(181 days)
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.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.