Rex Medical Aspiration Pump

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". January 30, 2018 Rex Medical, L.P. % Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Re: K173389 Trade/Device Name: Rex Medical Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: January 12, 2018 Received: January 16, 2018 Dear Ms. Goldstein-Falk: 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, 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). # Sincerely. Jennifer R. Stevenson - # S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173389 Device Name Rex Medical Aspiration Pump Indications for Use (Describe) The Aspiration Pump is intended for general suction use in hospitals or clinics. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X | 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}------------------------------------------------ ## 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K173389 | Submitter: | Rex Medical, L.P.<br>555 E. North Ln, Suite 5035<br>Conshohocken, PA 19428 | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ms. Susan D. Goldstein-Falk<br>Official Correspondent for Rex Medical<br>55 Northern Blvd., Suite 200<br>Great Neck, New York 11021<br>TEL: (516) 829-0451<br>FAX: (516) 466-3427<br>Email: sgoldstein@mdiconsultants.com | | Date Prepared: | January 30, 2018 | | Trade Name: | Rex Medical Aspiration Pump | | Common Name: | Pump, Portable, Aspiration (Manual or Powered) | | Regulation Name: | Pump, Portable, Aspiration (Manual or Powered) | | Regulation Number: | 21 CFR 878.4780 | | Product Code: | BTA | | Device Class: | Class II | Predicate Device(s): Primary: K051758, Penumbra Aspiration Pump Reference: K971749, EasyGo Aspirator, Precision Medical, Inc. #### Device Description The Aspiration Pump is a portable suction / aspirator / vacuum system which is used to remove debris, blood and other bodily fluids through the application of continuous negative pressure. The Aspiration Pump includes two suction / vacuum ports on the input side, each with individual flow control valves and standard 6% Luer taper connectors. A 500cc collection bag is attached to the output side of the Aspiration Pump for collection of removed debris, blood and bodily fluids. Patient Contacting Components: There are no patient contacting components for the Rex Medical Aspiration Pump. The pump connects to a catheter and is never place directly into the body of vasculature. The pump only aspirates and does not infuse any substances into the body. {4}------------------------------------------------ The Aspiration Pump is used in conjunction with suction tubes, catheters, etc. to remove surgical fluids, tissues, bodily fluids and infectious materials from a wound, patient's airway or espiratory system during surgery. During procedural use, the collection bag is kept on the same surface as the Aspiration Pump so that they are at the same elevation. The Aspiration Pump has two flow control valves that can be attached to other devices with a standard luer connection. The Aspiration Pump is activated by pressing the ON/OFF switch and deactivated by pressing the switch again. The Aspiration Pump contains an over-pressure safety device which will cease device operation during an over-pressure situation. An over-pressure situation can occur if fluid contained within the collection bag exceeds the collection bag's maximum capacity. A red L.E.D. will illuminate during an over-pressure situation and will remain illuminated until the over-pressure state is resolved. ### Indication for Use: The Rex Medical Aspiration Pump is intended for general suction use in hospitals or clinics. #### Comparison to the 510(k) Cleared Device: The Rex Medical Aspiration Pump is substantially equivalent to the Penumbra Aspiration Pump (K051758). #### Discussion of Similarities: The Rex Medical Aspiration Pump and Penumbra Aspiration Pump are both design to connect to other devices such as catheters and sheaths with a standard luer connection and provide general suction. Both pumps provide a continuous suction through the creation on negative pressure in a closed system. The Rex Medical Aspiration Pump and EasyGo Aspirator are both compact, portable pumps with similar indications for use. Both pumps are powered with batteries (DC) and provide continuous suction with comparable vacuum pressure. #### Discussion of Differences: The Rex Medical Aspiration Pump is a compact, portable, single use device that is powered by a 12V DC battery. Contrarily, the Penumbra pump is a large, reusable pump that is powered by 110V AC and plugged into a standard wall outlet. The collection cannister and aspiration tubing are single use disposable and are replaced for each use. The Rex Medical Aspiration Pump differs with the EasyGo Aspirator in a few key aspects. The Rex Medical Pump is a single use disposable pump as opposed to re-usable. The Rex Medical Aspiration Pump feature an inline pressure switch as opposed to a floating valve. Additionally, the EasyGo Aspirator can be recharged. {5}------------------------------------------------ # Table 1: Comparison Chart | Design Feature | Proposed Device<br>Rex Medical<br>Aspiration Pump | Predicate Device<br>Penumbra<br>Aspiration Pump<br>K051758 | Comments | Alternate Predicate Device<br>Precision Medical<br>EasyGo Aspirator<br>K971749 | Comments | |-------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | Intended for general<br>suction use in hospitals or clinics. | Intended for general<br>suction use in hospitals or clinics. | SAME | Intended for use in the homecare<br>or hospital environment. | SIMILAR | | Closed System | YES | YES | SAME | YES | SAME | | Fluid Collection<br>Disposal | Disposable, collection bag | Disposable collection canister. | Rex Medical Aspiration<br>Pump utilizes a bag as<br>opposed to a container. The<br>bag is more beneficial to<br>shipping and packaging but<br>does not affect product<br>safety or efficacy. | Disposable collection canister. | Rex Medical Aspiration<br>Pump utilizes a bag as<br>opposed to a container. The<br>bag is more beneficial to<br>shipping and packaging but<br>does not affect product<br>safety or efficacy. | | Product Code | BTA | BTA, JCX | SIMILAR | BTA | SAME | | FDA Regulation,<br>21 CFR | 878.4780 | 878.4780 | SAME | 878.4780 | SAME | | Dimensions -<br>Mobile Unit | 6" X 4.125" X 2.5" | Est. 16" X 10" X 8" | Smaller unit to take up less<br>operating table space and<br>become less intrusive to the<br>physician. | 12" X 9.5" X 10.2" | Smaller unit to take up less<br>operating table space and<br>become less intrusive to the<br>physician. | | Weight -Mobile<br>Unit | 1.5 lbs | Unknown | From the size of the pump, it<br>can be assumed that it is<br>substantially heavier. | 11 lbs | Rex Medical Aspiration<br>Pump is lighter as it requires<br>smaller battery & pump for<br>operation. | | Electrical<br>Requirements | 12V DC powered, standalone | 100-115V AC | Uses wall outlet vs. battery<br>powered. | 12V DC powered, re-chargeable.<br>AC adapter for re-charging. | SAME (When Portable) | | Suction Source | Integrated vacuum pump | Integrated vacuum pump | SAME | Integrated vacuum pump | SAME | | Mobile Unit<br>Vacuum Range | 5-28 inHG, depending on diameter<br>of attached suction tubing | 29inHG Max, varies depending on<br>diameter of attached suction<br>tubing | SIMILAR | 2-21 inHG depending on diameter<br>of attached suction tubing &<br>vacuum control knob. | The vacuum pressure<br>generates adequate flow<br>rates to aspirate materials<br>and fluids with varied<br>diameters of tubing. A<br>higher maximum vacuum<br>pressure increases the<br>effectiveness with small<br>diameter catheters.<br>The aspiration flow rate is<br>sufficient to effectively<br>aspirate material and fluids. | | Flow Rate | 22 - 650 mL/min H₂O<br>depending on catheter used | 42 - 480 mL/min<br>depending on catheter used | SIMILAR | 14 Lpm Air, Under AC Power | SAME | | Run Time | 45min Minimum | Infinite | AC powered does not have a<br>runtime. | 45min Minimum | SAME | | Vacuum<br>Regulator | None | Regulator Valve | Rex Medical Aspiration<br>Pump's vacuum is based on<br>flow and volumetric load.<br>Maximal vacuum is<br>regulated by designed<br>supplied voltage parameter<br>which is non-adjustable. | Regulator Valve | Rex Medical Aspiration<br>Pump's vacuum is based on<br>flow and volumetric load.<br>Maximal vacuum is<br>regulated by designed<br>supplied voltage parameter<br>which is non-adjustable. | | Fluid Suction<br>Filter | None | Inline Filter | Rex Medical Aspiration<br>Pump does not require a<br>filter, as the collection unit is<br>downstream of the pump. | Bacterial Filter | Rex Medical Aspiration<br>Pump does not require a<br>filter, as the collection unit is<br>downstream of the pump. | | Single Patient<br>Use | Single | Single use cannister and aspiration<br>tubing. Reusable pump. | Rex Medial Aspiration Pump<br>is designed and marketed as<br>a onetime use device. | Reusable | Rex Medial Aspiration Pump<br>is designed and marketed as<br>a onetime use device. | | Holding<br>Container<br>Capacity | 500 mL | 1000 mL | | 800 mL | | | Suction Mode | Continuous | Continuous | SAME | Continuous | SAME | | OTC or<br>Prescription | Prescription | Prescription | SAME | Prescription | SAME | | Overflow<br>Prevention<br>Mechanism | Integrated Pressure Switch | None | Rex Medical Aspiration<br>Pump utilizes a pressure<br>switch which ceases device<br>operation when a positive | Float Shut-off | Rex Medical Aspiration<br>Pump utilizes a pressure<br>switch which ceases device<br>operation when a positive | | | | | pressure of 3psi (±10%) is<br>reached on the output side<br>of the pump. This prevents<br>system operation if a<br>downstream tube is kinked<br>or if the volume of fluid<br>within the collection bag<br>exceeds 500 mL. | | pressure of 3psi (±10%) is<br>reached on the output side<br>of the pump. This prevents<br>system operation if a<br>downstream tube is kinked<br>or if the volume of fluid<br>within the collection bag<br>exceeds 500 mL. | | Suction Inlet Port<br>Dimensions | .125" ID with Luer Connector | 0.071" – 0.110" ID with Luer<br>Connector | SIMILAR | .125" ID | Rex Medical Aspiration<br>Pump is compatible with<br>Luer fittings commonly<br>found on catheters used<br>within the surgical field. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## Non-Clinical Performance Testing: Testing information demonstrating safety and effectiveness of the Rex Medical Aspiration Pump in the intended environment of use is supported by testing that was conducted in accordance with Guidance on the Content of Premarket Notification Submissions for portable aspiration pumps. The following table provides the in vitro testing that was performed for the Rex Medical Aspiration Pump to show substantial equivalence to the predicate device: | Report Title | Pass / Fail | |----------------------------------------------------------------------------------------|-------------| | Aspiration Pump Pressure Study Technical Report | Pass | | Aspiration Pump Battery Life Study Technical Report | Pass | | Aspiration Pump Voltage Comparison Study Technical Report | Pass | | Distal Assembly IPA Resistance Study Technical Report | Pass | | EPEC Engineered Technologies Battery Sample Study<br>Technical Report | Pass | | Flow Rate of Rex Medical Aspiration Pump and Predicate<br>Device Technical Report | Pass | | Battery Life of Rex Aspiration Pump and Predicate Device | Pass | | Maximum Volume of Rex Medical Aspiration Pump and<br>Predicate Device Technical Report | Pass | | UL Test Report for Disposable Aspiration Pump, NT-Pump | Pass | | Aspiration Pump Backflow Report | Pass | #### Table 2: In Vitro Testing Summary of Aspiration Pump Backflow Testing: The Rex Medical Aspiration Pump uses a liquid aspiration pump to aspirate fluid from the patient and into the collection bag. The liquid aspiration pump is designed to prevent back flow through the pump. The objective of the test is to verify that backflow does not occur. The acceptance criteria for the test is no backflow when a 45psi minimum back pressure is applied. Two liquid aspiration pumps were each tested three times. All tests passed. The liquid aspiration pump did not allow any backflow of fluids. The following table provides the in vivo testing that was performed for the Rex Medical Aspiration Pump to show substantial equivalence to the predicate device: ### Table 3: In Vivo Testing | Report Title | Pass / Fail | |-----------------------------------------------------------|-------------| | Aspiration Pump in vivo Fluid Flow Study Technical Report | Pass | | Aspiration Pump in vivo Efficacy Study Technical Report | Pass | {9}------------------------------------------------ ## Testing to Standards: The following national and international standards were utilized for testing the subject device: ## Table 2: Standards | Report Title | Pass / Fail | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | ISO 14161 (2009) Sterilization of Health Care Products- “Biological Indicators - Guidance<br>for The Selection, Use and Interpretation of Results” | Pass | | BS EN ISO 11737-2 (2009) "Sterilization of Medical Devices - Microbiological Methods -<br>Part 2: Tests of Sterility Performed in The Definition, Validation and Maintenance of A<br>Sterilization Process" | Pass | | AAMI/ANSI/ISO 11135 (2014) "Sterilization of Health-Care Products - Ethylene Oxide -<br>Requirements for The Development, Validation and Routine Control of a Sterilization<br>Process For Medical Devices" | Pass | | ISO 11737-1 (2009) "Sterilization of Health Care Products - Microbiological Methods -<br>Part 1: Determination Of The Population of Microorganisms On Product" | Pass | | ISO 10993-7 (1995) "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals" | Pass | | ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) "Medical Electrical Equipment - Part 1:<br>General Requirements for Basic Safety And Essential Performance" | Pass | | AAMI ANSI IEC 60601-1-2 (2007/(R)2012) “Medical Electrical Equipment - Part 1-2:<br>General Requirements For Basic Safety And Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility - Requirements And Tests" | Pass | | ASTM F 88 (2015) "Standard Test Method for Seal Strength of Flexible Barrier Materials" | Pass | | ASTM D 4169 (2016) “Standard Practice for Performance Testing of Shipping Containers<br>and Systems" | Pass | | ASTM F1886 (2016) "Standard Test Method for Determining Integrity of Seals for<br>Flexible Packaging By Visual Inspection" | Pass | | ASTM F 2096 (2013) "Standard Test Method for Detecting Gross Leaks in Packaging by<br>Internal Pressurization (Bubble Test)" | Pass | | ISTA 2A (2012) "Packaged Products Weighting 150(lbs) or Less" | Pass | ## Clinical Performance Testing: No clinical testing was conducted for this device. ### Conclusion: Conclusions based on aforementioned testing and information demonstrate the Rex Medical Aspiration Pump is substantially equivalent to the predicate device.