Exsalta

{0}------------------------------------------------ September 16, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. DRW Medical % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704 Re: K221676 Trade/Device Name: Exsalta Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 18, 2022 Received: August 18, 2022 # Dear Paul Dryden: 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use K221676 510(k) Number (if known) Device Name Exsalta Indications for Use (Describe) Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Date Prepared: | 18-Aug-22 | |-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | DRW Medical, LLC<br>2710 Concord Road<br>Aston PA 19014 USA<br>Tel - 610-996-5308 | | | Official Contact: | Dan Tatum- President | | Submission Correspondent: | Paul Dryden<br>ProMedic, LLC<br>St. Petersburg, FL | | Proprietary or Trade Name: | Exsalta | | Common/Usual Name:<br>Classification CFR:<br>Classification Code:<br>Classification Name:<br>Class: | Powered Suction Pump<br>21 CFR 878.4780<br>BTA<br>Pump, Portable, Aspiration (Manual Or Powered)<br>Class II | | Predicate Device: | Medela Vario 8/18/ci Suction Pumps K153663 | ## Device Description: Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use. Exsalta complies with the following FDA recognized standards: - AAMI ANSI ES 60601-1: 2005 +A1: 2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance - IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements ● and Tests - ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction . equipment [Including: Amendment 1 (2018)] ## Safety Features: The suction circuit and collection container isolate suction contents from the room and from the pump, providing for safe handling and disposal. The collection container is under positive pressure and has three ports. A first port is where the patient media is pumped into the container. The second port provides an air vent to the atmosphere. The air vent port incorporates a viral filter to protect the atmosphere from patient media. When the container is full the internal liguid float valve closes, and the air vent closes. The third port has a tube that extends to the internal pressure sensor for communication with the microprocessor. When the collection container is full and activates the float valve, the increase in pressure signals the microprocessor to stop the pump. {4}------------------------------------------------ The pump provides a clinician with the ability to adjust vacuum levels without changing the flowrate. The flow rate is fixed by the ID of the pump tube (6.4mm) and the pump RPMs (400) which is constant. The user may select any vacuum limit from 60-300 mmHg vacuum and the flow rate remains at ~1.4 L/min. ## Specifications: Vacuum: Medium Vacuum, 8-40 kPa, (60-300 mmHg,) low flow - 1.4 L/min at max vacuum. Vacuum measured from Zero level – atmosphere +/- 10% Electrical: AC-120V, 60 Hz, 2A ## Operating/Storage Ranges Operating: +5°C to +40 °C Storage: 25°C to +70 °C Humidity Limits: 15 to 93% RH (non-condensing) Atmospheric Pressure: 700 hPA-1060 hPA ## Indications for Use: Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient. ## Patient Population: The Exsalta is indicated for patients that may require aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside. ## Environments of use: Medical facilities. We present the proposed device vs. the predicate in the Table below. {5}------------------------------------------------ K221676 # 510(k) Summary Page 3 of 6 | Attribute | Predicate Vario 8/18/ci | Proposed Device | | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------| | Regulation | 21CFR 878.4780 | 21CFR 878.4780 | | | | Product Code | BTA - Pump, Portable, Aspiration (manual or powered) | BTA - Pump, Portable, Aspiration (manual or powered) | | | | Indications for Use | The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.<br><br>Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode. | Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patent | | | | Environment of Use | Professional healthcare facility environment | Professional healthcare facility environment | | | | User Interface | | | | | | User Control | On/off switch for Vario 18 / 8 versions<br>On/off/intermittent switch for Vario c/i versions<br>Vacuum regulator, press knob to turn | On / Off switch<br>Touch Panel | | | | Visual Indicator | Vacuum gauge<br>LED for battery operation | Vacuum gauge uses Digital Display<br>Various screens for control, use and maintenance of the device | | | | Accessories | Patient tubing connectors (with and without coupling pieces)<br>Reusable lids, jars<br>Disposable liners<br>Disposable jars<br>Connectors and Tubing<br>Filters | Disposable Connectors and Tubing<br>Disposable Collection jar<br>Disposable Filters | | | | Flow liters/min | Vario 8 / Vario 8 c/I 8 liters/min | 1.4 liters/min | | | | Maximum vacuum mmHg/kPa | Vario 8 / Vario 8 c/i<br>-68mmHg<br>-9kPa | Vario 18<br>563mmHg<br>-75kPa | Vario 18 c/i<br>-413 mmHg<br>-55 kPa | 60-300 mmHg<br>8 - 40 kPa | | Attribute | Predicate Vario 8/18/ci | | Proposed Device | | | Therapy modes | Vario 8 and<br>Vario 18<br>Continuous | Vario 8 c/i and Vario 18<br>c/i<br>Continuous / intermittent | Continuous | | | Power Source | AC versions:<br>230-240V, 50/60 Hz, 90 VA<br>120V, 60 Hz, 70 VA | AC/DC versions:<br>100-240V, 50/60 Hz, 80 VA | AC-120V, 60 Hz, 2A | | | Electrical<br>Protection Type | Class II | | Class I | | | Ingress | IP21 | | IP21 | | | Applied Part Type | CF | | B | | | Operating Ambient<br>Temperatures | +5...+40°C | | +5 to 40°C | | | Operating Ambient<br>Humidity | 15...93% R.L. | | 15 to 93% RH | | | Operating Pressure | 70 - 106 kPa | | 70 to 106 kPa | | | Storage Ambient<br>Temperatures | -25 to +70°C | | -25 to +70°C | | | Storage Ambient<br>Humidity | 15 to 93% RH | | 15 to 93% RH | | | Storage Pressure | 70 - 106 kPa | | 70 to 106 kPa | | | Weight [kg] | 7.7lbs (3.5kg) (AC-version)<br>9.3 lbs (4.2 kg) ( AC/DC-Version with NiMH<br>Battery) | | 12.3 pounds | | | Dimensions<br>(hxwxd) | 15x7x11 inches / 380x170x285 mm | | Height 5", Width 12", Depth 10" | | | Principles of Operation | | | | | | Suction aggregate<br>type | QuatroFlexTM AC or DC-Motor with flat belt<br>transmission to the four piston/cylinder<br>modules | | Peristaltic | | {6}------------------------------------------------ {7}------------------------------------------------ ## 510(k) Summarv Page 5 of 6 | Attribute | Predicate Vario 8/18/ci | Proposed Device | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Flow control | To adjust the level of suction, the regulator<br>knob has to be pressed inwards and turned in<br>the desired direction. The knob will be locked<br>when it's not pressed down to prevent<br>accidental adjustment. The tubing is clamped<br>and the user can use the gauge to adjust the<br>suction level.<br>When the desired vacuum is reached, the knob<br>can be released. | Touch screen slide bar with digital display of<br>suction level set | | Vacuum Regulation<br>type | Mechanical regulator | Microprocessor controlled Proportional valve<br>Mechanical regulator | | Vacuum Gauge type | Analog vacuum gauge | Digital vacuum display | | Standards | AAMI/ANSI ES60601-1:2005<br>IEC 60601-1-2: 2007<br>ISO 10079-1: 2009 | AAMI/ANSI ES60601-1:2005 + A1: 2012<br>IEC 60601-1-2: 2014<br>ISO 10079-1: 2015 | ## Substantial Equivalence Discussion and Rationale The table above compares the key features of the proposed device with the identified predicate -Medela Vario 8/18/ci K153663. The comparison demonstrates that the proposed devices can be found to be substantially equivalent. ## Indications for Use - The indications for use are similar for the proposed device when compared to the predicate device. Discussion - Both devices are indicated for bodily fluids (including vomit) or infectious materials from a patient's airway. Both devices have equivalent range of pressure and flow. Minor difference does not raise different concerns of risk than the predicate. ## Technology and construction - Both devices use electrical power to pump fluids into a reservoir. Discussion - The subject devices uses a peristaltic pump whereas the predicate uses a piston pump. In either case similar pressures and flow are obtained. The differences do not raise different concerns of safety or effectiveness compared to the predicate. ## Environment of Use - The environments of use for the subject and predicate device are similar, namely clinical settings. Discussion - The environments of use are identical. # Patient Population - The patient population is similar to the predicate device. {8}------------------------------------------------ ## 510(k) Summary Page 6 of 6 Discussion - The subject device provides a wide range of control in pressure and flow and will always be used by a trained clinician. ## Non-clinical Testing We performed a number of tests to demonstrate that the proposed device performed as intended. Testing includes: - Shelf-life / Aging - . Software Verification and Validation - IEC 60601-1 ● - . IEC 60601-1-2 - ISO 10079-1:2015 ● The subject device met all performance criteria. ## Animal No animal testing was performed. # Clinical No human clinical testing was performed. # Discussion of Differences – There are no significant differences in critical function between the proposed device and the predicate device. The performance testing has demonstrated that the subject device met the applicable standard performance requirements. The above table plus the risk analysis do not identify any new or different risks compared to the predicate. ## Substantial Equivalence Conclusion The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.