(122 days)
No
The description details a standard medical aspirator with mechanical and electrical components, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for use as a medical vacuum source to draw fluids, which makes it a therapeutic device. It is described as a "medical vacuum source" and "suction pump" and is used to remove fluids from the body, indicating it provides a direct therapy.
No
Explanation: The device description clearly states "The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container". This indicates it is a therapeutic device for fluid removal, not a diagnostic device that identifies or characterizes a medical condition.
No
The device description explicitly details numerous hardware components including a pump unit, power adapter, switches, valves, gauges, filters, tubing, and a battery pack. It is a physical medical device with electrical and mechanical components.
Based on the provided information, the DV-XXX aspirator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide a medical vacuum source for drawing fluids through tubing and into a collection container. This is a physical process for removing fluids from the body or a wound, not for examining or analyzing samples in vitro (outside the body).
- Device Description: The description details a suction pump that creates negative pressure to draw fluids. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The DV-XXX is a medical device used for suction, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
Product codes
BTA
Device Description
The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing.
The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.
The DV-XXX must only be used on the order of a physician.
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
home care or hospital environment.
physician
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)
Non-clinical performance and safety tests conducted on the Cliq Aspirator DV-XXX (model family) include the following consensus standards:
- IEC 60601-1: Basic safety and essential performance
- IEC 60601-1-2: Electromagnetic compatibility
- IEC 60601-1-11: Requirements for medical electrical equipment used in the home healthcare environment
- ISO 10079: Electrically powered suction equipment safety requirements
Testing Conclusions:
The Cliq Aspirator DV-XXX (model family) met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility. Full test reports can be found in Section of Standard Conformance of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 and Drug Administration (FDA). On the left 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.
September 3, 2020
ANEST IWATA SPARMAX CO., LTD. % Robert Dean President Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, New York 14223
Re: K201203
Trade/Device Name: Cliq Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 5, 2020 Received: August 21, 2020
Dear Robert Dean:
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.
1
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 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 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.
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
Indications for Use
510(k) Number (if known) K201203
Device Name
Cliq Aspirator DV-XXX (model family)
Indications for Use (Describe)
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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510(k) Summary
Cliq Aspirator DV-XXX (Model Family)
February 20, 2020
1. Applicant Identification
Anest Iwata Sparmax Co., Ltd. No. 121, Sec 3, Zhongshan Rd. Dacun, Taiwan 51542
Telephone: +886-2-2345-1868 +886-2-2345-3162 Fax: Establishment Registration: 3006789357
2. Contact Person
Robert O. Dean Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, NY 14223
716-440-7362 Telephone: Email: compliancesystems@yahoo.com
4
Device Name for Which Clearance is Sought 3.
| Trade Name: | Cliq Aspirator DV-XXX (model family) |
|---|---|
| Common/Usual Name: | Suction Pump / Aspirator |
| Regulation Description: | Powered Suction Pump |
4. Device Classification
| Product Code: | BTA |
|---|---|
| Device: | Pump, Portable, Aspiration (Manual or Powered) |
| Regulation Number: | 878.4780 |
| Class: | II |
| Review Panel: | General and Plastic Surgery |
5. Intended Use
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the homecare or hospital environment.
6. Device Description
The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power
5
adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing.
The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.
The DV-XXX must only be used on the order of a physician.
7. Performance and Safety Testing
Non-clinical performance and safety tests conducted on the Cliq Aspirator DV-XXX (model family) include the following consensus standards:
- Basic safety and essential performance ● IEC 60601-1:
- IEC 60601-1-2: Electromagnetic compatibility ●
- IEC 60601-1-11: Requirements for medical electrical equipment ● used in the home healthcare environment
- ISO 10079: ● Electrically powered suction equipment safety requirements
Testing Conclusions:
The Cliq Aspirator DV-XXX (model family) met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility. Full test reports can be found in Section of Standard Conformance of this submission.
6
Predicate Device 8.
| Trade Name: | EasyGo Aspirator |
|---|---|
| Manufacturer: | Precision Medical |
| 510(k) Number: | K971749 |
| Product Code: | BTA |
Reference Device
| Trade Name: | EasyVac Aspirato |
|---|---|
| Manufacturer: | Precision Medical |
| 510(k) Number: | K932494 |
| Product Code: | BTA |
9. Substantial Equivalence
The Cliq Aspirator DV-XXX (model family) suction pump design is substantially equivalent to the legally marketed EasyGo Aspirator manufactured by Precision Medical (K971749).
- Intended Use: Both the DV-XXX and the predicate device are suction pumps that are intended for use as medical vacuum sources in the homecare or hospital environments.
- Technology: The pump units for both the DV-XXX and the predicate device are 12 VDC positive displacement reciprocating pumps. Both units use an AC adapter for connection to mains; and both units can be powered by rechargeable battery.
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- Both the DV-XXX and the predicate device require connection Operation: to a hydrophobic filter, which, in turn, connects, via tubing, to a collection container. Both devices have a knob for adjustment of vacuum pressure; and both devices have an analog gauge that displays current pressure. Both devices use LED light(s) to indicate battery status.
- Performance: Both the DV-XXX and the predicate device meet substantially equivalent testing and acceptance criteria. Both devices conform to the requirements of the following consensus standards: IEC 60601-1, IEC 60601-1-2, and ISO 10079-1. Further, in accordance with ISO 10079-1.
10. Substantial Equivalence Comparison Chart
See next page
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| | Cliq Aspirator
DV-XXX | Precision Medical
EasyGo Aspirator | Substantially
Equivalent? |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Unknown | K971749 | N/A |
| Manufacturer | Anest Iwata Sparmax
Co., Ltd. | Precision Medical | N/A |
| Trade Name | Aspirator | Aspirator | N/A |
| Model Number | DV-XXX (model family) | EasyGo | N/A |
| Device Classification | 878.4780
Powered Suction Pump
Class II
Product Code: BTA | 878.4780
Powered Suction Pump
Class II
Product Code: BTA | Equivalent |
| Intended Use | The DV-XXX aspirator
provides a portable,
battery-powered
medical vacuum
source. The DV-XXX
can also be powered
from a standard wall
outlet with the use of
an AC power adapter.
It is intended for use in
the homecare or
hospital environment. | The EasyGo Aspirator
provides a portable,
battery power medical
vacuum source. The
EasyGo Aspirator can
also be powered from a
standard wall outlet
with the use of an AC
power adapter. It is
intended for use in the
homecare or hospital
environment. | Equivalent |
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| Consensus
Standards | IEC 60601-1:2005
IEC 60601-1-2:2015
EN ISO 10079-1:2015+
A: 2018
IEC 60601-1-11:2012 | IEC 60601-1:2006
IEC 60601-1-2:2007
EN ISO 10079-1:2009 | Equivalent |
| ------------------------ | -------------------------------------------------------------------------------------------------- | --------------------------------------------------------------- | ------------ |
|---|
| | Technological and System Specifications | Cliq Aspirator
DV-XXX | Precision Medical
EasyGo Aspirator | Substantially
Equivalent? |
|--------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------|
| Electrical
requirements | | AC Adaptor:
100-240 VAC, 50-60Hz
Pump Unit: 12 VDC | AC Adaptor:
100-240 VAC, 50-60Hz
Pump Unit: 12 VDC | Equivalent |
| Protection against
electric shock | | Class II with Type BF
applied part | Class I with Type BF
applied part | Equivalent |
| Battery type | | NiMH rechargeable
battery pack | Lead acid battery | Equivalent |
| Battery status
indicator | | Colored LED lights used
to indicate:
- battery fully charged
- battery low | Colored LED lights used
to indicate: - battery fully charged
- battery low | Equivalent |
| Vacuum Pressure | | Max: ~620 mmHg
Vacuum adjustable
Vacuum gauge | Max: 533 mmHg
Vacuum adjustable
Vacuum gauge | Equivalent |
| Pump Type | | Positive displacement
reciprocating pump | Positive displacement
reciprocating pump | Equivalent |
| Flow | | Up to ~20 l/min | Up to ~14 l/min | Equivalent |
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| Sound level |