Cliq Aspirator

K201203 · Anest Iwata Sparmax Co., Ltd. · BTA · Sep 3, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201203
• Device Name: Cliq Aspirator
• Applicant: Anest Iwata Sparmax Co., Ltd.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Sep 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

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 home care or hospital environment.

Device Story

Portable AC/DC high vacuum/high flow suction pump; creates negative pressure to draw fluids through tubing into a collection container. Components: maintenance-free pump unit, AC adapter, on/off switch, pressure relief valve, pressure adjustment knob, analog pressure gauge, inline filter, rechargeable battery pack. Used in home or hospital settings; operated by clinicians or patients under physician order. Provides vacuum source for fluid aspiration; output monitored via analog gauge and LED battery status indicators. Benefits include portable fluid management.

Clinical Evidence

Bench testing only. Device met all predefined criteria for performance, safety, and electromagnetic compatibility per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 10079-1 standards.

Technological Characteristics

Portable suction pump; 12 VDC positive displacement reciprocating pump; AC/DC powered (100-240 VAC or NiMH battery). ABS plastic housing; IP22 ingress protection; Class II double-insulated; Type BF applied part. Max vacuum 620 mmHg; flow rate up to 20 l/min. Analog pressure gauge; LED battery status indicators. Sterilization not specified.

Indications for Use

Indicated for use as a portable, battery-powered or AC-powered medical vacuum source in home care or hospital environments. Must be used on the order of a physician.

Regulatory Classification

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.

Predicate Devices

• EasyGo Aspirator (K971749)

Reference Devices

• EasyVac Aspirator (K932494)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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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# 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)

| <span style="font-family: Arial, sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|

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K201203

# 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: [phone] [phone] 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: [e-mail]

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#### 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

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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.

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#### 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<br>DV-XXX | Precision Medical<br>EasyGo Aspirator | Substantially<br>Equivalent? |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Unknown | K971749 | N/A |
| Manufacturer | Anest Iwata Sparmax<br>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<br>Powered Suction Pump<br>Class II<br>Product Code: BTA | 878.4780<br>Powered Suction Pump<br>Class II<br>Product Code: BTA | Equivalent |
| Intended Use | The DV-XXX aspirator<br>provides a portable,<br>battery-powered<br>medical vacuum<br>source. The DV-XXX<br>can also be powered<br>from a standard wall<br>outlet with the use of<br>an AC power adapter.<br>It is intended for use in<br>the homecare or<br>hospital environment. | The EasyGo Aspirator<br>provides a portable,<br>battery power medical<br>vacuum source. The<br>EasyGo Aspirator can<br>also be powered from a<br>standard wall outlet<br>with the use of an AC<br>power adapter. It is<br>intended for use in the<br>homecare or hospital<br>environment. | Equivalent |

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K201203

| Consensus<br>Standards | IEC 60601-1:2005<br>IEC 60601-1-2:2015<br>EN ISO 10079-1:2015+<br>A: 2018<br>IEC 60601-1-11:2012 | IEC 60601-1:2006<br>IEC 60601-1-2:2007<br>EN ISO 10079-1:2009 | Equivalent |
|------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------|
|------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------|

| | Technological and System Specifications | Cliq Aspirator<br>DV-XXX | Precision Medical<br>EasyGo Aspirator | Substantially<br>Equivalent? |
|--------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------|
| Electrical<br>requirements | | AC Adaptor:<br>100-240 VAC, 50-60Hz<br>Pump Unit: 12 VDC | AC Adaptor:<br>100-240 VAC, 50-60Hz<br>Pump Unit: 12 VDC | Equivalent |
| Protection against<br>electric shock | | Class II with Type BF<br>applied part | Class I with Type BF<br>applied part | Equivalent |
| Battery type | | NiMH rechargeable<br>battery pack | Lead acid battery | Equivalent |
| Battery status<br>indicator | | Colored LED lights used<br>to indicate:<br>- battery fully charged<br>- battery low | Colored LED lights used<br>to indicate:<br>- battery fully charged<br>- battery low | Equivalent |
| Vacuum Pressure | | Max: ~620 mmHg<br>Vacuum adjustable<br>Vacuum gauge | Max: 533 mmHg<br>Vacuum adjustable<br>Vacuum gauge | Equivalent |
| Pump Type | | Positive displacement<br>reciprocating pump | Positive displacement<br>reciprocating pump | Equivalent |
| Flow | | Up to ~20 l/min | Up to ~14 l/min | Equivalent |

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| Sound level | < 53 dBa | Not known |
|-----------------------|-----------------------|----------------------------------|
| Weight | 3.5 kg / 7.7 lbs | 4.4 kg / 9.6 lbs |
| Dimensions | L30 x W16.5 x H19 cm | L30 x W24 x H25 cm |
| Operating Environment | Temperature: | Temperature: 10 - 40°C |
| | Humidity: | Humidity: not known |
| | Atmospheric Pressure: | Atmospheric Pressure: not known |
| Storage Environment | Temperature: | Temperature: -20 - 50°C |
| | Humidity: | Humidity: 15 - 93% |
| | Atmospheric Pressure: | Atmospheric Pressure: 50-106 kPa |

## 11. Conclusion

The Anest Iwata Sparmax Co., Ltd. Cliq Aspirator DV-XXX (model family) described in this 510(k) submission is substantially equivalent in design, technology, specifications, intended use, operation, and performance to the predicate device (K971749). Further the Cliq Aspirator DV-XXX (model family) does not raise any new safety or effectiveness issues when compared to the predicate device.