(14 days)
Not Found
No
The summary describes a standard suction pump and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
No.
The device removes bodily fluids, which is a supportive function, but it does not directly treat a disease or condition.
No
The device is a suction pump designed to remove bodily fluids; it does not diagnose medical conditions.
No
The device description explicitly states it is an "AC-powered, stand-alone device" and describes laboratory testing of the physical pump, indicating it is a hardware device with potential software components, not a software-only device.
Based on the provided information, the ASA01 Heavy Duty Suction Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "remove bodily fluids from the patients' airway or respiratory support system." This is a direct intervention on the patient's body for therapeutic or supportive purposes, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on its function as a "vacuum suction device designed to collection of nonflammable fluid materials in medical applications." This aligns with a medical device used for physical removal of substances.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory testing of samples.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. The ASA01 Heavy Duty Suction Pump's function is purely mechanical suction for patient care.
N/A
Intended Use / Indications for Use
The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.
Product codes
BTA
Device Description
The ASA01 Heavy Duty Suction Pump is an AC-powered, stand-alone device, designed to collection of nonflammable fluid materials in medical applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel under the direction of the physician / during surgery in the operating room or at the patient's bedside.
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)
Bench performance testing has demonstrated that the ASA01 Heavy Duty Suction Pump is substantially equivalent to the predicate device. Laboratory testing was conducted to validate and verify that the ASA01 Heavy Duty Suction Pump met all design specifications and was substantially equivalent to the predicate device. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation. The conclusions drawn from the testing of the ASA01 Heavy Duty Suction Pump demonstrates that the device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
The ASA01 Heavy Duty Suction Pump is not a software controlled medical device, the software test according the software guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is not applicable.
§ 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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: Submitter:
JUN 26 2007
Zhongshan A & J Medical Equipment CO., LTD
Address: No.3 Shenghui South Road Nantou Town, Zhongshan, City, Guangdong CHINA P.R.C
- Contact Person: 0
R&D Manager Polo Chen Email: polochen888@hotmail.com Tel: 0086-760-3133726 Fax: 0086-760-3133724 Applicant: Zhongshan A & J Medical Equipment CO., LTD Address: No.3 Shenghui South Road Nantou Town, Zhongshan, City, Guangdong CHINA P.R.C
Date Prepared:
January 15, 2007
Name of the device:
- Trade/Proprietary Name: The ASA01 Heavy Duty Suction Pump .
- Common Name: Powered suction pump
- Classification
Pump, Portable, Aspiration (Manual or Powered) 21 CFR 878.4780 Class II Legally Marketed Predicate Device:
K052650 Pioneer U601 Series Aspiration
Description:
Powered suction pumps are described in FDA regulations, 21 CFR 878.4780, as:
"A powered suction pump is an AC-powered device intended to be used to remove infectious materials from wounds or fluids from 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. The FDA classified the device as a class II medical device".
0015
Page 1 of 2
1
The ASA01 Heavy Duty Suction Pump is an AC-powered, stand-alone device, designed to collection of nonflammable fluid materials in medical applications.
Statement of intended Use:
The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.
Technological Characteristics:
Technologies utilized by the ASA01 Heavy Duty Suction Pump bring forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.
Bench performance testing has demonstrated that the ASA01 Heavy Duty Suction Pump is substantially equivalent to the predicate device.
Testing:
Laboratory testing was conducted to validate and verify that the ASA01 Heavy Duty Suction Pump met all design specifications and was substantially equivalent to the predicate device. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation. The ASA01 Heavy Duty Suction Pump has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-1-2, ISO10779-1 and ISO14971.
The ASA01 Heavy Duty Suction Pump is not a software controlled medical device, the software test according the software guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is not applicable.
The accessories which contact the patients directly are provided by the hospital but not the manufacture. All the accessories of the ASA01 Heavy Duty Suction Pump are not contact the patients, the biocompatibility test is not applicable.
The clinical performance test is not applicable
Conclusion:
The conclusions drawn from the testing of the ASA01 Heavy Duty Suction Pump demonstrates that the device is substantially equivalent to the predicate device.
0016
Page 2 of 2
2
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zhongshan A & J Medical Equipment Co. % Underwriters Laboratories, Inc. Mr. Morton S. Christensen 2600 NW Lake Road Camas. Washington 98607
JUN 26 2007
Re: K071607
Trade/Device Name: ASA01 Heavy Duty Suction Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: May 29, 2007 Received: June 12, 2007
Dear Mr. Christensen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Morton S. Christensen
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely you
Fuk P.d.pm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indication for Use
Page __ 1 __ of __ 1
K071607 510(k) Number (if known):
Device Name: ASA01 Heavy Duty Suction Pump
Indications For Use:
The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is . intended for use by trained personnel under the direction of the physician.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-The Counter Use OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currencer CRI, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number /