The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

Device Description

The Pocket Colposcope is a reusable, high-definition video colposcope intended to be used in a hospital / clinical environment for examination of the tissues of the vagina, cervix and external female genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The Pocket Colposcope can be used outside of the body to capture images of the vagina and external genitalia or can be inserted through a vaginal speculum to capture images of the cervix and surrounding tissue. The Pocket Colposcope it is not intended to come into direct contact with the body.

The Pocket Colposcope utilizes a ring or single loop of LED lights to illuminate the target tissue. The digital color image generated by the Pocket Colposcope is intended to be used to aid in diagnosing abnormalities and selecting areas for biopsy. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances.

The Pocket Colposcope has a 5 MP CMOS camera with a 0° angled lens. The Pocket Colposcope uses a computer-based software program to display the camera output on a computer screen and to capture images. Together, the Pocket Colposcope and the software comprise the Pocket Colposcope System.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study directly comparing the device's performance against specific clinical efficacy metrics. Instead, it focuses on demonstrating safety, essential performance, and technological equivalence to a predicate device.

However, based on the Summary of Performance Testing section, we can infer some general "acceptance criteria" through the standards the device was tested against and the statement "All test results met pre-determined acceptance criteria."

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic claim) are not provided, the table below reflects what can be inferred from the regulatory submission document. The "Reported Device Performance" here refers to the outcome of the testing mentioned, which is that the device complied or met the standards.

Acceptance Criteria (Inferred from standards tested)	Reported Device Performance
Electrical Safety (Compliance with IEC 60601-1:2005, + A1:2012)	Meets requirements
Essential Performance (Compliance with IEC 60601-1:2005, + A1:2012)	Meets requirements
Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2 and related standards)	Meets requirements
Software Verification and Validation (Compliance with FDA guidance for software in medical devices)	Met documentation requirements; level of concern considered minor.
Imaging Performance - Field of View (Compliance with ISO 8600-3:2003)	Met acceptance criteria.
Imaging Performance - Optical Resolution (Compliance with ISO 8600-5:2005)	Met acceptance criteria.
Imaging Performance - Distortion (Compliance with ISO 9039:2008)	Met acceptance criteria.
Illumination Performance (Compliance with ANSI/NEMA FL-1:2009)	Met acceptance criteria.
Photobiological Safety (Compliance with IEC/EN 62471:2008)	Met acceptance criteria.
User Needs/Requirements (Validation through evaluation by trained medical professionals)	Performed as intended and met user needs and requirements.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in terms of cases (e.g., patient images for diagnostic performance). The performance testing described is primarily engineering and usability-focused.

Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. For the "Design Validation" where medical professionals evaluated the device, the sample size is referred to as "several trained medical professionals," which is not a specific number.
Data Provenance: Not applicable for engineering and usability testing as described. If "Design Validation" involved patient interaction, the provenance is not specified.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: "several trained medical professionals"
Qualifications of Experts: "trained medical professionals (intended users)" - no specific experience level (e.g., "10 years of experience") or specialization (e.g., "radiologist") is given. They are described as "intended users."

4. Adjudication Method for Test Set

Not applicable. The performance testing described does not involve a multi-reader, multi-case adjudication process for establishing ground truth for diagnostic accuracy, as it's not a diagnostic AI device requiring such. The "Design Validation" focused on user satisfaction and device function, not diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The Pocket Colposcope System is a physical imaging device, not an AI diagnostic aid for human readers in the described context.
Effect size of improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

Was a standalone performance study done? No. The device itself is an imaging tool. The "Software Verification and Validation Testing" focused on the software within the device meeting regulatory requirements, not on a standalone diagnostic algorithm's performance on a dataset.

7. Type of Ground Truth Used

For the engineering and usability tests, the "ground truth" was compliance with established industry standards (e.g., IEC, ISO, ANSI/NEMA, CISPR) and, for design validation, user feedback on device function and meeting needs.
The document does not describe a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy testing for the device.

8. Sample Size for Training Set

Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set for diagnostic classification.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no mention of a training set or machine learning components that would require such ground truth.

Summary

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September 21, 2018

Hadleigh Health Technologies, LLC % Spencer Walker Director of Regulatory Affairs University of Utah Center for Medical Innovation 10 North 1900 East, EHSL Rm. 22B Salt Lake City, Utah 84112

Re: K181034

Trade/Device Name: Pocket Colposcope System Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: Class II Product Code: HEX Dated: August 15, 2018 Received: August 17, 2018

Dear Spencer Walker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael T. Bailey -S

for

Benjamin R. Fisher, Ph.D. Director 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

510(k) Number (if known) K181034

Device Name Pocket Colposcope System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Hadleigh Health Technologies Traditional 510(k) Premarket Notification Pocket Colposcope System

	510(k) Summary - K181034
Submitter:	Hadleigh Health Technologies, LLC30 Castro AveSan Rafael, CA 94901
Contact Person:	Spencer Walker, MScDirector Regulatory AffairsCenter for Medical Innovation10 North 1900 East, Rm 22BSalt Lake City, UT 84112 (801)581-5080
Date Prepared:	September 20, 2018
Trade Name:	Pocket Colposcope System
Common Name:	Colposcope
Classification:	Colposcope, 21 CFR §884.1630Product Code HEX, Colposcope (and colpomicroscope)Class II

Predicate Device(s):

K151878 - Edan Instruments, Video Colposcope, models C3A, C6A

The predicate device has not been subject to a design-related recall.

Device Description:

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comprise the Pocket Colposcope System.

Pocket Colposcope Features

The Pocket Colposcope Device is used like other colposcopes, and has the following features:

Camera & Lens: 0° lens, 5 Mega Pixel CMOS sensor o
Light Source: Four (4) white and four (4) green LEDs arranged in a ring at the o probe tip
Rigid Shaft (Probe): 13.7 cm length, 1.8 cm diameter at the distal tip O
Rigid Handle: 13 cm length O
Zoom, light, and image capture controls O
USB type A video cable attached to scope handle to connect to a computer. O
Packaged non-sterile and designed for reuse after cleaning and High Level O Disinfection,
High-definition video output o

Indications For Use:

The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals. clinics, and private offices, and is not intended for home use.

Comparison of Technological Characteristics:

The following table compares the technological characteristics of the subject and predicate device:

Table 1: Substantial Equivalence Table Comparison
	Subject Device	K151878
Device Name	Pocket Colposcope	EDAN C3, C6A Colposcope
Indications for use	The Pocket Colposcope is a digital videocolposcope intended for gynecologicalexamination. It provides a portable means ofmagnified visualization of the tissues of thevagina, cervix and external genitalia in order toaid in diagnosing abnormalities and selectingareas for biopsy. The image system isintended to provide documentation of theimage in the field of view of the colposcope.The Pocket Colposcope System is intended tobe inserted into the vagina via a speculum bytrained medical personnel in hospitals, clinics,and private offices, and is not intended forhome use.	The C3A, C6A video colposcope isintended for gynecologicalexamination.It provides magnified visualization ofthe vagina, cervix and externalgenitalia, which can help diagnoseabnormalities and select areas forbiopsy. It is intended to be used onlyby trained and qualified personnel inhospitals, clinics and private offices,and not intended for home use or totouch the patient.
Class	21 CFR §884.1630	Same

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Table 1: Substantial Equivalence Table Comparison
	Subject Device	K151878
	Product code: HEXClass II
Multiple Use	Yes	Yes
Prescription (RxOnly)	Yes	Yes
Anatomical site	Cervix, vagina, and external genitalia	Same
Where used	Hospitals and clinics	Same
Device Design
Device Design	Image: Subject Device	Image: K151878
Standard Config.	Digital CMOS camera used without stand	Digital CCD camera with Stand,may be used without the stand.
External PowerSource	Voltage: 5 V,Frequency: DCInput power: USB 5V	Voltage: 100 - 240VAC,Frequency: 50/60Hz,Input power: Maximum 48VA
Materials	Housing - ABS PlasticLens—PMMA	Housing - ABS PlasticLens - Glass
Fundament.ScientificTechnology	The camera has optics that relay opticalvideo information to a PC or Laptop(visualization/ annotation module).	The camera has optics that relaysoptical video information to thevisualization/ annotation module.
Device Specifications: Light
Light Module	Single loop group LED light	Single loop group LED light(C3A),Double loop group LED light(C6A)
Light Source	White and Green LED light	White LED light/ Green Filter
Max. Illumination	20,000 lux at working distance of 5mm462 lux at working distance of 50mm	1600 lux at working distance 300mm (C3A)3000 lux at working distance 300mm (C6A)
Illumination Range/Beam Diameter	74.5 mm at working distance of 50 mm	≥ Φ 60 mm at working distance200 mm
Light SourceLifetime	≥ 10,000 hrs	Same
Device Specifications: Camera
Magnification	3 X ~ 52 X	1 ~ 28X (C3A)1 ~ 36X (C6A)
System Resolution	≥ 1944 TVL	≥500 TVL
Optical Resolution	Lowest: 13.51 lp/mmHighest: 121.02 lp/mm	≥10 lp/mm
Table 1: Substantial Equivalence Table Comparison
	Subject Device	K151878
Image GeometricDistortion	+0.3% to -3.24%	<3%
Working Distance	5 – 50 mm	200 – 300 mm
Field of View (FOV)	At min. magnification$≥$ 54.2 mmAt max. magnification$≥$ 5.87 mm	At min. mag. $≥$ $\Phi$ 80 mmAt max. mag. $≥$ $\Phi$ 12 mm
Depth of Field	At min. magnification11.71 mmAt max. magnification$≥$ 1.86 mm	At min. mag. $≥$ 120 mmAt max. mag. $≥$ 6 mm
Focus Mode	Manual control:Auto focus only	Electronic control:Manual and auto focus
Video Output	USB	S-Video
Freeze Function	Yes	Yes
VascularVisualization	Green LED light	Electronic Filter: Green filter (3grades)
Cleaning	Handle and Cord: Surfaces disinfectedwith disinfectant wipeProbe: High Level Disinfection	Surfaces disinfected withdisinfectant wipe
Radiation safety:	Does not emit any ionizing radiation	Does not emit any ionizingradiation

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The subject and predicate device have different indications for use statements, as the subject device can be inserted into the vagina via a speculum. However, the subject and predicate device have the same intended use - magnified viewing of the vagina, cervix and external genitalia to assist doctors in diagnosing abnormalities and select areas for biopsy.

As evidenced by the table above, the subject and predicate device have different technological characteristics. These differences in technological characteristics do not raise different questions of safety or effectiveness.

Summary of Performance Testing:

The following performance tests were conducted in support of the substantial equivalence determination. All test results met pre-determined acceptance criteria.

. Electrical Safety and Essential Performance Requirements – The Pocket Colposcope System was tested to verify safety and essential performance requirements and complies with the following standard: IEC 60601-1:2005, + A1:2012 о
Electromagnetic Compatibility (EMC) - The (EMC) series of test demonstrates the EMC characteristics of the Pocket Colposcope System. The Pocket Colposcope was tested to the requirements of and complies with the following standards:

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o IEC 60601-1-2 (2014) Medical Device
- IEC 61000-4-2 (2008) Electrostatic Discharge .
- IEC 61000-4-3 (2006), A1(2007), A2(2010) Radiated Immunity ■
- IEC 61000-4-4 (2012) Electrical Fast Transient/ Burst ■
- IEC 61000-4-5 (2006) Surge l
- IEC 61000-4-6 (2013) Conducted Immunity ■
- IEC 61000-4-8 (2009) Magnetic Field Immunity ■
- IEC 61000-4-11 (2004) Voltage Dips & Variations l
- CISPR 11 Emissions Class A (2009), A1(2010) l
- I CISPR 11 (EN 55011) - Radiated Emissions
- CISPR 11 (EN 55011) Conducted Emissions I
. Software Verification and Validation Testing - The Pocket Colposcope firmware/software verification and validation testing were conducted and documented as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software's level of concern for this device was considered as minor.
. Imaging Evaluation - The performance specifications associated with the features associated with imaging were tested to show the effectiveness of the subject device, including:
- ISO 8600-3:2003 Optics and Photonics Medical endoscopes and o endotherapy devices – Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-5:2005 Optics and Photonics Medical endoscopes and o endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
- ISO 9039:2008 Optics and Photonics Quality Evaluation of Optical o Systems - Determination of Distortion
- ANSI/ NEMA FL-1:2009 Flashlight Basic Performance Standard for O Illumination
- IEC/EN 62471:2008 Photobiological Safety of Lamps and Lamp Systems o
Design Validation The design was validated through an evaluation of the Pocket ● Colposcope System by several trained medical professionals (intended users). The devices performed as intended and met the user's needs and requirements.

Conclusion:

The results of the testing demonstrate that the Pocket Colposcope System met all acceptance criteria and is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.