CLIQ DV-300 ASPIRATOR

{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: +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 {1}------------------------------------------------ # 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. 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 : +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 {2}------------------------------------------------ 140809 Page 3/6 Substantial Equivalence Comparison Table: | Comparison Table | | | | |-----------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | | Cliq Aspirator<br>Model DV-300 | Olympus Suction Pump<br>Model KV-5 | Substantially<br>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<br>Powered Suction Pump<br>Class II,<br>Product Code JCX | 878.4780<br>Powered Suction Pump<br>Class II,<br>Product Code JCX | Equivalent | | Indications | The device is intended to<br>be used for aspiration<br>during flexible endoscopy. | For aspiration during<br>flexible endoscopy and<br>general or surgical suction<br>in a healthcare<br>establishment. It is not<br>intended for thoracic,<br>domiciliary, field or<br>transport use. | Equivalent | | | Cliq Aspirator<br>Model DV-300 | Olympus Suction Pump<br>Model KV-5 | Substantially<br>Equivalent? | | Performance<br>Standards | EN IEC 60601-1<br>EN IEC 60601-1-2<br>EN ISO10079-1 | EN IEC 60601-1<br>(220-240V model)<br>EN IEC 60601-1-2<br>EN ISO10079-1<br>UL 2601-1<br>CAN/CSA Std. No. C22.2<br>No.601.1-M90 | Equivalent | | Packaging | The device is packaged in a<br>foam-secured carton. | The device is packaged in<br>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<br>electric shock | Class II with Type BF<br>Applied part | Class I with Type BF<br>applied part | | | Maximum Vacuum<br>pressure | 620 mm Hg | 638 mm Hg | | | Vacuum Pump Type | Piston | Piston | | | Comparison Table | | | | | | Cliq Aspirator<br>Model DV-300 | Olympus Suction Pump<br>Model KV-5 | Substantially<br>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<br>Environment | Temperature: 0 - 40 °C<br>Humidity: 0 - 90 %<br>Atm. Pressure: 70 - 106 kPa | Temperature: 10 - 40 °C<br>Humidity: 0 - 95 %<br>Atm. Pressure: 70 - 106 kPa | | | Storage Environment | Temperature: -20 - 50 °C<br>Humidity: 0 - 95 %<br>Atm. Pressure: 50 - 106 kPa | Temperature: -40 - 70 °C<br>Humidity: 0 - 95 %<br>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 {3}------------------------------------------------ # 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 {4}------------------------------------------------ # 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 . {5}------------------------------------------------ # Page 6/6 ## 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 {6}------------------------------------------------ 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 (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 {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 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)