(36 days)
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic testing.
The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in different colors which identify the general type of additive or anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.
The provided document is a 510(k) summary for the SAFE-T-FILL® Capillary Blood Collection System, a blood specimen collection device. The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with quantifiable metrics. Therefore, the requested information regarding acceptance criteria, study details, and expert involvement is largely not explicitly stated in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with corresponding performance results in a quantifiable manner, as might be expected for an AI/software device. Instead, the "performance" is assessed through a comparison of characteristics and intended use with predicate devices to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | SAFE-T-FILL® Performance (Reported) |
|---|---|---|
| Combination capillary tube and microtube | Yes (similar to StatSampler®) | Yes |
| Available with different additives or anticoagulants | Yes (similar to all predicates) | Yes |
| All Components Plastic | Yes (similar to CapiJect® & Microtainer®) | Yes |
| Used to collect, Anticoagulate and Store Skin Puncture Blood Specimens | Yes (similar to all predicates) | Yes |
| Similar Hematological Determinations | Yes (similar to all predicates) | Yes |
| Fill Lines | Range covering 100μl to 625μl (across predicates) | 125μl, 150μl, & 200μl |
| Preassembled | Yes (similar to CapiJect®) | Yes |
| Sterile | No (similar to all predicates) | No |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not explicitly stated in the provided document. It describes the device and its intended use, along with a comparison to predicate devices, but no specific test set or study data is presented.
- Data provenance: Not applicable as no specific test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set with ground truth is described.
4. Adjudication method for the test set:
- Not applicable as no specific test set or ground truth establishment is described.
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 for blood collection, not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific ground truth for performance evaluation is described. The "ground truth" for the 510(k) submission is the existence and established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not a machine learning model.
Summary of the Study:
The "study" presented in this 510(k) summary is not a traditional performance study as one might expect for a novel device or an AI/software product. Instead, it is a comparative analysis for substantial equivalence against legally marketed predicate devices. The document outlines the characteristics of the SAFE-T-FILL® Capillary Blood Collection System and compares them to those of three predicate devices: StatSampler® (K896206), CapiJect® Capillary Blood Collection System (K833475), and Microtainer® Tube with EDTA and Microgard™ Closure (K931368).
The "proof" that the device meets "acceptance criteria" (which are implicitly defined by the characteristics and performance of the predicate devices) is demonstrated through this comparative table and the assertion that the new device shares similar characteristics and intended use with the existing, legally marketed devices. The FDA's letter states that they have reviewed the submission and determined the device is "substantially equivalent" to the predicate devices, thereby permitting it to be marketed.
§ 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.