(198 days)
The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury
The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder.
The Sol-Care Safety Blood Collection Needle consists of:
- Stainless steel cannula (Intravenous end and Non-patient end of Cannula)
- Wings (Color coded according to needles gauge)
- Tubing
- Female luer adaptor
- Intravenous (IV) needle protector (covers the needle before use)
The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.
The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.
The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder) meets these criteria. Since this is a medical device submission, the "acceptance criteria" are derived from recognized ISO standards and specific internal test protocols, and the "reported device performance" is the successful completion of these tests.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Form/Fit/Functionality | ISO 8536-4:2010 (Infusion Sets) | Met appropriate requirements. |
| ISO 7864:1993 (Sterile Hypodermic Needles) | Met appropriate requirements. | |
| PRJ001_096: Butterfly Needle Chemistry Test | Protocol and Report successfully completed. | |
| PRJ001_062: Butterfly Needle Appearance and Size Test | Protocol and Report successfully completed. | |
| PRJ001_060: Butterfly Needle Systematic Flow Test | Protocol and Report successfully completed. | |
| PRJ001_056: Butterfly Needle Systematic Blocking Test | Protocol and Report successfully completed. | |
| PRJ001_057: Butterfly Needle Protector Drawing Force Test | Protocol and Report successfully completed. | |
| PRJ001_054: Butterfly Needle Puncture Force Test | Protocol and Report successfully completed. | |
| PRJ001_053: Butterfly Needle Unlocking Force Test | Protocol and Report successfully completed. | |
| PRJ001_052: Butterfly Needle Shield Pulling Force Test | Protocol and Report successfully completed. | |
| PRJ001_049: Butterfly Needle Rubber Sealing Test | Protocol and Report successfully completed. | |
| Sharps Injury Protection | ISO 23908:2011 (Sharps Protection Features) | Met appropriate requirements. |
| Simulated Use Study with Nurse Evaluators | Successfully demonstrated effectiveness. | |
| Packaging & Sterilization | ISO 11607-1:2009+A1:2014 (Packaging for Sterilized Medical Devices) | Met appropriate requirements. |
| ISO 11607-2:2006 (Validation for Forming, Sealing, Assembly Processes) | Met appropriate requirements. | |
| Seal Validation of the Soft Pack | Successfully completed. | |
| Seal Validation of the Hard Pack | Successfully completed. | |
| Simulated Transit Test for the Soft Pack | Successfully completed. | |
| Simulated Transit Test for the Hard Pack | Successfully completed. | |
| Accelerated Aging (Soft Pack, 0, 1, 2, 3 years) | Product testing at specified time points successfully completed. | |
| Accelerated Aging (Hard Pack, 0, 1, 2, 3 years) | Product testing at specified time points successfully completed. | |
| Low Temperature (-20°C) Product Qualification | Successfully completed. | |
| High Temperature (60°C) Product Qualification | Successfully completed. | |
| ISO 11135-1:2007 (Ethylene Oxide Sterilization Confirmation and Routine Control) | Device family adopted into existing validated sterilization, complying with AAMI TIR 28. Cycle validated per ISO 11135-1:2014. | |
| Interoperability/Connections | ISO 594-2:1998 (Conical fittings with 6% Luer taper) | Met appropriate requirements. |
| PRJ001_059: Butterfly Needle Systematic Leakage Test | Protocol and Report successfully completed. | |
| Biocompatibility | ISO 10993-1:2006 (Biological evaluation of medical devices) | Met appropriate requirements. |
| Cytotoxicity | Successfully completed. | |
| Irritation Test/Intracutaneous Reactivity | Successfully completed. | |
| Sensitization Study | Successfully completed. | |
| USP and ISO Systemic Toxicity Studies | Successfully completed. | |
| Haemolysis test | Successfully completed. | |
| Thrombosis Testing | Successfully completed. | |
| Complement Activation C3a and SC5b-9 Assay (GLP) | Successfully completed. | |
| ASTM Hemolysis Assay Direct Contact and Extract Method (GLP) | Successfully completed. |
Important Note: The document consistently states "met the appropriate requirements" or "Protocol and Report successfully completed" for each test, implying that the device successfully passed all established criteria within those tests/standards. The specific quantitative acceptance thresholds are not detailed in this summary document but would be part of the full test reports (e.g., PRJ001_096).
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2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but a "Simulated Use Study with Nurse Evaluators" was conducted, implying human interaction with the device. For the accelerated aging tests, product testing occurred at "time 0, years 1, 2 and 3," which points to batches of devices being tested.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by the manufacturer or their contracted laboratories as part of their premarket submission. The regulatory context (FDA 510(k) submission in the USA) implies the data is generated for US regulatory standards. All nonclinical tests are listed, indicating these are internal or contract lab results rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is largely not applicable in the context of this device and report. The "ground truth" for a blood collection needle in this submission is established by adherence to recognized engineering and biocompatibility standards (e.g., ISO, ASTM). Performance is measured against physical, chemical, and biological criteria, not against expert medical interpretations of complex images or patient outcomes in the same way an AI diagnostic device would be.
- A "Simulated Use Study with Nurse Evaluators" was conducted, indicating that nurses (experts in using such devices) evaluated the device. However, the number and specific qualifications (beyond "nurse") are not detailed, and their role was likely to assess usability and safety features in a simulated environment, rather than establishing a "ground truth" diagnosis.
4. Adjudication method for the test set
- Not applicable in the context of this submission. Adjudication methods like 2+1 or 3+1 panels are typically used to establish a definitive "ground truth" when interpreting subjective data (e.g., medical images). This submission focuses on objective engineering, material, and biological performance criteria against established standards, where the test results themselves constitute the "ground truth" of performance.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (blood collection needle), not an AI diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" for performance is based on fulfilling the requirements of International Standards (ISO, ASTM) and internal validated test protocols. This includes:
- Engineering specifications (e.g., flow rate, puncture force, needle dimensions).
- Material properties (e.g., chemical compatibility, strength).
- Safety features physical performance (e.g., pulling force for shield activation, locking mechanism).
- Sterility assurance levels.
- Biocompatibility testing results (e.g., cytotoxicity, hemolysis).
- Packaging integrity (e.g., seal strength, transit simulation).
- The Simulated Use Study with Nurse Evaluators provides practical "ground truth" for usability and effective activation of the safety mechanism by intended users.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm is involved.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.