The LT-300 HD digital video colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.

Device Description

LT-300 HD digital video colposcope is a digital video colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. LT-300 HD digital video colposcope is used to diagnose abnormalities and select areas for biopsy. LT-300 HD digital video colposcope acquires and displays high-resolution still and sequentially captured images and videos.

LT-300 HD digital video colposcope offers non-patient contact, fully digital and highresolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor.

AI/ML Overview

The provided text is a 510(k) summary for the LT-300 HD digital video colposcope. It describes the device, its intended use, and a comparison to a predicate device (LT-300 Digital Colposcope, K143119). However, it does not contain a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to performance standards. It explicitly states that "These differences do not raise different questions of safety or effectiveness, and accepted test methods were used to assess the effects of these differences on device performance."

Therefore, I cannot populate most of the requested fields as the information is not present in the provided text. The document refers to "nonclinical tests" on image quality but does not provide specific acceptance criteria or results from studies involving human readers or ground truth for diagnostic accuracy.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

The document lists performance standards the device meets, but these are general engineering and optical standards, not specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for disease detection).

Acceptance Criteria (from standards)	Reported Device Performance (from standards)
Optical Performance (Met general standards)	Met general optical standards
Field of View (ISO 8600-3:1997)	Conforms to standard
Optical Resolution (ISO 8600-5:2005)	Conforms to standard
Electrical Safety & EMC (Met general standards)	Met general electrical safety & EMC standards
Medical Electrical Equipment Safety (IEC 60601-1:2005)	Conforms to standard
Electromagnetic Compatibility (IEC 60601-1-2:2007)	Conforms to standard
Other Nonclinical Tests	Met as tested
Thermal Safety Test	Met
Image Distortion Test	Met
Field of View Test	Met
Illuminance (≥ 2000Lux at 300mm working distance)	≥ 2000Lux
Field of View (min mag > Φ 60mm & max mag > Φ 10mm)	> Φ 60mm & > Φ 10mm
Depth of Field (min mag > 120mm; max mag ≥5mm)	> 120mm & ≥5mm

Missing information: Acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value) are not provided, as this is a 510(k) summary focusing on substantial equivalence through technical characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing from text: No information provided regarding a test set for clinical performance. The "tests" mentioned are non-clinical engineering and performance standard tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing from text: No information provided, as there is no described test set for diagnostic accuracy with a stated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing from text: No information provided, as there is no described test set for diagnostic accuracy.

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

Missing from text: No MRMC study or AI assistance is mentioned. This device is a colposcope, not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing from text: Not applicable, as this is a medical device (colposcope) that is used by a human operator, not an algorithm, and no standalone algorithm performance is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing from text: No information about ground truth for diagnostic accuracy is provided. The tests described are engineering and compliance tests, not clinical performance evaluations against a diagnostic ground truth.

8. The sample size for the training set

Missing from text: Not applicable. This is not a machine learning or AI-driven device requiring a training set in the conventional sense.

9. How the ground truth for the training set was established

Missing from text: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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

May 13, 2016

Lutech Industries, Inc. % Jimmy Wu Associate Lee & Xiao 2600 Mission St. Ste. 100 San Marino, CA 91108

Re: K160380

Trade/Device Name: LT-300 HD Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: Class II Product Code: HEX Dated: February 11, 2016 Received: February 16, 2016

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.

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 device

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related 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain and does not contain any other significant elements.

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)

K160380

Device Name LT-300 HD

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter 1.

Lutech Industries Inc. 105 Remington Boulevard, Suite C Ronkonkoma, New York 11779 U.S.A.

Phone:	1-631-584-6688
Fax:	1-631-584-6699

Contact:	Jimmy Wu
Phone:	1-513-693-3697
Email:	jwu@leexiao.com

2/5/2016 Date Submitted:

2. Device

Device Name:	LT-300 HD
Common Name:	Colposcope (HEX)
CFR Section:	21 CFR 884.1630
Product Classification:	Class II
Classification Panel:	Obstetrics/Gynecology-
Product Code:	HEX

3. Predicate Device

LT-300 Digital Colposcope, K143119

4. Device Description:

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Digital Camera, Vertical Stand, Remote Control Components:

5. Intended Use

6. Comparison of Technological Characteristics With The Predicate Device

Both subject and predicate devices use digital camera with accessories to provide magnified viewing of the vagina, cervix and external genitalia.

The subject and predicate devices are based on the following same technological elements:

Digital Camera with magnification both devices contain digital camera with ● Auto/Manual focus, and the digital cameras are used to view the target body organs;
. Vertical Stand - used to adjust the position of the digital camera;
. Light Source - loop group LED white light;
. Illuminance - both device's illuminances are ≥ 2000Lux at working distance 300 mm:
. Field of View - both devices' Field of Views are 52° or at minimum magnification > Φ 60mm & at maximum magnification > Φ 10mm;
Depth of Field both devices' Depth of Fields are: at minimum magnification > . 120mm; at maximum magnification ≥5mm;
. Performance Standards - both devices conform to same consensus standards.

The following technological differences exist between the subject and predicate devices:

System Resolution .
Image Geometric Distortion .
Optical Magnification ●
Electronic Filter
Video Output
Accessory Remote Control ●

These differences do not raise different questions of safety or effectiveness, and accepted test methods were used to assess the effects of these differences on device performance.

7. Nonclinical Tests

LT-300 HD digital video colposcope meets following performance standards:

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. ISO 8600-3:1997 Optics and optical instruments-Medical endoscopes and endoscopic accessories part 3: Determination of field of view and direction of view of endoscopes with optics.
ISO 8600-5:2005 Optics and photonics-Medical endoscopes and endotherapy . devices part 5: Determination of optical resolution of rigid endoscopes with optics
IEC 60601-1:2005 Medical Electrical Equipment - Part 1 General requirements for safety and essential performance.
. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.

Other nonclinical tests on thermal safety, image quality and device reliability were met:

Thermal Safety Test .
. Image Distortion Test
Field of View Test

8. Conclusion

The LT-300 HD digital video colposcope has the same intended use as the predicate device and the technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device. The non-clinical testing, which included the use of recognized performance standards, demonstrates that the LT-300 HD digital video colposcope is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1630 Colposcope.

(a)
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.(b)
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.