← Product Code [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX) · K963593 # IMT LOUPE-COLPOSCOPE (K963593) _Inventive Medical Technology · HEX · Apr 22, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K963593 ## Device Facts - **Applicant:** Inventive Medical Technology - **Product Code:** [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX.md) - **Decision Date:** Apr 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1630 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use Approval is sought for this device with the intent of marketing it. It is truly felt that it is a very safe instrument for attendants to use for evaluations and aid to certain treatments. ## Device Story Portable, self-contained colposcope; features integrated light source, green filter, and variable magnification. Used by clinicians for patient evaluations and treatment assistance; provides magnified visualization of tissue. Designed for use in diverse settings including remote areas, emergency situations, and standard clinical environments. Output is direct visual observation by the clinician; facilitates diagnostic assessment and biopsy guidance. Performance compared to standard operating microscopes; portability offers utility in resource-limited settings. ## Clinical Evidence Blinded control study of 61 patients; compared Loupe-Colposcope performance against Zeiss OM-1 operating microscope. Diagnoses validated against Papanicolaou smear and histological biopsy results. Remainder of cases compared to concurrent Papanicolaou smears and biopsy pathology. No adverse effects reported. ## Technological Characteristics Portable, self-contained optical device; includes integrated light source, green filter, and variable magnification mechanism. Mechanical/optical design. ## Regulatory 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. ## Special Controls *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. ## Reference Devices - Zeiss OM-1 operating microscope ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K963593 510(k) k963593 Premarket Notification of New Device THE LOUPE-COLPOSCOPE Summary APP 22 1997 Approval is sought for this device with the intent of marketing it. It is truly felt that it is a very safe instrument for attendants to use for evaluations and aid to certain treatments. It is felt that it has distinct advantages over existing instruments that are presently available for such procedures because it is portable and self contained, since it has its own light source, green filter and variable magnification. The testing done on this instrument was done safely and scientifically controlled; these showed that this Loupe -Colposcope is equal in performance and accuracy to standard operating microscopes. Because of its portability, it should be of great value in evaluating patients in remote areas, third world countries, and emergency situations. There were no adverse effects to patients when this instrument was used to examine them or assist in treatment procedures. For the first sixty-one patients the following blinded control study was used. The examinations used to evaluate this instrument were blinded between the Loupe and the Zeiss OM-1 operating microscope operators and these operator colposcopic diagnoses were compared to Papanicolaou smear diagnoses and histological diagnoses from the ones taken during the testing procedures. The patient's colposcopic findings were also blinded to the pathologist. Because the results of these sixty-one control cases showed excellent comparative results, the remainder of the case results were compared to Papanicolaou smear tests taken at the time of the examination and pathological results from biopsies taken at the time of the examination. --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K963593](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K963593) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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