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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the ASA01 Heavy Duty Suction Pump, but it does not contain specific acceptance criteria or a study proving the device meets them in the way typically expected for an AI/CADe device.

This device is a physical medical device (a suction pump), not an AI or software-controlled device for diagnostic imaging or similar applications. Therefore, many of the requested categories (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "ground truth" in the context of image interpretation, "training set size") are not applicable to this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating "substantial equivalence" to a predicate device (K052650 Pioneer U601 Series Aspiration) rather than meeting precise performance metrics derived from a clinical study for diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance (as far as applicable to this type of device):

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Bench performance testing demonstrated substantial equivalence to predicate device.
Design Specifications	Met all design specifications.
Environmental Testing	Passed all environmental testing identified in FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.
Hazard Analysis	Hazard analysis of the system and its software was performed. Testing conducted to validate overall system operation.
Compliance to Standards	Tested to assure compliance to IEC60601-1, IEC60601-1-2, ISO10779-1, and ISO14971.
Biocompatibility	Not applicable, as accessories that contact patients are not provided by the manufacturer.
Software Performance	Not applicable, as the device is not software-controlled.
Clinical Performance	Not applicable for this device type.

Study Details (as applicable)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a "test set" for AI/CADe performance. The evaluation was primarily through bench testing and compliance with standards.
- Data Provenance: Not applicable for a physical suction pump. The testing was laboratory-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the AI/CADe sense (e.g., expert interpretation of images) is not relevant for a physical suction pump's functional testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader consensus for diagnostic truth, which is not part of this device's evaluation.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not a physical suction pump.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm only) study was not done. This device does not involve an "algorithm" in the AI sense. Its performance is inherent to its physical operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a suction pump would be its ability to achieve certain vacuum pressures, flow rates, and maintain sterility, as measured by calibrated equipment and adherence to engineering specifications and standards.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary for this specific device:

The ASA01 Heavy Duty Suction Pump is a basic physical medical device. Its acceptance criteria and proof of performance are based on engineering bench testing, compliance with relevant industrial and medical device standards (IEC, ISO), hazard analysis, and demonstrating "substantial equivalence" in technological characteristics and intended use to a legally marketed predicate device (K052650 Pioneer U601 Series Aspiration). Concepts related to AI/CADe performance evaluation (like ground truth, test sets, training sets, reader studies) are not relevant to this submission.

Summary

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510(K) SUMMARY

K071607

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

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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:

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

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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

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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

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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 /<07/607

0014

Regulation Number and Section

§ 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.