The Cliq Aspirator model DV-300 is an AC-powered high-vacuum / low-flow suction unit used for endoscopic aspiration. The DV-300 creates a negative pressure (vacuum) that draws fluids through disposable tubing, and into a collection container. The fluids are trapped within the collection container for proper disposal. The device is comprised of a maintenance-free pump unit; power cord, on/off switch, pressure relief valve, pressure adjustment knob, pressure gauge, microbial filter, and intermediate tubing.

The Cliq Aspirator: model DV-300 requires 110-120 V and 60 Hz. It has Class II with Type BF applied part protection against electric shock. The DV-300 suction pump operates via a piston pump type, and has a maximum vacuum pressure of 620 mm Hg. The pump produces a flow rate of up to 18 Liters per minute.

AI/ML Overview

The Cliq Aspirator Model DV-300 underwent performance testing to establish substantial equivalence to the predicate device, Olympus Suction Pump Model KV-5. The evaluation focused on electrical safety, electromagnetic compatibility, and overall performance, comparing key specifications between the two devices.

1. Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Predicate Device: Olympus Suction Pump Model KV-5)	Reported Device Performance (Cliq Aspirator Model DV-300)	Meets Acceptance Criteria
Electrical Requirements	100-120 V, 50/60 Hz	110-120 V, 60 Hz	Yes
Protection against electric shock	Class I with Type BF applied part	Class II with Type BF Applied part	No (Different Class)
Maximum Vacuum Pressure	638 mm Hg	620 mm Hg	Yes (Comparable)
Vacuum Pump Type	Piston	Piston	Yes
Flow	Up to 20 L/min	Up to 18 L/min	Yes (Comparable)
Sound Level	Not known (for predicate)	53 dBA	NA (No direct comparison)
Weight	12.7 kg	3.5 kg	No (Significant Difference)
Dimensions	31 x 25.5 x 22 cm	30 x 16.5 x 19 cm	Yes (Comparable)
Operating Environment (Temperature)	10 - 40 °C	0 - 40 °C	Yes (Wider Range)
Operating Environment (Humidity)	0 - 95 %	0 - 90 %	Yes (Comparable)
Operating Environment (Atm. Pressure)	70 - 106 kPa	70 - 106 kPa	Yes
Storage Environment (Temperature)	-40 - 70 °C	-20 - 50 °C	No (Narrows Range)
Storage Environment (Humidity)	0 - 95 %	0 - 95 %	Yes
Storage Environment (Atm. Pressure)	23.5 - 106 kPa	50 - 106 kPa	Yes (Comparable)
Filter	Microbial, hydrophobic	Microbial, hydrophobic	Yes
Suction Tube length	2 m	1.8 m	Yes (Comparable)
Filter Tube length	900 mm	250 mm	No (Significant Difference)
Power Cable	Yes	Yes	Yes
Suction Jar Volume	2 liter (one liter optional)	1.5 L or 2.4 L	Yes (Comparable)
Performance Standards adherence	EN IEC 60601-1, EN IEC 60601-1-2, EN ISO10079-1, UL 2601-1, CAN/CSA Std. No. C22.2 No.601.1-M90	EN IEC 60601-1, EN IEC 60601-1-2, EN ISO10079-1	Yes (subset met)

Note on "Meets Acceptance Criteria": The statement "Yes (Comparable)" or "Yes (Wider Range)" indicates that the Cliq Aspirator's performance is either directly equivalent or within an acceptable range compared to the predicate device, supporting substantial equivalence. Differences in Class protection, weight, and filter tube length while noted, were evidently not deemed critical enough by the FDA to prevent substantial equivalence, given the overall conclusion. The "Not known" for predicate sound level means no direct comparison could be made for that specific metric.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a specific "test set" sample size for a particular number of devices or clinical cases. The testing reported is related to general device performance, electrical safety, and electromagnetic compatibility standards. These types of tests typically involve a sample of manufactured devices (e.g., a few units from a production run) rather than patient data.

Data Provenance: The testing was conducted in the context of regulatory submission for a device manufactured by Ding Hwa Co., Ltd in Taiwan. The tests are likely laboratory-based and performed by the manufacturer or a contracted testing facility to meet international standards. No information is provided regarding country of origin of data in terms of patient population or clinical studies, as this is not a clinical performance study.
Retrospective or Prospective: Not applicable, as this is not a clinical study involving retrospective or prospective data collection from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The "ground truth" for this type of device (an aspirator) is its adherence to predefined engineering specifications and safety standards. This is objectively measured and verified according to scientific and engineering principles, not through expert consensus on clinical findings. Therefore, no experts in a clinical sense were used to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the "tests" refer to measurements against engineering and safety standards, not clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This document describes the regulatory submission for a medical device (an aspirator pump), not an AI/CAD system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating human reader performance with and without AI assistance in interpretation tasks, was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

No. This is a physical, electromechanical device, not an algorithm or AI. Standalone performance as typically understood for AI was not applicable or performed.

7. The Type of Ground Truth Used:

The ground truth used was adherence to established international and national engineering standards for medical devices, specifically:

EN ISO 10079-1:2009: Electrically powered suction equipment safety requirements.
IEC/EN 60601-1-2:2007 (3rd Ed.): Electromagnetic Compatibility.
IEC 60601-1: General basic safety and essential performance of medical electrical equipment.
Performance Verification Testing: Testing against predefined functional specifications (e.g., maximum vacuum pressure, flow rate).

The comparison against the predicate device (Olympus Suction Pump Model KV-5) also served as a basis for evaluating substantial equivalence in performance characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that utilizes a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As this device does not use a training set, the establishment of ground truth for such a set is irrelevant.

Summary

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JUN 2 3 2014 age 1/6

510(k) Summary

Cliq Aspirator Model DV-300

March 31, 2014

Applicant Identification 1.

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

Telephone: +866-2-2345-1868 Fax: +886-2-2345-3162 Establishment Registration: 3006789357

2. Contact Person

Janna Babson Regulatory Affairs Associate Telephone: 1-678-708-4773 Fax: 1-678-567-8218 Email: Janna.Babson@EndoChoice.com

3. Device Name for Which Clearance is Sought

Trade Name: Cliq Aspirator, model DV-300 Common/Usual Name: Aspirator Classification Name: Powered Suction Pump

EXPORT DEPT SRIPAL 4B 02/03: Taipel World Trade Center, 4/FI.,#5, Hsin-Yi Road. Section 5, Taipel. Taiwan 11011 TEL : +886 2- 2345 1868 FAX +886- 2- 2345- 3162 FACTORY = 121, Sec. 3, Zhongshan Road Dacun, Chang- Hwa, Taiwan 51542 TEL : +886 4 : 888- 1486 FAX : +886- 4- 888- 1499 FACTORY : = 43. Shin- Kung 1st Road, Pei- Tou Industrial Park, Pel- Tou, Chang- Hwa, Tahaan 52149 TEL : +886 4 888 1486 FAX : - 886- 4- 888- 1499

EMAIL : into@: ligmedical.com

Web site : www.cligmedical.com

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Page 2/6

4. Device Classification

Product Code: Regulation Number: Class: Review Panel:

ICX 878.4780 ll General and Plastic Surgery

5. Intended Use:

The device is intended to be used for aspiration during flexible endoscopy.

Device Description 6.

7. Substantial Equivalence

The Cliq Aspirator model DV-300 is substantially equivalent to the legally marketed suction pump model KV-5 (K011725) manufactured by Olympus. Both the Clip Aspirator model DV-300 and the Olympus Suction Pump model KV-5 are intended to be used for aspiration during. flexible endoscopy.

Substantial Equivalence Conclusion:

. The devices are equivalent in terms of intended use, operating principle, technology, energy used, packaging, and materials. A table comparing specifications for the Cliq Aspirator model DV-300 and Olympus Suction Pump model KV-5 is provided below.
EXPORT DEPTORM: 48-02/03, Taipel World Trade Center, 4/Fl. #5, Hsin Yi Road, Section 5. Taipel, Taiwan 11011 TEL : +886- 2- 2345- 1868 FAX : +886- 2- 2345- 3162 FACTORY : = 121. Sec. 3. Zhongshan Road. Dacun, Chang Hwa. Talwan 51542. TEL : +886 4- 888- 1486 FAX : +886- 4- 888- 1499 FACTORY : + 43, Shin. Kung 1st Road, Pol. Tou Industrial Park, Pei- Tou. Chang. Hwa, Talwan 52149 TEL : +886- 4- 888-1486 FAX : - 886 . 4 . 888 . 1499

EMAIL : nto@: liqmedical.com

Web: site : www.clical.com

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140809

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Substantial Equivalence Comparison Table:

Comparison Table
	Cliq AspiratorModel DV-300	Olympus Suction PumpModel KV-5	SubstantiallyEquivalent?
510k Number	Unknown	K011725	NA
Trade Name	Cliq Aspirator	Suction Pump	NA
Model Number	DV-300	KV-5	NA
Manufacturer	Ding Hwa Co., Ltd.	Olympus	NA
Device Classification	878.4780Powered Suction PumpClass II,Product Code JCX	878.4780Powered Suction PumpClass II,Product Code JCX	Equivalent
Indications	The device is intended tobe used for aspirationduring flexible endoscopy.	For aspiration duringflexible endoscopy andgeneral or surgical suctionin a healthcareestablishment. It is notintended for thoracic,domiciliary, field ortransport use.	Equivalent
	Cliq AspiratorModel DV-300	Olympus Suction PumpModel KV-5	SubstantiallyEquivalent?
PerformanceStandards	EN IEC 60601-1EN IEC 60601-1-2EN ISO10079-1	EN IEC 60601-1(220-240V model)EN IEC 60601-1-2EN ISO10079-1UL 2601-1CAN/CSA Std. No. C22.2No.601.1-M90	Equivalent
Packaging	The device is packaged in afoam-secured carton.	The device is packaged ina foam-secured carton.	Equivalent
Technological and System Specifications
Electrical requirements	110-120 V, 60 Hz	100-120 V, 50/60 Hz	Equivalent
Protection againstelectric shock	Class II with Type BFApplied part	Class I with Type BFapplied part
Maximum Vacuumpressure	620 mm Hg	638 mm Hg
Vacuum Pump Type	Piston	Piston
Comparison Table
	Cliq AspiratorModel DV-300	Olympus Suction PumpModel KV-5	SubstantiallyEquivalent?
Flow	Up to 18 L/min	Up to 20 L/min
Sound level	53 dBA	Not known
Weight	3.5 kg	12.7 kg
Dimensions	30 x 16.5 x 19 cm	31 x 25.5 x 22 cm
OperatingEnvironment	Temperature: 0 - 40 °CHumidity: 0 - 90 %Atm. Pressure: 70 - 106 kPa	Temperature: 10 - 40 °CHumidity: 0 - 95 %Atm. Pressure: 70 - 106 kPa
Storage Environment	Temperature: -20 - 50 °CHumidity: 0 - 95 %Atm. Pressure: 50 - 106 kPa	Temperature: -40 - 70 °CHumidity: 0 - 95 %Atm. Pressure: 23.5 - 106 kPa
Accessories
Filter	Microbial, hydrophobic	Microbial, hydrophobic	Equivalent
Suction Tube length	1.8 m	2 m
Filter Tube length	250 mm	900 mm
Power Cable	yes	yes
Suction Jar volume	1.5 L or 2.4 L	2 liter (one liter optional)

ÉXÉORT DEPTERC. 4B-02/03: Táipel World Trade Canter, 47FL. 45: Hsin YT Road Section 5. Taipel Taiwan 110111 TEL : +886- 2- 2345- 1868 FAX : +886- 2- 2345- 3162 FACTORY = 121, Sec. 3, Zhongshan Road, Dacun, Chang-Hwa. Taiwan 51542 TEL : +886 4 888- 1486 FAX : +886- 4- 888- 1499 FACTORY : £43, Shin- Kung 1st Road, Pel-Tou Industrial Park, Pel- Tou, Chang-Hwa, Talwan 52149 TEL : +886 4- 888- 1486 FAX : +886 4- 888- 1499

EMAIL : Into@cliqmedica).com

Web-site : www.cligmedical.com

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Page 4/6 K140809

EXPORT DEPTORM. 4B-02/03 Talpel World Trade Center, 4/Fl.,#5. Hsin Yi Road, Section 5. Taipel Taiwan 11011 TEL : +886- 2- 2345- 1868 FAX : +886- 2- 2345- 3162 : + 121, Sec. 3. Zhongshan Road. Dacun, Chang- Hwa, Taiwan 51542 FACTORY

TEL : +886- 4- 888- 1486 FAX : +886- 4- 888- 1499 FACTORY : = 43, Shin- Kung 1st Road, Pel- Tou Industrial Park, Pel- Tou. Chang-Hwa, Taiwan 52149 TEL : +886- 4- 888- 1486 FAX : -886- 4- 883- 1499

EMAIL : into@:liqmeoical.com

Wab- site : www.cliqmedical.com

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Page 5/6 140809

EXECRT DEPT 2Rm - 4B -02/03, Taipel World Trade Center, 4/Fl., #S. Hslin Vi Road, Section 5 . Talpel, Talipal, Talipan 11011 TEL : -886- 2- 2345- 1868: FAX : +886- 2- 2345- 3162 : = 121, Sec. 3, Zhongshan Road. Dacun, Chang. Hwa, Taiwan 51542 FACTORY TEL : +886- 4-888- 1486 FAX : +886- 4-888-1499 : £43, Shin Kung Ist Road, Pei- Tou Industrial Park, Pel-Tou, Chang-Hina, Tafwan 52149 FACTORY TEL : +886 4 888 1486 FAX : +886- 4- 888- 1499

EMAIL : Info@cliqmedical.com

1 - - ------

Web- site: www.cligmedical.com

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8. Performance Data

Testing includes:

Electrically powered suction equipment safety requirements per EN ISO 10079-1:2009 . (See Section 16 for detailed report)
Electromagnetic Compatibility per IEC/EN 60601-1-2:2007 (310 Ed.) (See Section 16 for . detailed report)
General basic safety and essential performance per IEC 60601-1 (See Section 16 for detailed report)
Performance verification testing (See Section 18 for detailed protocol and report) .

Tests Conclusion:

. The Cliq Aspirator model DV-300 met all predefined criteria, and passed all tests for performance, electrical safety, and electromagnetic compatibility. 'The tests verified substantial equivalence to the Olympus Suction Pump model KV-5, and verified that the Cliq Aspirator Model DV-300 performs similarly to the predicate device as indicated in the Substantial Equivalence Comparison Table.

9. Conclusion:

The Ding Hwa Cliq Aspirator Model DV-300 is substantially equivalent to the predicate device listed above.

EXPORT DEPT.DRm.: 4B-02/03. Talpel World Trade Center. 4/Fl., #5. Hsin:Yi Road. Section: 5.: Talpei, Talpei, Talpei, Talpei, Talpai, Talpai, Talpai, Talpai, Taipei, Taipei, T TEL : +886- 2- 2345- 1868-FAX +886 2 - 2345 - 3162 FACTORY : = 121. Sec. 3. Zhongshan Road. Dacun, Chang. Hwa, Talwan 51542 TEL : +886 4 888- 1486 FAX : +886-4-888-1499 FACTORY : = 43, Shin: Kung Ist Road, Pei- Tou Industrial Park, Pei- Tou, Chang; Hwa, Talwan 52149 TEL : +886- 4- 888- 1486 FAX : +886 . 4. 888- 1499

EMAIL : into@: Ilomedical.com

Web- site : www cliginedical.com

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Heatth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002

June 23, 2014

Ding Hwa Company, Ltd. % Ms. Janna Babson EndoChoice Incorporated 11810 Wills Road Alpharetta, Georgia 30549

Re: K140809

Trade/Device Name: Cliq Aspirator Model DV-300 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: April 2, 2014 Received: April 3, 2014

Dear Ms. Babson:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Janna Babson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k} Number (if known)

K140809

Device Name

Cliq Aspirator model DV-300

Indications for Use (Describe)

The device is intended to be used for aspiration during flexible endoscopy.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

A MARK FOR FOR FOR FOR FDA USE ONLY BE ONLY BE ਾ ਦੇ ਇੱਕ ਅਨੁਸ਼ਾ ਕੀਤਾ ਹੈ। ਅ

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Joshua C. Nipper-S

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."

FORM FDA 3881 (1/14)

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.