(304 days)
The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.
The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications.
The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.
The provided text is a 510(k) Premarket Notification for the Acare Suction Unit, model ASU-200. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy through studies with ground truth established by experts.
Therefore, the information requested about acceptance criteria and studies (especially those involving expert ground truth, sample sizes for training/test sets, MRMC studies, or standalone performance of an AI algorithm) is not applicable to this type of device and submission.
The document describes performance testing conducted to ensure safety and functionality in comparison to predicate devices, but this is engineering and compliance testing, not a clinical study to assess diagnostic performance.
Here's an attempt to populate the table and address the questions based solely on the provided text, acknowledging the limitations:
1. Table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Acare Suction Unit, ASU-200) |
|---|---|---|
| Common Features | ||
| Classification Name | Apparatus, Suction, Ward use, Portable, Ac-Powered | Apparatus, Suction, Ward use, Portable, Ac-Powered |
| Classification / Product Code | Class II / JCX | Class II / JCX |
| Product Type | AC-Powered suction pump | AC-Powered suction pump |
| Indication of Vacuum Level | Analogue Vacuum Gauge / 760mmHg/100kPa | Analogue Vacuum Gauge / 760mmHg/100kPa |
| Maximum Vacuum (Pressure) | 600 mmHg | 600 mmHg |
| Maximum Flow Rate | 24 LPM (or 20-25LPM for predicate b) | 24 LPM |
| Sound Level (Noise level) | Pass ISO 10079-1 | Pass ISO 10079-1 |
| Type of Pump | Oil-less Piston pump | Oil-less Piston pump |
| Pressure Control | adjusted by tuning knob of vacuum adjusting set | adjusted by tuning the knob of vacuum adjusting set |
| Disposable Canister | Yes | Yes |
| Connection tube | Yes | Yes |
| Patient Tube | Yes | Yes |
| Overflow protection | Yes | Yes |
| Bacterial filter | Yes | Yes |
| Performance Testing (Safety & Standards Compliance) | ||
| Electromagnetic compatibility (EMC) IEC 60601-1-2 | Passed | Passed (met acceptance criteria) |
| Basic safety and Essential performance IEC 60601-1 (ANSI/AAMI ES 60601-1) | Passed | Passed (met safety and essential performance acceptance criteria) |
| Electrically powered suction equipment - Safety requirements ISO 10079-1 | Passed | Passed (met Safety requirements acceptance criteria) |
| Degrees of protection provided by enclosures (IP Code) IEC 60529 | IP 21 | IP 21 (met IP 21 testing acceptance criteria) |
Details of the "Study" (Non-Clinical Testing) that proves the device meets acceptance criteria:
The "study" described is a series of non-clinical, engineering, and compliance tests. The goal was to demonstrate that the Acare Suction Unit, model ASU-200, is as safe and effective as its predicate devices, primarily through meeting established international and national standards for medical electrical equipment.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. These were engineering and compliance tests performed on the device itself, not on a dataset or patient samples. Typically, one or a few units are tested to demonstrate compliance.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting to specific engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no ground truth established by experts in a clinical or diagnostic sense. The "ground truth" was the compliance with published international and national standards (e.g., IEC 60601-1-2, ANSI/AAMI ES 60601-1, ISO 10079-1, IEC 60529). Compliance was assessed by engineering testing.
4. Adjudication method for the test set:
- Not applicable. This was not a study requiring adjudication of expert interpretations. Compliance was determined by whether the device's performance met the specified thresholds and requirements of the safety and performance standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a suction unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance studies, which are not relevant to a medical suction unit.
7. The type of ground truth used:
- Not applicable in the conventional sense of medical imaging/diagnostic studies. The "ground truth" for this submission was the defined requirements and specifications within the referenced international and national safety and performance standards (e.g., maximum vacuum pressure, flow rate thresholds, EMC limits, electrical safety parameters, IP code requirements).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or associated ground truth was established for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2019
ACARE Technology Co., Ltd. % Ming-Yie Jan RusCert Technology Co., Ltd. 8F .- 2, No.21, Sec. 6, Zhongxiao E. Rd., Nangang Dist. Taipei City, Taiwan
Re: K182950
Trade/Device Name: Acare Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: July 26, 2019 Received: July 29, 2019
Dear Ming-Yie Jan:
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
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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) 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.
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
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SECTION 4 INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182950
Device Name Acare Suction Unit, model ASU-200
Indications for Use (Describe)
The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
ACARE TECHNOLOGY CO., LTD. Acare Suction Unit
PAGE 11 PREMARKET NOTIFICATION
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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510 (K) Summary
5.1 Submitter's Information
| Name: | ACARE TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 5f-4, No.24, Wuquan 2nd Rd., Xinzhuang Dist.,New Taipei City 242, Taiwan |
| Establishment RegistrationNumber: | 3006395447 |
| Contact: | Kevin Tsai / QA managerTel: + 886-2-2298-8170 #204Fax: +886-2-22988560E-mail: Kevin@acarecorp.comOrLinda Cheng / General Manager |
| Date Prepared: | September 30, 2018 |
| 2. Device Name | |
| Trade Name: | Acare Suction Unit, model ASU-200 |
| Common/usual Name: | Acare Suction Unit, model ASU-200 |
| Device Classification Names: | Apparatus, Suction, Ward use, Portable, Ac-Powered |
| Panel: | General & Plastic Surgery, |
| Product Code: | JCX |
| Classification: | Class II |
| Regulation Description: | Powered Suction Pump |
| Regulation Number: | §878.4780 |
| 5.3 Predicate Devices: | (a) VacPlus Suction Unit, 510(k) Number: K103535(b) EMG Suction Unit, 510(k) Number: K112421 |
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5.4 Indication for Use
The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.
5.5 Device Description
The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications.
The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.
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5.6 Comparison of Technological Characteristics
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-1.
Table 5-1. Summary of the Proposed and Predicate Devices Technological Characteristics
| Feature | Proposed device | Predicate device (a) | Predicate device (b) | Comparison |
|---|---|---|---|---|
| Device | Acare Suction Unit,model ASU-200 (K182950) | VacPlus Suction Unit(K103535) | EMG Suction Unit(K112421) | |
| ClassificationName | Apparatus, Suction,Ward use, Portable, Ac-Powered | Apparatus, Suction,Ward use, Portable, Ac-Powered | Apparatus, Suction,Ward use, Portable, Ac-Powered | Same |
| Classification /Product Code | Class II / JCX | Class II / JCX | Class II / JCX | Same |
| Indication forUse | The device is to be usedto remove fluids fromthe airway or respiratorysystem. The devicecreates a negativepressure (vacuum) thatdraws fluids throughdisposable tubing that isconnected to a collectioncanister. The fluids aretrapped in the collectioncanister for properdisposal. It is for use onthe order of a physicianonly. | The device is to be usedto remove fluids fromthe treated Tracheotomypatient airway. | The device is to be usedto remove body fluidsfrom a patient's airwayor respiratory system. Itis for use on the order ofa physician only. | Similarity |
| Product Type | AC-Powered suctionpump | AC-Powered suctionpump | AC-Powered suctionpump | Same |
| Electricalrequirement | AC 100-240V, 50/60HzDC 18V | AC 110-240V, 50/60HzDC 12V | AC 100-240V, 47-63Hz,DC14V, | Similarity |
| PowerConsumption | 35 VA | 40W | 38W | Similarity |
| Battery | Li-ion Battery:14.8Vdc, 2.5Ah | Lead Acid battery,12Vdc, 2.8Ah | Li-ion Battery:12Vdc, 2.5Ah | Similarity |
| Indication ofVacuum Level | Analogue VacuumGauge/760mmHg/100kPa | Analogue VacuumGauge/760mmHg/100kPa | Analogue VacuumGauge76cmHg/30inHg | Same |
| MaximumVacuum(Pressure) | 600 mmHg | 600 mmHg | 600 mmHg | Same |
| Maximum FlowRate | 24 LPM | 24 LPM | 20~25LPM | Same |
| Sound Level(Noise level) | Pass ISO 10079-1 | Pass ISO 10079-1 | Pass ISO 10079-1 | Same |
| Feature | Proposed device | Predicate device (a) | Predicate device (b) | |
| Device | Acare Suction Unit,model ASU-200 (K182950) | VacPlus Suction Unit(K103535) | EMG Suction Unit(K112421) | Comparison |
| Type of Pump | Oil-less Piston pump | Oil-less Piston pump | Oil-less Piston pump | Same |
| Pressure Control | adjusted by tuning theknob of vacuum adjustingset | adjusted by tuning theknob of vacuumadjusting set | adjusted by tuning theknob of vacuumadjusting set | Same |
| DisposableCanister | Yes | Yes | Yes | Same |
| Connection tube | Yes | Yes | Yes | Same |
| Patient Tube | Yes | Yes | Yes | Same |
| Overflowprotection | Yes | Yes | Yes | Same |
| Bacterial filter | Yes | Yes | Yes | Same |
| OperatingEnvironment | Temp: 50°F~104°F (10°C~40°C)Humidity:10%-90% RH | Temp: 50°F | Temp: 32°F~104°F(0°~40 °C)Humidity:< 95%RH | Similarity |
| OperatingAtmospheric | 700~1060hPa | 700~1013hPa | 700~1060hPa | Similarity |
| StorageEnvironment | Temp: 59°F~122°F (15°C | Temp: -15°C to 50°C(+5°F to +122°F)Humidity:10%~ 90%RH | Temp: 14°F | Similarity |
| Dimensions | 19.0cm×11.0cm×17.5cm | 35.2cm×20.6cm×19.2cm | 38.0cm×25.0cm×26.0cm | Similarity |
| Weight | 1.7 kg | 3.3 kg | 2.6 kg | Similarity |
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Table 5-2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
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K182950
ACARE TECHNOLOGY CO., LTD.
Table 5-2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
| Feature | Proposed device | Predicate device (a) | Predicate device (b) | |
|---|---|---|---|---|
| Performance Testing | Acare Suction Unit,model ASU-200(K182950) | VacPlus Suction Unit(K103535) | EMG Suction Unit(K112421) | Comparison |
| Electromagneticcompatibility (EMC)IEC 60601-1-2 | Passed | Passed | Passed | Same |
| Basic safety andEssential performanceIEC 60601-1(ANSI/AAMI ES 60601-1) | Passed | Passed | Passed | Same |
| Electrically poweredsuction equipment -Safety requirementsISO 10079-1 | Passed | Passed | Passed | Same |
| Degrees of protectionprovided by enclosures(IP Code)IEC 60529 | IP 21 | IP 21 | IP 21 | Same |
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5.7 Summary of Non-Clinical Testing
The Acare Suction Unit, model ASU-200 has the identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the electrical specifications, vacuum range, flow rate, power options, and operation environment.
The results of the Acare Suction Unit, model ASU-200 validation studies demonstrate that the Suction Unit perform as intended. The results are summarized as follows:
- · The electromagnetic compatibility (EMC) testing performed as described in IEC 60601-1-2 Edition 3: 2007-03, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests". The results confirm that the testing results demonstrate of the Acare Suction Unit, model ASU-200 met the electromagnetic compatibility (EMC) encompasses both emissions (interference with electronic products) and immunity (interference with device performance created by emissions from other electronic products).
- · The protection against electrical hazards from equipment, Protection against excessive temperates and other hazards, hazards situations and fault conditions, construction of equipment and electromagnetic compatibility of equipment and systems, etc. testing performed as described in ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". The testing results demonstrate of the Acare Suction Unit, model ASU-200 met safety and essential performance testing acceptance criteria for each test mentioned above.
- The Needle Flame Test, Measurement of the patient leakage current, Measurement of the vibration and noise of equipment other than the low vacuum equipment, Liquid overflow/ spillage test, Air Leakage test, Interruption of the power supply, Abnormal operation and fault conditions, Environmental tests for equipment for field and/or transport use, Degree of collapse test, Airflow and Vacuum tests, and Resistance to implosion, etc. testing performed as described in ISO 10079-1:2009, "Medical suction equipment Part 1: Electrically powered suction equipment - Safety requirements". The testing results demonstrate of the Acare Suction Unit, model ASU-200 met Safety requirements testing acceptance criteria for each test mentioned above.
- The classification of degrees of protection provided by enclosures for electrical equipment testing performed as described in IEC 60529-2013, "Degrees of protection provided by enclosures (IP Code)". The testing results demonstrate of the Acare Suction Unit, model ASU-200 met IP 21 testing acceptance criteria for each test mentioned above.
8. CONCLUSION
The conclusions drawn from the-nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the predicate device K103535 and K112421.
§ 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.