(93 days)
Not Found
No
The summary describes a standard digital video colposcope with image acquisition and display capabilities, and there is no mention of AI, ML, or advanced image processing beyond basic viewing.
No
The device is used for diagnosing abnormalities and selecting areas for biopsy, not for treating any condition. Its function is limited to magnified viewing and imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "in order to aid in diagnosing abnormalities and select areas for biopsy." The "Device Description" also states it is "used to diagnose abnormalities."
No
The device description explicitly mentions hardware components such as a circular LED group light source and a high-resolution color CCD camera, indicating it is not software-only.
Based on the provided information, the LT-300 HD digital video colposcope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The LT-300 HD digital video colposcope is used for direct, magnified viewing of the vagina, cervix, and external genitalia on a living patient. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use and device description clearly state it's for viewing and imaging anatomical sites. There is no mention of analyzing biological samples.
Therefore, the LT-300 HD digital video colposcope falls under the category of a medical device used for imaging and examination, but not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Optical imaging with a high-resolution color CCD camera
Anatomical Site
vagina, cervix and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests on thermal safety, image quality and device reliability were met:
- Thermal Safety Test
- Image Distortion Test
- Field of View Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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,
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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)
Device Name LT-300 HD
Indications for Use (Describe)
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.
| 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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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:
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.
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Digital Camera, Vertical Stand, Remote Control Components:
5. Intended Use
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.
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.