Table 2. Characteristics of Predicate Devices Used to Support Clearance of Recalled 510(k) Devices.
| No. (%) | |
|---|---|
| Total No. of predicates cited by index devices | 243 |
| No. of predicates per device, median (IQR) | 1 (1-2) |
| Time between predicate and index device clearance, median (IQR), y | 4.0 (2.0-7.9) |
| No. of index devices with information about predicatesa | 127 |
| Using recalled predicates | 92 (72.4) |
| Using a predicate with ≥1 Class I–designated recall | 56 (44.1) |
| Total No. of unique predicatesb | 229 |
| Use of clinical data in predicate device’s 510(k) application | |
| Included clinical data | 10 (4.4) |
| No clinical testing | 137 (59.8) |
| Insufficient information in decision letterc | 35 (15.3) |
| Information about device evidence unavailabled | 47 (20.5) |
| No. of recalls per predicate, median (IQR) | 1 (0-2) |
| Predicate devices with history of recall | 123 (53.7) |
| Recalled predicate devices with at ≥1 Class I–designated recall | 64 (28.0) |
a
Of the 156 index devices, 127 had information available about their predicates.
b
Of the 243 predicates identified for the 127 index devices, 14 were duplicates (cited by multiple index devices); 229 reflects the number of unique predicates.
c
Decision memo was available in the Devices@FDA database for the index device but did not state explicitly whether premarket clinical testing was conducted.
d
No decision memo was posted for the index device in the Devices@FDA database, and as such, it was not possible to determine what, if any, premarket clinical testing was conducted.