(511 days)
SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.
Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation.
Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.
Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports).
Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body.
Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.
Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers.
Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:
The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants.
Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim.
All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.
The SafePort™ Manifold (or Stopcock) is a medical device used for flow control and fluid delivery in IV therapy. Based on the provided document, the device did not undergo clinical studies, therefore, there is no information about reader studies, effect sizes, training sets, or expert qualifications. The performance data is derived from non-clinical laboratory testing.
Here's the summary of the acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison to a predicate device and lists various non-clinical performance tests. The acceptance criteria for most tests remained the same as previously established. A specific difference in handle door burst pressure is noted but deemed clinically non-sensible. Since specific numerical acceptance criteria are not provided for all tests, the table below will describe the test and the reported outcome.
| Test Category | Acceptance Criteria (Internal/Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993-1, -4, -5, -10, -11) | Standard per ISO 10993 series and FDA Guidance | All tests performed successfully on final-sterile devices (Cytotoxicity, Maximization Sensitization, Intracutaneous Study, Acute Systemic Toxicity, Pyrogen Study, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Platelet Activation). |
| Initial Handle Torque Test | Based on internal protocol (K032393) | Performed successfully. |
| Handle Stopper Torque (Override) Test | Based on internal protocol (K111016) | Performed successfully. |
| Leakage Tests (200 kPa / 2 bar & 300 kPa / 3 bar) | Recognized standard ISO 8536-10:2015 | Performed successfully. (Note: 3 bar maximum pressure tested for standard port, predicate was 2 bar). |
| Leakage Test (50 kPa / 0.5 bar) | Recognized standard ISO 8536-10:2015 | Performed successfully. |
| Vacuum Test | Recognized standard ISO 8536-4:2010 | Performed successfully. |
| Handle "Door" Burst Pressure Test | Based on internal protocol (K111016). (Note: 1.5 PSI difference from predicate, but deemed clinically insignificant) | Performed successfully. |
| Chemical Resistance (Lipid) for 24 hours | Based on internal protocol (K111016) | Performed successfully. |
| Flow Rate Test (ISO 8536-4:2010) | Recognized standard ISO 8536-4:2010 | Performed successfully. |
| Particulate Contamination Test | Recognized standard ISO 8536-4:2010 | Performed successfully. |
| Subvisible Particulate Matter Test | USP | Performed successfully. |
| Luer Tests (ISO 80369-7:2016 & ISO 80369-20:2015) | Recognized standards ISO 80369-7 and ISO 80369-20 | Performed successfully (Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding). |
| Luer Dimensions Measurement | Based on internal protocol for Stopcocks and Manifolds | Performed successfully. |
| LAV Cap Wiping Effectiveness | AAMI TIR30:2011/(R)2016, ISO 11737-1:2018, FDA Guidance | Performed successfully. |
| Flow Rate Test (ISO 1135-4:2015) | Recognized standard ISO 1135-4:2015 | Performed successfully. |
| Blood Leakage Test in Low Pressure | Recognized standards ISO 1135-4:2015 and ISO 8536-10:2015 | Performed successfully. |
| Mechanical Hemolysis (main line) | Recognized standards ASTM F756-17 and ISO 10993-4 | Performed successfully. |
| LAV Microbial Ingress Study | AAMI/ISO CN27:2021 and FDA Guidance | Performed successfully. |
| Shelf-life Package Tests | ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F1980-16, ASTM F2096, ASTM F1140/F1140M, ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929 | Performed successfully after sterilization, shipping simulation, and accelerated aging. Included bubble, burst, peel (manual and mechanical), dye, and visual tests. Note: Validated shelf life for 3 years, compared to predicate's 5 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "Performance tests were conducted successfully by Elcam in order to validate the changes presented in this 510(k) Submission using well established methods." These are laboratory tests conducted by the manufacturer, Elcam Medical ACAL, based in Kibbutz Baram, Merom HaGalil, Israel. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document explicitly states: "No clinical Study was performed for the purpose of this submission." The evaluation relies on non-clinical performance testing against recognized standards and internal protocols, not expert-derived ground truth from patient data.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical study or human reader evaluation was performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on non-clinical performance testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a physical medical device (SafePort™ Manifold or Stopcock) and not an AI algorithm.
7. The Type of Ground Truth Used
For non-clinical performance testing, the "ground truth" is defined by adherence to established, recognized consensus standards (e.g., ISO, ASTM, USP, AAMI TIR) and Elcam's internal, previously validated test methods and specifications. These standards provide objective criteria for device performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
§ 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.