CLIQ DV-300 ASPIRATOR

• K Number: K140809
• Device Name: CLIQ DV-300 ASPIRATOR
• Manufacturer: DING HWA CO., LTD.
• Date Cleared: 2014-06-23 ( 83 days)
• Product Code: JCX REG
• Regulation Number: 878.4780

Intended Use

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

Device Description

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.

Predicate Devices

K011725

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and electrical components of a suction pump, with no mention of AI or ML capabilities. Performance testing is based on safety and electrical standards, not algorithmic performance.

Therapeutic

No
The device is used for aspiration during flexible endoscopy, which is a supportive function during a medical procedure, not a direct therapeutic intervention.

Diagnostic

No

The device is described as a suction unit for aspiration, which is a therapeutic function to remove fluids, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, AC-powered suction unit with various hardware components (pump, power cord, switches, gauges, etc.). The performance studies also focus on electrical safety and physical performance, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "aspiration during flexible endoscopy." This describes a procedure performed directly on a patient to remove fluids or other substances from within the body.
• Device Description: The device is a "high-vacuum / low-flow suction unit" that creates negative pressure to draw fluids into a collection container. This is a mechanical process for removing material from the body.
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any analysis or testing of the collected fluids for diagnostic purposes. It simply collects them.

The device is a medical device used during a medical procedure, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

JCX

Device Description

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.

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

Not Found

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)

Testing includes:

• Electrically powered suction equipment safety requirements per EN ISO 100779-1:2009.
• Electromagnetic Compatibility per IEC/EN 60601-1-2:2007 (310 Ed.)
• General basic safety and essential performance per IEC 60601-1
• Performance verification testing

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011725

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

2. Contact Person

Janna Babson Regulatory Affairs Associate Telephone: [phone] Fax: [phone] Email: [e-mail]

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 : [phone] FAX [phone] FACTORY = 121, Sec. 3, Zhongshan Road Dacun, Chang- Hwa, Taiwan 51542 TEL : +886 4 : 888- 1486 FAX : [phone] FACTORY : = 43. Shin- Kung 1st Road, Pei- Tou Industrial Park, Pel- Tou, Chang- Hwa, Tahaan 52149 TEL : [phone] FAX : - 886- 4- 888- 1499

EMAIL : into@: ligmedical.com

Web site : www.cligmedical.com

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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.

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.

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 : [phone] FAX : [phone] FACTORY : = 121. Sec. 3. Zhongshan Road. Dacun, Chang Hwa. Talwan 51542. TEL : [phone] FAX : [phone] FACTORY : + 43, Shin. Kung 1st Road, Pol. Tou Industrial Park, Pei- Tou. Chang. Hwa, Talwan 52149 TEL : [phone] 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 Aspirator
Model DV-300	Olympus Suction Pump
Model KV-5	Substantially
Equivalent?
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	878.4780
Powered Suction Pump
Class II,
Product Code JCX	878.4780
Powered Suction Pump
Class II,
Product Code JCX	Equivalent
Indications	The device is intended to
be used for aspiration
during flexible endoscopy.	For aspiration during
flexible endoscopy and
general or surgical suction
in a healthcare
establishment. It is not
intended for thoracic,
domiciliary, field or
transport use.	Equivalent
	Cliq Aspirator
Model DV-300	Olympus Suction Pump
Model KV-5	Substantially
Equivalent?
Performance
Standards	EN IEC 60601-1
EN IEC 60601-1-2
EN ISO10079-1	EN IEC 60601-1
(220-240V model)
EN IEC 60601-1-2
EN ISO10079-1
UL 2601-1
CAN/CSA Std. No. C22.2
No.601.1-M90	Equivalent
Packaging	The device is packaged in a
foam-secured carton.	The device is packaged in
a foam-secured carton.	Equivalent
Technological and System Specifications
Electrical requirements	110-120 V, 60 Hz	100-120 V, 50/60 Hz	Equivalent
Protection against
electric shock	Class II with Type BF
Applied part	Class I with Type BF
applied part
Maximum Vacuum
pressure	620 mm Hg	638 mm Hg
Vacuum Pump Type	Piston	Piston
Comparison Table
	Cliq Aspirator
Model DV-300	Olympus Suction Pump
Model KV-5	Substantially
Equivalent?
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
Operating
Environment	Temperature: 0 - 40 °C
Humidity: 0 - 90 %
Atm. Pressure: 70 - 106 kPa	Temperature: 10 - 40 °C
Humidity: 0 - 95 %
Atm. Pressure: 70 - 106 kPa
Storage Environment	Temperature: -20 - 50 °C
Humidity: 0 - 95 %
Atm. Pressure: 50 - 106 kPa	Temperature: -40 - 70 °C
Humidity: 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 : [phone] FAX : [phone] FACTORY = 121, Sec. 3, Zhongshan Road, Dacun, Chang-Hwa. Taiwan 51542 TEL : [phone] FAX : [phone] FACTORY : £43, Shin- Kung 1st Road, Pel-Tou Industrial Park, Pel- Tou, Chang-Hwa, Talwan 52149 TEL : [phone] FAX : [phone]

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 : [phone] FAX : [phone] : + 121, Sec. 3. Zhongshan Road. Dacun, Chang- Hwa, Taiwan 51542 FACTORY

TEL : [phone] FAX : [phone] FACTORY : = 43, Shin- Kung 1st Road, Pel- Tou Industrial Park, Pel- Tou. Chang-Hwa, Taiwan 52149 TEL : [phone] 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 : [phone] : = 121, Sec. 3, Zhongshan Road. Dacun, Chang. Hwa, Taiwan 51542 FACTORY TEL : [phone] FAX : [phone] : £43, Shin Kung Ist Road, Pei- Tou Industrial Park, Pel-Tou, Chang-Hina, Tafwan 52149 FACTORY TEL : [phone] FAX : [phone]

EMAIL : [e-mail]

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 : [phone]-FAX +886 2 - 2345 - 3162 FACTORY : = 121. Sec. 3. Zhongshan Road. Dacun, Chang. Hwa, Talwan 51542 TEL : [phone] FAX : [phone] FACTORY : = 43, Shin: Kung Ist Road, Pei- Tou Industrial Park, Pei- Tou, Chang; Hwa, Talwan 52149 TEL : [phone] 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

7

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 [phone] or [phone] 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 [phone] or [phone] 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

8

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 [e-mail]

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FORM FDA 3881 (1/14)