(21 days)
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No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities typically associated with these technologies (like image processing for analysis or decision-making based on learned patterns). The intended use is purely for preparing and dispensing fluids.
No
Explanation: The device is described as preparing and dispensing I.V. fluids and chemotherapeutic medications, which are tasks related to drug preparation and delivery, not direct therapeutic treatment of a disease or condition.
No
The intended use is for "preparing and dispensing I.V. fluids and chemotherapeutic medications," which is a preparative or dispensing function, not a diagnostic one.
No
The intended use describes a device for preparing and dispensing fluids from vials, which strongly suggests a physical device with hardware components, not a software-only solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials." This describes a process related to preparing and handling medications for administration to a patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with patient specimens or diagnostic purposes.
The device appears to be a system for handling and preparing medications, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials
Product codes
LHI
Device Description
Chemo Dispensing Pin
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 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them that could represent water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Mr. Nicohl R. Wilding Specialist, Regulatory Affairs Abbott Laboratories Hospital Products Division Dept. 0389, Building J-45 200 Abbott Park Road Abbott Park, Illinois 60064-6133
Re: K024239
Trade/Device Name: Chemo Dispensing Pin Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: December 20, 2002 Received: December 23, 2002
Dear Mr. Wilding:
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.
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Page 2 - Mr. Wilding
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 (QS) 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 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 (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timot A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (If known)
Device Name: Chemo Dispensing Pin
Indications For Use:
Chemo Dispensing Pin intended use
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For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR Over-The_Counter Use________
Patrice Cucenti
(Division of Anesthesiology, General Hospital, Infection Control, Der
510(k) Number. K024239