(158 days)
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial sampler for collection of arterial samples for pH, blood gas, oximetry, electrolyte and blood metabolite analyses. The safePICO is a vented sampler for sample volumes in the range from 0.7 to 1.5 mL. The safePICO includes a vented tip cap allowing the sampler to be vented after the appliance of the tip cap and may include a needle shield device to prevent a user from accidental needle stick.
The barrel and plunger of the safePICO are identical to the barrel and plunger of the PICO Arterial Blood Sampler manufactured by Radiometer Medical ApS and cleared under K962158, PICO Arterial Blood Sampler. In the sampler barrel the safePICO includes a soft magnetic steel ball for mixing the sample. On the outside of the sampler barrel the safePICO has a barcode allowing independent identification of each sampler. The safePICO sampler is delivered with a new vented tip cap that allows the sampler to be vented after the appliance of the tip cap to the male connector of the sampler. Further, the safePICO may be delivered either with a conventional needle cube of PVC or with a new safePICO needle shield device in order to avoid accidental needle stick of a user.
Here's an analysis of the provided 510(k) summary for the safePICO device, focusing on acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary from 2005, does not explicitly list quantitative acceptance criteria for the safePICO device in the typical format of a modern regulatory submission (e.g., "The device shall achieve a sensitivity of > X% with a specificity of > Y%").
Instead, the summary describes performance tests conducted and then states a qualitative conclusion regarding their results or equivalence to predicate devices. The "reported device performance" is largely described through these qualitative statements of equivalence or "no new issues."
Here's an attempt to extract related information, acknowledging the limitations of the original document:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Arterial Blood Sampler Performance (Overall) | |
| - Equivalence to predicate PICO70 Arterial Blood Sampler | "a large comparison study has been performed between the safePICO Arterial Blood Sampler, a predicate device, the PICO70 Arterial Blood Sampler, both used on an ABL800 FLEX Analyzer. This study showed that the safePICO Arterial Blood Sampler is substantially equivalent to the predicate device, the PICO70 Arterial Blood Sampler." (Implies comparable performance in parameter values for pH, blood gas, oximetry, electrolyte, and blood metabolite analyses, and absence of air entrapment issues.) |
| - Equivalence to predicate PRO-VENT with Needle Pro | "a large Simulated Use Study has been performed on the safePICO with Needle Shield Device and the predicate device Pro-Vent with Needle Pro. This study showed that the safePICO with Needle Shield Device and the products are at least as safe and effective as the Pro-Vent with Needle Pro." (Implies comparable safety and effectiveness regarding needle stick prevention). |
| Specific Sampler Features: | |
| - Air entrapment during sampling | "The results of the tests [including air entrapment] showed no new issues of safety and effectiveness." (Implies acceptable levels of air entrapment, comparable to predicate). |
| - Parameter values (pH, blood gas, oximetry, electrolytes, etc.) | "The results of the tests [including parameter values] showed no new issues of safety and effectiveness." (Implies parameter values obtained with safePICO were within acceptable clinical ranges and comparable to predicate, though no specific numerical range is provided). |
| Vented Tip Cap Performance: | |
| - Maximum holding pressure | "The results of the tests showed no new issues of safety and effectiveness." (Implies that the tip cap can withstand expected pressures without failure). |
| - Ventilation capability | "The results of the tests showed no new issues of safety and effectiveness." (Implies proper ventilation when the tip cap is applied). |
| - Penetration of ABL800 FLEX inlet probe | "The results of the tests showed no new issues of safety and effectiveness." (Implies the tip cap allows proper and easy penetration by the analyzer probe). |
| - Friction of ABL800 FLEX inlet probe | "The results of the tests showed no new issues of safety and effectiveness." (Implies the friction of the probe upon penetration and withdrawal from the tip cap is within acceptable limits). |
| Needle Shield Device Performance: | |
| - Initial activation force | "The results of the tests showed no new issues of safety and effectiveness." (Implies the force required to activate the shield is appropriate). |
| - Forward displacement force | "The results of the tests showed no new issues of safety and effectiveness." (Implies the shield provides effective protection against forward movement of the needle after activation). |
| - Shield lock force | "The results of the tests showed no new issues of safety and effectiveness." (Implies the shield locks securely once activated). |
| - Unlocking force | "The results of the tests showed no new issues of safety and effectiveness." (Implies the shield, once locked, requires an appropriate amount of force to unlock, preventing accidental unlocking, or if designed to be permanent, is difficult to unlock). |
| Sterility Assurance | "The safePICO is sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶." (This is a specific, quantitative acceptance criterion, met by validation according to ISO/CD 11135:2001 and EN550:1994). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document repeatedly uses the term "large comparison study" and "large Simulated Use Study" but does not provide any specific numerical sample sizes for either the comparison study (safePICO vs. PICO70) or the simulated use study (safePICO with Needle Shield vs. Pro-Vent with Needle Pro).
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter's address (Brønshøj, Denmark), it is likely the studies were conducted by Radiometer Medical ApS or its affiliates, possibly in Denmark or other European locations. The studies appear to be prospective as they are performance tests conducted on prototypes to support a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or radiologists being used to establish ground truth for this device. The safePICO is a blood collection device, not an imaging or diagnostic AI medical device where expert interpretation would typically be the ground truth. The "ground truth" (or reference standard) would have been the analytical results from the ABL800 FLEX Analyzer for the comparison study, and the physical performance/safety assessments (e.g., needle stick prevention) for the simulated use study.
4. Adjudication Method for the Test Set
Not applicable. Since no human expert interpretation is involved in establishing a "ground truth" for this type of medical device, there is no adjudication method 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. The safePICO is a physical blood sampler, not an AI system that assists human readers in interpreting medical data. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical product (blood sampler), not an algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.
7. The Type of Ground Truth Used
- For the "large comparison study" (safePICO vs. PICO70): The ground truth would have been the analytical results (parameter values) obtained from the ABL800 FLEX Analyzer. This is essentially an instrument-based reference standard for blood gas, oximetry, electrolyte, and blood metabolite analyses. The comparison aimed to show that samples collected with safePICO yielded results that were "substantially equivalent" to those collected with the predicate.
- For the "large Simulated Use Study" (safePICO with Needle Shield vs. Pro-Vent with Needle Pro): The ground truth revolved around safety and effectiveness metrics related to needle stick prevention. This implies objective measurements of activation forces, displacement forces, lock forces, and observations of successful needle encapsulation, likely against pre-defined engineering and safety specifications (though these specific numerical specs are not provided in the summary).
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "prototype" devices used for testing would be equivalent to the test set, and there's no mention of a separate set of data used for training an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.