The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system. It is for use on the order of a physician only

Device Description

The Merits Pioneer U601 Series Aspirator operates using standard AC Power from a wall outlet. This device consists of a motor-driven oil-less dual piston pump, a vacuum regulation components, a gauge, a bacterial filter and collection system.

AI/ML Overview

The provided text is a 510(k) summary for the Merits Health Products Pioneer U601 Series Aspirator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information specifically requested in your prompt.

Specifically, the document states under "9.8 Performance": "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." And under "9.9 Conclusion": "Based on the design, performance specifications and testing and intended use, the Merits U601 Aspirator is substantially equivalent to the currently marketed device, Thomas Aspirator model 1135."

These statements indicate that performance testing was conducted, and the device met specifications, but the document does not provide the specific acceptance criteria, reported performance values, or any details about the study design (sample sizes, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot populate the table or answer most of your questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

Cannot be provided. The document states "the device meets specifications" but does not list the specifications or the specific performance results.

2. Sample size used for the test set and the data provenance:

Cannot be provided. No information on sample sizes or data provenance for any testing is included. This is typically found in the test reports, which are not part of this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. Since this is a physical medical device (aspirator) and not an AI/imaging device, the concept of "ground truth" established by human experts for a test set in the way you've described for AI models does not directly apply here. Performance testing for an aspirator would typically involve engineering tests (e.g., vacuum pressure, flow rate, durability) against established technical standards.

4. Adjudication method for the test set:

N/A. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This is a physical aspirator, not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. See point 5.

7. The type of ground truth used:

N/A. Performance is likely assessed against engineering specifications and possibly clinical performance metrics as defined by relevant standards for aspirators (e.g., ISO, ASTM).

8. The sample size for the training set:

N/A. This is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:

N/A. See point 8.

In summary: The provided 510(k) summary confirms that performance testing was done and the device met its specifications to demonstrate substantial equivalence to the predicate. However, it does not detail what those specifications were or how the testing was conducted in the granular manner requested by your prompt for AI/diagnostic studies. This type of detailed performance data (acceptance criteria, test methods, results) is typically found in the full 510(k) submission, not the summary.

Summary

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9.0 510 (K) Summary

"510(k) SUMMARY"

Trade/Proprietary Name: 9.1
Common/Usual Name: 9.2
9.3 Classification Name:

Pioneer U601 Series Aspirator Aspirator Pump, Portable, Aspiration (Manual or Powered)

Comparison to Currently Marketed Devices 9.4
The Merits Health Products Pioneer U601 Series Aspirator is substantially equivalent to the THOMAS INDUSTRIES MEDI Pump Aspirator Model 1135.
Device Description 9.5
The Merits Pioneer U601 Series Aspirator operates using standard AC Power from a wall outlet. This device consists of a motor-driven oil-less dual piston pump, a vacuum regulation components, a gauge, a bacterial filter and collection system.
9.6 Intended use
The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system.
9.7 Technological Characteristics
Merits U601 aspirator is equivalent in functions to the legally marketed predicate device. The devices both use an AC motor driven vacuum pump to provide a source of vacuum for suction. The Merits U601 differs from the Thomas 1135 in following characteristics; Merits U601 uses dual piston type pump and has dual fuses for over current protection, Thomas 1135 uses single diaphragm type pump and has no fuse.

9.8 Performance

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

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ರಿ.9 Conclusion

Based on the design, performance specifications and testing and intended use, the Merits U601 Aspirator is substantially equivalent to the currently marketed device, Thomas Aspirator model 1135.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Mr. Steve Chao Merits Health Products Company Limited 9. Road 36 Taichung Industrial Park Taichung, CHINA (TAIWAN) 407

Re: K052650

Trade/Device Name: Pioneer U601 Series Aspirator Regulation Number: 21 CFR 868.4780 Regulation Name: Pump, Portable, Aspiration (Manual or Powered) Regulatory Class: II Product Code: BTA Dated: September 20, 2005 Received: September 27, 2005

Dear Mr. Chao:

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. Iisting 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.

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Page 2 - Mr. Chao

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 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) File Number:

Device Name:	Merits Health Products Pioneer U601 Series Aspirator
Indications For Use:	The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system. It is for use on the order of a physician only

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 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)


Division Sign-Off
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number	K 052650

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.