DV-300 Aspirator

K181398 · Ding Hwa Co., Ltd. · JCX · Jul 23, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181398
• Device Name: DV-300 Aspirator
• Applicant: Ding Hwa Co., Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Jul 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DV-300 is intended for general suction use in hospitals or clinics.

Device Story

The Cliq Aspirator DV-300 is a portable, AC-powered suction pump used in hospitals or clinics to aspirate fluids and small particles. Operated by healthcare professionals, the device generates negative pressure (up to 24.4 inHg) via a positive displacement pump. Inputs include electrical power; the device transforms this into vacuum pressure, which draws fluids through tubing into a disposable collection canister (≥ 800 ml). A microbial filter and overflow protection prevent fluid ingress into the pump. The operator adjusts vacuum levels using a knob and monitors pressure via an analog gauge. The device facilitates the removal of surgical or clinical fluids, aiding in site clearance or sample collection for analysis. It is a durable, Class II electrical appliance designed for clinical environments.

Clinical Evidence

Bench testing only. The device underwent performance and safety testing, including compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10079-1 (suction equipment). Testing confirmed 100% pass rates for vacuum uniformity, control usability, canister integrity, and overflow protection.

Technological Characteristics

ABS plastic housing; IP22 ingress protection; Class II double-insulated electrical appliance with Type BF applied part protection. Positive displacement pump mechanism. AC input 110-120V 60Hz. Includes analog pressure gauge, pressure relief valve, and hydrophobic filter. Dimensions: 30 x 16.5 x 19 cm; Weight: 3.5 kg.

Indications for Use

Indicated for general suction use in hospitals or clinics for patients requiring fluid and particle aspiration. 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

• Penumbra Pump MAX™ (K122756)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 23, 2018

Ding Hwa Co., Ltd. % Mr. John MacMahon CEO V2K Medical, Inc. 1221 Innsbruck Drive Sunnyvale, California 94089

Re: K181398

Trade/Device Name: Cliq Aspirator DV-300 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: March 16, 2018 Received: May 29, 2018

Dear Mr. MacMahon:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Mr. John MacMahon

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number

K181398

Device Name

Cliq Aspirator DV-300

Indications for Use (Describe)

The DV-300 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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# DING HWA CO., 股份有限

## 510(k) Summary

## Cliq Aspirator DV-300

## Date Prepared: April 27, 2018

## 1. Applicant Identification

Ding Hwa Co., Ltd. No. 121, Sec 3, Zhongshan Rd. Dacun, Taiwan 51542

Telephone: [phone] Fax: [phone] Establishment Registration: 3006789357

#### Contact Person 2.

John MacMahon, CEO V2K Medical, Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 Phone: [phone] Email: [e-mail]

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone]    FAX : [phone] | |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

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### Device Name for Which Clearance is Sought 3.

| Trade Name: | Cliq Aspirator DV-300 |
|-------------------------|--------------------------|
| Common/Usual Name: | Suction Pump / Aspirator |
| Regulation Description: | Powered Suction Pump |

### 4. Device Classification

| Product Code: | JCX |
|---------------|------------------------------------------------|
| Device: | Pump, Portable, Aspiration (Manual or Powered) |
| Reg. Number: | 878.4780 |
| Class: | II |
| Review Panel: | General and Plastic Surgery |

#### 5. Intended Use

The DV-300 is intended for general suction use in hospitals or clinics.

### Device Description 6.

The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection.

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone] | FAX : [phone] |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

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The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 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-300 must only be used on the order of a physician.

### 7. Predicate Device

| Trade Name: | Penumbra Pump MAX™ |
|----------------|-----------------------------|
| Manufacturer: | Penumbra Inc. (Alameda, CA) |
| 510(k) Number: | K122756 |
| Product Code: | JCX |

### Substantial Equivalence 8.

The Cliq Aspirator DV-300 suction pump design is substantially equivalent to the legally marketed Penumbra Pump MAX™ manufactured by Penumbra Inc. (K122756).

- Both the DV-300 and the predicate device are suction Intended Use: pumps that are intended for general suction use in hospitals or clinics.

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone] | FAX : [phone] |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

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- The pump units for both the DV-300 and the predicate Technology: device are positive displacement pumps that generate negative pressure using the same operating principles. Both units are AC units powered by a connection to mains.
- Both the DV-300 and the predicate device require Operation: connection 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.
- Performance: Both the DV-300 and the predicate device meet substantially equivalent testing and acceptance criteria, as outlined below, in subsection 9 of this 510k Summary.

Further details on substantial equivalence are provided in the table below:

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone]    FAX : [phone] |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] |

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# DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

## Substantial Equivalence Comparison Chart

| | Cliq Aspirator<br>DV-300 | Penumbra<br>Pump MAX™ | Substantially<br>Equivalent? |
|--------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Unknown | K122756 | N/A |
| Manufacturer | Ding Hwa Co., Ltd. | Penumbra Inc. | N/A |
| Trade Name | Aspirator | Aspiration Pump | Equivalent |
| Model Number | DV-300 | Pump MAX™ | N/A |
| Device<br>Classification | 878.4780<br>Powered Suction<br>Pump<br>Class II<br>Product Code: JCX | 878.4780<br>Powered Suction<br>Pump<br>Class II<br>Product Code: JCX | Equivalent |
| Intended Use | The DV-300 is<br>intended for general<br>suction use in<br>hospitals or clinics. | The Penumbra<br>Pump MAX™ is<br>intended for general<br>suction use in<br>hospitals or clinics. | Equivalent |

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone]<br>FAX : [phone] |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] |

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# DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

## Substantial Equivalence Comparison Chart (cont.)

| Technological and System Specifications | | | |
|-----------------------------------------|-----------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cliq Aspirator<br>DV-300 | Penumbra<br>Pump MAX™ | Substantially<br>Equivalent? |
| Electrical<br>requirements | 110-120 VAC<br>60 Hz | 110-115 VAC<br>50 Hz or 60 Hz | Equivalent |
| Protection against<br>electric shock | Class II with Type BF<br>applied part | Class I with Type CF<br>applied part | Equivalent<br>Both the subject and<br>predicate device have<br>been verified to<br>provide appropriate<br>protective measures to<br>prevent the user or<br>patient from being<br>electrically shocked. |
| Vacuum Pressure | Max: 24.4 inHg<br>Vacuum adjustable<br>Vacuum gauge | Max: 29 inHg<br>Vacuum adjustable<br>Vacuum gauge | Equivalent |
| Pump Type | Positive<br>displacement pump | Positive<br>displacement pump | Equivalent |
| Flow | Up to ~18 l/min | Up to ~21 L/min | Equivalent |
| Sound level | < 53 dBa | < 60 dBa | DV-300 Quieter |
| Weight | 3.5 kg / 7.7 lbs | 10.1 kg / 22.3 lbs | DV-300<br>lighter |
| Dimensions | L30 x W16.5 x H19<br>cm | L40 x W28 x H34 cm | DV-300<br>smaller |

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011 | |
|--------------|-------------------------------------------------------------------------------------------------------|------------------------|
| | TEL : [phone] | FAX : [phone] |
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542 | |
| | TEL : [phone] | |

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# DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

| Operating<br>Environment | Temp: 0 – 40°C<br>Humidity: 0 – 90%<br>Atmospheric Pressure: 70–106 kPa | Temp: 18 – 24°C<br>Humidity: 0 – 75%<br>Atmospheric Pressure: not known | DV-300 can<br>operate in<br>wider temp<br>range. |
|--------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------|
| Storage Environment | Temp: -20 – 50°C<br>Humidity: 0 – 95%<br>Atmospheric Pressure: 50–106 kPa | Temp: -29 – 49°C<br>Humidity: 0 – 95%<br>Atmospheric Pressure: not known | Equivalent |

| Accessories | | | |
|----------------------|--------------------------|-----------------------|------------------------------|
| | Cliq Aspirator<br>DV-300 | Penumbra<br>Pump MAX™ | Substantially<br>Equivalent? |
| Filter | inline, hydrophobic | inline, hydrophobic | Equivalent |
| Collection Container | ≥ 800 ml | 1000 ml | |

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone] | FAX : [phone] |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

EMAIL : [e-mail]

K181398

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# DING HWA CO., LTI 漢 弓 股 份 有 限 公

K181398

## 9. Performance and Safety Testing (Non-Clinical)

The safety and performance testing of the Cliq DV-300 further demonstrates that this device is substantially equivalent to the predicate device.

| Attribute | Acceptance<br>Criteria | Results |
|---------------------------------------------------------------------|------------------------|------------|
| The pump shall be compliant with<br>IEC 60601-1 requirements. | 100% Pass | Pass: 100% |
| The pump shall be compliant with<br>IEC 60601-1-2 requirements. | 100% Pass | Pass: 100% |
| The pump shall be compliant with<br>ISO 10079-1 requirements. | 100% Pass | Pass: 100% |
| The pump controls shall be easily<br>identifiable by the User. | 100% Pass | Pass: 100% |
| The pump controls shall be validated<br>for Usability | 100% Pass | Pass: 100% |
| The DV-300 should supply uniform<br>vacuum level for an entire case | 100% Pass | Pass: 100% |
| The DV-300 will be a durable piece of<br>capital equipment | 100% Pass | Pass: 100% |
| The DV-300 should be quiet | 100% Pass | Pass: 100% |

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone] | FAX : [phone] |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

{11}------------------------------------------------

| Attribute | Acceptance<br>Criteria | Results |
|--------------------------------------------------------------------------------------------------------|------------------------|------------|
| After use, any blood or clot collected<br>in the canister should be able to be<br>removed for analysis | 100% Pass | Pass: 100% |
| The canister should have volume<br>reference markings | 100% Pass | Pass: 100% |
| The canister should be able to<br>withstand the maximum pressure<br>delivered by the pump | 100% Pass | Pass: 100% |
| The canister lid should include a<br>feature to prevent excess fluid from<br>entering the pump. | 100% Pass | Pass: 100% |

Testing Conclusions:

The Cliq Aspirator DV-300 met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility. Full test reports can be found in Section 16 of this submission.

## 10. Conclusion

The Ding Hwa Co., Ltd. Cliq Aspirator DV-300 described in this 510(k) submission is substantially equivalent in design, technology, specifications, intended use, operation, and performance to the predicate device (K122756). Further the Cliq Aspirator DV-300 does not raise any new safety or effectiveness issues when compared to the predicate.

| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,<br>4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011<br>TEL : [phone] | FAX : [phone] |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,<br>Dacun, Chang- Hwa, Taiwan 51542<br>TEL : [phone] | |

EMAIL : [e-mail]