(42 days)
Not Found
No
The summary describes a mechanical device for transferring medication and does not mention any computational or learning capabilities.
No.
The device is described as a medical accessory used to transfer medication, not to treat or cure a medical condition itself.
No
Explanation: The device is used for transferring medication, which is a therapeutic or procedural function, not a diagnostic one. It facilitates the handling of medication but does not provide information about a patient's health status.
No
The device description clearly states it is a physical, sterile, nonpyrogenic vial adapter with a filter, indicating it is a hardware device.
Based on the provided information, the CODAN Spike is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transfer medication between vials, syringes, and IV sets. This is a drug delivery and preparation function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on its function as a vial adapter for preparing and withdrawing medications, including a filter for safety. This aligns with a drug handling device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Predicate Devices: The predicate devices listed (Acacia Transfer Pins and B. Braun Mini-Spike® Dispensing Pin™) are also devices used for transferring and preparing medications, not for in vitro diagnostic testing.
In vitro diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. The CODAN Spike's function is entirely focused on the handling and preparation of medications for administration to a patient, which falls outside the scope of IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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/0 description: The image shows the letters 'm', 'd', and 'i' in a simple, outlined font. The letters are arranged horizontally, with 'm' on the left, 'd' in the middle, and 'i' on the right. The letters are all in lowercase and have a uniform line thickness. The overall impression is clean and legible.
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.
1
m oli
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.