Insulin Pump v3.2 - 510(k) predicate comparison
510(k) predicate comparison
Sample read-only Evidence Matrix. Six requirements shown. Every cell carries a citation; one row was originally a gap that the agent resolved on a re-run.
Row
Predicate claim
Clearance date
Indications match
Risk class
Source document
Substantial equivalence
Indications for use
Continuous subcutaneous insulin infusion for adults and children with diabetes mellitus.
2024-08-12August 12, 2024
Yes
Class II - LZG
K240812 - Indications for Use, p.4
Device description
Battery-powered, microprocessor-controlled portable infusion pump with replaceable cartridge.
2023-11-04November 4, 2023
Yes
Class II - LZG
K231104 - Device Description, p.6
Performance testing
Bench testing per IEC 60601-2-24 demonstrated +/- 5% delivery accuracy across the operating range.
2024-08-12August 12, 2024
Yes
Class II - LZG
PerfBench-2024.pdf, p.18
Biocompatibility
Patient-contacting materials evaluated per ISO 10993-1 with no findings of concern.
2024-02-19February 19, 2024
Yes
Class II - LZG
BioComp-Report-v3.pdf, p.22
Sterilization
Single-use cartridges sterilized by ethylene oxide; SAL of 10E-6 validated per ISO 11135.
2023-11-04November 4, 2023
Yes
Class II - LZG
Steril-Validation-2023.pdf, p.9
Software documentation
Major level of concern software, V&V documented per IEC 62304 with full traceability.
2024-08-12August 12, 2024
Yes
Class II - LZG
SW-VnV-v2.pdf, p.31