(39 days)
THOMAS INDUSTRIES MEDI Pump Aspirator Model 1135
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device operates using a standard motor-driven pump and mechanical components.
No.
The device is used to remove bodily fluids, not to treat a disease or condition. While it assists in patient care, it does not have a direct therapeutic effect on the body.
No
Explanation: The device is an aspirator used to remove bodily fluids, which is a treatment or procedural function, not a diagnostic one. It does not analyze data or generate information for diagnosis.
No
The device description clearly outlines hardware components such as a motor-driven pump, vacuum regulation components, a gauge, a bacterial filter, and a collection system. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Merits Pioneer U601 Series Aspirator is used to remove bodily fluids directly from the patient's airway or respiratory system. This is a therapeutic or procedural function performed on the patient, not an analysis of a sample taken from the patient.
- Intended Use: The intended use clearly states it's for removing bodily fluids from the patient's airway or respiratory support system. This is a direct intervention on the patient.
The device is a medical device, but it falls under the category of devices used for patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
BTA
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
THOMAS INDUSTRIES MEDI Pump Aspirator Model 1135
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.
0
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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 |