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510(k) Data Aggregation
(181 days)
KOLPLAST CI LTDA
The KOLPLUX System when used with a vaginal speculum provides illumination during pelvic examination and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
The KOLPLUX System consists of a power source adapter, 2 meter long electrical cord, and the illumination system body and a carrying case. The Illumination System Body accommodates the LED and provides a keyhole female opening for the insertion of the optic fiber tube (found on the vaginal speculum).
The KOLPLUX System is a vaginal speculum illumination system. The device's substantial equivalence to a predicate device, the Welch Allyn Kleenspec Single Use Vaginal Speculum & 790 Series Cordless Illumination System, was established through a comparison of technical characteristics and compliance with international safety standards. There is no study for this 510(k) summary that provided the acceptance criteria and device performance table, the sample size for the test set, the number of experts used to establish ground truth, the adjudication method, details of a multi-reader multi-case (MRMC) comparative effectiveness study, or details of standalone algorithm performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (KOLPLUX System) |
|---|---|---|
| Indications for Use | Illumination during pelvic examinations and other gynecological procedures (pap smears, D&C, biopsy, electrosurgery) | Illumination during pelvic examinations and other gynecological procedures (pap smears, D&C, biopsy, electrosurgery) |
| Input | 120V - 60Hz, 100mA | 115-220 V - 60Hz, 11.5 VA |
| Output | 4.7 VAC, 850 mA | 3.5 VAC, 400 mA |
| Physical Specifications - Illuminator | 91.4 cm (36 in) | Ø 33 mm x 48 mm |
| Physical Specifications - Transformer | 183 cm (72 in) | 80 x 57 x 48 mm |
| Illumination - Lamp Life | 100 Hours | 2,600 Hours |
| Illumination - Lamp Voltage | 4.6 V | 4.71V |
| Operating Environment - Operating | +10° C to +35° C | +10° C to +35° C |
| Operating Environment - Transport/Storage | -20° C to +49° C | -20° C to +49° C |
| Intermittent Operation | 10 minutes on max: 5 minutes off min | 60 minutes on max: 10 minutes off min |
| Safety and EMC Standards | Not explicitly stated, but assumed to meet relevant standards | UL60601-1 (2003), 1st Edition Medical Electrical Equipment, Part 1, General Requirements for Safety; IEC 60601-2 (2001), 2nd Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility |
2. Sample size used for the test set and the data provenance:
- This 510(k) summary does not describe a clinical study or a test set for assessing device performance against acceptance criteria. The evaluation is focused on technical characteristics and compliance with standards rather than clinical performance against specific metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no test set requiring ground truth established by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no test set requiring adjudication 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:
- No MRMC comparative effectiveness study was performed or described. This device is an illumination system, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware for illumination assistance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no ground truth was established for performance evaluation in this 510(k) summary. The comparison is against technical specifications and indications for use of a predicate device.
8. The sample size for the training set:
- Not applicable, as there is no training set for an algorithm described.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm described.
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