(225 days)
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No
The summary describes a portable colposcope with basic optical features (light source, filter, magnification) and a performance study comparing it to standard operating microscopes. There is no mention of AI, ML, image processing, or any computational analysis of data beyond the comparison of diagnoses.
No.
The device is described as an "aid to certain treatments," but its primary function, as detailed in the "Summary of Performance Studies," is for "evaluations" and diagnostic purposes (colposcopic diagnoses, comparison to Papanicolaou smear diagnoses and histological diagnoses), not direct therapeutic intervention.
Yes.
The device is used for "evaluations" and its performance and accuracy were compared to other diagnostic tools like "Papanicolaou smear diagnoses and histological diagnoses," indicating its role in diagnosis.
No
The device description explicitly mentions hardware components like a light source, green filter, and variable magnification, indicating it is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "instrument for attendants to use for evaluations and aid to certain treatments." This points towards a device used for direct examination or treatment, not for testing samples in vitro (outside the body).
- Device Description: The description highlights features like a light source, filter, and magnification, consistent with a device used for visual examination of a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. The performance studies compare the device's findings to other diagnostic methods (Papanicolaou smear, histological diagnoses), but the device itself is not performing these tests.
The device appears to be a type of colposcope, which is used for visual examination of the cervix, vagina, and vulva. This is a clinical diagnostic tool used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / 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. 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.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
attendants
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) K963593 Premarket Notification of New Device THE LOUPE- COLPOSCOPE Summary
APR 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.