(124 days)
The Monarch Safety Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended to be used with evacuated blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use.
The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal. The Monarch Blood Collection set is not intended for infusion, IV administration, or transfusion.
The Monarch Blood Collection Set is a sterile, single-use, winged needle with tubing and luer connector. Each Monarch Blood Collection device is individually wrapped in a blister pouch. Monarch Blood collection sets include configurations for three (3) needle gauges (21, 23, 25) each with a tubing length of 12 inches. All the models are included with the back-end needle and a vacutainer holder.
A blood collection assembly, comprises of a needle assembly fixedly coupled to a fingeractivated actuator and tubing, the needle assembly comprising a needle; a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end defining a cavity and a distal passageway, the channel slidably engaging the fingeractivated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position toward a proximal end of the hub; an active closure assembly including a door and a biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door along the cavity to contact the needle; and a support wall positioned adjacent the cavity such that, when the finger-activated actuator is in the second position, the needle contacts the support wall.
Nature of contact duration for the device is limited exposure ≤ 24 h. Nature of body contact is external communicating device: Circulating blood.
This is a medical device 510(k) summary, not a study evaluating an AI algorithm, therefore, information regarding acceptance criteria, device performance, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The document describes the Monarch Blood Collection Set and compares it to a predicate device (SOL-GUARD™ Safety Pull-Button Blood Collection Set, K213718) to demonstrate substantial equivalence.
Here's the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of an AI algorithm study. Instead, it compares the technological characteristics and performance specifications of the Monarch Blood Collection Set to those of a predicate device. The performance aspects listed for the subject device include:
- Sterilization Method: Ethylene Oxide
- Sterility Assurance Level (SAL): 10^-6
- Non-pyrogenic: Yes
- Shelf life: 5 years (demonstrated with performance testing after 5 years of aging)
These are compared against the predicate device's characteristics to show substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission, not an AI algorithm study. There is no "test set" in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device submission, not an AI algorithm study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device submission, not an AI algorithm study.
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
Not applicable. This is a medical device submission, not an AI algorithm study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device submission, not an AI algorithm study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This is a medical device submission, not an AI algorithm study. The "ground truth" equivalent would be established by validated test methods and standards for medical devices (e.g., ISO, ASTM standards for sterilization, biocompatibility, needle safety, etc.).
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI algorithm study.
9. How the ground truth for the training set was established
Not applicable. This is a medical device submission, not an AI algorithm study.
General Device Information from the Document:
The provided document (a 510(k) summary) states that Monarch Blood Collection Set is substantially equivalent to a predicate device (SOL-GUARD Safety Pull-Button Blood Collection Set, K213718).
Study for Device Performance (Non-Clinical Testing):
The document references a comprehensive list of recognized standards and guidance documents under "8. Testing Summary for the Non-Clinical testing" (pages 9-10). These standards cover various aspects of the device's performance, safety, and manufacturing, including:
- Packaging: ISO 11607-1, ISTA-3A, ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F2096-11R19, ASTM F88/F88M-21, ASTM F1929-15
- Sterilization: ISO 11135, ISO 11737-2, ISO 10993-7
- Needle Properties: ISO 7864, ISO 9626
- Small-bore connectors: ISO 80369-7, ISO 80369-20
- Sharps Injury Protection: ISO 23908 (This standard specifically addresses the safety feature to prevent accidental needlestick injuries, which is a key feature of the Monarch Blood Collection Set).
- Biocompatibility (ISO 10993 series):
- Acute Systemic Toxicity
- Complete Blood Count and Leukocyte study
- Cytotoxicity Study
- Genotoxicity Studies (Bacterial reverse mutation, In-Vitro mammalian chromosomal Aberration)
- Hemolysis Study
- Intracutaneous reactivity study
- Material mediated Pyrogenicity Study
- Skin sensitization Study
- Thrombosis Study (Platelet Count and Morphology by SEM image)
- ISO 10993-3 (genotoxicity, carcinogenicity, reproductive toxicity)
- ISO 10993-33 (guidance on genotoxicity)
- ISO 10993-4 (interactions with blood)
- ISO 10993-5 (in vitro cytotoxicity)
- ISO 10993-10 (skin sensitization)
- ISO 10993-11 (systemic toxicity)
- ISO 10993-23 (irritation)
- ISO 10993-17 (leachable substances)
- Other: ANSI AAMI ST72:2019 / USP (Bacterial endotoxins), USP Chapter 788 (Particulate matter in Injection)
The statement "Clinical studies are not required to demonstrate substantial equivalence to the predicate device" (page 12) indicates that the non-clinical testing performed in accordance with these recognized standards was deemed sufficient by the FDA to demonstrate the safety and effectiveness of the device.
The study proving the device meets acceptance criteria is implied to be the battery of non-clinical tests performed according to the listed international and national standards. These tests assess various attributes such as sterility, biocompatibility, physical integrity, and the effectiveness of the safety mechanism. The results of these tests, conducted according to the specified methodologies, collectively form the evidence that the device meets the safety and performance requirements for its intended use and is substantially equivalent to the predicate device.
For example, the compliance with ISO 23908 demonstrates that the sharps injury protection feature meets the required standards. Biocompatibility testing per ISO 10993 series ensures the materials used are safe for bodily contact. Shelf-life testing after 5 years of aging, as mentioned in the comparison table, demonstrates the device's performance over its stated shelf life.
§ 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.