | Merit Medical Systems, Inc. |
| Product Code | DWM · Cardiovascular |
| Decision Date | Mar 3, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Aspira Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion.
Device Story
Aspira Pleural Drainage System facilitates home-based management of pleural effusions; enables patients to drain accumulated pleural fluid intermittently. System comprises indwelling pleural catheter, valve assembly, and drainage collection containers (bag or bottle). Physician implants catheter into pleural cavity; patient or caregiver performs drainage at home using vacuum-based collection containers or external suction sources. Valve assembly provides secure access point; prevents fluid leakage and air entry. Device relieves symptoms like dyspnea and chest discomfort; improves patient quality of life by reducing hospital visits for thoracentesis. Subject device expands valve compatibility to include competitive silicone catheters (0.103"-0.116" ID) and introduces drainage bottle as alternative to bag.
Clinical Evidence
Bench testing only. No clinical data presented. Performance testing included biocompatibility (ISO 10993), sterility (ISO 11135), mechanical integrity (tensile, leak, vacuum, and flow rate testing), and human factors/usability engineering for lay users.
Technological Characteristics
Silicone drainage catheter; valve assembly; drainage bag/bottle. Materials meet ISO 10993 biocompatibility standards. Sterilization via ethylene oxide. Connectivity: mechanical luer/universal adapters for vacuum/suction sources. Design conforms to ISO 594-1/2, ISO 80369-7, and ISO 20697. No software or electronic components.
Indications for Use
Indicated for long-term intermittent drainage of pleural fluid in patients with recurrent, symptomatic pleural effusions (e.g., malignant effusions) to relieve dyspnea and chest discomfort. Components include drainage catheter, bag, bottle, dressing kit, valve assembly, and adapters for suction/vacuum drainage.
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.
Predicate Devices
- Aspira Pleural Drainage System (K110409)
Reference Devices
Submission Summary (Full Text)
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March 3, 2023
Merit Medical Systems, Inc. Jennifer Webb Regulatory Affairs Manager 1600 West Merit Parkway South Jordan, Utah 84095
Re: K212696
Trade/Device Name: Aspira Pleural Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: Class II Product Code: DWM Dated: January 31, 2023 Received: February 1, 2023
Dear Jennifer Webb:
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
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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. 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 Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K212696
Device Name Aspira Pleural Drainage System
#### Indications for Use (Describe)
The Aspira Pleural Drainage System is intended for long-term internittent drainage of pleural fluid accumulated in the pleural cavity forth purpose of relieving symptoms associated with pleural effusion.
· Aspira Drainage Catheter: The Aspira Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access of the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusions and other recurrent effusions.
• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
· Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
· Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.
• Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with silicone catheters with inner diameters between 0.103" - 0.116 such as the Aspira, Asept®, PleurX® and Rocket® catheters.
• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.
· Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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# 510(k) Summary (K212696)
| General<br>Provisions | Submitter Name:<br>Address: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Telephone Number: | (801) 208-4403 |
| | Contact Person: | Desiree Bond |
| | Date Prepared: | 02 Mar 2023 |
| | Registration Number: | 1721504 |
| Subject<br>Device | Trade Name: | Aspira Pleural Drainage System |
| | Classification | Apparatus, Suction, Patient Care |
| | Regulatory Class: | Class II |
| | Product Code: | DWM |
| | Regulation Number: | 21 CFR 870.5050 |
| | Premarket Notification: | K212696 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| Predicate<br>Device | Trade Name: | Aspira Pleural Drainage System |
| | Classification Name: | Apparatus, Suction, Patient Care |
| | Premarket Notification: | K110409 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| | This predicate has not been subject to a design-related recall. | |
| Reference<br>Device | PleurX Catheter: PN 50-7510 (K201155; K160450) | |
| Device<br>Description | The Aspira Pleural Drainage System provides patients with a convenient method to<br>relieve pleural effusion symptoms at home. The primary components of the Aspira Pleural<br>Drainage System are the Aspira Pleural Drainage Catheter, the Aspira Drainage Bag, and the<br>Aspira Drainage Bottle. | |
| Intended Use | The Aspira Pleural Drainage System is intended for long-term intermittent<br>drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving<br>symptoms associated with pleural effusion.<br>The Aspira Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid<br>accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural<br>effusion. | |
| Indications<br>for Use<br>(Cont.) | Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with inner diameters between 0.103" - 0.116 such as the Aspira, Asept®, PleurX® and Rocket® catheters. Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. The Indications for Use statement for the subject Aspira Pleural Drainage System device is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use: intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion. | |
| Comparison<br>to Predicate<br>Device | Technological characteristics of the subject Aspira Pleural Drainage System are equivalent with respect to the basic catheter design and function to those of the predicate devices. Differences do not raise any new questions regarding safety and effectiveness.<br><br>The design and technological characteristics of the subject device are substantially equivalent to those of the predicate device. The subject device has the same materials and use as the predicate device. The main difference between the subject and the predicate device is the expanded scope of the indications to expand the compatibility of the Aspira Valve/Repair Kit portion of the Aspira Pleural Drainage System with competitive drainage catheters as well as the introduction of the Aspira Drainage Bottle as an alternative to the Aspira Drainage Bag.<br><br>At a high level, the subject and predicate devices are based on the following same technological elements: Same Clinical Use Same Intended Use Same Materials Same Overall Device Design Same Sterilization Methods Same Labeling and Packaging Same Fundamental Technology/Principle of Operation The following differences exist between the subject and predicate devices: Expanded Indications for use to include: Compatibility of the Merit Aspira replacement valve used in the Aspira Repair Kit with silicone catheters with inner diameters between 0.103" - 0.116, including competitive drainage catheters such as Asept®, PleurX® and Rocket® catheters. Use of the Aspira Drainage Bottle as an alternative to the Aspira Drainage Bag. | |
| Performance<br>Data | No performance standards have been established under Section 514 of the Food, Drug<br>and Cosmetic Act for these devices. Performance testing of the subject Aspira Pleural<br>Drainage System was conducted based on the risk analysis and based on the<br>requirements of the following international standard(s):…
