(261 days)
RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
The RMS Subcutaneous Needle Set is a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel needle mounted to a butterfly on one end, and a luer lock on the other end, connected by medical grade tubing. Each set is equipped with a slide clamp used to stop flow immediately, as well as a snap together capture arrangement used to close the set upon completion. RMS Subcutaneous Needle Sets are available as single sets, as well as 2-needle, 3-needle, 4-needle, 5-needle and 6-needle assemblies, with the use of a low residual volume Y or multi-connector. The device is for single use only.
The provided text describes a 510(k) summary for the RMS Subcutaneous Needle Set, which aims to demonstrate substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria in the sense of a novel AI or diagnostic device. Therefore, several of the requested sections about AI-specific criteria (e.g., sample size for AI test and training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of submission.
However, I can extract information related to performance testing that served to support the claim of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are implicitly defined by demonstrating that the device performs similarly to or better than the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The reported performance is compared directly to the predicate devices.
| Performance Characteristic | Acceptance Criteria (Implicit: Comparable or Better than Predicate) | RMS Device Performance (K102512) | Predicate Device 1 Performance (Evans Medical, K020530) | Predicate Device 2 Performance (Marcal Medical, K082818) |
|---|---|---|---|---|
| Fluid Flow Rate | Comparable or better than predicate devices | 1996.35 (Total for 26G) | 838.98 (Total for 27G), 1988.98 (Total for 24G) | 4041.17 (Total for 24G) |
| Priming/Residual Volume | Comparable or better than predicate devices | Lower values across all needle counts (e.g., 0.074ml for 1-needle) | Higher values across all needle counts (e.g., 0.23ml for 1-needle) | Higher values across all needle counts (e.g., 0.15ml for 1-needle) |
| Needle Tip Dimensions | No substantial difference from predicate devices | Top Angle: 52.3°, Side Angle: 16.5°, Length: 0.018 in | Top Angle: 52.3°, Side Angle: 16.5°, Length: 0.022 in | Top Angle: 51.9°, Side Angle: 16.3°, Length: 0.016 in |
| Wing Flexibility | Equal or better (less force to flex) than predicate devices | Mean: 22 grams (less force) | Mean: 39 grams | Mean: 48 grams |
| Sterility 10-6 | PASS | PASS | (Not explicitly stated for predicates, assumed to meet standard) | (Not explicitly stated for predicates, assumed to meet standard) |
| Biocompatibility | PASS for various tests (Cytotoxicity, Irritation, Sensitization, Hemocompatibility) | PASS for all listed tests | (Implicitly comparable as per textual claim for thrombogenicity and hemocompatibility) | (Implicitly comparable as per textual claim for thrombogenicity and hemocompatibility) |
| Materials | Similar enough not to raise new issues of safety/effectiveness | PVC, Polypropylene, 3M Dressing | PVC, Polyethylene, 3M Dressing | PVC, Polyethylene |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Flow Rate Testing: The table shows results for 4 individual measurements for each needle set configuration (Needle 1, 2, 3, 4). The "Total" represents the sum of these four measurements for each device type. Therefore, a sample size of 4 measurements per device type/configuration was used.
- Priming/Residual Volume Measurements: Not explicitly stated, but measurements are provided for 1-needle to 6-needle configurations for each device.
- Needle Tip Measurements: One measurement is provided for each characteristic (Top Angle, Side Angle, Length) for each company.
- Wing Flexibility: For each of the three manufacturers (RMS, Marcal, Evans Medical), 4 individual "Butterfly" measurements are provided for flexibility, along with a calculated mean.
- Biocompatibility/Sterility: These are standard compliance tests, typically performed on a statistically significant sample based on the specific ISO standards, but the exact sample sizes for each test are not detailed in this summary.
- Data Provenance: Not explicitly stated. The tests were performed according to RMS's "Needle Set Fluid Flow Rate Test Procedure" (SOP 5071) and ISO standards. The data is likely from laboratory testing conducted as part of the submission process, not from patient studies or specific geographical regions. It is retrospective in the sense that it was generated for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a medical accessory (subcutaneous needle set), and the testing performed involves objective physical and material performance measurements (e.g., flow rate, volumes, dimensions, flexibility, biocompatibility), not diagnostic image analysis or clinical assessment requiring expert consensus ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.
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
This is not applicable. This is a 510(k) submission for a physical medical device, not an AI/diagnostic software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is a 510(k) submission for a physical medical device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance comparisons in this 510(k) submission consists of objective physical measurements, material properties, and compliance with specified standards (e.g., ISO for sterility and biocompatibility). The predicate devices' performance serves as the benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" for physical device performance testing in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for physical device performance testing in this context.
§ 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.