(32 days)
The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.
The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
The provided text describes a 510(k) premarket notification for a medical device, the CADD® Administration Set and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive studies.
Therefore, the typical structure for reporting acceptance criteria and study details for an entirely new device (including metrics like sensitivity, specificity, or reader performance improvement) is not directly applicable here. Instead, the "acceptance criteria" can be inferred as demonstration of "substantial equivalence" to the predicate device, supported by functional testing and comparisons.
Here's how the information can be organized based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Comparison with Predicate Device) |
|---|---|
| Intended Use Equivalence: Designed for fluid delivery with Deltec CADD® Pumps from a flexible remote bag with female luer connector. | Matches: "The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector." (Identical to predicate CADD® Admin Set, and similar to Sabratek) |
| Compatibility with Remote Flexible Reservoir: Capable of being used with a remote flexible reservoir. | Matches: YES (for both the new device with accessories and all predicate devices) |
| Compatibility with Enclosure for Medication Access Limitation: Capable of being used with an enclosure and remote flexible reservoir to limit access to medication. | Matches: YES (Modified Security Shell, Security Shell Adapter, and 250 ml Flexible Medication Reservoir included as part of this submission; similar to predicate Sabratek and CADD® Admin Set) |
| Free Flow Protection Mechanism: Includes a mechanism to protect against unregulated gravity infusion. | Matches: YES (Add-on anti-siphon valve) (Similar to predicate CADD® Admin Set, Sabratek status unknown) |
| Biocompatibility: Fluid path components must be biocompatible. | Meets: Biocompatibility testing was conducted on the set's fluid path components, and results indicated that the fluid path materials are biocompatible. |
| Physical Dimensions (Nominal): Dimensions of the administration set. | Similar: |
- Length: 69 in. (Predicate CADD®: 77 in., Sabratek: 56 in.)
- Tubing I.D.: 0.040 in. (Predicate CADD®: 0.040 in., Sabratek: Unknown)
- Tubing O.D.: 0.105 in. (Predicate CADD®: 0.105 in., Sabratek: Unknown)|
| Priming Volume: Priming volume of the administration set. | Similar: 2 ml (Predicate CADD®: 2.3 ml, Sabratek: 3 ml) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size for "test sets" in the typical sense of clinical trials. The evaluation was primarily based on comparative analysis of design specifications and functional testing (biocompatibility).
- Data Provenance: The biocompatibility testing would have been conducted in a laboratory setting, likely in the US (as the applicant is SIMS Deltec, Inc. in St. Paul, MN). The comparison data for predicate devices is based on their known specifications.
- Retrospective or Prospective: Primarily retrospective comparison to predicate device specifications and prospective laboratory testing for biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable to this type of submission. "Ground truth" in the context of clinical device performance, expert consensus, or pathology is not established for this 510(k). The evaluation relies on engineering and material science principles, and comparison to existing, legally marketed devices.
4. Adjudication Method for the Test Set
- Not applicable. No clinical adjudication process involving human reviewers or experts for specific cases is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device for fluid administration, not an imaging or diagnostic AI-powered device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. There is no "algorithm" or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the comparison of functional and design specifications is the published specifications and documented performance of the legally marketed predicate devices.
- For biocompatibility, the "ground truth" is established by biocompatibility testing standards and protocols.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set."
Summary of the Study:
The "study" presented here is a functional and comparative analysis rather than a clinical trial.
- Functional Testing: Biocompatibility testing was performed on the fluid path components of the new CADD® Administration Set and Accessories.
- Comparative Analysis: The new device was compared to two predicate devices: an existing CADD® Administration Set (manufactured by SIMS Deltec, Inc.) and the Sabraset™ 560500-100 Administration Set (manufactured by Sabratek). This comparison covered intended use, compatibility with remote reservoirs and security enclosures, free-flow protection, and physical dimensions (length, tubing diameter, priming volume).
Conclusion:
The results of the biocompatibility testing indicated that the materials were acceptable for human use. The comparison demonstrated that the new CADD® Administration Set and Accessories are substantially equivalent to the predicate devices in terms of materials, design, and function, thereby meeting the requirements for 510(k) clearance. Clinical studies were not deemed necessary due to this demonstrated similarity.
§ 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.