(23 days)
The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.
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.
The Easycess Aspiration Pump is a medical device intended for general suction use in hospitals or clinics. The study provided in the document focuses on bench testing to demonstrate its substantial equivalence to a predicate device, the Penumbra Pump MAX (K122756).
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Conclusion) |
|---|---|---|
| Appearance | The surface of the product is clear, the shell component has no burr sharp edge, the assembly splicing fixed firmly, no obvious gap, loose. | The appearance is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Vacuum levels | 10s vacuum levels ≥60.0Kpa(18 inHg) | The vacuum level is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Free air flows | Free air flows ≥20L/min | The free air flow is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Final vacuum | -98.2Kpa±7 Kpa(-29 inHg±2inHg) | The final vacuum is suitable for intended clinical use. 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. 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. 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. 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. 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 graduation representing ≤ 5% of the full-scale value. | The vacuum level indicators are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. 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. 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. 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. 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 are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. 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. The subject device is equivalent to the predicate device. |
| Pharyngeal suction equipment | Suction equipment intended for pharyngeal suction shall evacuate ≥200ml of simulated vomitus in not more than 10s. | The pharyngeal suction equipment is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. |
| Negative pressure values and flow performance requirements - Power interruption | The interruption and restoration of the power supply of the suction device should not cause any danger, and the change of the negative pressure value and flow rate should not exceed ±10% of the set value. The same performance requirement applies if the original power supply is replaced by another power supply. | The negative pressure values and flow performance requirements - Power interruption is suitable for intended clinical use and met requirements of ISO 10079-1. The subject device is equivalent to the predicate device. |
| Simulated use | The pump could provide stable vacuum in accompany with compatible devices. | Device performs as intended under simulated use conditions. The subject device is equivalent to the predicate device. |
| Connections | With the company's production of disposable suction pipe, and suitable for the vast majority of the market suction extension tube. | The connections are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Work cycle | Non-continuous duty [ 45min( 97.8%) ON/ 1 min (2.2%) OFF ] | The work cycle is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Vacuum feedback lamp | When the device runs to vacuum less than -85 Kpa, the vacuum feedback light will turn on. | The negative pressure feedback lamp is suitable for intended clinical use. |
| Electrical Safety | Comply with IEC 60601-1:2020 | Comply with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2:2014+A1:2020 | Comply with IEC60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing, which typically does not involve patient data. The tests were performed on the Easycess Aspiration Pump itself to verify its physical and mechanical performance. Therefore, there is no specific "sample size" of patient data for a test set in the traditional sense, nor data provenance related to country of origin or retrospective/prospective collection as one would find in clinical studies.
The testing 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.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or their qualifications being used to establish a ground truth. Since this was bench testing of a hardware device's performance characteristics, the "ground truth" was the objective measurement of the device against established engineering and safety standards (e.g., ISO, IEC, FDA guidance).
4. Adjudication Method for the Test Set
As there were no human readers or interpretations involved in establishing a ground truth for a test set (it was objective bench testing), there was no adjudication method applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study presented here is focused on the device's adherence to technical standards and its substantial equivalence based on bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Easycess Aspiration Pump is a hardware medical device; it is not an algorithm-based device or an AI system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.
7. The Type of Ground Truth Used
For this device, the "ground truth" for the bench testing was established by objective engineering specifications, regulatory standards (ISO 10079-1:2022, IEC 60601-1, IEC 60601-1-2), and FDA guidance documents for powered suction pumps. These are physical and mechanical performance metrics rather than clinical outcomes or expert interpretations.
8. The Sample Size for the Training Set
As this is a hardware medical device and not an AI/ML algorithm, there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Again, since there is no training set, this question is not applicable.
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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.
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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
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and Infection Control 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)
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)
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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:
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| Item | Penumbra Pump MAX(Predicate device) | Easycess Aspiration Pump(Subject device) | Comments |
|---|---|---|---|
| ClassificationName | Apparatus, Suction, WardUse,Portable, AC-Powered | Apparatus, Suction, WardUse,Portable, AC-Powered | Same |
| Class | II | II | Same |
| Product Code | JCX | JCX | Same |
| Intended Use | The Penumbra PumpMAXTM is intended forgeneral suction use inhospitals or clinics. | The Easycess AspirationPump is intended forgeneral suction use inhospitals or clinics. | Same |
| Pump Type/VacuumSource | Oil-less, piston, integratedvacuum pump | Oil-less, piston, integratedvacuum pump | Similar, nosubstantialdifference |
| Electricalrequirement | Voltage100-115V ac 230V ac | 110V ac 220 V ac | Similar, differentdescription |
| Frequency50Hz;60Hz 50Hz | 60Hz 50Hz | Similar, differentdescription | |
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | 0-29 inHg (0-98.2 kPa) | Same |
| Maximum vacuumpressure | 29 inHg (98.2 kPa) | 29 inHg (98.2 kPa) | Same |
| Vacuum Regulator | Stepless, mechanical | Stepless, mechanical | Same |
| Vacuum feedback lamp | / | Yes | Different,indicator to showthe pump is readyfor 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(39.37 cm×28.45cm×33.53 cm) | 7.9 in×16.5 in×11.8 in(20 cm×42 cm×30cm) | Similar, both areportable |
| Weight | 22.3 lb (10.1kg) | 10.5 kg | Similar, both areportable |
| Canister Filter | Yes | Yes | Similar, air filter |
| Pump filter | None | Yes | Different,additionalprotection |
| Accessories | One set of disposablecanister and connectiontubing | One set of disposablecanister and connectiontubing | Same |
| Fluid Collection Disposal | Disposable collectioncanister | Disposable collectioncanister | Same |
| Disposable CanisterVolume | 1L | 1L | Same |
| Overflow protection | Yes | Yes | Similar, bothcould fulfill theoverflowprotection |
| Aspiration Mode | Continuous | Continuous | Same |
| Single Patient Use | Single use cannister andaspiration tubing | Single use cannister andaspiration tubing | Same |
| Item | Penumbra Pump MAX(Predicate device) | Easycess AspirationPump(Subject device) | Comments |
| Reusable pump. | Reusable pump. | ||
| OTC or Prescription | Prescription | Prescription | Same |
| Duty Cycle | Non-continuous duty[45 min (97.8%) ON / 1min(2.2%) OFF] | Non-continuous duty[45 min (97.8%) ON / 1min(2.2%) OFF] | Same |
| Service Life | 500 Hours | 500 Hours | Same |
| IEC60601-1 Compliance | Yes | Yes | Same |
| IEC60601-1-2Compliance | Yes | Yes | Same |
| Operating environment | Temp: 65°F | Temp: 65°F | Same |
| Operatingatmosphericpressure | Sea Level - 6000 ft(1829m) | Sea Level - 6000 ft(1829m) | Same |
| Storage environment | Temp: -20°F | Temp: -20°F | Same |
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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 shellcomponent has no burr sharp edge, theassembly splicing fixed firmly, no obviousgap, loose. | The appearance is suitable forintended clinical use.The subject device is equivalent tothe predicate device. |
| Vacuum levels | 10s vacuum levels ≥60.0Kpa(18 inHg) | The vacuum level is suitable forintended clinical use and metrequirements of ISO 10079-1 and10079-4.The subject device is equivalent tothe predicate device. |
| Free air flows | Free air flows ≥20L/min | The free air flow is suitable forintended clinical use and metrequirements of ISO 10079-1 and10079-4.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.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.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.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.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.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.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.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.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.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.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.The subject device is equivalent to the predicate device. |
| Test | Specification | Conclusion |
| Pharyngeal suctionequipment | Suction equipment intended for pharyngealsuction shall evacuate ≥200ml of simulatedvomitus in not more than 10s. | The pharyngeal suction equipmentis suitable for intended clinical useand met requirements of ISO10079-1 and 10079-4. |
| Negative pressurevalues andflowperformancerequirementsPower interruption | The interruption and restoration of the powersupply of the suction device should not causeany danger, and the change of the negativepressure value and flow rate should notexceed ±10% of the set value.The same performance requirement applies ifthe original power supply is replaced byanother power supply. | The negative pressure values andflow performance requirements -Power interruption is suitable forintended clinical use and metrequirements of ISO 10079-1.The subject device is equivalent tothe predicate device. |
| Simulated use | The pump could provide stable vacuum inaccompany with compatible devices. | Device performs as intended undersimulated use conditions.The subject device is equivalent tothe predicate device. |
| Connections | With the company's production of disposablesuction pipe, and suitable for the vast majorityof the market suction extension tube. | The connections are suitable forintended clinical use and metrequirements of ISO 10079-1 and10079-4.The subject device is equivalent tothe predicate device. |
| Work cycle | Non-continuous duty [ 45min( 97.8%) ON/ 1min (2.2%) OFF ] | The work cycle is suitable forintended clinical use .The subject device is equivalent tothe predicate device. |
| Vacuumfeedbacklamp | When the device runs to vacuum less than-85 Kpa, the vacuum feedback light will turnon | The negative pressurefeedbacklamp is suitable forintendedclinical use |
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. 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 Medicalelectrical equipment - Part 1 General requirements for basic safety andessential performance) | Comply with IEC 60601-1. |
| EMC Test (IEC60601-1-2:2014+A1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances - Requirements andtests) | Comply withIEC60601-1-2. |
. Performance Testing -Clinical
Clinical study was not needed to demonstrate substantial equivalence.
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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.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.