Updated on February 23, 2024

·

Created on October 13, 2020

Pocket Colposcope

Upcoming Update

The Pocket Colposcope is a handheld microscope and imaging device for the cervix.

Developed By
  1. Duke University
Tested By
  • Duke University
Content Partners
Unknown

Author

Product Description

The Pocket Colposcope is a handheld microscope and imaging device for the cervix developed by biomedical researchers at Duke University and 3rd Stone Design.

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$500.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Unknown

Competitive Landscape

Direct competitors include EVA System.

Manufacturing/Building Method

This product is currently in the prototyping phase and not yet manufactured at scale.

Intellectural Property Type

Patent

User Provision Model

The designers have not yet selected their user provision model.

Distributions to Date Status

None

Consumables

None

Detection sensitivity

75% of standard-of-care colposcope

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

No

Number of Tests Performed

Over 20,000 tests performed

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Continuous

Time required for procedure (minutes)

5 minutes

Design Specifications

Pocket colposcope is consist of a probe, USB cord, camera, light, focus slider, and shutter button. The product weighs less than 1 kg. The device enables healthcare providers to optically zoom in and capture acetic acid, Lugol’s iodine, and vascular images (green light imaging) by pressing a button with their thumb. Images taken with the Pocket Colposcope are transmitted instantly to a smartphone, tablet, or laptop.

Product Schematics

Technical Support

Provided by manufacturer

Replacement Components

Replaceable components include the probe of the product.

Lifecycle

5-10 years

Manufacturer Specified Performance Parameters

Designer specified performance targets include: lightweight, portable, and low-cost.

Vetted Performance Status

The level of agreement between the Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24).

Safety

Potential hazards related to the operation of this product include hygiene and electric leakage.

Complementary Technical Systems

None

Academic Research and References

Christopher, T., Marlee, S., Jennifer, E., et al., 2015, Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. Plos One.

Mercy, N., Anish, S., Usamah, C., et al., 2018, Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope. IEEE, pp. 2306-2318.

Jenna, L., Elizbeth, A., Christoper, T., et al., 2017, International Image Concordance Study to Compare a Point of Care Tampon Colposcope to a Standard-of-Care Colposcope. HHS Public Access, 21, pp. 112-119.

Schmitt, John, “Comparison of a Portable Colposcope with State of the Art Cervical Screening in the U.S., Peru, and Tanzania“, IFCPC World congress, 2017

Food and Drug Administration, “Pocket Colposcope System“, Department of Health and Human Services, 2020

Compliance with regulations

The product is certified by US FDA and complies to standards for colposcope. The regulation and testing includes electrical safety and essential performance requirements, electromagnetic compatibility, software verification and validation testing.

Evaluation methods

The product is evaluated by comparing with standard of care colposcope and pathology in certified third-party health care centers.

Other Information

None

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