(77 days)
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Not Found
No
The summary describes a mechanical fluid flow controller and contains no mention of AI, ML, or related concepts.
Yes
The device is used to regulate the flow of fluids to a patient's vascular system, which implies it is used for treatment or palliation, thus qualifying it as a therapeutic device.
No
The device regulates the flow of fluids, which is a therapeutic or delivery function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly indicates a physical device ("A device used to regulate the flow of fluids from a container..."). 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 describes a device that regulates the flow of fluids into a patient's vascular system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
The device described is a medical device used for administering fluids directly to a patient, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.
Product codes
FPA
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 vascular system
Indicated Patient Age Range
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Intended User / Care Setting
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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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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines extending from the head, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Mr. Greg Holland ·Principal Computer Medical Diagnostics (CMeD) 3722 Avenue Sausalito Irvine, California 92606
Re : K981157 Trade Name: Stable Flow IV Flow Controller Regulatory Class: II Product Code: FPA March 27, 1998 Dated: Received: March 31, 1998
Dear Mr. Holland:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
1
Page 2 - Mr. Holland
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
Timothy R. Valentine
Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
!】
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K981157
Stable Flow, I.V. Flow Controller Device Name:
Indications For Use:
=
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A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sand Salata La La Millio Samura Persona mana a comments and manus and manus and (Division . . . . . . . . . Division - 19- - 1. enfection Control, and Goneral Terrains and ces-
$10(k) = 11:100 = ____________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Date of Application March 27, 1998