Easycess 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 3, 2023 Guangzhou Easycess Medical Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K233428 Trade/Device Name: Easycess Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: October 11, 2023 Received: October 11, 2023 Dear Prithul Bom: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.03 11:40:25 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical {2}------------------------------------------------ and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Easycess Aspiration Pump Indications for Use (Describe) The Easycess 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." {4}------------------------------------------------ ### 510(k) Summary ### I. SUBMITTER Guangzhou Easycess Medical Co., Ltd Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District, Guangzhou, China, 510530 Phone: +86 020-31603990 Fax: +86 020-31603675 Contact Person: Xingcheng Liu Date Prepared: September 26, 2023 ## II, DEVICE Name of Device: Easycess Aspiration Pump Common or Usual Name: Aspiration Pump Classification Name: Powered suction pump (21 CFR 878.4780) Regulatory Class: II Product Code: JCX Review Panel: General & Plastic Surgery Regulation number: 21 CFR 878.4780 ## III. PREDICATE DEVICE Predicate Device: Penumbra Pump MAX (K122756) ### IV. DEVICE DESCRIPTION The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only. ### V. INTENDED USE/INDICATIONS FOR USE The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Technological Comparison: {5}------------------------------------------------ | Item | Penumbra Pump MAX<br>(Predicate device) | Easycess Aspiration Pump<br>(Subject device) | Comments | |--------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Classification<br>Name | Apparatus, Suction, Ward<br>Use,<br>Portable, AC-Powered | Apparatus, Suction, Ward<br>Use,<br>Portable, AC-Powered | Same | | Class | II | II | Same | | Product Code | JCX | JCX | Same | | Intended Use | The Penumbra Pump<br>MAXTM is intended for<br>general suction use in<br>hospitals or clinics. | The Easycess Aspiration<br>Pump is intended for<br>general suction use in<br>hospitals or clinics. | Same | | Pump Type/Vacuum<br>Source | Oil-less, piston, integrated<br>vacuum pump | Oil-less, piston, integrated<br>vacuum pump | Similar, no<br>substantial<br>difference | | Electrical<br>requirement | Voltage<br>100-115V ac 230V ac | 110V ac 220 V ac | Similar, different<br>description | | | Frequency<br>50Hz;60Hz 50Hz | 60Hz 50Hz | Similar, different<br>description | | Vacuum Range | 0-29 inHg (0-98.2 kPa) | 0-29 inHg (0-98.2 kPa) | Same | | Maximum vacuum<br>pressure | 29 inHg (98.2 kPa) | 29 inHg (98.2 kPa) | Same | | Vacuum Regulator | Stepless, mechanical | Stepless, mechanical | Same | | Vacuum feedback lamp | / | Yes | Different,<br>indicator to show<br>the pump is ready<br>for aspiration | | Flow Rate | 0-0.8 SCFM(0-23 LPM) | 0-0.8 SCFM(0-23 LPM) | Same | | Maximum flow rate | 0.8 SCFM(23 LPM) | 0.8 SCFM(23 LPM) | Same | | Noise | <60 dBa | ≤70 dBa | Similar | | Dimensions | 15.5 in×11.2 in×13.2 in<br>(39.37 cm×28.45<br>cm×33.53 cm) | 7.9 in×16.5 in×11.8 in<br>(20 cm×42 cm×30cm) | Similar, both are<br>portable | | Weight | 22.3 lb (10.1kg) | 10.5 kg | Similar, both are<br>portable | | Canister Filter | Yes | Yes | Similar, air filter | | Pump filter | None | Yes | Different,<br>additional<br>protection | | Accessories | One set of disposable<br>canister and connection<br>tubing | One set of disposable<br>canister and connection<br>tubing | Same | | Fluid Collection Disposal | Disposable collection<br>canister | Disposable collection<br>canister | Same | | Disposable Canister<br>Volume | 1L | 1L | Same | | Overflow protection | Yes | Yes | Similar, both<br>could fulfill the<br>overflow<br>protection | | Aspiration Mode | Continuous | Continuous | Same | | Single Patient Use | Single use cannister and<br>aspiration tubing | Single use cannister and<br>aspiration tubing | Same | | Item | Penumbra Pump MAX<br>(Predicate device) | Easycess Aspiration<br>Pump<br>(Subject device) | Comments | | | Reusable pump. | Reusable pump. | | | OTC or Prescription | Prescription | Prescription | Same | | Duty Cycle | Non-continuous duty<br>[45 min (97.8%) ON / 1<br>min(2.2%) OFF] | Non-continuous duty<br>[45 min (97.8%) ON / 1<br>min(2.2%) OFF] | Same | | Service Life | 500 Hours | 500 Hours | Same | | IEC60601-1 Compliance | Yes | Yes | Same | | IEC60601-1-2<br>Compliance | Yes | Yes | Same | | Operating environment | Temp: 65°F~75°F (18°C~<br>24°C)<br>Humidity: <75% RH | Temp: 65°F~75°F (18°C~<br>24°C)<br>Humidity: <75% RH | Same | | Operating<br>atmospheric<br>pressure | Sea Level - 6000 ft<br>(1829m) | Sea Level - 6000 ft<br>(1829m) | Same | | Storage environment | Temp: -20°F~120°F<br>(-29°C~ 49°C)<br>Humidity: <95% RH | Temp: -20°F~120°F<br>(-29°C~ 49°C)<br>Humidity: <95% RH | Same | {6}------------------------------------------------ # VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. #### • Bench testing The bench testing covered physical and mechanical performance of the Easycess Aspiration Pump and was conducted according to the FDA special control guidance document: Guidance Document for Powered Suction Pump 510(k)s, and the ISO 10079-1:2022 Medical suction equipment - Part 1: Electrically powered suction equipment. These tests verified the performance characterization of the Easycess Aspiration Pump. All the test results from the performance testing passed the acceptance criteria set forth by the design specifications. The results of bench test are listed in table below: | Test | Specification | Conclusion | |----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appearance | The surface of the product is clear, the shell<br>component has no burr sharp edge, the<br>assembly splicing fixed firmly, no obvious<br>gap, loose. | The appearance is suitable for<br>intended clinical use.<br>The subject device is equivalent to<br>the predicate device. | | Vacuum levels | 10s vacuum levels ≥60.0Kpa(18 inHg) | The vacuum level is suitable for<br>intended clinical use and met<br>requirements of ISO 10079-1 and<br>10079-4.<br>The subject device is equivalent to<br>the predicate device. | | Free air flows | Free air flows ≥20L/min | The free air flow is suitable for<br>intended clinical use and met<br>requirements of ISO 10079-1 and<br>10079-4.<br>The subject device is equivalent to | | Test | Specification | Conclusion | | Final vacuum | $-98.2Kpa±7 Kpa(-29 inHg±2inHg)$ | The final vacuum is suitable for intended clinical use.<br>The subject device is equivalent to the predicate device. | | Vacuum adjustment range | $-98.2Kpa(-29 inHg)$ | The vacuum adjustment range is suitable for intended clinical use.<br>The subject device is equivalent to the predicate device. | | Liquid level | Clearly show the level of contents. | The liquid level is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Volume | Volume ≥1L | The volume is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Strength | Collection containers shall not implode, crack or permanently deform after 5 minutes of continuous pumping at atmospheric pressure of -95 Kpa. | The strength is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Vacuum level indicators | The full scale of analogue vacuum level indicators shall be≤ 60 inHg. Analog displays shall have graduations≥ 2mm apart with each with each graduation representing≤ 5% of the full-scale value. | The vacuum level indicators is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Vacuum level indicators accuracy | Digital displays shall indicate the vacuum level at intervals≤ 5% of the full-scale value. | The vacuum level indicators accuracy is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Operating position | When placed at any position on an incline at an Angle of (10±1) °with the horizontal plane, the equipment meets the requirements for use. | The operating position is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Overfill protection devices | Overfill protection devices shall not activate until at least 90% of the indicated maximum capacity of the collection container has been reached.<br>When an overfill protection devices is activated, suction shall cease and prevent> 5ml of fluid from passing downstream of the overfill protection device within 2min. | The overfill protection devices is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Noise | The maximum A-weighted sound pressure level (steady or peak value) ≤70 dB(A). | The noise is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4.<br>The subject device is equivalent to the predicate device. | | Test | Specification | Conclusion | | Pharyngeal suction<br>equipment | Suction equipment intended for pharyngeal<br>suction shall evacuate ≥200ml of simulated<br>vomitus in not more than 10s. | The pharyngeal suction equipment<br>is suitable for intended clinical use<br>and met requirements of ISO<br>10079-1 and 10079-4.<br> | | Negative pressure<br>values and<br>flow<br>performance<br>requirements<br>Power interruption | The interruption and restoration of the power<br>supply of the suction device should not cause<br>any danger, and the change of the negative<br>pressure value and flow rate should not<br>exceed ±10% of the set value.<br>The same performance requirement applies if<br>the original power supply is replaced by<br>another power supply. | The negative pressure values and<br>flow performance requirements -<br>Power interruption is suitable for<br>intended clinical use and met<br>requirements of ISO 10079-1.<br>The subject device is equivalent to<br>the predicate device. | | Simulated use | The pump could provide stable vacuum in<br>accompany with compatible devices. | Device performs as intended under<br>simulated use conditions.<br>The subject device is equivalent to<br>the predicate device. | | Connections | With the company's production of disposable<br>suction pipe, and suitable for the vast majority<br>of the market suction extension tube. | The connections are suitable for<br>intended clinical use and met<br>requirements of ISO 10079-1 and<br>10079-4.<br>The subject device is equivalent to<br>the predicate device. | | Work cycle | Non-continuous duty [ 45min( 97.8%) ON/ 1<br>min (2.2%) OFF ] | The work cycle is suitable for<br>intended clinical use .<br>The subject device is equivalent to<br>the predicate device. | | Vacuum<br>feedback<br>lamp | When the device runs to vacuum less than<br>-85 Kpa, the vacuum feedback light will turn<br>on | The negative pressure<br>feedback<br>lamp is suitable for<br>intended<br>clinical use | {7}------------------------------------------------ {8}------------------------------------------------ #### . Electromagnetic Compatibility and Electrical Safety The Electromagnetic Compatibility and Electrical Safety testing for the Easycess Aspiration Pump was conducted in accordance with IEC 60601-1: 2020 and IEC 60601-1-2, the results of testing are listed in the table below: | Test | Conclusion | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Safety Test (IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical<br>electrical equipment - Part 1 General requirements for basic safety and<br>essential performance) | Comply with IEC 60601-1. | | EMC Test (IEC60601-1-2:2014+A1:2020 Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential performance<br>- Collateral Standard: Electromagnetic disturbances - Requirements and<br>tests) | Comply with<br>IEC60601-1-2. | #### . Performance Testing -Clinical Clinical study was not needed to demonstrate substantial equivalence. {9}------------------------------------------------ # VIII. CONCLUSIONS The data presented in this submission demonstrates the technological similarity and equivalency of the Easycess Aspiration Pump when compared with the predicate device Penumbra Pump MAX (K122756). The devices, - . have the same indications, - use the same operating principle, - . incorporate the same basic design, - are packaged using similar material and sterilized with same processes. In summary, the Easycess Aspiration Pump described in this submission is substantially equivalent to the predicate device and should perform comparably to the predicate device marketed for the same intended use.