(129 days)
Not Found
No
The description mentions "integrated image quality assessment algorithms" but does not use terms like AI, ML, deep learning, or neural networks, and the function described (ensuring focused, centered, and balanced-contrast images) is a common image processing task that doesn't necessarily require AI/ML.
No
The device is a diagnostic tool that acquires images to identify abnormalities; it does not provide any form of therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is used to diagnose abnormalities."
No
The device description explicitly mentions hardware components like an optical subsystem, illumination, LCD, and the ability to acquire images, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the Cervical MD™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Cervical MD™ is used to acquire images directly from the vagina, cervix, and external genitalia of a patient. It is a medical device used for direct visualization and imaging of anatomical sites.
- The device description focuses on imaging and image processing. While it mentions image quality assessment algorithms, these are related to the technical quality of the acquired images, not the analysis of biological samples.
- There is no mention of analyzing biological samples or specimens. The device's function is to capture images for diagnosis and biopsy selection, which are clinical procedures performed on the patient.
Therefore, the Cervical MD™ falls under the category of a medical device used for imaging and visualization, not an IVD.
N/A
Intended Use / Indications for Use
Cervical MD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Product codes (comma separated list FDA assigned to the subject device)
HEX
Device Description
Cervical MD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for hiopsy. The illumination and optical design of the device allow the user to carture ligh resolution quality images. The optical subsystem is augmented by integrated image quality assessment algorithms ensuring that focused, centered and balanced-contrast images are acquired. A liquid crystal display (LCD) provides a video display and user interface information. The acquired images can be transferred to a computer and viewed on a monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Colposcope
Anatomical Site
vagina, cervix and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing has been conducted to verify that the device satisfies the performance requirements of the device specification and that the device performance is equivalent to the predicate device in relevant areas of comparison.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Welch Allen Video Colposcope Model 88000 (K955635)
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.
0
Image /page/0/Picture/0 description: The image shows the number K072691 at the top. Below the number is the logo for STI. The logo is a circle with a design in the middle and the letters "sti" to the right of the circle. The letters "TM" are in superscript to the right of the letters "sti".
733 Bishop Street Makai Tower, Suite 3100 Honolulu, Hawaii 96813 Telephone: 808.540.4700 Facsimile: 808.540.4850
September 21, 2007
510(k) Summary
JAN 31 2008
Submitter's Name and Address:
STI Medical Systems 733 Bishop St. Suite 3100 Honolulu, HI 96813
Contact Person and Telephone Number:
Rolf Wolters, Ph.D. VP of Programs/Product Management (808) 540-4728
| Trade/Proprietary Name: | Cervical MD TM |
|---|---|
| Common/Usual Name: | Digital Colposcope |
| Classification Name: | Colposcope |
| Classification Regulation: | 21 CFR 884.1630 |
| Device Class: | Class II |
| Product Code: | HEX |
| Advisory Panel: | Obstetrics/Gynecology |
| Predicate Device: | Welch Allen Video Colposcope Model 88000 (K955635) |
Device Description:
Cervical MD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for hiopsy. The illumination and optical design of the device allow the user to carture ligh resolution quality images. The optical subsystem is augmented by integrated image quality assessment algorithms ensuring that focused, centered and balanced-contrast images are acquired. A liquid crystal display (LCD) provides a video display and user interface information. The acquired images can be transferred to a computer and viewed on a monitor.
1
Cervical MD is substantially equivalent to the Welch Allyn Video Colposcope (K955635). Both devices have the same intended use. Both incorporate illumination, power and video into stand-alone units. They provide image capture
functions at the same working distance and provide a means of displaying the digital image on a video screen and record pictures of the examination area.
Both devices have focusing, magnification and green filter capabilities however the software contained in each device has slightly different technological characteristics. Cervical MD contains software that indicates when quality (focused, centered and balanced contrast) imagery has been acquired. Cervical MD has image polarization capabilities the predicate device does not. None of the software-managed features presents any new risks or hazards and are only provided to enhance the acquisition and analysis of the image in real time.
Indications for Use:
Cervical MD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Performance Testing:
Design verification testing has been conducted to verify that the device satisfies the performance requirements of the device specification and that the device performance is equivalent to the predicate device in relevant areas of comparison.
Conclusion:
The STI Cervical MD is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 31 2008
Mr. Rolf Wolters Vice President/Program Management Science and Technology International® (sti) 733 Bishop Street Makai Tower, Suite 3100 HONOLULU HAWAII 96813
Re: K072691
Trade/Device Name: Cervical MD™ (Model C10) Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: January 14, 2008 Received: January 16, 2008
Dear Mr. Wolters:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be actibou that i brommation that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any Fourth all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Pat 607); mooning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I the letter with ation. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you door opter for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indication for Use Statement 4
510(k) Number (if known):
Device Name: Cervical MD™ (Model C10)
Indications for Use: Cervical MD™ is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Helentenson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K072091