(158 days)
The device is to be used to remove fluids from the treated tracheotomy patient airway.
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.
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.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document describes the device, the Cliq Aspirator, DV-300, and compares its performance characteristics to two predicate devices (SPARMAX Aspirator TC-2000V and VC-701), both manufactured by Ding Hwa Co., Ltd. The acceptance criteria are implicitly defined by these performance characteristics, and the "reported device performance" refers to the values listed for the subject device.
| Performance Characteristic | Predicate Device 1 (TC-2000V) | Predicate Device 2 (VC-701) | Acceptance Criteria (Implicit) | Reported Device Performance (Cliq Aspirator DV-300) |
|---|---|---|---|---|
| Sound level | < 54dB | < 54dB | Max Sound Level < 54dB (as per predicate) | < 50dB |
| Vacuum (Max.) | 650mmHg | 650mmHg | Max Vacuum around 650mmHg (as per predicate) | 620mmHg |
| Air flow rate | > 32 LPM | > 16 LPM | Air Flow Rate > 16 LPM (as per predicate 2) | > 18 LPM |
| Electrical requirements | 110-120 VAC, 60Hz, 1.2A(max) | 110-120 VAC, 60Hz, 0.9A(max) | N/A (Comparison only) | 110-120 VAC, 60Hz, 0.5A(max) |
| Size (LWH) (mm) | 380165240 | 340155210 | N/A (Comparison only) | 300165190 |
| Weight | 5.2kg | 4.25kg | N/A (Comparison only) | 3.5 kg |
| Collection jar | 1800c.c. | 800c.c. | N/A (Comparison only) | 800c.c. |
| Other shared characteristics (Implicit acceptance criteria: "Same" as predicate, meaning meets predicate's criteria) | ||||
| Intended Use | Same | Same | To remove fluids from treated tracheotomy patient airway. | Same |
| Collection tubing Length / material | 180cm / PVC | 180cm/ PVC | "Same" (180cm / PVC) | Same |
| Connection tubing length / material | 400mm / Silicon | 400mm / Silicon | "Same" (400mm / Silicon) | Same |
| Internal battery | None | None | "Same" (None) | Same |
| Adaptor | None | None | "Same" (None) | Same |
| Bacteria filter | Appointed | Appointed | "Same" (Appointed) | Same |
| Thermal switch | Appointed | Appointed | "Same" (Appointed) | Same |
| Operating temp. | 0 ~ 40°C | 0 ~ 40°C | "Same" (0 ~ 40°C) | Same |
| Operating relative humidity | 0 ~ 95% | 0 ~ 95% | "Same" (0 ~ 95%) | Same |
| Storage & transport temp | -40°C ~ 70°C | -40°C ~ 70°C | "Same" (-40°C ~ 70°C) | Same |
| Storage & transport humidity | 0 ~ 95% | 0 ~ 95% | "Same" (0 ~ 95%) | Same |
| Where used | Hospital | Hospital | "Same" (Hospital) | Same |
| Standards complied | IEC 60601-1-2, UL 60601, CAN/CSA-C22.2 No.68~92, UL 1450 | IEC 60601-1-2, UL 60601, CAN/CSA-C22.2 No.68~92, UL 1450 | Compliance with relevant medical electrical equipment and suction standards. | IEC 60601-1-2:2007, IEC 60601-1:2005 +C1:2006+C2:2007, ISO 10079-1:2009, IEC 60601-1-11:2010 |
The study proving the device meets these criteria is a substantial equivalence comparison to legally marketed predicate devices. The document explicitly states: "The major difference between the subject device and the predicate devices is the electrical power. The subject device has a less electrical power than the predicate devices. This leads to 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."
This statement, combined with the detailed comparison table, implies that the manufacturer performed tests on the Cliq Aspirator DV-300 to determine its specifications (sound level, vacuum, air flow rate, etc.) and compared these specifications to those of the predicate devices. The conclusion of the 510(k) summary is that the new device "does not raise any safety and effectiveness compared to the predicate devices, thus the subject device is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a "test set" in the context of clinical or performance data from human/patient cases. This 510(k) summary describes a comparison of device specifications and compliance with recognized standards, not a clinical trial with a patient test set. The data provenance is based on engineering specifications and compliance testing, likely conducted by the manufacturer (Ding Hwa Co., Ltd. in Taiwan). It's a technical comparison, not a clinical data comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The "ground truth" here is the engineering specifications and safety/performance standards. These are established through recognized industry standards (e.g., IEC, ISO, UL, CSA) and the technical expertise of the device manufacturer's engineers, rather than through expert clinical review of a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no "test set" in the sense of patient data requiring adjudication in this 510(k) summary. The comparison is based on technical specifications and standard compliance, which are typically verified through engineering tests and documentation.
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 document describes a medical device (an aspirator), not an AI-powered diagnostic tool or image analysis system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical, powered medical suction pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on engineering specifications and compliance with recognized national and international safety and performance standards. The manufacturer compared the subject device's technical characteristics (sound level, vacuum, airflow, etc.) and its adherence to standards like IEC 60601-1-2, IEC 60601-1, ISO 10079-1, and IEC 60601-1-11, to established values and predicate devices.
8. The sample size for the training set
This is not applicable. This document describes a physical medical device submission, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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4
DING HWA CO., LTD.
#121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542
Phone: +886 4 852 5755 Fax: +886 4 852 5795
DEC 30 2013 Website: www.cliqmedical.com Email: info@cligmedical.com
510(k) SUMMARY (According to 21 CFR 807.92)
| 510(k) Owner's Name | DING HWA CO., LTD.#121, Section 3, Zhongshan Road, Dacun, Chang-Hua, Taiwan,R.O.C. 51542Phone: +886 4 852 5755 Fax: +886 4 852 5795Email: info@cliqmedical.comWebsite: www.cliqmedical.com |
|---|---|
| Name of Contact | Robert O. DeanCompliance Systems International, LLc.1083 Delaware Ave.Buffalo, NY 14209Phone: +01.716.440.7362Email: compliancesystems@yahoo.com |
| 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.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: +886 4 852 5755 Fax: +886 4 852 5795
Website: www.cliqmedical.com Email: info@cligmedical.com
| SubjectDeviceComparedtoLegallyMarketedPredicateDevices | |||
|---|---|---|---|
| Comparisonitems | Predicate device 1 | Predicate device 2 | Subject device |
| Proprietary name | SPARMAXAspiratorTC-2000V | SPARMAXAspirator VC-701 | Cliq AspiratorDV-300 |
| Manufacturer | Ding Hwa Co., Ltd. | Ding Hwa Co., Ltd. | Ding Hwa Co., Ltd. |
| 5109k0 number | K080005 | K080005 | TBA |
| Regulatorynumber | 878.4780 | 878.4780 | 878.4780 |
| Product code | JCX | JCX | JCX |
| Classification | II | II | II |
| Common name | Aspirator | Aspirator | Aspirator |
| Classificationidentification | Powered suctionpump | Powered suctionpump | Powered suctionpump |
| Indications forUse | The device is to beused to removefluids from thetreatedtracheotomypatient air way. | The device is to beused to removefluids from thetreatedtracheotomypatient airway. | Same |
| Collection tubingLength / material | 180cm / PVC | 180cm/ PVC | Same |
| Connectiontubing length /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 |
| Operatingrelative humidity | 0~95% | 0~95% | Same |
| Storage &transport temp | -40°C ~ 70°C | -40°C ~ 70°C | Same |
| Storage &transporthumidity | 0~95% | 0~95% | Same |
| Where used | Hospital | Hospital | Same |
| Standardscomplied | IEC 60601-1-2,UL 60601CAN/CSA-C22.2No.68~92UL 1450 | IEC 60601-1-2,UL 60601CAN/CSA-C22.2No.68~92UL 1450 | IEC 60601-1-2:2007IEC 60601-1:2005+C1:2006+C2:2007ISO 10079-1:2009IEC 60601-1-11:2010 |
| Sound level | < 54dB | < 54dB | < 50dB |
| Vacuum(Max.) | 650rnmHg | 650rnmHg | 620rnmHg |
| Air flow rate | >32 LPM | >16 LPM | >18 LPM |
| Electricalrequirements | 110-120 VAC,60Hz,1.2A(max) | 110-120 VAC,60Hz,0.9A(max) | 110-120 VAC,60Hz,0.5A(max) |
| Size (LWH)(mm) | 380165240 | 340155210 | 300165190 |
| Weight | 5.2kg | 4.25kg | 3.5 kg |
| Collection jar | 1800c.c. | 800c.c. | 800c.c. |
SubjectDeviceComparedtoLegallyMarketedPredicateDevices
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DING HWA CO., LTD.
#121, Section 3. Zhongshan Road, Dacun, Chang-Hua, Taiwan, R.O.C. 51542 Page 3 of
Phone: +886 4 852 5755 Fax: +886 4 852 5795
Email: info@cligmedical.com
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: +886 4 852 5755 Fax: +886 4 852 5795 Email: info@cligmedical.com 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: +886 4 852 5755 Fax: +886 4 852 5795 Website: www.cliginedical.com Email: info@cligmedical.com
Indications for Use
510(k) Number:
- در - مرتبر -
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)
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|---|---|---|
| Division of Surgical DevicesK132308S 10(k) Number: | rona HW.S. And I S. Governmentpartiers, consumer Lin, care Partieantang it Chen -A9.200302.100.1 1 = 1 300.009.nen -ADate: 2013. I 1.37 Okt254 of 00 | for BSA |
4-2
§ 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.