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.

Device Description

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).

AI/ML Overview

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.

Summary

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K110766 P 1 of 3

510(k) Summary 807.92(c)

SEP 1 5 2011

510(k) #

K070964

807.92(a)(1)

SPONSOR

KOLPLAST CI LTDA

Company Address

Company Name:

312/318 Mundo Novo Sao Paulo, Brazil 05028-030

Telephone: Fax:

011 55 11 4496 1404 011 55 11 3876 6128

Contact Person:

Daniela Feracin Pertpetuo

Summary Preparation Date: March 15, 2011

DEVICE NAME Trade Name:

Product Code:

Device Class:

Common/Usual Name: Classification Name:

Regulation Number:

807.92(a)(2) KOLPLUX System Vaginal Speculum Illumination System Speculum, Vaginal, Nonmetal 884.4530 HIB

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device Company Product Welch Allyn Inc. Kleenspec Single Use Vaginal Speculum & 790 Series Cordless Illumination System

ー

DEVICE DESCRIPTION

807.92(a)(4)

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K110766 p 2 of 3

Indication for Use

807.92(a)(5)

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

Predicate Product Comparison Table

Parameter	KolplastKOLPLUX System	Welch AllynKleenSpec® VaginalSpecula IlluminationSystem
510(k) Number		K070964
Indications for Use	The KOLPLUX Systemwhen used with a vaginalspeculum providesillumination during pelvicexamination and othergynecological procedures,such as pap smears,dilation and curettage(D&C), biopsy, andelectrosurgery.	KleenSpec® VaginalSpecula IlluminationSystem when used withthe vaginal, the cordlessilluminator providesillumination during pelvicexaminations and othergynecological procedures,such as pap smears,dilation and curettage(D&C), biopsy, andelectrosurgery
Input	115-220 V - 60Hz, 11,5 VA	120V - 60Hz, 100mA
Output	3.5 VAC, 400 mA	4.7 VAC, 850 mA
Physical Specifications
• Illuminator	Ø 33 mm x 48 mm	91.4 cm (36 in)
• Transformer	80 x 57 x 48 mm	183 cm (72 in)
Illumination
• Lamp Life	2.600	100 Hours
• Lamp Voltage	4.71V	4.6 V
Operating Environment
• Operating	+10° C to +35° C	+10° C to +35° C
• Transport/Storage	-20°C to +49° C	-20°C to +49° C
Intermittent Operation	60 minutes on max: 10minutes off min	10 minutes on max: 5minutes off min

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K110766 P 30f3

NONCLINICAL TEST

807.92(b) (

The KOLPLUX System is compliant to the Following international standards: UL60601-1 (2003), 1st Edition Medical Electrical Equipment, Part 1, General Requirements for Safety IEC 60601-2 (2001), 2ns Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility

CONCLUSION

807.92(b)(3)

The KOLPLUX System is similar to the Welch Allyn KleenSpec® Vaginal Specula lllumination System as it relates to indications for use and both provide illumination during pelvic examination.

Differences

The Welch Allyn KleenSpec® Vaginal Specula Illumination System is a cordless device whereas, the KOLPLUX System is not.

The KOLPLUX System introduces no new questions concerning safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Kolplast ci Lida % Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Ave. CROFTON MD 21114

SEP 15 20

Re: K110766

Trade/Device Name: KOLPLUX System Regulation Number: 21 CFR$ 884.4530 Regulation Name: Obstetric - gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: August 3, 2011 Received: August 5. 2011

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Huchal Leuner MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number (if known): K110766

Device Name: KOLPLUX System

Indications for Use:

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D) ·

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Reem

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110766

Page 1 of 1

Regulation Number and Section

§ 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.