(84 days)
Current Baxter Solution Administration Sets
No
The device description and performance studies focus on the mechanical components (spike and drip chamber) and their functional performance (air passage, leakage, tensile strength). There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a solution administration set, which is used for delivering solutions, not for therapy or treatment itself.
No
Explanation: The device description indicates it is a "solution administration set," which is used for delivering fluids, not for diagnosing conditions. The performance studies focus on functional aspects like "air passage, air leakage and tensile strength."
No
The device description explicitly states it is a "solution administration set" with physical components (spike and drip chamber), indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a "solution administration set" and its components (spike and drip chamber). This is a device used for delivering fluids into a patient, not for testing samples outside the body.
- Functional performance testing: The performance studies mentioned (air passage, air leakage, tensile strength) are related to the physical function and integrity of the administration set, not to diagnostic measurements of biological samples.
- Predicate device: The predicate device is "Current Baxter Solution Administration Sets," which are also devices for administering fluids, not for in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's description and testing clearly indicate it's for administering solutions to a patient, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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)
Data regarding the functional performance of the proposed spike and drip chamber assemblies have been generated including air passage, air leakage and tensile strength tests. Performance testing indicates that sets with the proposed components will meet or exceed all functional requirements.
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.
Current Baxter Solution Administration Sets
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.
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 a handwritten string of characters, "K961225". The characters are written in a bold, black font, and they appear to be on a white background. The characters are all connected, and they are all the same size.
N 21 1006
510(k) Premarket Notification Modified Solution Administration Sets
510(k) SUMMARY
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
March 18, 1996 .
Proposed Device: Modified Baxter Solution Administration Sets
Predicate Devices: Current Baxter Solution Administration Sets
Proposed Device Description:
Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed Baxter sets are the same as existing Baxter sets except for the design change in the spike and drip chamber components. All other components of the solution administration sets remain unchanged. The proposed spike and drip chamber components are identical in material composition and function to existing components. The spike remains the same in all container interfacing dimensions. Thus the proposed sets will continue to be compatible with both Baxter and competitive solution containers as was established in K860272 for the current spike design. Also the geometry of the drop former and portion of the spike which engages the drip chamber is the same as the current design.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Data regarding the functional performance of the proposed spike and drip chamber assemblies have been generated including air passage, air leakage and tensile strength tests. Performance testing indicates that sets with the proposed components will meet or exceed all functional requirements.