(23 days)
Not Found
No
The 510(k) summary describes a standard aspiration pump and canister system with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is described as a "suction pump" intended for "general suction use in hospitals or clinics," which fits the definition of a therapeutic device as it directly assists in patient care by removing fluids.
No
Explanation: The device is described as an "Aspiration Pump" intended for "general suction use." Its purpose is to provide suction, not to diagnose medical conditions or analyze patient data. The performance studies focus on suction capabilities and electrical safety, not diagnostic accuracy.
No
The device description explicitly states it is composed of a "negative pressure suction pump host" and a "canister," both of which are physical hardware components. The summary also details performance testing related to the physical pump and electrical safety.
Based on the provided information, the Easycess Aspiration Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for general suction use in hospitals or clinics." This describes a physical process of removing fluids or other substances from a patient or area, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description focuses on the mechanical function of creating negative pressure for suction. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing blood, urine, tissue, or any other biological samples for diagnostic purposes. The device's function is purely mechanical suction.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Easycess Aspiration Pump's function falls outside this definition.
N/A
Intended Use / Indications for Use
The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.
Product codes (comma separated list FDA assigned to the subject device)
JCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench 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. 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.
Key results from bench testing showed the device is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4 for Appearance, Vacuum levels, Free air flows, Final vacuum, Vacuum adjustment range, Liquid level, Volume, Strength, Vacuum level indicators, Vacuum level indicators accuracy, Operating position, Overfill protection devices, Noise, Pharyngeal suction equipment, Negative pressure values and flow performance requirements - Power interruption, Simulated use conditions, Connections, Work cycle and Vacuum feedback lamp.
Electromagnetic Compatibility and Electrical Safety testing was conducted in accordance with IEC 60601-1: 2020 and IEC 60601-1-2. The device complied with IEC 60601-1 and IEC60601-1-2.
Clinical study was not needed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
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)
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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 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Classification
Name | Apparatus, Suction, Ward
Use,
Portable, AC-Powered | Apparatus, Suction, Ward
Use,
Portable, AC-Powered | Same |
| Class | II | II | Same |
| Product Code | JCX | JCX | Same |
| Intended Use | The Penumbra Pump
MAXTM is intended for
general suction use in
hospitals or clinics. | The Easycess Aspiration
Pump is intended for
general suction use in
hospitals or clinics. | Same |
| Pump Type/Vacuum
Source | Oil-less, piston, integrated
vacuum pump | Oil-less, piston, integrated
vacuum pump | Similar, no
substantial
difference |
| Electrical
requirement | Voltage
100-115V ac 230V ac | 110V ac 220 V ac | Similar, different
description |
| | Frequency
50Hz;60Hz 50Hz | 60Hz 50Hz | Similar, different
description |
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | 0-29 inHg (0-98.2 kPa) | Same |
| Maximum vacuum
pressure | 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 show
the pump is ready
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 | 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 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 |
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 | |
| electrical equipment - Part 1 General requirements for basic safety and | |
| essential 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 and
tests) | Comply with
IEC60601-1-2. |
. 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.