(220 days)
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Not Found
No
The summary describes a standard suction pump with no mention of AI or ML capabilities.
No
The device is a suction pump designed to remove infectious materials or fluids, not to treat a condition or restore health. Its function is primarily to clear, not to therapeutically intervene.
No
Explanation: The device is described as a suction pump to remove materials from wounds or fluids, which is a therapeutic or supportive function, not a diagnostic one. It does not analyze or interpret medical data to identify a disease or condition.
No
The device description explicitly states it is a "portable, AC powered suction pump," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove infectious materials from wounds or fluids from a patient's airway or respiratory system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- Device Description: It's a suction pump, which is a mechanical device used for physical removal of substances.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of specimens.
The device described is a medical device used for patient care, specifically for suctioning, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A portable, AC powered suction pum to be used to remove infectious materials from wounds or fluids from a patients airway or respiratory Support system. The pump may be used during Surgery! • the operating room or at the patien bedside. The device includes a microbial
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
wounds, airway, respiratory Support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room, patient bedside
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Medco Manufacturing c/o E.J. Smith Smith Associates Medical Marketing & Research P.O. Box 4341 Crofton, Maryland 21114
K982371 Re: Trade Name: Medco Aspirator IV Regulatory Class: II Product Code: BTA Dated: January 19, 1999 Received: January 20, 1999
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. E.J. Smith
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Page . I at 1
K9823'11',
510(k) Number (ii known) K982371 Device Name -Spirator IV Indications For Use
A portable, AC powered suction pum
to be used to remove infectious
materials from wounds or fluids
from a patients airway or.
respiratory Support system. The
pump may be used during Surgery!
• the operating room or at the patien
bedside. The device includes a microbial
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Concurrence of CDRH, Office of Device Evaluation (ODE)
ence of CDRH, Office of Device Evaluation (ODE)
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