(367 days)
RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).
The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90-degree, 26gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.
The provided document is a 510(k) premarket notification for a medical device (HIgH-Flo Super26™ Subcutaneous Needle Sets) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving acceptance criteria for a new AI/software-based device.
Therefore, many of the requested details regarding acceptance criteria for a study proving device performance (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document as it's primarily a regulatory submission for a physical medical device based on bench testing for an incremental design modification, not a study of an AI algorithm or a diagnostic tool requiring extensive human reader involvement or ground truth establishment in a clinical context.
However, I can extract information related to the acceptance criteria for this specific device, which are mainly focused on bench performance to demonstrate equivalence.
Here's an attempt to answer the questions based on the provided text, noting where specific questions are not applicable to this type of regulatory submission:
Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)
The study described here is a bench performance study designed to demonstrate that the redesigned device (HIgH-Flo Super26™ Subcutaneous Needle Sets) is substantially equivalent to its predicate device (Integrated Catch-up Freedom Syringe Driver Infusion System) despite differences in tubing diameter and needle set configurations. The primary performance metric assessed is flow rate.
1. A table of acceptance criteria and the reported device performance
Given that this is a 510(k) summary for a physical device where the "acceptance criteria" are implicitly meeting functional specifications and demonstrating performance comparable to a predicate, the "acceptance criteria" are not explicitly stated with numerical thresholds in the same way they would be for an AI algorithm's performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "conclusion" is that the device "performs as intended and is substantially equivalent to the predicate device" based on bench testing.
The reported device performance presented is the achievable flow rates under various conditions (different fluid types, number of needles, and pump settings). The tables themselves represent the performance data that presumably met the implicit acceptance criteria of demonstrating comparable or improved flow for the intended use.
Implicit Acceptance Criteria (derived from context):
- Biocompatibility: Device materials must meet ISO 10993 standards and be non-hemolytic.
- Flow Rate: The device must achieve flow rates suitable for the intended subcutaneous infusion of specified medications (Hizentra, Cuvitru) across various needle configurations and pump settings, and ideally meet or exceed drug manufacturer's recommended flow rates. The stated purpose of the design modification was to allow for "high flow rates."
- Sterility, non-pyrogenicity, single-use, safety features: These are standard performance and design criteria for such devices.
Reported Device Performance:
The document provides tables of "Achievable Flow Rates with Super26™ and Specific Medications/Indications." These tables are the reported performance data. For brevity, only a summary of insights from these tables is provided here, rather than reproducing them entirely:
| Performance Aspect / Criteria | Reported Device Performance (HIgH-Flo Super26™) |
|---|---|
| Biocompatibility | Meets ISO 10993 requirements. Modified ASTM Hemolysis test showed 0.68% difference in hemolytic index, placing it in a non-hemolytic range. (Based on identical materials and manufacturing to predicate). |
| Hizentra - Max Flow Rate Per Site (ml/hr/site) (Example rows) | Varied by needle count and pump setting. Examples (F275 pump setting): |
- 1 needle: 19.5 ml/hr/site
- 4 needles: 5.8 ml/hr/site
- 8 needles: 3.0 ml/hr/site
Some combinations "Exceeds drug manufacturer's maximum indicated flow rate." |
| Hizentra® CIDP - Max Flow Rate Per Site (ml/hr/site) (Example rows) | Varied by needle count and pump setting. Examples (F275 pump setting): - 1 needle: 19.5 ml/hr/site
- 4 needles: 5.8 ml/hr/site
- 8 needles: 3.0 ml/hr/site
Some combinations "Exceeds drug manufacturer's maximum indicated flow rate." |
| Cuvitru™ PI - Max Flow Rate Per Site (ml/hr/site) (Example rows) | Varied by needle count and pump setting. Examples (F275 pump setting): - 1 needle: 19.1 ml/hr/site
- 4 needles: 5.7 ml/hr/site
Some combinations "Exceeds drug manufacturer's maximum indicated flow rate."
*Some combinations were "Flow rate per site is lower than what is recommended on the biologic label" (e.g., 1-4 needles at lower F-settings). |
Note on "Acceptance Criteria" for this submission: The document states, "Bench testing has been conducted to verify that the product performance of the subject device and predicate device are substantially equivalent." The tables of flow rates are the data used to demonstrate this equivalence, implicitly meeting the "acceptance criteria" that the new design performs effectively for its intended use.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of devices tested for flow rates. The text only mentions "Bench Performance Studies" and "Flow Rate Testing." Typical bench testing involves a statistically significant number of samples, but the exact count isn't in this summary.
- Data Provenance: The data is generated from bench testing conducted by the manufacturer, Repro-Med Systems, Inc. dba RMS Medical Products. It is not clinical data from patients.
- Retrospective or Prospective: N/A. This is bench testing, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical device (subcutaneous needle set) and the "ground truth" for flow rate performance is established through repeatable physical measurements using laboratory equipment (e.g., pumps, timers, volume measurements), not by expert human interpretation of images or other clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. See point 3.
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
- N/A. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance (flow rate) is established via direct physical measurement during bench testing. For biocompatibility, it's based on laboratory test results (ISO 10993 series standards, Modified ASTM Hemolysis).
8. The sample size for the training set
- N/A. This is not an AI/machine learning device that requires a training set. The device is a physical product for which performance is verified through engineering bench tests.
9. How the ground truth for the training set was established
- N/A. See point 8.
In summary: The provided document is a 510(k) premarket notification for a physical medical device, not an AI or software-based medical device. Therefore, many of the questions related to AI study design, expert ground truth, and human reader studies are not applicable. The "study" proving the device meets acceptance criteria is primarily bench testing to demonstrate functional equivalency, particularly concerning flow rates and biocompatibility, compared to a legally marketed predicate device.
§ 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.