(16 days)
Not Found
No
The device description and intended use describe a standard optical colposcope for magnified viewing, with no mention of AI/ML features, image processing, or data analysis capabilities typically associated with AI/ML medical devices.
No
The device is described as a colposcope used for direct magnified viewing for diagnosis and selecting biopsy areas, but not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "the purpose of diagnosing abnormalities and selecting areas for biopsy."
No
The device description clearly outlines physical hardware components (Microscope head and lens, Stand, and Illuminator) made of materials like optical glass, brass, steel, and aluminum. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy." This describes a visual examination of the body, not a test performed on samples taken from the body.
- Device Description: The description details a colposcope, which is an optical instrument used for visual examination. It explicitly states it "magnifies the area of the human body to be observed by a physician."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), reagents, or any other components typically associated with in vitro diagnostic tests.
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. This device is used for direct visual examination of the human body.
N/A
Intended Use / Indications for Use
The UNICO Colpo-Master 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.
Product codes (comma separated list FDA assigned to the subject device)
HEX
Device Description
The Colposcope consists of three main assemblies: Microscope head and lens; Stand; and Illuminator. The microssope zoom 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The Colpo-Master meets the requirements of IEC 601-1-2. The Colpo-Master has been tested to verify its specifications.
Clinical tests: Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Wallach Zoom K853389, Intermed Zoom K031639, Welch-Allyn K955635
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 201-727-1703 Fax 201-727-1708
Date Prepared: June 21, 2007
(2) Name of Device
Trade Namc: Colpo-Master Common Name: Colposcope Classification name: Colposcope
(3) Equivalent legally-marketed devices.
(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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a bird in flight or a stylized representation of a human figure.
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,
3
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 (800) 638-2041 or (240) 276-3150 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
4
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