AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE

K122973 · Medgyn Products, Inc. · HEX · Jun 12, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K122973
• Device Name: AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
• Applicant: Medgyn Products, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Jun 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctor's offices.

Device Story

Active, non-contact digital colposcope; utilizes 1/4" HAD CCD camera to capture magnified video of vaginal, cervical, and external genital tissues. System includes floor stand (or swing-arm for AL-106SA), LED light source, and signal conversion box. Connects to external monitor via composite or S-video cable for real-time viewing. Operated by physicians/trained personnel in hospitals/clinics. Features include auto/manual focus, digital/optical magnification (up to 40x), green filter, and image freeze. Enables clinician to explain findings to patients during examination; facilitates biopsy site selection. Benefits include enhanced visualization of tissue abnormalities compared to traditional optical colposcopes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and optical performance standards (ISO 8600-3, ISO 8600-5).

Technological Characteristics

1/4" HAD CCD digital video camera; double circular LED light source; 3-grade green filter. Magnification: 1-40x (AL-106/SA) or 1-32x (AL-106B). Connectivity: S-video/composite output to external monitor. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5. Features: auto/manual focus, image freeze, magnification/acetic acid reaction timer.

Indications for Use

Indicated for magnified visualization of vaginal, cervical, and external genital tissues to assist clinicians in diagnosing abnormalities (e.g., lesions, cancer) and selecting biopsy sites. Intended for use in clinical settings by qualified personnel.

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

• Goldway Digital Video Colposcope Imaging System, model number SLC-2000 (K021153)

Submission Summary (Full Text)

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K122973 Page 1 of 4

510(k) Summary # K122973 MedGyn Products, Inc.

#### 510(k) Summary

## JUN 1 2 2013

#### 1. Submitter's Identification:

MedGyn Products, Inc. 100 W. Industrial Road Addison, IL 60101 Phone: [phone] Fax: [phone] Attn: Lakshman Agadi, President

#### Attorney Contact:

Intellectual Property Law Group LLP 12 South First Street, 12th Floor San Jose, CA 95113 Phone: [phone] Fax: [phone] Attn: Stephanie Blair, Attorney

#### Date Summary Prepared: June 10, 2013

#### 2. Name of Device.

Device Name:

AL-106, AL-106SA and AL-106B MedGyn Digital Video Colposcope

Trade/ Proprietary Name: AL-106, AL-106SA and AL-106B MedGyn Digital Video Colposcope

Common Name:

Colposcope

Classification:

Class II 21 CFR884.1630 Colposcope 85HEX

#### 3. Predicate Device Information

Identification of Legally Marketed Device with Which We Claim Substantial Equivalence (Predicate Device):

The Goldway Digital Video Colposcope Imaging System, model number SLC-2000, manufactured by Goldway, 510(k) number: K021153.

Note that the Goldway Digital Video Colposcope Imaging System included an LCD screen for viewing the images from the colposcope, but the MedGyn Digital Video Colposcope does not include a monitor.

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#### 4. Device Description

#### a. Executive Summary:

The MedGyn Digital Video Colposcope, models AL-106, AL-106SA and AL-106B (collectively, the "MedGyn Colposcope"), has the same application as traditional colposcopes. However, while traditional optical colposcopes use binocular eyepieces for magnification, the MedGyn Colposcope uses electronic imaging technology to assist doctors in reviewing, checking, analyzing, and diagnosing abnormalities or lesions of the vulva, vagina, cervix and external genitalia. It is designed to be used in hospitals, doctors' offices and clinics by qualified or trained personnel.

The MedGyn Colposcope is an active, non-contact examination device. It uses a HAD CCD color digital video camera with a digital magnification of up to 40x (or only 32x for model AL-106B), a field of view of 52° at 1x and 2° at 32X, and a green filtered light source. The camera is attached to a floor stand; model AL-106SA has a swing-arm floor stand. A cable coming from the bottom of the floor stand connects to the signal conversion box. The customer then uses the composite video cable or the s-video cable to connect a commercially available monitor to the conversion signal box.

Tissue is magnified and viewed on the doctor's own computer monitor (not included with device). Both the doctor and the patient can observe the monitor's screen, thus helping the doctor explain the abnormalities and the suggested treatments to the patient, and allowing patient to see the abnormalities for herself and better understand her medical situation.

#### b. Technical Description:

The MedGyn Colposcope has the following technical features:

- . 1/4" HAD CCD digital video camera
- Fast auto focus, and manual focus .
- Digital Magnification 1~40x (For AL-106B model, digital magnification is 1~32x) .
- Optical Magnification 1~36x (For AL-106B model, optical magnification is 1~18x) ●
- . Double circular LED group light source
- 3 grade green filter function .
- . S-video output
- . Image freeze control
- Field of View (at a working distance of 200mm) .
- o At 1X >= 195mm (52°)
- o At 32X >= 6.978mm (20)
- . Depth of view: 5mm~120mm
- Magnification and acetic acid reaction timing display .
- . Multi-function button control which allows for direct and convenient control of operations such as magnification, zoom, focus, freeze and green filter.

#### 5. Intended Use:

MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video

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510(k) Summary # K122973 MedGyn Products, Inc.

> Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctors' offices.

### 6. Comparison to Predicate Device:

Both the predicate device, the Goldway SLC-2000 Digital Video Colposcope Imaging System, and the MedGyn Colposcope have the same intended use, which is to provide an imaging system that facilitates direct viewing and imaging of the tissues of the vagina, cervix and external genitalia.

The MedGyn Colposcope is very similar to the predicate device, with only slight differences in the CCD chip, resolution, illumination, focal length, depth of view and field of view. The MedGyn Colposcope allows for a wider direction of view and a higher optical magnification than Goldway's colposcope. Both colposcopes use LED light and a green filter, and are configured to provide the necessary working distance and magnification for patient observation.

The Goldway and MedGyn devices are both self-contained, stand-alone units incorporating light, power and video into a compact system. Both devices are offered with similar floor stands, but MedGyn also offers a swing-arm stand (model AL-106SA). However, note that the Goldway Digital Video Colposcope Imaging System included an LCD screen for viewing the images from the colposcope, but the MedGyn Digital Video Colposcope does not include a monitor.

#### 7. Discussion of Non-Clinical Tests Performed:

The following voluntary Performance Standards were met:

- . IEC60601-1:1988 + A1:1001 + A2: 1995 (MEDICAL ELECTRICAL EQUIPMENT PART : GENERAL REQUIREMENTS FOR SAFETY)
- IEC60601-1-1:2000 (MEDICAL ELECTRICAL EQUIPMENT PART 1-1: GENERAL . REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS)
- IEC60601-1-2:2007 (MEDICAL ELECTRICAL EQUIPMENT PART I-2: GENERAL . REQUIREMENTS FOR SAFETY -COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY-REQUIREMENTS AND TESTS)
- ISO 8600-3:1997 (MEDICAL ENDOSCOPES AND ENDOSCOPIC ACCESSORIES --. PART 3: DETERMINATION OF FIELD OF VIEW AND DIRECTION OF VIEW OF ENDOSCOPES WITH OPTICS)
- . ISO 8600-5:2005 (MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES --PART 5: DETERMINATION OF OPTICAL RESOLUTION OF RIGID ENDOSCOPES WITH OPTICS)

#### Resolution Information:

MedGyn's Digital Video Colposcopes have the following resolution:

- On-Axis Resolution: i = = = = = = = 11.31 line-pairs/mm ।
- 0.02534 degrees On-Axis Angular Resolution: ।

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510(k) Summary # K 122973 MedGyn Products, Inc.

Distortion Information (note - a geometrical distortion of ≤ 3% is acceptable):

- AL-106B = +1% ..
- AL-106 & AL-106SA = +2.49% -

Thermal Safety Testing Information:

- After working continuously for 30 minutes, from a distance of 200mm, the temperature of the test surface rose by only 0.20 Celsius.
#### 8. Discussion of Clinical Tests Performed:

Not Applicable.

#### 9. Conclusion

The MedGyn Colposcope has equivalent indications for use and principals of operation as compared to the predicate device. The differing features of the MedGyn Colposcope do not affect the use, safety or effectiveness of the device. The MedGyn Colposcope is substantially equivalent to the Goldway Digital Video Colposcope Imaging System.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2013

MedGyn Products, Inc. % Ms. Stephanie Blair Attorney Intellectual Property Law Group, LLP 12 South First Street, 12th Floor SAN JOSE CA 95113

Re: K122973

Trade/Device Name: AL-106, AL-106SA, AL-106B MedGyn Digital Video Colposcope Regulation Number: 21 CFR\$ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: May 23, 2013 Received: May 29, 2013

Dear Ms. Blair:

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. 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 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 (reporting of

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Page 2 - Ms. Stephanie Blair

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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):

Device Name: AL-106, AL-106SA, AL-106B MedGyn Digital Video Colposcope

Indications For Use:

MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctor's offices.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert | Parner -S

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(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122973 510(k) Number