(42 days)
The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set.
The Codan Spike is a sterile, nonpyrogenic, multiple dose vial adapter for the preparation and withdrawal of medications and cytotoxic solutions. The Codan Spike contains a 0.20 pm pressure resistant hydrophobic filter that is pressure stable and hydrophobic.
It appears the provided document describes a 510(k) premarket notification for a medical device called the "CODAN Spike Vial Adapter." This is a regulatory submission for a device, not a study evaluating an AI algorithm or diagnostic tool.
Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory approval, not to present performance data from a clinical or diagnostic study in the way you've outlined.
The document discusses:
- Device Name: CODAN Spike Vial Adapter
- Predicate Devices: Acacia Transfer Pins and Micron Filter (K901063), B. Braun Mini-Spike® Dispensing Pin™ (K925401)
- Device Description: A sterile, nonpyrogenic, multiple dose vial adapter with a 0.20 pm pressure resistant hydrophobic filter.
- Intended Use: To transfer medication from a vial to a syringe and from a syringe to an IV set.
- Comparison to Predicate Devices: Stated that the CODAN Spike is substantially equivalent to the predicate devices in materials, design, and intended uses.
There is no mention of acceptance criteria for a diagnostic performance study, results from such a study, sample sizes, ground truth, or expert involvement as would be relevant for an AI or diagnostic device evaluation.
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APR 17 1996
ATTACHMENT A 510(k) SUMMARY PAGE 1 of 2
Submitter's Identification:
CODAN MEDLON, INC. 3325 N. Glenoaks Boulevard 818-954-9541 Phone: Burbank, CA 91504 Fax: 818-848-7045
Contact Person: Aziz Mohabbat
Date Summary Prepared: March 1, 1996
Name of the Device:
CODAN Spike Vial Adapter
Predicate Device Information:
- ﻤﺴﺘﺸﻔﻪ Acacia Transfer Pins and Micron Filter (K901063) B. Braun Mini-Spike® Dispensing Pin™ (K925401)
Device Description:
The Codan Spike is a sterile, nonpyrogenic, multiple dose vial adapter for the preparation and withdrawal of medications and cytotoxic solutions. The Codan Spike contains a 0.20 pm pressure resistant hydrophobic filter that is pressure stable and hydrophobic.
Intended Use:
The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set.
Comparison to Predicate Devices:
The CODAN Spike is substantially equivalent to the Acacia Luer Lock Transfer pin and to the Braun Mini-Spike® Dispensing Pin™. The CODAN Spike and the predicate devices are constructed from the same materials and similar in design and intended uses.
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ATTACHMENT A 510(k) SUMMARY PAGE 2 OF 2
Conclusion:
The CODAN Spike is a sterile nonpyrogenic disposable device that is made of identical materials as the legally marketed predicate devices (Acacia Luer Lock Transfer Piamond the Braun Mini-Spike® Dispensing Pin™), with similar indications for user and is identically processed and sterilized.
§ 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.