(106 days)
The Seiler colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose and examine abnormalities of the vagina and cervix and select areas for biopsy. This generic type of device may include a light source, cables, and components parts.
The Model 935 colposcope with a 300mm objective lens has 3-magnifications, 3x, 7x, and 17x. The optics are mounted on a column and roll-around base for easy access to the areas of examination.
The Model 955 colposcope with a 300mm objective lens has 5-magnification, 3x, 4x, 7x, 11x, and 17x. The optics are mounted on swing-arms on a roll-around base.
The Model 985 colposcope with a 300mm lens also has 5-magnifications. 3x. 4x. 7x. 11x. and T Model 955, the optics are mounted on a swing-arm on a roll-around base, however the optics and arm can be swung into place from a stored position above and to the side of the user.
Most predicate colposcopes have an optical pod with various magnifications, a power supply, usually halogen, and a delivery system i.e. floor stand and base. We offer similar features, however our power unit has 2 modes of illumination which allows for the spare illumination to be accessed with a flip of a switch.
I am sorry, but the provided text does not contain the detailed information needed to describe acceptance criteria and a study proving device performance in the manner requested. The document is a 510(k) summary for a colposcope, focusing on establishing substantial equivalence to predicate devices and detailing the device's intended use, indications for use, and a general summary of electrical, optical, and safety testing.
Specifically, the document states:
- "ALL ELECTRICAL TESTING INCLUDING ELECTRICAL SAFETY, EMC TESTING, THERMAL TESTING, OPTICAL QUALITY TESTING AND TUV CERTIFICATION WERE PERFORMED BY CERTIFIED TESTING LABORATORIES, THE PRODUCT PASSED ALL TESTS."
- "COPIES OF THE TEST RESULTS ARE LOCATED IN SECTIONS D. AND E. IN OUR SUBMISSION."
However, it does not provide:
- A table of specific acceptance criteria (e.g., numerical thresholds for optical quality, electrical safety) or the reported device performance against those criteria.
- Details about sample sizes used for testing, data provenance, or information about specific studies.
- Information regarding expert involvement for ground truth, adjudication methods, or multi-reader, multi-case studies.
- Information about standalone algorithm performance, ground truth types used, or training set details, as the device described is a physical instrument (a colposcope), not an AI algorithm.
Therefore, I cannot fulfill the request for information organized into the specified table format or answer the detailed questions about study methodology for AI devices. The document confirms that testing was done and passed, but the specifics are not included in this summary.
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Image /page/0/Picture/0 description: The image shows the logo for Seiler Instrument. The logo features a stylized "S" with a crosshair design incorporated into the upper portion. Below the main logo, the word "INSTRUMENT" is written in a smaller, sans-serif font.
K101141
pg. 1 of 2
ISO
9001:2000
Registered
October 2001
INSTRUMENT
300-489-2282 · 314-968-2282 Fax: 314-968-2637 Corporate 314-968-9217 Survey Fax: 314-968-3601 Microscope
Since 1945
Date: July 2010
Section 6.
AUG - 6 2010
510(k) Summary
We believe our product is (SE) Substantially Equivalent to a number of other devices currently approved by the FDA. Our device by common name is "COLPOSCOPE" a Class II device, Product Code HEX.
Common Name: Colposcope Proprietary Name: Seiler Colposcope Current models - Model 935 Series, Model 955 Series, Model 985 Series
Intended Use: A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose and examine abnormalities of the vagina and cervix and select areas for biopsy. This generic type of device may include a light source, cables, and components parts.
Indications for Use:
The Seiler colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.
Summary:
The Model 935 colposcope with a 300mm objective lens has 3-magnifications, 3x, 7x, and 17x. The optics are mounted on a column and roll-around base for easy access to the areas of examination.
The Model 955 colposcope with a 300mm objective lens has 5-magnification, 3x, 4x, 7x, 11x, and 17x. The optics are mounted on swing-arms on a roll-around base. This mounting system allows the user to "swing" the optics out of the way when not in use while storing the colposcope in a more permanent location close to the examination table.
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The Model 985 colposcope with a 300mm lens also has 5-magnifications. 3x. 4x. 7x. 11x. and T Model 955, the optics are mounted on a swing-arm on a roll-around base, however the optics and arm can be swung into place from a stored position above and to the side of the user. This also allows the optics to be stored in a permanent location. An additional benefit of this mounting system is there are no mounting arms or a column directly in front of the user to utilize examining/surgical instruments in a clear work space directly in front of the areas of examination.
Most predicate colposcopes have an optical pod with various magnifications, a power supply, usually halogen, and a delivery system i.e. floor stand and base. We offer similar features, however our power unit has 2 modes of illumination which allows for the spare illumination to be accessed with a flip of a switch. This quick change feature means that if one of the illuminator lamps fails during an examination or procedure, the examination or procedure will not have to pause while a new lamp is installed.
ALL ELECTRICAL TESTING INCLUDING ELECTRICAL SAFETY, EMC TESTING, THERMAL TESTING, OPTICAL QUALITY TESTING AND TUV CERTIFICATION WERE PERFORMED BY CERTIFIED TESTING LABORATORIES, THE PRODUCT PASSED ALL TESTS. COPIES OF THE TEST RESULTS ARE LOCATED IN SECTIONS D. AND E. IN OUR SUBMISSION.
There are a number of predicate device colposcopes registered with the FDA. Please see below.
Classification Number: 21 CFR 884.1630 Regulation Name: Colposcope Class II Product Code: HEX
| Company Name | 510(k) Number |
|---|---|
| D.F. Vasconcellos | K021854 |
| Jedmed Inst. Co | K884934 |
| Leisegang | K940094 |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES,". The text is in all caps and is in a sans-serif font. The text is centered horizontally in the image. The text is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Meyer Microscope Consultant Seiler Precision Microscopes Seiler Instrument & Mfg Co., Inc. 3433 Tree Court Industrial Blvd. ST. LOUIS MO 63122
AUG - 6 2010
Re: K101141
Trade Name: Seiler Colposcopes -- Models 935, 955, & 985 Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: June 24, 2010 Received: June 25, 2010
Dear Mr. Meyer:
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,
Michael Lemond
Herbert P. Lerner, M.D., Director (Acting) 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 Form
AUG - 6 2010
510(k) Number (if known): K101141
Device Name: _ Seiler Colposcopes Models_935, 955, & 985
Indications for Use:
The Seiler Colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix and anogenital area. It is used to evaluate these tissues select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP conization, etc.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| ------------------------------------------------------------------- |
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101141
Page 1 of
§ 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.