(568 days)
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No
The summary describes a simple intravenous infusion device (Y Set) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: A therapeutic device is used to treat or cure a disease or medical condition. This device is an "infusion of drug solutions and fluids" intended to connect multiple infusion lines, not to directly treat or cure a condition itself.
No
The device is described as connecting multiple infusion lines for administering intravenous fluids, not for diagnosing conditions.
No
The device description and intended use clearly describe a physical medical device (intravenous infusion set) and do not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravenous infusion of drug solutions and fluids" and connects "multiple infusion lines" for administration into a "cannula." This describes a device used in vivo (within the body) for delivering substances directly into the bloodstream.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
The description focuses on the physical administration of fluids into a patient, which is characteristic of a device used for therapeutic or supportive purposes in vivo, not for diagnostic testing in vitro.
N/A
Intended Use / Indications for Use
The Y Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 (FR 801.109(b)(1))
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
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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
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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.
0
Image /page/0/Picture/1 description: The image shows a logo with three stylized birds in flight, arranged diagonally from the upper right to the lower left. The birds are depicted with curved lines, suggesting movement and freedom. The birds are enclosed within a circular border, which appears to be made up of small, indistinct elements, possibly text or symbols. The logo has a simple, monochrome design, with the birds and border rendered in black against a white background.
Rockville MD 20850
AUG 2 9 2003
Dr. George O'Neil P.T. Greenleaf 25 Shann Street Floreat Perth, 6014 Western Australia
Re: K020419
Trade/Device Name: V Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 11, 2003 Received: August 14, 2003
Dear Mr. O'Neil:
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.
1
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 vour device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. 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 vours.
Susan Russo
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center of Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K020419 510 (k) Number:
Trade Name: V Set
Indications For Use:
The Y Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 (FR 801.109(b)(1))
Pulivan Cucente
510(k) Number. K020419