(108 days)
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No
The summary describes a standard suction unit and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device is used to remove materials and fluids, which is a diagnostic or supportive function, not a therapeutic one that directly treats a disease or condition.
No
Explanation: The device is described as a "Suction unit" intended to "remove infectious materials from wounds or fluids from a patients airway or respiratory support unit." This functionality is therapeutic, not diagnostic, as it does not involve identifying, analyzing, or determining the presence or nature of a disease or condition.
No
The device description explicitly states "Model SUA01 Suction unit," which is a physical piece of equipment used for suction, indicating it is a hardware device.
Based on the provided information, the Model SUA01 Suction unit is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- The intended use of the Model SUA01 Suction unit is to remove materials directly from a patient's body (wounds, airway, respiratory support unit). This is a direct intervention on the patient, not an analysis of a specimen outside the body.
Therefore, the Model SUA01 Suction unit is a medical device, but it falls under a different category than IVDs. It's likely classified as a surgical or general hospital device.
N/A
Intended Use / Indications for Use
The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Product codes
JCX
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
both adult and pediatric patients.
Intended User / Care Setting
professional use
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 is a black and white 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 top half of the circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a person's profile.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2004
EMG Technology Company, Ltd. c/o Mr. Leonard Fryer MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, Maryland 21230
Re: K042349
Trade/Device Name: Model SUA01 Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Unit Regulatory Class: II Product Code: JCX Dated: November 5, 2004 Received: November 9, 2004
Dear Mr. Fryer:
We have reviewed your Section 510(k) premarket notification of intent to market the device in die in die in We have reviewed your Section 3 ro(x) premained is substantially equivalent (for the indications felerenced above and nave determined the acted predicate devices marketed in interstate for use stated in the encrosuly manatinent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food - France commerce prior to May 20, 1770, the enaochance with the provisions of the Federal Food. Drug, devices that have been icclassified in accessfited in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to such additional controliations, 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 r least of advised that I Dr o modalite or our device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I cactar statutes and regulations and and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) certer and 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Leonard Fryer
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
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
2
Indications for Use Statement
KO42349 510K number:
Device Name: Model SUA01 Suction Unit
Indications For Use: The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Prescription Use X (Part 21 CFR 801 Subpart D) (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 General, Restorative and Neurological Devices, Mirillandk) Numberovovat
Revised 11/5/04
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042349