(16 days)
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
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.
Here's an analysis of the provided text regarding the UNICO Colpo-Master Colposcope's acceptance criteria and studies:
Based on the provided document, the UNICO Colpo-Master Colposcope's submission states: "Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices." This explicitly indicates that no dedicated clinical study was performed for this device to prove its performance against acceptance criteria in the typical sense of a novel device. Instead, the justification for market clearance relied on substantial equivalence to existing legally marketed predicate devices.
Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not available or applicable from this document as no such study was conducted for the Colpo-Master itself.
However, we can infer some information based on the overall context of a 510(k) submission for a device deemed substantially equivalent.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
Since direct clinical performance data for the UNICO Colpo-Master is explicitly stated as "not necessary," the acceptance criteria for this device are implicitly tied to demonstrating that it performs as safely and effectively as its predicate devices. The "reported device performance" would therefore be the assertion that it meets these implied criteria by sharing the same technology and intended use.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (UNICO Colpo-Master) |
|---|---|
| Magnification of target area | Functions like a "telescope," closest point >300mm away (optical components mentioned) |
| Ability to view cervix, vagina, external genitalia | Intended for direct magnified viewing of these areas |
| Aid in diagnosing abnormalities | Intended for diagnosing abnormalities |
| Aid in selecting areas for biopsy | Intended for selecting areas for biopsy |
| Safety (Electrical, Mechanical) | Meets IEC 601-1-2 requirements; specifications verified through non-clinical tests |
Study Information (Based on Substantial Equivalence)
-
Sample size used for the test set and the data provenance:
- Not Applicable. No dedicated clinical test set was used for the UNICO Colpo-Master. Its performance relies on the established performance of its predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set was created or evaluated by experts for this specific device.
-
Adjudication method for the test set:
- Not Applicable.
-
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. No MRMC study was performed as no clinical study was deemed necessary for this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an optical medical device, not an AI or algorithm-based device.
-
The type of ground truth used:
- Not Applicable for the UNICO Colpo-Master itself. For the predicate devices whose performance is implicitly referenced, the ground truth for diagnosing abnormalities and selecting biopsies would typically involve a combination of expert pathological examination of biopsies (histopathology) and clinical expert consensus or follow-up.
-
The sample size for the training set:
- Not Applicable. This device did not involve AI or machine learning that would require a training set.
-
How the ground truth for the training set was established:
- Not Applicable.
Summary of the UNICO Colpo-Master's Justification:
The UNICO Colpo-Master Colposcope received 510(k) clearance based on its substantial equivalence to existing predicate devices (Wallach Zoom K853389, Intermed Zoom K031639, Welch-Allyn K955635). The manufacturer stated that "Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices." This means the device met its implied acceptance criteria by demonstrating that its design, technology, and intended use were fundamentally the same as devices already cleared for market, and it met relevant non-clinical safety standards (IEC 601-1-2). No new clinical studies were conducted to explicitly measure performance against novel acceptance criteria.
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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 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.
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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,
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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 (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
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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
§ 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.