(55 days)
Not Found
No
The device description details a standard suction pump with mechanical components and controls, with no mention of AI or ML capabilities.
No
The device is described as a general suction pump for drawing fluids and small particles, which is typically for diagnostic, palliative, or supportive care rather than directly therapeutic. It does not actively treat a disease or condition.
No
Explanation: The device description states its use is "general suction use" to "draw fluids and small particles," and the intended use confirms this. It is a pump designed for physical fluid removal, not for analyzing or diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a pump unit, power cord, switches, valves, gauges, filters, tubing, and a collection canister.
Based on the provided information, the DV-300 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "general suction use in hospitals or clinics" to draw fluids and small particles from the body. This is a physical process performed on the patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description details a suction pump, collection canister, tubing, and controls for vacuum pressure. These are components for physical suction, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples (like blood, urine, tissue), or any diagnostic purpose related to identifying diseases or conditions based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DV-300's function is purely mechanical suction for fluid removal.
N/A
Intended Use / Indications for Use
The DV-300 is intended for general suction use in hospitals or clinics.
Product codes (comma separated list FDA assigned to the subject device)
JCX
Device Description
The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (>= 800 ml) with overflow protection.
The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.
The DV-300 must only be used on the order of a physician.
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
The DV-300 is intended for general suction use in hospitals or clinics. The DV-300 must only be used on the order of a physician.
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)
The safety and performance testing of the Cliq DV-300 further demonstrates that this device is substantially equivalent to the predicate device. The Cliq Aspirator DV-300 met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility. Full test reports can be found in Section 16 of this submission.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 23, 2018
Ding Hwa Co., Ltd. % Mr. John MacMahon CEO V2K Medical, Inc. 1221 Innsbruck Drive Sunnyvale, California 94089
Re: K181398
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: March 16, 2018 Received: May 29, 2018
Dear Mr. MacMahon:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. John MacMahon
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number
Device Name
Cliq Aspirator DV-300
Indications for Use (Describe)
The DV-300 is intended for general suction use in hospitals or clinics.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
DING HWA CO., 股份有限
510(k) Summary
Cliq Aspirator DV-300
Date Prepared: April 27, 2018
1. Applicant Identification
Ding Hwa Co., Ltd. No. 121, Sec 3, Zhongshan Rd. Dacun, Taiwan 51542
Telephone: +886-2-2345-1868 Fax: +886-2-2345-3162 Establishment Registration: 3006789357
Contact Person 2.
John MacMahon, CEO V2K Medical, Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 Phone: 408-940-5587 Email: JMacMahon@V2KMedical.com
| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,
4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011
TEL : +886-2-2345-1868 FAX : +886-2-2345-3162 | |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,
Dacun, Chang- Hwa, Taiwan 51542
TEL : +886-4-852-5755 | |
4
Device Name for Which Clearance is Sought 3.
| Trade Name: | Cliq Aspirator DV-300 |
|---|---|
| Common/Usual Name: | Suction Pump / Aspirator |
| Regulation Description: | Powered Suction Pump |
4. Device Classification
| Product Code: | JCX |
|---|---|
| Device: | Pump, Portable, Aspiration (Manual or Powered) |
| Reg. Number: | 878.4780 |
| Class: | II |
| Review Panel: | General and Plastic Surgery |
5. Intended Use
The DV-300 is intended for general suction use in hospitals or clinics.
Device Description 6.
The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection.
| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,
4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011
TEL : +886-2-2345-1868 | FAX : +886-2-2345-3162 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,
Dacun, Chang- Hwa, Taiwan 51542
TEL : +886-4-852-5755 | |
5
The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.
The DV-300 must only be used on the order of a physician.
7. Predicate Device
| Trade Name: | Penumbra Pump MAX™ |
|---|---|
| Manufacturer: | Penumbra Inc. (Alameda, CA) |
| 510(k) Number: | K122756 |
| Product Code: | JCX |
Substantial Equivalence 8.
The Cliq Aspirator DV-300 suction pump design is substantially equivalent to the legally marketed Penumbra Pump MAX™ manufactured by Penumbra Inc. (K122756).
- Both the DV-300 and the predicate device are suction Intended Use: pumps that are intended for general suction use in hospitals or clinics.
| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,
4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011
TEL : +886-2-2345-1868 | FAX : +886-2-2345-3162 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,
Dacun, Chang- Hwa, Taiwan 51542
TEL : +886-4-852-5755 | |
6
- The pump units for both the DV-300 and the predicate Technology: device are positive displacement pumps that generate negative pressure using the same operating principles. Both units are AC units powered by a connection to mains.
- Both the DV-300 and the predicate device require Operation: connection to a hydrophobic filter, which, in turn, connects, via tubing, to a collection container. Both devices have a knob for adjustment of vacuum pressure; and both devices have an analog gauge that displays current pressure.
- Performance: Both the DV-300 and the predicate device meet substantially equivalent testing and acceptance criteria, as outlined below, in subsection 9 of this 510k Summary.
Further details on substantial equivalence are provided in the table below:
| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,
4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011
TEL : +886-2-2345-1868 FAX : +886-2-2345-3162 |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,
Dacun, Chang- Hwa, Taiwan 51542
TEL : +886-4-852-5755 |
7
DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司
Substantial Equivalence Comparison Chart
| | Cliq Aspirator
DV-300 | Penumbra
Pump MAX™ | Substantially
Equivalent? |
|--------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Unknown | K122756 | N/A |
| Manufacturer | Ding Hwa Co., Ltd. | Penumbra Inc. | N/A |
| Trade Name | Aspirator | Aspiration Pump | Equivalent |
| Model Number | DV-300 | Pump MAX™ | N/A |
| Device
Classification | 878.4780
Powered Suction
Pump
Class II
Product Code: JCX | 878.4780
Powered Suction
Pump
Class II
Product Code: JCX | Equivalent |
| Intended Use | The DV-300 is
intended for general
suction use in
hospitals or clinics. | The Penumbra
Pump MAX™ is
intended for general
suction use in
hospitals or clinics. | Equivalent |
| HEADQUARTERS | Rm. 4B-02/03, Taipei World Trade Center,
4 FL, No. 5, HsinYi Road, Section 5, Taipei, Taiwan 11011
TEL : +886-2-2345-1868
FAX : +886-2-2345-3162 |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| FACTORY | No. 121, Sec. 3, Zhongshan Road,
Dacun, Chang- Hwa, Taiwan 51542
TEL : +886-4-852-5755 |
8
DING HWA CO., LTD. 漢 弓 股 份 有 限 公 司
Substantial Equivalence Comparison Chart (cont.)
| Technological and System Specifications | |||
|---|---|---|---|
| Cliq Aspirator | |||
| DV-300 | Penumbra | ||
| Pump MAX™ | Substantially | ||
| Equivalent? | |||
| Electrical | |||
| requirements | 110-120 VAC | ||
| 60 Hz | 110-115 VAC | ||
| 50 Hz or 60 Hz | Equivalent | ||
| Protection against | |||
| electric shock | Class II with Type BF | ||
| applied part | Class I with Type CF | ||
| applied part | Equivalent | ||
| Both the subject and | |||
| predicate device have | |||
| been verified to | |||
| provide appropriate | |||
| protective measures to | |||
| prevent the user or | |||
| patient from being | |||
| electrically shocked. | |||
| Vacuum Pressure | Max: 24.4 inHg | ||
| Vacuum adjustable | |||
| Vacuum gauge | Max: 29 inHg | ||
| Vacuum adjustable | |||
| Vacuum gauge | Equivalent | ||
| Pump Type | Positive | ||
| displacement pump | Positive | ||
| displacement pump | Equivalent | ||
| Flow | Up to ~18 l/min | Up to ~21 L/min | Equivalent |
| Sound level |