CHEMO DISPENSING PIN, MODEL 12495

• K Number: K024239
• Device Name: CHEMO DISPENSING PIN, MODEL 12495
• Manufacturer: ABBOTT LABORATORIES
• Date Cleared: 2003-01-13 ( 21 days)
• Product Code: LHI
• Regulation Number: 880.5440
• Type: Special
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K081361

Intended Use

For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a 510(k) clearance letter from the FDA for a device called "Chemo Dispensing Pin," which primarily addresses regulatory approval based on substantial equivalence to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes or data provenance for any test sets.
• Information on the number or qualifications of experts establishing ground truth.
• Adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
• Details of a standalone algorithm performance study.
• The type of ground truth used.
• Sample sizes for a training set or how ground truth for a training set was established.

This document is a regulatory approval notice, not a study report or technical specification outlining performance metrics and validation studies.

Summary

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

Regulation Number and Section

§ 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.