(87 days)
The Intermed Zoom 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.
The Intermed Zoom Colposcope consists of a stereo zoom microscope mounted to a mobile floor stand. A halogen light source with an integrated green filter is also mounted to the stand providing subject illumination.
The provided 510(k) summary for the Intermed Zoom Colposcope (K031639) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or technical study using a test set with established ground truth.
Instead, this 510(k) relies on a demonstration of substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a device already legally marketed, based on technological similarities, rather than presenting novel performance data from a new study.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable in the context of this 510(k) submission.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not specify quantitative acceptance criteria or report specific performance metrics for the Intermed Zoom Colposcope. Instead, it states: "Non-clinical testing has demonstrated that any differences in technological characteristics, does not adversely affect the intended use, performance, or safety of the device." This implies the "acceptance criteria" were met by demonstrating that the device functions comparably to predicate devices in terms of its intended use.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The submission does not describe a test set or a study with performance data. The "non-clinical testing" mentioned is not detailed, but generally, for substantial equivalence, it would involve internal engineering verification and validation, not a formal clinical test set with human subjects and ground truth for performance evaluation in the way a new AI/diagnostic device would be studied.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC study was not done. This submission focuses on technological equivalence, not comparative effectiveness with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a colposcope, a medical instrument operated by a human, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable. No ground truth is described in the context of device performance evaluation in the provided summary. The "purpose of diagnosing abnormalities and selecting areas for biopsy" refers to the intended clinical use by a medical professional, not a ground truth for evaluating the device itself.
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware medical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is described.
Summary of the basis for device acceptance:
The Intermed Zoom Colposcope's acceptance, as indicated by the 510(k) clearance (K031639), is based on substantial equivalence to legally marketed predicate devices: Accuscope (K913365), Wallach Zoom Colposcope (K853389), and LM1Z Zoom Scope (K902313).
The submission states:
- Technological Similarity: The Intermed Zoom Colposcope utilizes "technologically similar, commercially available optical systems configured in a like manner" and "technologically similar 150watt halogen light sources with integrated green filters" compared to the predicate devices.
- Non-clinical Testing: "Non-clinical testing has demonstrated that any differences in technological characteristics, does not adversely affect the intended use, performance, or safety of the device." This implies that internal tests confirmed the device's basic functionality and safety were comparable.
- Intended Use: The intended use is identical to the predicate devices: "direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy."
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the analysis of technological characteristics and intended use compared to predicate devices, and the conclusion that any differences do not negatively impact safety or effectiveness. This is a common pathway for medical device clearance when a new device is very similar in design and function to existing ones.
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K031639
page 1 of 2
510(k) Summary
1. Submitter
Intermed Group, Inc. 3550 23rd Ave. S. Ste. 1 Lake Worth, FL 33461
Tel: 561.586.3667 Fax: 561.588.5030
Contact: George Garamy, Jr. Vice President, Intermed Group, Inc.
Date Prepared: May 12, 2003
2. Device Name
Proprietary Name: Intermed Zoom Colposcope Common Name: Colposcope Classification Name: Colposcope (per 21CFR section 884.1630), Class II, 85 HEX
3. Marketed Devices to Which Equivalence is Claimed
| Device | Manufacturer | 510(K) |
|---|---|---|
| Accuscope | Vineland Medical Products | K913365 |
| Wallach Zoom Colposcope | Wallach Surgical Devices | K853389 |
| LM1Z Zoom Scope | Leisegang Medical | K902313 |
4. Device Description
The Intermed Zoom Colposcope consists of a stereo zoom microscope mounted to a mobile floor stand. A halogen light source with an integrated green filter is also mounted to the stand providing subject illumination.
5. Intended Use
The Intermed Zoom 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.
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K031639
Page 2 of 2
510(k) Summary
Comparison with Predicate Devices 6.
The Intermed Zoom Colposcope, Accuscope(K913365), Wallach Zoom Colposcope(K853389) and LM1Z Zoom Scope(K902313) are intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.
The Intermed Zoom Colposcope and all of the aforementioned predicate devices utilize technologically similar, commercially available optical systems configured in a like manner in order provide the necessary working distance and magnification for patient observation. In addition, all devices utilize technologically similar 150watt halogen light sources with integrated green filters for subject illumination.
The "Table of Comparison with Predicate Devices" (pg F.1), demonstrates that the technological characteristics of the Intermed Zoom Colposcope and predicate devices are virtually the same. Non-clinical testing has demonstrated that any differences in technological characteristics, does not adversely affect the intended use, performance, or safety of the device. Therefore, the Intermed Zoom Colposcope is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." written around the top half of the circle. Inside the circle is a stylized image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2003
Mr. George Garamy, Jr. Vice President Intermed Group, Inc. 3550 23td Ave. S. Ste. 1 LAKE WORTH FL 33461 Re: K031639
Trade/Device Name: Intermed Zoom Colposcope Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: 85 HEX Dated: May 12, 2003 Received: May 27, 2003
Dear Mr. Garamy:
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.
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); 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.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K031639
Device Name: Intermed Zoom Colposcope
Indications for Use:
The Intermed Zoom 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Lygum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use J L (Per 21 CFR 801.109)
§ 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.