(124 days)
The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.
The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.
MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.
These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.
The MICRO Arterial Filters are the modified version of the following currently marketed devices:
a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);
c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).
This document is a 510(k) summary for the MICRO Arterial Filters, detailing their substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics and non-clinical performance data, rather than providing specific acceptance criteria and study results in the context of an AI/human reader performance study.
Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, MRMC studies, and training set details for an AI-powered device cannot be extracted from this document because it describes a hardware medical device (a filter), not an AI/software as a medical device (SaMD).
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
Information that CAN be extracted:
- Device Name: MICRO Arterial Filters
- Regulation Number/Name: 21 CFR 870.4260, Cardiopulmonary Bypass Arterial Line Blood Filter
- Regulatory Class: Class II
- Product Code: DTM
- Applicant: SORIN GROUP ITALIA S.R.L.
- Indications for Use: "The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised."
- Device Description: Single-use, non-toxic, non-pyrogenic fluid path devices, sterile and individually packaged, made of plastic (mainly PVC) and a silicon filtering net. Used for up to 6 hours. Modified versions of existing devices, with changes to tubing material (removal of DEHP) and silicon formulation of the valve's diaphragm. Ethylene oxide sterilized.
- Predicate Devices: Multiple predicate devices listed by 510(k) number and trade name (e.g., K952270 DIDECO ADULT ARTERIAL FILTERS).
- Type of Study (General): Non-clinical performance data (verification and validation testing) was conducted to demonstrate substantial equivalence.
- Clinical Performance Data: "No clinical testing was conducted in support of the MICRO Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
- Ground Truth Type (for this device's testing): Implied to be based on adherence to applicable voluntary standards and "proven safety and efficacy" of predicate devices through non-clinical testing.
Information that CANNOT be extracted (as this is not an AI/SaMD submission):
- A table of acceptance criteria and the reported device performance (in the context of AI metrics like sensitivity, specificity, AUC): Not applicable for this hardware device. Acceptance criteria would relate to physical performance (e.g., filtration efficiency, pressure drop, biocompatibility), which are not explicitly detailed here beyond a general statement of compliance.
- Sample sizes used for the test set and the data provenance: Not applicable. Testing was likely bench testing, not a clinical study on human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a filter device is based on engineering specifications and material science, not expert image interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While "ground truth" exists for the filter's performance, it's not in the AI/clinical interpretation sense. It's about meeting engineering and biocompatibility standards.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
To summarize, this document describes the FDA clearance of a medical device (an arterial filter) based on "substantial equivalence" to existing hardware devices, primarily through non-clinical performance testing (bench-top testing, material compatibility, etc.). It does not involve any AI/machine learning components or associated studies on human or expert annotated data.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”