(304 days)
Not Found
No
The description focuses on the mechanical and electrical functions of a suction device and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to remove fluids from the airway or respiratory system, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is designed to remove fluids from the airway or respiratory system, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's condition.
No
The device description clearly outlines physical components like a pump, casing, power button, suction adjustment knob, suction gauge, canister holder, and a collection canister with tubing and filter. The performance studies also focus on testing the electrical and mechanical aspects of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove fluids from the airway or respiratory system." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a suction unit that creates negative pressure to remove fluids. This is a physical process for removing substances from the body, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing the collected fluids for diagnostic purposes. The fluids are simply collected for "proper disposal."
- Performance Studies: The performance studies focus on the device's electrical specifications, vacuum range, flow rate, power options, and operational environment. These are related to the device's function in removing fluids, not its ability to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform such analysis.
N/A
Intended Use / Indications 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.
Product codes
JCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
on the order of a physician, field, transport and hospital/clinical use applications
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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.
3
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 Registration | |
| Number: | 3006395447 |
| Contact: | Kevin Tsai / QA manager |
| Tel: + 886-2-2298-8170 #204 | |
| Fax: +886-2-22988560 | |
| E-mail: Kevin@acarecorp.com | |
| Or | |
| Linda 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 |
4
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.
5
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) | ||||
| Classification | ||||
| Name | 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 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. | The device is to be used | |||
| to remove fluids from | ||||
| the treated Tracheotomy | ||||
| patient airway. | The device is to be used | |||
| to remove body fluids | ||||
| from a patient's airway | ||||
| or respiratory system. It | ||||
| is for use on the order of | ||||
| a physician only. | Similarity | |||
| Product Type | AC-Powered suction | |||
| pump | AC-Powered suction | |||
| pump | AC-Powered suction | |||
| pump | Same | |||
| Electrical | ||||
| requirement | AC 100-240V, 50/60Hz | |||
| DC 18V | AC 110-240V, 50/60Hz | |||
| DC 12V | AC 100-240V, 47-63Hz, | |||
| DC14V, | Similarity | |||
| Power | ||||
| Consumption | 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 of | ||||
| Vacuum Level | Analogue Vacuum | |||
| Gauge/ | ||||
| 760mmHg/100kPa | Analogue Vacuum | |||
| Gauge/ | ||||
| 760mmHg/100kPa | Analogue Vacuum | |||
| Gauge | ||||
| 76cmHg/30inHg | Same | |||
| Maximum | ||||
| Vacuum | ||||
| (Pressure) | 600 mmHg | 600 mmHg | 600 mmHg | Same |
| Maximum Flow | ||||
| Rate | 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 the | |||
| knob of vacuum adjusting | ||||
| set | adjusted by tuning the | |||
| knob of vacuum | ||||
| adjusting set | adjusted by tuning the | |||
| knob of vacuum | ||||
| adjusting set | Same | |||
| Disposable | ||||
| Canister | Yes | Yes | Yes | Same |
| Connection tube | Yes | Yes | Yes | Same |
| Patient Tube | Yes | Yes | Yes | Same |
| Overflow | ||||
| protection | Yes | Yes | Yes | Same |
| Bacterial filter | Yes | Yes | Yes | Same |
| Operating | ||||
| Environment | Temp: 50°F~104°F (10°C | |||
| ~40°C) | ||||
| Humidity:10%-90% RH | Temp: 50°F~104°F | |||
| (10°C~40°C) | ||||
| Humidity:10%-90% | ||||
| RH | Temp: 32°F~104°F | |||
| (0°~40 °C) | ||||
| Humidity: |