(272 days)
RMS HigH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are 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 grade needle mounted to a butterfly assembly on one end, and a luer lock on the other end, connected by medical grade tubing. The needles are available in 24 and 26 gauges and in lengths of 4mm, 6mm, 12mm and 14mm. The 4mm and 14mm lengths are added for children and obese adult patients, respectively. The optional convenience 24" Extension Set is used to add length to a needle set when desired.
There is a snap closure to safely capture the needle after use. This minimizes the potential for a needlestick injury. Each leg in a set is equipped with a slide clamp to stop flow immediately, if needed. The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are available for up to 8 infusion sites using our basic sets of one, two, three or four legs ganged together using a low residual "Y-Connector" (for example to achieve a 7 site infusion, a RMS 4 set will be ganged with a RMS 3 set using a Y-Connector). All needle sets, regardless of combination, are for single use only.
The provided text describes the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and the studies performed to demonstrate its substantial equivalence to predicate devices, particularly focusing on performance, biocompatibility, and safety.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Device Performance (RMS HIgH-Flo™ Subcutaneous Safety Needle Sets) | Study/Method to Prove Acceptance |
|---|---|---|
| Biocompatibility | ||
| Systemic Toxicity (Extract - NaCl) | Meets acceptable ISO criteria | ISO Systemic Toxicity Study |
| Systemic Toxicity (Extract - Sesame Oil) | Meets acceptable ISO criteria | ISO Systemic Toxicity Study |
| Subcutaneous Implantation (Rabbits - 6wks) | Meets acceptable ISO criteria | ISO Subcutaneous Implantation Study |
| Non-pyrogenic | Within acceptable USP limits ( and ) | Pyrogen Study (Material Mediated), Limulus Amebocyte Lysate |
| Cytotoxicity | Equal to, or better than, predicate devices | Studies submitted for predicate K102512 |
| Irritation | Equal to, or better than, predicate devices | Studies submitted for predicate K102512 |
| Sensitization | Equal to, or better than, predicate devices | Studies submitted for predicate K102512 |
| Hemocompatibility | Equal to, or better than, predicate devices | Studies submitted for predicate K102512 |
| Safety | ||
| Minimized needlestick injury potential | Snap closure safely captures needle after use | Device design, Clinical Simulated Use Study |
| Overall safety classification | Met criteria, classified as "safety sets" | RMS Clinical Simulated Use Study (per FDA guidance, FDA reviewed protocol) |
| No adverse effects/complications | No adverse effects or complications reported | RMS Clinical Simulated Use Study |
| Critical/Essential task evaluation | All critical and essential tasks evaluated, no difficulties | RMS Clinical Simulated Use Study |
| Performance (Flow Rate) | ||
| Flow rate with 7-needle sets (26G) | No degradation of flow compared to single 26G set | Comparison test (26 gauge sets up to 8-needles) |
| Leg-to-leg consistency (7th/8th needles) | No negative effect on leg-to-leg consistency | Additional test |
| Flow rate with 24 gauge needle set | Equal or better flow performance than Evans and MarCal predicate devices (up to 8-needle configurations) | Flow testing (24 gauge sets up to 8-needles) |
| Flow rate vs. predicate 27G | 26 gauge RMS HIgH-Flo™ flows better | Flow testing (comparison to predicate 27G) |
| Flow rate vs. predicate Evans 24G | 26 gauge RMS HIgH-Flo™ flows somewhat better | Flow testing (comparison to Evans 24G) |
| Flow rate vs. predicate MarCal 24G | 26 gauge RMS HIgH-Flo™ flows slower | Flow testing (comparison to MarCal 24G) |
| Flow rate 24G vs. all predicates | Flows as well as, or better than, any listed predicate devices | Flow testing (comparison to all predicates) |
| Flow degradation with 7th/8th 24G needles | No degradation of flow rates | Second test (24 gauge, single vs. multiple configurations) |
| Flow variation (leg-to-leg 24G) | Less than 7% | Second test (24 gauge, leg-to-leg consistency) |
| Flow with 5cp viscosity fluid (24G) | Thicker drugs will flow as designed | Flow test (24 gauge with 5cp viscosity fluid) |
| Impact of 24" Extension Set (26G) | Minor impact on flow rate | Flow test |
| Residual Volume | ||
| Priming/residual volumes | Similar performance to predicate devices (substantially equivalent) | Priming/residual volume measurements |
| Sterilization & Shelf Life | ||
| Packaging/product integrity (3-year aging) | Acceptable integrity, no degradation of product | ISO 11137 aging studies (dye migration, bag seal, luer function, needle/hub bond, flexibility, butterfly wing performance, luer/tube integrity) |
| Material Characteristics | Identical or equivalent medical grade materials as predicates | Materials Comparison Chart |
| Device Characteristics | Equivalent physical properties, material grade, indications for use, compared to predicates for 4mm and 14mm needle lengths | Predicate Device Comparison Chart |
| Needle Tip Measurements | No substantial difference from predicate devices | Comparison of needle tip dimensions |
| Performance Testing (General) | Similar performance to predicate devices | Needle tip, stiffness, resistance to breakage and corrosion, conical fitting, and fatigue tests |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size for individual tests within the "Clinical Simulated Use Study" or the flow rate studies. It mentions "medical professionals participated" in the clinical study and "comparative tests" and "flow tested" for the performance studies without giving specific numbers of devices or test runs.
- Provenance: This is a 510(k) summary submitted to the FDA (United States). The studies appear to be internal RMS Medical Products studies ("RMS internal procedure (SOP 8001)") or performed in accordance with international (ISO) and national (USP) standards, indicating the data is likely from studies conducted by or for the manufacturer. The document doesn't specify countries of origin for the test data beyond the manufacturer's location in New York, USA.
- Retrospective/Prospective:
- Biocompatibility and Sterilization/Shelf Life: These are typically prospective laboratory/animal studies.
- Clinical Simulated Use Study: This was a prospective study ("medical professionals participated in an RMS Clinical Simulated Use Study, per FDA guidance documents with FDA review of the proposed protocol").
- Performance Testing (flow rate, residual volume, material/device characteristics): These were prospective laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document mentions "medical professionals participated" in the RMS Clinical Simulated Use Study. However, it does not specify the number or qualifications of these medical professionals, nor does it explicitly define their role in establishing a "ground truth" in the way one might for diagnostic accuracy studies. Their role was to evaluate the device during simulated use, and their subjective and statistical data contributed to the safety determination.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth from multiple experts. For the "Clinical Simulated Use Study," it states, "An analysis of all subjective and statistical data concludes that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets met the criteria set." This implies an analysis of the collected data rather than a consensus or adjudication process among multiple reviewers to determine a 'truth' independently.
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 MRMC Comparative Effectiveness Study: This device is a medical device (subcutaneous needle set), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The studies focus on the physical performance, biocompatibility, and safety of the needle set itself.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable: As this is a physical medical device and not an AI algorithm, a standalone performance study in the context of AI is not relevant. The device's performance is standalone in the sense that its physical properties (flow rate, material, etc.) are tested without human intervention impacting the measurement of those properties, but it is ultimately used by a human.
7. The Type of Ground Truth Used
The concept of "ground truth" in the context of this device's evaluation is primarily based on:
- Established Scientific Standards: For biocompatibility (ISO standards), pyrogenicity (USP limits), and sterilization (ISO 11137).
- Pre-defined Acceptance Criteria: For the Clinical Simulated Use Study, criteria were "set" and the device "met the criteria."
- Direct Measurement and Comparison: For flow rates, residual volumes, material characteristics, device dimensions, and mechanical properties, the "ground truth" is the measured physical data, which is then compared against predicate devices and internal performance expectations.
8. The Sample Size for the Training Set
- Not applicable: This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As there is no training set for an AI algorithm, this question is not relevant.
§ 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.