(15 days)
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Not Found
No
The document describes a suction pump and does not mention any AI or ML capabilities.
No
The device is used for removal of fluids, tissue, etc., from a patient, which is a diagnostic or surgical function, not a therapeutic one. It assists in medical procedures rather than directly treating a disease or condition.
No
The device is described as a suction pump for fluid removal, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description is not found, but the intended use clearly describes a "Suction Pump," which is a hardware device used for vacuum extraction and aspiration. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for vacuum extraction, aspiration, and removal of fluids, tissue, gases, and bodily fluids from a patient. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- IVD Definition: In vitro diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. They are used outside the body (in vitro).
The described suction pumps are used on the patient's body, not for analyzing specimens taken from the patient. Therefore, they fall under the category of medical devices used for direct patient care, not IVDs.
N/A
Intended Use / Indications for Use
The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, aspiration an removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from removal or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.
Product codes
BTA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Medela AG c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K021368
Trade/Device Name: Basic 30, Dominant 50 Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 24, 2002 Received: April 30, 2002
Dear Mr. Job:
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 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.
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Page 2 - Mr. Mark Job
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of of 1
510(k) Number (if known); KO21368
Basic 30, Dominant 50 Device Name:_
Indications For Use:
The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, aspiration an removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from removal or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Optional Format 3-10-98)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021368