(87 days)
Not Found
No
The description focuses on optical and mechanical components (stereo zoom microscope, light source, stand) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training/test sets typically associated with AI/ML development.
No
Explanation: The device is intended for diagnostic purposes (viewing and selecting areas for biopsy) and does not provide therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is for "the purpose of diagnosing abnormalities and selecting areas for biopsy." This explicitly indicates a diagnostic purpose.
No
The device description explicitly states it consists of a stereo zoom microscope, mobile floor stand, and halogen light source, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Intermed Zoom Colposcope is used for direct magnified viewing of anatomical sites (cervix, vagina, external genitalia). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "direct magnified viewing... for the purpose of diagnosing abnormalities and selecting areas for biopsy." This is a visual examination, not an in vitro test.
The device is a medical device used for visual examination and diagnosis, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, 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 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.
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.
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
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.
1
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.
2
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.
3
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
4
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)