(129 days)
Intended to magnify the view of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Not Found
The provided document is an FDA 510(k) clearance letter for the Ecleris Microstar colposcope (K100595). This document primarily focuses on establishing substantial equivalence for a physical medical device (colposcope) and does not contain the kind of information requested about acceptance criteria and a study proving a device meets them, especially in the context of an AI/algorithm-based device.
Therefore, I cannot extract the requested information from the provided text. The document does not discuss:
- Acceptance criteria table and reported device performance.
- Sample size for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect size of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes, expert consensus).
- Sample size for training set or how its ground truth was established.
This document is concerned with the regulatory clearance of a physical medical device (a colposcope), not AI or algorithmic performance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ecleris USA c/o Raymond J. Kelly IV RA/QA Specialist KRCS, LLC 56B Shadowbrook Drive HUDSON NH 03051
JUL -- 9 2010
Re: K100595
Trade Name: Ecleris Microstar colposcope Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: July 6, 2010 Received: July 6, 2010
Dear Mr. Kelly:
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 of medical device-related
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): Ki00595
Device Name:
Ecleris Microstar colposcope
Indications For Use:
Intended to magnify the view of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Over-The-Counter Use AND/OR Prescription Use イ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.