COLPO-MASTER

K073053 · United Products & Instruments, Inc. · HEX · Nov 15, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K073053
• Device Name: COLPO-MASTER
• Applicant: United Products & Instruments, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The UNICO Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.

Device Story

The Colpo-Master is a colposcope used by physicians for direct magnified visualization of the cervix, vagina, and external genitalia. The device consists of a microscope head, a stand, and an illuminator. It functions as a telescope, with the microscope head positioned at a distance of more than 300mm from the patient to provide magnification for the identification of abnormalities and biopsy site selection. The device is intended for clinical use.

Clinical Evidence

No clinical data; bench testing only. The device was tested to verify specifications and compliance with IEC 601-1-2.

Technological Characteristics

Optical colposcope consisting of a microscope head, stand, and illuminator. Materials include optical glass, brass, steel, and aluminum. Operates as a telescope with a working distance >300mm. Complies with IEC 601-1-2.

Indications for Use

Indicated for direct magnified viewing of the cervix, vagina, and external genitalia in patients to diagnose abnormalities and select areas for biopsy. Prescription use only.

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

• Wallach Zoom (K853389)
• Intermed Zoom (K031639)
• Welch-Allyn (K955635)

Submission Summary (Full Text)

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K07-3053
page 1 of 2

United Products and Instruments Inc. "UNICO"

> 510(k) submission Colpo-Master Colposcope

NOV 1 5 2007

510(k) Summary

(1) Submitter Information

Name: United Products and Instruments Inc. ("UNICO")

Address:

United Products and Instruments Inc. 182 E. Ridge Road Dayton, NJ 08810

Tclephone Number: 732-274-1155

Contact Person:

Dr. George Myers Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: June 21, 2007

(2) Name of Device

Trade Namc: Colpo-Master Common Name: Colposcope Classification name: Colposcope

(3) Equivalent legally-marketed devices.

1. Wallach Zoom K853389

2. Intermed Zoom K031639

3. Welch-Allyn K955635

(4) Description

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K07-3053 page 2 of 2

The Colposcope consists of three main assemblies: Microscope head and lens; Stand; and Illuminator. . The microssope 200m head magnifies the arca of the human body to be observed by a physician. It works like a "tclcscope" and the closest point is more than 300mm away from the body part. The microscope head and lens are made of optical glass, brass, stecl, and aluminum.

## (5) Intended Use

The UNICO Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.

## (6) Performance Data

## (a) Non-clinical tests

The Colpo-Master meets the requirements of IEC 601-1-2. The Colpo-Master has been tested to verify its specifications/

## (b) Clinical tests

Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices.

## 7) Conclusions

The Colpo-Master is equivalent in safety and efficacy to the legally-marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 5 2007

United Products and Instruments Inc. c/o Mr. Jason Launders CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462

Re: K073053

Trade/Device Name: UNICO Colpo-Master Colposope Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: October 29, 2007 Received: October 30, 2007

Dear Mr. Launders:

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 cnactment 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.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 Rederal Register,

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. E rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# Indications for Use

510(k) Number (if known):

Device Name: _UNICQ Colpo-Master Colposcope

Indications for Use:

. The UNICO Colpo-Master Colposcope is indicated for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helus Lemon

(Division Sign-Off) (Division of Reproductive, Abdominal and
Radiological Devices Radiological Devices 510(k) Number