Pocket Colposcope System

K181034 · Hadleigh Health Technologies, LLC · HEX · Sep 21, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K181034
• Device Name: Pocket Colposcope System
• Applicant: Hadleigh Health Technologies, LLC
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Sep 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended 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.

Device Story

Pocket Colposcope System is a portable, reusable digital video colposcope for gynecological exams. Device captures high-definition images of cervix, vagina, and external genitalia using a 5 MP CMOS camera with 0° lens. Illumination provided by ring of white and green LEDs; green light used for vascular visualization. Device connects to a computer via USB; computer-based software displays output and captures images. Used by trained medical personnel in clinical settings; inserted via speculum for internal imaging or used externally. Provides magnified visualization to assist clinicians in identifying abnormalities and selecting biopsy areas. Benefits include portability and high-definition documentation of clinical findings.

Clinical Evidence

Bench testing only. Performance validated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and imaging standards (ISO 8600-3, ISO 8600-5, ISO 9039, ANSI/NEMA FL-1, IEC/EN 62471). Design validation performed by trained medical professionals confirmed the system meets user needs.

Technological Characteristics

Rigid probe (13.7 cm length, 1.8 cm diameter) with 5 MP CMOS camera and 0° lens. Housing: ABS plastic; Lens: PMMA. Illumination: 4 white/4 green LEDs. Connectivity: USB 2.0 to PC. Power: 5V DC via USB. Magnification: 3X-52X. Cleaning: High-level disinfection for probe; surface disinfection for handle/cord. Software: PC-based visualization/annotation module.

Indications for Use

Indicated for gynecological examination in hospitals, clinics, and private offices by trained medical personnel to provide magnified visualization of vaginal, cervical, and external genitalia tissues to aid in diagnosing abnormalities and selecting biopsy sites.

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.

Predicate Devices

• Edan Instruments, Video Colposcope, models C3A, C6A (K151878)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> 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, LLC<br>30 Castro Ave<br>San Rafael, CA 94901 |
| Contact Person: | Spencer Walker, MSc<br>Director Regulatory Affairs<br>Center for Medical Innovation<br>10 North 1900 East, Rm 22B<br>Salt Lake City, UT 84112 (801)<br>581-5080 |
| Date Prepared: | September 20, 2018 |
| Trade Name: | Pocket Colposcope System |
| Common Name: | Colposcope |
| Classification: | Colposcope, 21 CFR §884.1630<br>Product Code HEX, Colposcope (and colpomicroscope)<br>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:

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

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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 video<br>colposcope intended for gynecological<br>examination. It provides a portable means of<br>magnified visualization of the tissues of the<br>vagina, cervix and external genitalia in order to<br>aid in diagnosing abnormalities and selecting<br>areas for biopsy. The image system is<br>intended to provide documentation of the<br>image in the field of view of the colposcope.<br>The Pocket Colposcope System is intended to<br>be inserted into the vagina via a speculum by<br>trained medical personnel in hospitals, clinics,<br>and private offices, and is not intended for<br>home use. | The C3A, C6A video colposcope is<br>intended for gynecological<br>examination.<br>It provides magnified visualization of<br>the vagina, cervix and external<br>genitalia, which can help diagnose<br>abnormalities and select areas for<br>biopsy. It is intended to be used only<br>by trained and qualified personnel in<br>hospitals, clinics and private offices,<br>and not intended for home use or to<br>touch the patient. | | |
| Class | 21 CFR §884.1630 | Same | | |

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| Table 1: Substantial Equivalence Table Comparison | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Subject Device | K151878 |
| | Product code: HEX<br>Class II | |
| Multiple Use | Yes | Yes |
| Prescription (Rx<br>Only) | 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,<br>may be used without the stand. |
| External Power<br>Source | Voltage: 5 V,<br>Frequency: DC<br>Input power: USB 5V | Voltage: 100 - 240VAC,<br>Frequency: 50/60Hz,<br>Input power: Maximum 48VA |
| Materials | Housing - ABS Plastic<br>Lens—PMMA | Housing - ABS Plastic<br>Lens - Glass |
| Fundament.<br>Scientific<br>Technology | The camera has optics that relay optical<br>video information to a PC or Laptop<br>(visualization/ annotation module). | The camera has optics that relays<br>optical video information to the<br>visualization/ annotation module. |
| Device Specifications: Light | | |
| Light Module | Single loop group LED light | Single loop group LED light<br>(C3A),<br>Double loop group LED light<br>(C6A) |
| Light Source | White and Green LED light | White LED light/ Green Filter |
| Max. Illumination | 20,000 lux at working distance of 5mm<br>462 lux at working distance of 50mm | 1600 lux at working distance 300<br>mm (C3A)<br>3000 lux at working distance 300<br>mm (C6A) |
| Illumination Range/<br>Beam Diameter | 74.5 mm at working distance of 50 mm | ≥ Φ 60 mm at working distance<br>200 mm |
| Light Source<br>Lifetime | ≥ 10,000 hrs | Same |
| Device Specifications: Camera | | |
| Magnification | 3 X ~ 52 X | 1 ~ 28X (C3A)<br>1 ~ 36X (C6A) |
| System Resolution | ≥ 1944 TVL | ≥500 TVL |
| Optical Resolution | Lowest: 13.51 lp/mm<br>Highest: 121.02 lp/mm | ≥10 lp/mm |
| Table 1: Substantial Equivalence Table Comparison | | |
| | Subject Device | K151878 |
| Image Geometric<br>Distortion | +0.3% to -3.24% | <3% |
| Working Distance | 5 – 50 mm | 200 – 300 mm |
| Field of View (FOV) | At min. magnification<br>$≥$ 54.2 mm<br>At max. magnification<br>$≥$ 5.87 mm | At min. mag. $≥$ $\Phi$ 80 mm<br>At max. mag. $≥$ $\Phi$ 12 mm |
| Depth of Field | At min. magnification<br>11.71 mm<br>At max. magnification<br>$≥$ 1.86 mm | At min. mag. $≥$ 120 mm<br>At max. mag. $≥$ 6 mm |
| Focus Mode | Manual control:<br>Auto focus only | Electronic control:<br>Manual and auto focus |
| Video Output | USB | S-Video |
| Freeze Function | Yes | Yes |
| Vascular<br>Visualization | Green LED light | Electronic Filter: Green filter (3<br>grades) |
| Cleaning | Handle and Cord: Surfaces disinfected<br>with disinfectant wipe<br>Probe: High Level Disinfection | Surfaces disinfected with<br>disinfectant wipe |
| Radiation safety: | Does not emit any ionizing radiation | Does not emit any ionizing<br>radiation |

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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.