(122 days)
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing.
The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX 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-XXX must only be used on the order of a physician.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Cliq Aspirator DV-XXX (model family)". As such, it is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the detailed performance metrics of a novel AI/ML-driven device.
Therefore, the information typically requested for acceptance criteria and studies proving the device meets those criteria, particularly for AI/ML devices (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect sizes), is largely not present in this document.
This document describes a powered suction pump, a traditional medical device, not an AI/ML diagnostic or therapeutic device. The "performance" discussed refers to physical specifications and compliance with electrical and safety standards, not diagnostic accuracy or effectiveness in an AI context.
Here's how the provided information relates to your request, with an emphasis on what is not applicable or not found in this type of submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific "acceptance criteria" in the sense of a numerical threshold for clinical performance (like sensitivity/specificity for a diagnostic AI). Instead, it relies on demonstrating compliance with recognized consensus standards and substantial equivalence to a predicate device.
The "performance" metrics for this device are largely physical and electrical characteristics.
| Criterion Type | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Cliq Aspirator DV-XXX) |
|---|---|---|
| Intended Use | Portable, battery-powered medical vacuum source for homecare/hospital environment. | Portable, battery-powered medical vacuum source for homecare/hospital environment. (Equivalent) |
| Electrical Requirements | AC Adaptor: 100-240 VAC, 50-60Hz; Pump Unit: 12 VDC | AC Adaptor: 100-240 VAC, 50-60Hz; Pump Unit: 12 VDC (Equivalent) |
| Protection against electric shock | Class I or Class II with Type BF applied part | Class II with Type BF applied part (Equivalent) |
| Battery Type | Rechargeable battery (Predicate: Lead acid battery) | NiMH rechargeable battery pack (Different type, but deemed equivalent in function and safety) |
| Battery Status Indicator | Colored LED lights for fully charged/low battery status | Colored LED lights for fully charged/low battery status (Equivalent) |
| Vacuum Pressure | Max: 533 mmHg (Predicate: EasyGo Aspirator) | Max: ~620 mmHg; Vacuum adjustable; Vacuum gauge (Higher max pressure, but deemed equivalent; adjustable and with gauge like predicate) |
| Pump Type | Positive displacement reciprocating pump | Positive displacement reciprocating pump (Equivalent) |
| Flow Rate | Up to ~14 l/min (Predicate: EasyGo Aspirator) | Up to ~20 l/min (Higher flow rate, but deemed equivalent) |
| Sound Level | Not specified for predicate | < 53 dBa |
| Weight | 4.4 kg / 9.6 lbs (Predicate: EasyGo Aspirator) | 3.5 kg / 7.7 lbs (Lighter) |
| Dimensions | L30 x W24 x H25 cm (Predicate: EasyGo Aspirator) | L30 x W16.5 x H19 cm (More compact) |
| Compliance with Consensus Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10079-1 (specific versions vary between predicate and proposed, but functionality equivalent) | Met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility for referenced standards: IEC 60601-1:2005, IEC 60601-1-2:2015, EN ISO 10079-1:2015+A:2018, IEC 60601-1-11:2012. (Met) |
2. Sample sized used for the test set and the data provenance
- Not applicable / Not present. This is for a physical device, and testing involves engineering and safety compliance (e.g., electrical, mechanical, EMC), not a "test set" of clinical data to evaluate an algorithm's performance. The documentation mentions "Non-clinical performance and safety tests" were conducted and "met all predefined criteria," but gives no details on sample size of devices tested for these engineering aspects. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not present. Ground truth in the context of AI/machine learning (e.g., for image interpretation) is not relevant for this device. Ground truth for the device's function is established by its physical specifications and meeting engineering standards, measured by calibrated equipment and engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. This concept applies to expert consensus on clinical data labels, not to the performance testing of a powered suction pump.
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
- Not applicable / Not present. This document describes a medical device (suction pump), not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present. There is no algorithm being evaluated in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance is objective measurements against engineering specifications and international consensus standards (e.g., a pressure gauge measures actual vacuum pressure, electrical tests confirm safety compliance).
8. The sample size for the training set
- Not applicable / Not present. This device does not involve machine learning; therefore, there is no training set.
9. How the ground truth for the training set was established
- Not applicable / Not present. As there is no training set, this question is not relevant.
In summary: This FDA 510(k) submission for the "Cliq Aspirator DV-XXX" is typical for a traditional medical device (a powered suction pump). It focuses on demonstrating substantial equivalence to an existing predicate device and compliance with recognized safety and performance standards. The types of acceptance criteria and study designs you've listed (related to AI/ML performance, ground truth establishment, reader studies) are not pertinent to this specific device or its regulatory pathway.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 3, 2020
ANEST IWATA SPARMAX CO., LTD. % Robert Dean President Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, New York 14223
Re: K201203
Trade/Device Name: Cliq Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 5, 2020 Received: August 21, 2020
Dear Robert 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201203
Device Name
Cliq Aspirator DV-XXX (model family)
Indications for Use (Describe)
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
510(k) Summary
Cliq Aspirator DV-XXX (Model Family)
February 20, 2020
1. Applicant Identification
Anest Iwata Sparmax Co., Ltd. No. 121, Sec 3, Zhongshan Rd. Dacun, Taiwan 51542
Telephone: +886-2-2345-1868 +886-2-2345-3162 Fax: Establishment Registration: 3006789357
2. Contact Person
Robert O. Dean Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, NY 14223
716-440-7362 Telephone: Email: compliancesystems@yahoo.com
{4}------------------------------------------------
Device Name for Which Clearance is Sought 3.
| Trade Name: | Cliq Aspirator DV-XXX (model family) |
|---|---|
| Common/Usual Name: | Suction Pump / Aspirator |
| Regulation Description: | Powered Suction Pump |
4. Device Classification
| Product Code: | BTA |
|---|---|
| Device: | Pump, Portable, Aspiration (Manual or Powered) |
| Regulation Number: | 878.4780 |
| Class: | II |
| Review Panel: | General and Plastic Surgery |
5. Intended Use
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the homecare or hospital environment.
6. Device Description
The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power
{5}------------------------------------------------
adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing.
The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX 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-XXX must only be used on the order of a physician.
7. Performance and Safety Testing
Non-clinical performance and safety tests conducted on the Cliq Aspirator DV-XXX (model family) include the following consensus standards:
- Basic safety and essential performance ● IEC 60601-1:
- IEC 60601-1-2: Electromagnetic compatibility ●
- IEC 60601-1-11: Requirements for medical electrical equipment ● used in the home healthcare environment
- ISO 10079: ● Electrically powered suction equipment safety requirements
Testing Conclusions:
The Cliq Aspirator DV-XXX (model family) met all predefined criteria, and passed all tests for performance, safety, and electromagnetic compatibility. Full test reports can be found in Section of Standard Conformance of this submission.
{6}------------------------------------------------
Predicate Device 8.
| Trade Name: | EasyGo Aspirator |
|---|---|
| Manufacturer: | Precision Medical |
| 510(k) Number: | K971749 |
| Product Code: | BTA |
Reference Device
| Trade Name: | EasyVac Aspirato |
|---|---|
| Manufacturer: | Precision Medical |
| 510(k) Number: | K932494 |
| Product Code: | BTA |
9. Substantial Equivalence
The Cliq Aspirator DV-XXX (model family) suction pump design is substantially equivalent to the legally marketed EasyGo Aspirator manufactured by Precision Medical (K971749).
- Intended Use: Both the DV-XXX and the predicate device are suction pumps that are intended for use as medical vacuum sources in the homecare or hospital environments.
- Technology: The pump units for both the DV-XXX and the predicate device are 12 VDC positive displacement reciprocating pumps. Both units use an AC adapter for connection to mains; and both units can be powered by rechargeable battery.
{7}------------------------------------------------
- Both the DV-XXX and the predicate device require connection Operation: 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. Both devices use LED light(s) to indicate battery status.
- Performance: Both the DV-XXX and the predicate device meet substantially equivalent testing and acceptance criteria. Both devices conform to the requirements of the following consensus standards: IEC 60601-1, IEC 60601-1-2, and ISO 10079-1. Further, in accordance with ISO 10079-1.
10. Substantial Equivalence Comparison Chart
See next page
{8}------------------------------------------------
| Cliq AspiratorDV-XXX | Precision MedicalEasyGo Aspirator | SubstantiallyEquivalent? | |
|---|---|---|---|
| 510(k) Number | Unknown | K971749 | N/A |
| Manufacturer | Anest Iwata SparmaxCo., Ltd. | Precision Medical | N/A |
| Trade Name | Aspirator | Aspirator | N/A |
| Model Number | DV-XXX (model family) | EasyGo | N/A |
| Device Classification | 878.4780Powered Suction PumpClass IIProduct Code: BTA | 878.4780Powered Suction PumpClass IIProduct Code: BTA | Equivalent |
| Intended Use | The DV-XXX aspiratorprovides a portable,battery-poweredmedical vacuumsource. The DV-XXXcan also be poweredfrom a standard walloutlet with the use ofan AC power adapter.It is intended for use inthe homecare orhospital environment. | The EasyGo Aspiratorprovides a portable,battery power medicalvacuum source. TheEasyGo Aspirator canalso be powered from astandard wall outletwith the use of an ACpower adapter. It isintended for use in thehomecare or hospitalenvironment. | Equivalent |
{9}------------------------------------------------
| ConsensusStandards | IEC 60601-1:2005IEC 60601-1-2:2015EN ISO 10079-1:2015+A: 2018IEC 60601-1-11:2012 | IEC 60601-1:2006IEC 60601-1-2:2007EN ISO 10079-1:2009 | Equivalent |
|---|---|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------------- | --------------------------------------------------------------- | ------------ |
| Technological and System Specifications | Cliq AspiratorDV-XXX | Precision MedicalEasyGo Aspirator | SubstantiallyEquivalent? | |
|---|---|---|---|---|
| Electricalrequirements | AC Adaptor:100-240 VAC, 50-60HzPump Unit: 12 VDC | AC Adaptor:100-240 VAC, 50-60HzPump Unit: 12 VDC | Equivalent | |
| Protection againstelectric shock | Class II with Type BFapplied part | Class I with Type BFapplied part | Equivalent | |
| Battery type | NiMH rechargeablebattery pack | Lead acid battery | Equivalent | |
| Battery statusindicator | Colored LED lights usedto indicate:- battery fully charged- battery low | Colored LED lights usedto indicate:- battery fully charged- battery low | Equivalent | |
| Vacuum Pressure | Max: ~620 mmHgVacuum adjustableVacuum gauge | Max: 533 mmHgVacuum adjustableVacuum gauge | Equivalent | |
| Pump Type | Positive displacementreciprocating pump | Positive displacementreciprocating pump | Equivalent | |
| Flow | Up to ~20 l/min | Up to ~14 l/min | Equivalent |
{10}------------------------------------------------
| Sound level | < 53 dBa | Not known |
|---|---|---|
| Weight | 3.5 kg / 7.7 lbs | 4.4 kg / 9.6 lbs |
| Dimensions | L30 x W16.5 x H19 cm | L30 x W24 x H25 cm |
| Operating Environment | Temperature: | Temperature: 10 - 40°C |
| Humidity: | Humidity: not known | |
| Atmospheric Pressure: | Atmospheric Pressure: not known | |
| Storage Environment | Temperature: | Temperature: -20 - 50°C |
| Humidity: | Humidity: 15 - 93% | |
| Atmospheric Pressure: | Atmospheric Pressure: 50-106 kPa |
11. Conclusion
The Anest Iwata Sparmax Co., Ltd. Cliq Aspirator DV-XXX (model family) described in this 510(k) submission is substantially equivalent in design, technology, specifications, intended use, operation, and performance to the predicate device (K971749). Further the Cliq Aspirator DV-XXX (model family) does not raise any new safety or effectiveness issues when compared to the predicate device.
§ 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.