IMT LOUPE-COLPOSCOPE

K963593 · Inventive Medical Technology · HEX · Apr 22, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K963593
• Device Name: IMT LOUPE-COLPOSCOPE
• Applicant: Inventive Medical Technology
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for use by clinicians for colposcopic evaluations and as an aid to treatment procedures in patients requiring cervical or related tissue examination.

Regulatory Classification

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)

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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.