(85 days)
Not Found
No
The device description and performance studies focus on standard medical device components and testing, with no mention of AI or ML technologies.
Yes
The device is used to remove fluids from a tracheotomy patient airway, which is a therapeutic intervention aimed at improving the patient's condition.
No
Explanation: The device description states its purpose is to "remove fluids from the treated tracheotomy patient airway." This is a therapeutic action (removing something), not a diagnostic one (identifying a condition or disease). There is no mention of measurement, analysis, or interpretation of biological signals or samples for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (pump unit, collection jar, tubing, etc.) and the performance studies include electrical safety and other hardware-focused testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove fluids from the treated tracheotomy patient airway." This is a physical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a suction unit with components like a pump, collection jar, and tubing. These are all physical components used for 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.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and therapeutic (removing fluids).
N/A
Intended Use / Indications for Use
The device is to be used to remove fluids from the treated tracheotomy patient airway.
Product codes
JCX
Device Description
VacPlus is the portable AC/DC powered suction unit. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in EN 60601-1, EN 60601-1-2 and EN/ISO 10079-1. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. Biocompatibility testing is not applicable since the proposed device has no direct patient contact.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Page 1 of 2
FEB 2 4 2011
510(k) Summary [As required by section 807.92(c)]
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- Submitter: APEX MEDICAL CORP. 9, Min Sheng St., Tu-Cheng, Taipei County, 236, Taiwan.
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- Manufacturer: APEX MEDICAL CORP. 9, Min Sheng St., Tu-Cheng, Taipei County, 236, Taiwan.
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- Official Correspondent: Alan Chang (Mr.)
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- Date of 510(k) Submittal: 29/11/2010
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- Device Trade Name: VacPlus
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- Common Name: Aspirator
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- Classification Name: Powered Suction Pump (FDA 21 CFR 878.4780 Class II)
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- Device Product Code: JCX
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- Predicate Device: DeVilbiss Suction Unit, Model 7305P FDA 510(k) number: K982304
- 10.Device Description:
VacPlus is the portable AC/DC powered suction unit. 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.
1
10 3 535
l 1.Intended Use:
The device is to be used to remove fluids from the treated tracheotomy patient airway.
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- Technological Characteristics:
The VacPlus is with aesthetic appeal and meet of today's hygiene and infection control requirements. The VacPlus unit is lightweight, compact and can be used in either AC or DC mode. This unit is available with a rechargeable battery, remote controller.
- Technological Characteristics:
It has the identical performance characteristics and is equipped with the identical technology like the predicate devices. The technological features do not affect safety and effectiveness of the device or the application.
13.Performance Testing:
Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in EN 60601-1, EN 60601-1-2 and EN/ISO 10079-1. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. Biocompatibility testing is not applicable since the proposed device has no direct patient contact.
14.Conclusion:
In terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness of the VacPlus is substantially equivalent to the predicate device used for this application. The VacPlus doesn't with the internal rechargeable portable battery and adopter. There are not significant effecting the safety and effectiveness to our application aspirator.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Apex Medical Corp. % Electronics Testing Center Hui-chen Kai No. 8, Lane 29, Wenming Road Guisan, Taoyuan 33383 Taiwan
FEB 2 4 2011
Re: K103535
Trade/Device Name: VacPlus Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: November 26, 2010 Received: December 01, 2010
Dear Hui-chen Kai:
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
3
Page 2 - Hui-chen Kai
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 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 go to http://www.fdaggov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely, yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
10.3535
510(k) Number (if known): Not known
Device Name: VacPlus
Indications For Use:
The device is to be used to remove fluids from the treated tracheotomy patient airway.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mykede for n.am
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K103535