(84 days)
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Not Found
No
The summary describes a simple suction catheter kit for aspirating liquids and semi-solids. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found in detail) point to a mechanical device.
Yes
The device is used to aspirate liquids or semi-solids from a patient's upper airway, which is a therapeutic intervention.
No
The device's intended use is to aspirate liquids or semi-solids from a patient's upper airway, which is a therapeutic or procedural action, not a diagnostic one.
No
The device is described as a "suction catheter kit," which inherently implies physical hardware components (the catheter itself, potentially a collection reservoir, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aspirate liquids or semi-solids from a patient's upper airway." This is a direct intervention on the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed in vitro (outside the living organism).
The NI-MED suction catheter kit is a medical device used for a procedure performed directly on the patient, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.
Product codes
73 BSY
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
patient's upper airway
Indicated Patient Age Range
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Intended User / Care Setting
physician
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
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§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
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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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Mr. Michael Giblin Director of Quality Assurance Ni-Med, Inc. P.O Box 871 1601 Air Park Drive Farmington, MO 63640-0871
Re: K981910 Suction Catheter Requlatory Class: I (one) Product Code: 73 BSY Dated: May 29, 1998 Received: June 1, 1998
Dear Mr. Giblin:
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 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 You may, therefore, market the device, subject to the Act (Act). general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:
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Page 2 - Mr. Michael Giblin
General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
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 your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
DAspgh
for Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/3 description: The image shows a logo for NI-MED, INC. The logo consists of a black square with a white plus sign inside, followed by the text "NI-MED, INC." in black. The plus sign is centered within the square and is formed by two intersecting rectangles.
- August 20, 1998 K981910 Suction Catheter Kit
INDICATIONS FOR USE
The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.
\✓ Prescription Use
name
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .
P.O. BOX 871 1601 AIR PARK DR FARMINGTON, MO 63640-0871 PHONE: 573-756-1255 FAX: 573-756-1256