LT-300 SD Digital Video Colposcope

K170446 · Lutech Industries, Inc. · HEX · May 21, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K170446
• Device Name: LT-300 SD Digital Video Colposcope
• Applicant: Lutech Industries, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: May 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The LT-300 SD Digital Video Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

Device Story

The LT-300 SD Digital Video Colposcope is a medical imaging device used for the magnified visualization of the female reproductive tract. It captures high-resolution video of the cervix, vagina, and external genitalia, which is displayed to the clinician in real-time. The device is operated by trained medical professionals in hospitals, clinics, or private offices. By providing enhanced visual clarity, the colposcope assists the physician in identifying anatomical abnormalities and selecting precise locations for biopsy. The output is a live video feed that supports clinical decision-making during gynecological examinations. The device does not perform automated diagnosis; it serves as a diagnostic aid to facilitate visual inspection and clinical assessment.

Clinical Evidence

No clinical data provided. The document focuses on the regulatory determination of substantial equivalence for a Class II medical device.

Technological Characteristics

Digital video colposcope; provides magnified optical/digital visualization of gynecological tissues. System includes camera, light source, and display interface. Designed for professional clinical use. Connectivity and specific material standards are not detailed in the provided text.

Indications for Use

Indicated for magnified visualization of the vagina, cervix, and external genitalia to assist clinicians in diagnosing abnormalities and selecting biopsy sites. For use by trained professionals in clinical settings; not for home use.

Regulatory Classification

Identification

A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

Special Controls

*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Submission Summary (Full Text)

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Re:

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

May 21, 2017

Lutech Industries, Inc. % Jimmv Wu Associate Lee & Xiao 2600 Mission Street, Suite 100 San Marino, CA 91108

> K170446 Trade/Device Name: LT-300 SD Digital Video Colposcope Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: February 15, 2017 Received: February 21, 2017

Dear Jimmy Wu:

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 either 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Charles Viviano -S

For

Benjamin R. Fisher, Ph.D. Director 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

510(k) Number (if known)

#### K170446

Device Name LT-300 SD Digital Video Colposcope

#### Indications for Use (Describe)

The LT-300 SD Digital Video Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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