CLIQ DV-300 ASPIRATOR

K132308 · Ding Hwa Co., Ltd. · JCX · Dec 30, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132308
• Device Name: CLIQ DV-300 ASPIRATOR
• Applicant: Ding Hwa Co., Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Dec 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be used to remove fluids from the treated tracheotomy patient airway.

Device Story

Cliq Aspirator DV-300 is a portable AC-powered suction pump; used to remove fluids from tracheotomy patient airways. Device consists of pump unit, on/off switch, non-detachable power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, and suction tubing. Operates by creating negative pressure (vacuum) to draw fluids through tubing into a collection jar for disposal. Used in hospital or home settings; operated by physicians or trained caregivers. Output is physical fluid removal; healthcare providers use device to maintain airway patency. Benefits include effective fluid clearance for tracheotomy patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered suction pump; AC-powered (110-120 VAC). Components: pump, collection jar (800 c.c.), bacteria filter, pressure gauge, relief valve. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 10079-1:2009, IEC 60601-1-11:2010. Max vacuum 620 mmHg; air flow >18 LPM. Materials: PVC tubing, silicon connection tubing.

Indications for Use

Indicated for removal of fluids from the airway of patients with a tracheotomy. For use on the order of a physician only; if used outside a hospital, the caregiver must be trained and recorded.

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

• SPARMAX Aspirator TC-2000V (K080005)
• SPARMAX Aspirator VC-701 (K080005)

Submission Summary (Full Text)

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### DING HWA CO., LTD.

#121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542

Phone: [phone] Fax: [phone]

DEC 30 2013 Website: www.cliqmedical.com Email: [e-mail]

### 510(k) SUMMARY (According to 21 CFR 807.92)

| 510(k) Owner's Name | DING HWA CO., LTD.<br>#121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan,<br>R.O.C. 51542<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail]<br>Website: www.cliqmedical.com |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Contact | Robert O. Dean<br>Compliance Systems International, LLc.<br>1083 Delaware Ave.<br>Buffalo, NY 14209<br>Phone: [phone]<br>Email: [e-mail] |
| Date Of Submission: | July 28,2013 |
| Trade Name | Cliq Aspirator, DV-300 |
| Common Name | Aspirator |
| Classification Name | Powered suction pump (21 CFR 878.4780, Product Code JCX, classification: class II) |
| Panel | General & Plastic Surgery |
| Intended Use | The device is to be used to remove fluids from the treated tracheotomy patient airway. |
| Device Description | The predicate devices and the subject device have the same technological characteristics. Those devices are intended to be used to remove fluids from the treated tracheotomy patient airway. It creates a negative pressure (vacuum) that draws the fluids through disposable tubing that is connected to a collection jar. The fluids are trapped in the collection jar for the proper disposal. The devices are for use on the order of a physician only. If practiced out of the hospital, the care giver has to be trained and recorded.<br>The predicate devices and the subject device are the portable AC powered suction pumps. Each one consists of an on/off switch, a pump unit, a non-detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing. The major differences between the predicate devices and the subject device are the capacities and dimensions. |

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### DING HWA CO., LTD. #121, Section 3. Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542

.

Page 2 of 4

Phone: [phone] Fax: [phone]

Website: www.cliqmedical.com Email: [e-mail]

| | SubjectDeviceComparedtoLegallyMarketedPredicateDevices | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Comparison<br>items | Predicate device 1 | Predicate device 2 | Subject device |
| Proprietary name | SPARMAX<br>Aspirator<br>TC-2000V | SPARMAX<br>Aspirator VC-701 | Cliq Aspirator<br>DV-300 |
| Manufacturer | Ding Hwa Co., Ltd. | Ding Hwa Co., Ltd. | Ding Hwa Co., Ltd. |
| 5109k0 number | K080005 | K080005 | TBA |
| Regulatory<br>number | 878.4780 | 878.4780 | 878.4780 |
| Product code | JCX | JCX | JCX |
| Classification | II | II | II |
| Common name | Aspirator | Aspirator | Aspirator |
| Classification<br>identification | Powered suction<br>pump | Powered suction<br>pump | Powered suction<br>pump |
| Indications for<br>Use | The device is to be<br>used to remove<br>fluids from the<br>treated<br>tracheotomy<br>patient air way. | The device is to be<br>used to remove<br>fluids from the<br>treated<br>tracheotomy<br>patient airway. | Same |
| Collection tubing<br>Length / material | 180cm / PVC | 180cm/ PVC | Same |
| Connection<br>tubing length /<br>material | 400mm / Silicon | 400mm / Silicon | Same |
| Internal battery | None | None | Same |
| Adaptor | None | None | Same |
| Bacteria filter | Appointed | Appointed | Same |
| Thermal switch | Appointed | Appointed | Same |
| Operating temp. | 0 ~ 40°C | 0~40°C | Same |
| Operating<br>relative humidity | 0~95% | 0~95% | Same |
| Storage &<br>transport temp | -40°C ~ 70°C | -40°C ~ 70°C | Same |
| Storage &<br>transport<br>humidity | 0~95% | 0~95% | Same |
| Where used | Hospital | Hospital | Same |
| Standards<br>complied | IEC 60601-1-2,<br>UL 60601<br>CAN/CSA-C22.2<br>No.68~92<br>UL 1450 | IEC 60601-1-2,<br>UL 60601<br>CAN/CSA-C22.2<br>No.68~92<br>UL 1450 | IEC 60601-1-2:2007<br>IEC 60601-1:2005<br>+C1:2006+C2:2007<br>ISO 10079-1:2009<br>IEC 60601-1-11:2010 |
| Sound level | < 54dB | < 54dB | < 50dB |
| Vacuum(Max.) | 650rnmHg | 650rnmHg | 620rnmHg |
| Air flow rate | >32 LPM | >16 LPM | >18 LPM |
| Electrical<br>requirements | 110-120 VAC,<br>60Hz,<br>1.2A(max) | 110-120 VAC,<br>60Hz,0.9A(max) | 110-120 VAC,<br>60Hz,0.5A(max) |
| Size (L*W*H)<br>(mm) | 380*165*240 | 340*155*210 | 300*165*190 |
| Weight | 5.2kg | 4.25kg | 3.5 kg |
| Collection jar | 1800c.c. | 800c.c. | 800c.c. |

### SubjectDeviceComparedtoLegallyMarketedPredicateDevices

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ਪ

### DING HWA CO., LTD.

#### #121, Section 3. Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542 Page 3 of

Phone: [phone] Fax: [phone]

Email: [e-mail]

Website: www.cliqmedical.com

Summary of Comparison:

In terms of similar comparison items, i.e., intended use / place, construction, accessories, function, safety, operating / storage environmental conditions, compliance with the same Electromagnetic Compatibility Standard, IEC 60601-1-2:2007, the Cliq aspirator DV-300 does not raise any safety and effectiveness aspects, so it is substantially equivalent to the predicate devices used for this application.

Also the predicate devices comply with CAN/CSA-C22.2 No.68~92 and the subject device complies with IEC 60601-1:2005, both standards concern about the general requirements for safety of the medical electrical equipment. Further, the predicate devices comply with the UL 1450 and the subject device complies with ISO 10079-1, both standards are related with the safety requirements for the medical electrically powered suction equipment. At last, for the purpose of the safety of the electrical equipments used in the homecare environment, the subject device complies with the standard, IEC 60601-1-11:2010. This offers more safety and effectiveness to the subject device than the predicate device.

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#### DING HWA CO., LTD. #121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542 Page 4 Off 4 Phone: [phone] Fax: [phone] Email: [e-mail] Website: www.cliqmedical.com

The major difference between the subject device and the predicate devices is the electrical The subject device has a less electrical power than the predicate devices. This leads to power. the differences of the sound levels, maximum vacuum levels, air flow rates, sizes, weights, and the collection jars. The differences are not related to the safety and effectiveness,

In conclusion, the subject device does not raise any safety and effectiveness compared to the predicate devices, thus the subject device is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2013

Ding Hwa Corporation, Ltd % Mr. Robert O. Dean Compliance Systems 1083 Delaware Avenue Buffalo, New York 14209

Re: K132308

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: November 7, 2013 Received: November 14, 2013

Dear Mr. Dean:

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

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Page 2 - Mr. Robert O Dean

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashara 2013.12.30 16:24:13 -05'00'

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

Enclosure

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### DING HWA CO., LTD. #121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542 Phone: [phone] Fax: [phone] Website: www.cliginedical.com Email: [e-mail]

# Indications for Use

510(k) Number:

- در - مرتبر -

K132308

Cliq Aspirator, DV-300 Device Name:

Indications for Use :

The device is to be used to remove fluids from the treated tracheotomy patient airway.

4 Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

| DSD—DIVISION SIGN-OFF | aparay sajara ay Lorg H. Chan J. | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Division of Surgical Devices<br>K132308<br>S 10(k) Number: | rona H<br>W.S. And I S. Government<br>partiers, consumer Lin, care Partie<br>antang it Chen -A<br>9.200302.100.1 1 = 1 300.009.<br>nen -A<br>Date: 2013. I 1.37 Okt254 of 00 | for BSA |

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