DV-300 Aspirator

• K Number: K181398
• Device Name: DV-300 Aspirator
• Manufacturer: Ding Hwa Co., Ltd.
• Date Cleared: 2018-07-23 ( 55 days)
• Product Code: JCX
• Regulation Number: 878.4780
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K122756
• Predicate For: N/A

Intended Use

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

Device Description

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.

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.

AI/ML Overview

This document describes the Cliq Aspirator DV-300, a powered suction pump, seeking 510(k) clearance. The focus of the document is on the device's substantial equivalence to a predicate device and its performance and safety testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria	Reported Device Performance
The pump shall be compliant with IEC 60601-1 requirements.	100% Pass	Pass: 100%
The pump shall be compliant with IEC 60601-1-2 requirements.	100% Pass	Pass: 100%
The pump shall be compliant with ISO 10079-1 requirements.	100% Pass	Pass: 100%
The pump controls shall be easily identifiable by the User.	100% Pass	Pass: 100%
The pump controls shall be validated for Usability.	100% Pass	Pass: 100%
The DV-300 should supply uniform vacuum level for an entire case.	100% Pass	Pass: 100%
The DV-300 will be a durable piece of capital equipment.	100% Pass	Pass: 100%
The DV-300 should be quiet.	100% Pass	Pass: 100%
After use, any blood or clot collected in the canister should be able to be removed for analysis.	100% Pass	Pass: 100%
The canister should have volume reference markings.	100% Pass	Pass: 100%
The canister should be able to withstand the maximum pressure delivered by the pump.	100% Pass	Pass: 100%
The canister lid should include a feature to prevent excess fluid from entering the pump.	100% Pass	Pass: 100%

2. Sample size used for the test set and the data provenance:

The document explicitly states that "Full test reports can be found in Section 16 of this submission." However, Section 16 is not provided in the given text. Therefore, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) cannot be determined from the provided excerpt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given document. The acceptance criteria largely relate to technical specifications and physical performance of the device and its components, rather than diagnostic accuracy that would typically require expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the performance tests.

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:

This is not applicable as the device (Cliq Aspirator DV-300) is a powered suction pump, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is mechanical, not an algorithm. The reported performance is standalone with respect to the device's physical attributes and functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests appears to be based on engineering and physical measurements, compliance with international standards (IEC, ISO), and functional assessments against predefined technical criteria. For usability-related criteria, it would likely be based on internal testing and possibly user feedback, but the specific methodologies are not detailed.

8. The sample size for the training set:

This is not applicable as the device is a physical medical device (suction pump), not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

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);

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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,4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011TEL : [phone]    FAX : [phone]
FACTORY	No. 121, Sec. 3, Zhongshan Road,Dacun, Chang- Hwa, Taiwan 51542TEL : [phone]

{4}------------------------------------------------

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,4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011TEL : [phone]	FAX : [phone]
FACTORY	No. 121, Sec. 3, Zhongshan Road,Dacun, Chang- Hwa, Taiwan 51542TEL : [phone]

{5}------------------------------------------------

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,4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011TEL : [phone]	FAX : [phone]
FACTORY	No. 121, Sec. 3, Zhongshan Road,Dacun, Chang- Hwa, Taiwan 51542TEL : [phone]

{6}------------------------------------------------

• 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,4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011TEL : [phone]    FAX : [phone]
FACTORY	No. 121, Sec. 3, Zhongshan Road,Dacun, Chang- Hwa, Taiwan 51542TEL : [phone]

{7}------------------------------------------------

DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

Substantial Equivalence Comparison Chart

	Cliq AspiratorDV-300	PenumbraPump MAX™	SubstantiallyEquivalent?
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
DeviceClassification	878.4780Powered SuctionPumpClass IIProduct Code: JCX	878.4780Powered SuctionPumpClass IIProduct Code: JCX	Equivalent
Intended Use	The DV-300 isintended for generalsuction use inhospitals or clinics.	The PenumbraPump MAX™ isintended for generalsuction use inhospitals or clinics.	Equivalent

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

{8}------------------------------------------------

DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

Substantial Equivalence Comparison Chart (cont.)

Technological and System Specifications
	Cliq AspiratorDV-300	PenumbraPump MAX™	SubstantiallyEquivalent?
Electricalrequirements	110-120 VAC60 Hz	110-115 VAC50 Hz or 60 Hz	Equivalent
Protection againstelectric shock	Class II with Type BFapplied part	Class I with Type CFapplied part	EquivalentBoth the subject andpredicate device havebeen verified toprovide appropriateprotective measures toprevent the user orpatient from beingelectrically shocked.
Vacuum Pressure	Max: 24.4 inHgVacuum adjustableVacuum gauge	Max: 29 inHgVacuum adjustableVacuum gauge	Equivalent
Pump Type	Positivedisplacement pump	Positivedisplacement 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-300lighter
Dimensions	L30 x W16.5 x H19cm	L40 x W28 x H34 cm	DV-300smaller

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

{9}------------------------------------------------

DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司

OperatingEnvironment	Temp: 0 – 40°CHumidity: 0 – 90%Atmospheric Pressure: 70–106 kPa	Temp: 18 – 24°CHumidity: 0 – 75%Atmospheric Pressure: not known	DV-300 canoperate inwider temprange.
Storage Environment	Temp: -20 – 50°CHumidity: 0 – 95%Atmospheric Pressure: 50–106 kPa	Temp: -29 – 49°CHumidity: 0 – 95%Atmospheric Pressure: not known	Equivalent

Accessories
	Cliq AspiratorDV-300	PenumbraPump MAX™	SubstantiallyEquivalent?
Filter	inline, hydrophobic	inline, hydrophobic	Equivalent
Collection Container	≥ 800 ml	1000 ml

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

EMAIL : [e-mail]

K181398

{10}------------------------------------------------

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	AcceptanceCriteria	Results
The pump shall be compliant withIEC 60601-1 requirements.	100% Pass	Pass: 100%
The pump shall be compliant withIEC 60601-1-2 requirements.	100% Pass	Pass: 100%
The pump shall be compliant withISO 10079-1 requirements.	100% Pass	Pass: 100%
The pump controls shall be easilyidentifiable by the User.	100% Pass	Pass: 100%
The pump controls shall be validatedfor Usability	100% Pass	Pass: 100%
The DV-300 should supply uniformvacuum level for an entire case	100% Pass	Pass: 100%
The DV-300 will be a durable piece ofcapital equipment	100% Pass	Pass: 100%
The DV-300 should be quiet	100% Pass	Pass: 100%

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

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

Attribute	AcceptanceCriteria	Results
After use, any blood or clot collectedin the canister should be able to beremoved for analysis	100% Pass	Pass: 100%
The canister should have volumereference markings	100% Pass	Pass: 100%
The canister should be able towithstand the maximum pressuredelivered by the pump	100% Pass	Pass: 100%
The canister lid should include afeature to prevent excess fluid fromentering 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,4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011TEL : [phone]	FAX : [phone]
FACTORY	No. 121, Sec. 3, Zhongshan Road,Dacun, Chang- Hwa, Taiwan 51542TEL : [phone]

EMAIL : [e-mail]

Regulation Number and Section

§ 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.